xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05964335</url>
    </required_header>
    <id_info>
      <org_study_id>NAL03-202</org_study_id>
      <nct_id>NCT05964335</nct_id>
    </id_info>
    <brief_title>Cough Reduction in IPF With Nalbuphine ER</brief_title>
    <acronym>CORAL</acronym>
    <official_title>A Randomized, Double-Blind, Placebo-Controlled, Parallel, 4-Arm Dose Ranging Study of the Safety and Efficacy of Nalbuphine Extended-Release Tablets (NAL ER) for the Treatment of Cough in Idiopathic Pulmonary Fibrosis (IPF)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Trevi Therapeutics</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Trevi Therapeutics</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This is a multi-center randomized, double-blind, placebo-controlled, parallel, 4-arm study of&#xD;
        nalbuphine ER (NAL ER).&#xD;
  &#xD;
        After meeting eligibility during the Screening Period, subjects will be randomized (1:1:1:1)&#xD;
        to one of four treatment arms.&#xD;
  &#xD;
          -  Arm 1: Placebo&#xD;
  &#xD;
          -  Arm 2: 27 mg nalbuphine ER&#xD;
  &#xD;
          -  Arm 3: 54 mg nalbuphine ER&#xD;
  &#xD;
          -  Arm 4: 108 mg nalbuphine ER&#xD;
  &#xD;
        Each arm will be titrated to their fixed dose during the blinded 2-week Titration period&#xD;
        followed by the 4-week Fixed Dose Period for a total of 6 weeks on drug.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This is a multi-center randomized, double-blind, placebo-controlled, parallel, 4-arm study.&#xD;
  &#xD;
        After meeting eligibility during the Screening Period, subjects will be randomized (1:1:1:1)&#xD;
        to one of four treatment arms.&#xD;
  &#xD;
          -  Arm 1: Placebo&#xD;
  &#xD;
          -  Arm 2: 27 mg nalbuphine ER&#xD;
  &#xD;
          -  Arm 3: 54 mg nalbuphine ER&#xD;
  &#xD;
          -  Arm 4: 108 mg nalbuphine ER&#xD;
  &#xD;
        Each arm will be titrated to their fixed dose during the blinded 2-week Titration period&#xD;
        according to Table: Dosing Scheme, followed by the 4-week Fixed Dose Period for a total of 6&#xD;
        weeks on drug.&#xD;
  &#xD;
        Subjects will be taken off study drug at the end of the Fixed Dose Period and followed off&#xD;
        treatment for an additional 2 weeks.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 1, 2023</start_date>
    <completion_date type="Anticipated">October 14, 2024</completion_date>
    <primary_completion_date type="Anticipated">October 1, 2024</primary_completion_date>
    <phase>Phase 2</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Double (Participant, Investigator)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Effect of NAL ER on 24-hour cough frequency (coughs per hour)</measure>
      <time_frame>Week 6</time_frame>
      <description>Relative change from Baseline in 24-hour cough frequency versus placebo</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Effect of NAL ER on the EXAcerbation of Chronic pulmonary disease Tool</measure>
      <time_frame>Week 6</time_frame>
      <description>Relative change from Baseline in the EXACT© question 2 at Week 6 versus placebo</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Safety and tolerability of NAL ER</measure>
      <time_frame>Screening through 14 day post last dose</time_frame>
      <description>Adverse event, vitals signs, ECGs, clinical laboratory tests, spirometry, physical examinations, Subjective Opiate Withdrawal Scale (SOWS)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>24-hour cough frequency (Coughs per hour)</measure>
      <time_frame>Weeks 2, 4, 6</time_frame>
      <description>Relative change from Baseline in 24-hour cough frequency (coughs per hour) versus placebo&#xD;
  • Proportion of responders with ≥30%, ≥50% and ≥75% reduction in the 24-hour cough frequency at Week 2, 4, and 6, for NAL ER compared with placebo.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Awake cough frequency (Coughs per hour)</measure>
      <time_frame>Weeks 2, 4, 6</time_frame>
      <description>Relative change from Baseline in awake cough frequency (coughs per hour) versus placebo.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Sleep cough frequency (Coughs per hour)</measure>
      <time_frame>Weeks 2, 4, 6</time_frame>
      <description>Relative change from Baseline in sleep cough frequency (coughs per hour) at versus placebo.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>EXACT© (EXAcerbation of Chronic pulmonary disease Tool) (EXAcerbation of Chronic pulmonary disease Tool)</measure>
      <time_frame>Weeks 1, 2, 3, 4, 5, 6</time_frame>
      <description>Change from Baseline in the EXACT© question 2 compared with placebo. Proportion of EXACT© question 2 responders, with response defined as at least a one category improvement versus placebo. Change from Baseline in the EXACT© sub-domains and individual items versus placebo.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>CS-NRS (Cough Severity Numerical Rating Scale)</measure>
      <time_frame>Weeks 1, 2, 3, 4, 5, 6</time_frame>
      <description>Change from Baseline in the CS-NRS versus placebo.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>LCQ© (Leicester Cough Questionnaire)</measure>
      <time_frame>Week 6</time_frame>
      <description>Change from Baseline in the LCQ© total score versus placebo. Proportion of LCQ© responders, with response defined as 1.3-point increase versus placebo</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>L-IPF© (Living with Pulmonary Fibrosis Impacts Questionnaire)</measure>
      <time_frame>Week 6</time_frame>
      <description>Change from Baseline in the L-IPF© versus placebo.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>L-IPF© (Living with Pulmonary Fibrosis Symptoms Questionnaire)</measure>
      <time_frame>Week 6</time_frame>
      <description>Change from Baseline in the L-IPF© versus placebo.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>EQ-5D-5L™</measure>
      <time_frame>Week 6</time_frame>
      <description>Change from Baseline in the EQ-5D-5L™ versus placebo.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>PGI-S Cough (Patient Global Impression of Severity for Cough)</measure>
      <time_frame>Weeks 2, 4, 6</time_frame>
      <description>1 item measure rating the severity of cough past 7 days from No cough, Mild, Moderate or Severe</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>PGI-S IPF (Patient Global Impression of Severity and Change for IPF)</measure>
      <time_frame>Weeks 2, 4, 6</time_frame>
      <description>1 item measure rating the symptoms of IPF past 7 days from No symptoms, Mild, Moderate or Severe</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>CGI-S, (Clinicians Global Impression of Severity)</measure>
      <time_frame>Baseline and Week 6</time_frame>
      <description>A one-item measure evaluating severity of the condition. No Symptoms Mild Moderate Severe</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>PGI-C Cough; (Patient Global Impression of Change for Cough)</measure>
      <time_frame>Weeks 2, 4, 6</time_frame>
      <description>1 item measure rating the symptoms of IPF. (past 7 days)&#xD;
  Much better&#xD;
  Moderately better&#xD;
  A little better&#xD;
  No change&#xD;
  A little worse&#xD;
  Moderately worse&#xD;
  Much worse</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>PGI-C IPF (Patient Global Impression of Change in IPF symptoms)</measure>
      <time_frame>Weeks 2, 4, 6</time_frame>
      <description>1 item measure rating the symptoms of IPF. (Past 7 days)&#xD;
  Much better&#xD;
  Moderately better&#xD;
  A little better&#xD;
  No change&#xD;
  A little worse&#xD;
  Moderately worse&#xD;
  Much worse</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>CGI-C</measure>
      <time_frame>Week 6</time_frame>
      <description>A one-item measure evaluating change from the initiation of treatment on a seven point scale.&#xD;
  = Very much improved&#xD;
  = Much improved&#xD;
  = Minimally improved&#xD;
  = No change&#xD;
  = Minimally worse&#xD;
  = Much worse&#xD;
  = Very much worse</description>
    </secondary_outcome>
    <number_of_arms>4</number_of_arms>
    <enrollment type="Anticipated">160</enrollment>
    <condition>Idiopathic Pulmonary Fibrosis</condition>
    <arm_group>
      <arm_group_label>NAL ER 27 mg</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>BID</description>
    </arm_group>
    <arm_group>
      <arm_group_label>NAL ER 54 mg</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>BID</description>
    </arm_group>
    <arm_group>
      <arm_group_label>NAL ER 108 mg</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>BID</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Placebo</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Placebo, tablets BID</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>nalbuphine ER 27 mg</intervention_name>
      <description>Oral tablets</description>
      <arm_group_label>NAL ER 27 mg</arm_group_label>
      <other_name>Active</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Placebo</intervention_name>
      <description>Oral tablets</description>
      <arm_group_label>Placebo</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>nalbuphine ER 54 mg</intervention_name>
      <description>Oral Tablets</description>
      <arm_group_label>NAL ER 54 mg</arm_group_label>
      <other_name>Active</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>nalbuphine ER 108 mg</intervention_name>
      <description>Oral tablets</description>
      <arm_group_label>NAL ER 108 mg</arm_group_label>
      <other_name>Active</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Diagnosis of IPF as determined by the Principal Investigator based on ATS/ERS/JRS/ALAT&#xD;
               guidelines.&#xD;
  &#xD;
            -  Cough Severity Score ≥ 4 on CS-NRS (Cough Severity Numerical Rating Scale) during the&#xD;
               Screening period and Baseline.&#xD;
  &#xD;
            -  History of chronic cough for at least 8 weeks before screening.&#xD;
  &#xD;
            -  SpO2 ≥ 92%, taken after at least 5 minutes in a sitting position, undisturbed and&#xD;
               non-stimulated (Saturation of Hemoglobin with Oxygen as Measured by Pulse Oximetry).&#xD;
  &#xD;
            -  FVC ≥ 40% predicted of normal - Forced Vital Capacity, as determined by spirometry&#xD;
               adhering to ATS/ERS guidelines.&#xD;
  &#xD;
            -  DLCO ≥ 25% predicted of normal - Diffusing capacity of the lung for carbon monoxide&#xD;
               corrected for hemoglobin, assessed within the last 12 weeks, or at the time of&#xD;
               screening.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Currently on continuous oxygen therapy for longer than 16 hours at any level or&#xD;
               delivered by any modality. Intermittent oxygen use of any duration over any given&#xD;
               24-hour period is allowed.&#xD;
  &#xD;
            -  Inadequate swallow reflex as assessed by the ability to sip 3 fluid oz (or 89 mL) of&#xD;
               water without coughing or choking.&#xD;
  &#xD;
            -  Upper or lower respiratory tract infection in the last 8 weeks prior to the baseline&#xD;
               visit.&#xD;
  &#xD;
            -  Clinical history of aspiration pneumonitis.&#xD;
  &#xD;
            -  Diagnosis of sleep apnea.&#xD;
  &#xD;
            -  Abnormal kidney or liver functions based on Screening lab results.&#xD;
  &#xD;
            -  Known hypersensitivity to nalbuphine or to NAL ER excipients&#xD;
  &#xD;
            -  History of major psychiatric disorder.&#xD;
  &#xD;
            -  History of substance abuse.&#xD;
  &#xD;
            -  Significant medical condition or other factors that may interfere with the subject's&#xD;
               ability to successfully complete the study.&#xD;
  &#xD;
            -  Pregnant or lactating female subject.&#xD;
  &#xD;
            -  Known intolerance (gastrointestinal, central nervous system symptoms),&#xD;
               hypersensitivity, drug allergy following the use of an opioid drug.&#xD;
  &#xD;
            -  Use of opiates is prohibited within 14 days prior to the baseline visit.&#xD;
  &#xD;
            -  Use of benzodiazepines are prohibited within 14 days prior to the baseline visit and&#xD;
               for the duration of the study.&#xD;
  &#xD;
            -  Monoamine oxidase inhibitors (MAOIs) including methylene blue (methylthioninium&#xD;
               chloride) and the antibiotic linezolid are prohibited within 14 days prior to the&#xD;
               baseline visit and for the duration of the study.&#xD;
  &#xD;
            -  Use of oral corticosteroid cough treatment is prohibited within 4 weeks prior to the&#xD;
               baseline visit and for the duration of the study.&#xD;
  &#xD;
            -  Exposure to any investigational medication, including placebo, is prohibited within 4&#xD;
               weeks prior to the baseline visit and for the duration of the study.&#xD;
  &#xD;
            -  Medications prescribed as cough suppressants are prohibited unless on a stable dose&#xD;
               14-days prior to the baseline visit and are expected to remain on that dose for the&#xD;
               duration of the study.&#xD;
  &#xD;
            -  Use of medications that affect serotonergic neurotransmission and that when used&#xD;
               concomitantly with opioids can increase the risk of serotonin syndrome are prohibited&#xD;
               unless on a stable dose 14-days prior to the baseline visit and are expected to remain&#xD;
               on that dose for the duration of the study.&#xD;
  &#xD;
            -  Anti-fibrotic medications are prohibited unless on a stable dose for 8 weeks prior to&#xD;
               the baseline visit and are expected to remain on that dose for the duration of the&#xD;
               study.&#xD;
  &#xD;
            -  Strong inhibitors/inducers of the P450 Isozymes are prohibited unless on a stable dose&#xD;
               for 14-days prior to baseline visit and are expected to remain on that dose for the&#xD;
               duration of the study.&#xD;
  &#xD;
            -  Use of a medication having a &quot;known risk&quot; of Torsade de Pointes (categorized as &quot;KR&quot;&#xD;
               on the Credible Meds® website.) 4 weeks prior to Baseline.&#xD;
  &#xD;
            -  Use of unstable doses of medications associated with a potential risk of QT&#xD;
               prolongation but not clearly associated with Torsade de Pointes within 4 weeks of&#xD;
               screening.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>David Clark, MD</last_name>
      <role>Study Director</role>
      <affiliation>Trevi Therapeutics</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Beata Dworakowska</last_name>
      <phone>203-654-3284</phone>
      <email>Beata.Dworakowska@trevitherapeutics.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Catherine Weenink</last_name>
      <phone>203-684-2560</phone>
      <email>Catherine.Weenink@trevitherapeutics.com</email>
    </overall_contact_backup>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 7, 2023</study_first_submitted>
    <study_first_submitted_qc>July 19, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 27, 2023</study_first_posted>
    <last_update_submitted>September 5, 2023</last_update_submitted>
    <last_update_submitted_qc>September 5, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Cough</keyword>
    <keyword>Nalbuphine</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Pulmonary Fibrosis</mesh_term>
      <mesh_term>Idiopathic Pulmonary Fibrosis</mesh_term>
      <mesh_term>Fibrosis</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Nalbuphine</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05964335
  org study id: NAL03-202
  nct id: NCT05964335
  lead sponsor: 
  has dmc: No
  is fda regulated drug: Yes
  is fda regulated device: No
  This is a multi-center randomized, double-blind, placebo-controlled, parallel, 4-arm study of
        nalbuphine ER (NAL ER).
  
        After meeting eligibility during the Screening Period, subjects will be randomized (1:1:1:1)
        to one of four treatment arms.
  
          -  Arm 1: Placebo
  
          -  Arm 2: 27 mg nalbuphine ER
  
          -  Arm 3: 54 mg nalbuphine ER
  
          -  Arm 4: 108 mg nalbuphine ER
  
        Each arm will be titrated to their fixed dose during the blinded 2-week Titration period
        followed by the 4-week Fixed Dose Period for a total of 6 weeks on drug.
  This is a multi-center randomized, double-blind, placebo-controlled, parallel, 4-arm study.
  
        After meeting eligibility during the Screening Period, subjects will be randomized (1:1:1:1)
        to one of four treatment arms.
  
          -  Arm 1: Placebo
  
          -  Arm 2: 27 mg nalbuphine ER
  
          -  Arm 3: 54 mg nalbuphine ER
  
          -  Arm 4: 108 mg nalbuphine ER
  
        Each arm will be titrated to their fixed dose during the blinded 2-week Titration period
        according to Table: Dosing Scheme, followed by the 4-week Fixed Dose Period for a total of 6
        weeks on drug.
  
        Subjects will be taken off study drug at the end of the Fixed Dose Period and followed off
        treatment for an additional 2 weeks.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Double (Participant, Investigator)
  measure: Effect of NAL ER on 24-hour cough frequency (coughs per hour)
  time frame: Week 6
  description: Relative change from Baseline in 24-hour cough frequency versus placebo
  measure: Effect of NAL ER on the EXAcerbation of Chronic pulmonary disease Tool
  time frame: Week 6
  description: Relative change from Baseline in the EXACT© question 2 at Week 6 versus placebo
  measure: Safety and tolerability of NAL ER
  time frame: Screening through 14 day post last dose
  description: Adverse event, vitals signs, ECGs, clinical laboratory tests, spirometry, physical examinations, Subjective Opiate Withdrawal Scale (SOWS)
  measure: 24-hour cough frequency (Coughs per hour)
  time frame: Weeks 2, 4, 6
  description: Relative change from Baseline in 24-hour cough frequency (coughs per hour) versus placebo
  • Proportion of responders with ≥30%, ≥50% and ≥75% reduction in the 24-hour cough frequency at Week 2, 4, and 6, for NAL ER compared with placebo.
  measure: Awake cough frequency (Coughs per hour)
  time frame: Weeks 2, 4, 6
  description: Relative change from Baseline in awake cough frequency (coughs per hour) versus placebo.
  measure: Sleep cough frequency (Coughs per hour)
  time frame: Weeks 2, 4, 6
  description: Relative change from Baseline in sleep cough frequency (coughs per hour) at versus placebo.
  measure: EXACT© (EXAcerbation of Chronic pulmonary disease Tool) (EXAcerbation of Chronic pulmonary disease Tool)
  time frame: Weeks 1, 2, 3, 4, 5, 6
  description: Change from Baseline in the EXACT© question 2 compared with placebo. Proportion of EXACT© question 2 responders, with response defined as at least a one category improvement versus placebo. Change from Baseline in the EXACT© sub-domains and individual items versus placebo.
  measure: CS-NRS (Cough Severity Numerical Rating Scale)
  time frame: Weeks 1, 2, 3, 4, 5, 6
  description: Change from Baseline in the CS-NRS versus placebo.
  measure: LCQ© (Leicester Cough Questionnaire)
  time frame: Week 6
  description: Change from Baseline in the LCQ© total score versus placebo. Proportion of LCQ© responders, with response defined as 1.3-point increase versus placebo
  measure: L-IPF© (Living with Pulmonary Fibrosis Impacts Questionnaire)
  time frame: Week 6
  description: Change from Baseline in the L-IPF© versus placebo.
  measure: L-IPF© (Living with Pulmonary Fibrosis Symptoms Questionnaire)
  time frame: Week 6
  description: Change from Baseline in the L-IPF© versus placebo.
  measure: EQ-5D-5L™
  time frame: Week 6
  description: Change from Baseline in the EQ-5D-5L™ versus placebo.
  measure: PGI-S Cough (Patient Global Impression of Severity for Cough)
  time frame: Weeks 2, 4, 6
  description: 1 item measure rating the severity of cough past 7 days from No cough, Mild, Moderate or Severe
  measure: PGI-S IPF (Patient Global Impression of Severity and Change for IPF)
  time frame: Weeks 2, 4, 6
  description: 1 item measure rating the symptoms of IPF past 7 days from No symptoms, Mild, Moderate or Severe
  measure: CGI-S, (Clinicians Global Impression of Severity)
  time frame: Baseline and Week 6
  description: A one-item measure evaluating severity of the condition. No Symptoms Mild Moderate Severe
  measure: PGI-C Cough; (Patient Global Impression of Change for Cough)
  time frame: Weeks 2, 4, 6
  description: 1 item measure rating the symptoms of IPF. (past 7 days)
  Much better
  Moderately better
  A little better
  No change
  A little worse
  Moderately worse
  Much worse
  measure: PGI-C IPF (Patient Global Impression of Change in IPF symptoms)
  time frame: Weeks 2, 4, 6
  description: 1 item measure rating the symptoms of IPF. (Past 7 days)
  Much better
  Moderately better
  A little better
  No change
  A little worse
  Moderately worse
  Much worse
  measure: CGI-C
  time frame: Week 6
  description: A one-item measure evaluating change from the initiation of treatment on a seven point scale.
  = Very much improved
  = Much improved
  = Minimally improved
  = No change
  = Minimally worse
  = Much worse
  = Very much worse
  arm group label: NAL ER 27 mg
  arm group type: Experimental
  description: BID
  arm group label: NAL ER 54 mg
  arm group type: Experimental
  description: BID
  arm group label: NAL ER 108 mg
  arm group type: Experimental
  description: BID
  arm group label: Placebo
  arm group type: Placebo Comparator
  description: Placebo, tablets BID
  intervention type: Drug
  intervention name: nalbuphine ER 27 mg
  description: Oral tablets
  arm group label: NAL ER 27 mg
  other name: Active
  intervention type: Drug
  intervention name: Placebo
  description: Oral tablets
  arm group label: Placebo
  intervention type: Drug
  intervention name: nalbuphine ER 54 mg
  description: Oral Tablets
  arm group label: NAL ER 54 mg
  other name: Active
  intervention type: Drug
  intervention name: nalbuphine ER 108 mg
  description: Oral tablets
  arm group label: NAL ER 108 mg
  other name: Active
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: David Clark, MD
  role: Study Director
  affiliation: Trevi Therapeutics
  last name: Beata Dworakowska
  phone: 203-654-3284
  email: Beata.Dworakowska@trevitherapeutics.com
  last name: Catherine Weenink
  phone: 203-684-2560
  email: Catherine.Weenink@trevitherapeutics.com
  responsible party type: Sponsor
  mesh term: Pulmonary Fibrosis
  mesh term: Idiopathic Pulmonary Fibrosis
  mesh term: Fibrosis
  mesh term: Nalbuphine
  sharing ipd: No