<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/NCT02193620</url>
  </required_header>
  <id_info>
    <org_study_id>PH-CP025</org_study_id>
    <nct_id>NCT02193620</nct_id>
  </id_info>
  <brief_title>Study of PHN131 in Patients After Surgery</brief_title>
  <official_title>A Randomized, Double Blind, Placebo-controlled, Multiple Dose Study to Assess the Efficacy, Safety and Pharmacokinetics of Oral Nalbuphine, an Oral Soft Capsule, for Post-hemorrhoidectomy Pain Management</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>PhytoHealth Corporation</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>PhytoHealth Corporation</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to assess the effectiveness, safety and pharmacokinetics of Oral&#xD;
      Nalbuphine in the treatment of postoperative pain following hemorrhoidectomy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      • Primary Efficacy Endpoint: Pain assessment calculated as the area under the curve of VAS&#xD;
      pain intensity scores through 48 hours.&#xD;
&#xD;
      • Secondary Efficacy Endpoints:&#xD;
&#xD;
        1. Consumption of diclofenac (Day 1-2) via Intramuscular Injection (IM injection).&#xD;
&#xD;
        2. Time from the end of operation to the first IM injection diclofenac dose&#xD;
&#xD;
        3. Brief Pain Inventory (BPI).&#xD;
&#xD;
        4. Patient satisfaction.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 30, 2013</start_date>
  <completion_date type="Actual">February 13, 2019</completion_date>
  <primary_completion_date type="Actual">September 21, 2014</primary_completion_date>
  <phase>Phase 2/Phase 3</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>the area under the curve of VAS pain intensity scores</measure>
    <time_frame>at 1, 2, 3, 4±0.25, 8±0.5, 12±0.5, 16±0.5, 20±0.5, 24±1, 28±1, 32±2, 36±2, 40±2, 44±2, and 48±2 h after the surgery</time_frame>
    <description>Pain assessment calculated as the area under the curve of VAS pain intensity scores through 48 hours</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Consumption of diclofenac dose</measure>
    <time_frame>in 48 hours after surgery</time_frame>
    <description>Consumption of diclofenac (Day 1-2) via Intramuscular Injection (IM injection)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time of operation to diclofenac dose</measure>
    <time_frame>in 48 hours after surgery</time_frame>
    <description>Time from the end of operation to the first IM injection diclofenac dose</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Brief Pain Inventory (BPI)</measure>
    <time_frame>at 24h and 48h after surgery</time_frame>
    <description>Brief Pain Inventory (BPI)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient satisfaction</measure>
    <time_frame>at 48h after surgery</time_frame>
    <description>Patient satisfaction</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">106</enrollment>
  <condition>Analgesia Disorder</condition>
  <arm_group>
    <arm_group_label>Placebo group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo soft capsules</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Study group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>PHN131 soft capsule with Nalbuphine HCl 60 mg/cap</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>PHN131 soft capsule with Nalbuphine HCl 60 mg/cap</intervention_name>
    <description>Multiple dose of oral PHN131 soft capsule with Nalbuphine HCl 60 mg/cap, initial dose : 120 mg ( 2 capsules), then 60 mg (1 capsule); t.i.d.</description>
    <arm_group_label>Study group</arm_group_label>
    <other_name>PHN131</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo soft capsules</intervention_name>
    <description>Multiple dose of oral Placebo soft capsules, initial dose: 2 capsules, then 1 capsule; t.i.d.</description>
    <arm_group_label>Placebo group</arm_group_label>
    <other_name>Placebo</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dicofenac</intervention_name>
    <description>All subjects will receive diclofenac by IM injection for analgesia as rescue pain control.</description>
    <arm_group_label>Placebo group</arm_group_label>
    <arm_group_label>Study group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male or female &gt;= 20 years of age at Screening&#xD;
&#xD;
          2. Scheduled to electively undergo 2 or 3-column excisional hemorrhoidectomy&#xD;
&#xD;
          3. American Society of Anesthesiology Physical Class 1 - 3&#xD;
&#xD;
          4. Clinical lab values twice the upper limit of normal (values of potential clinical&#xD;
             concern are detailed in Appendix) or, if abnormal, deemed not clinically significant&#xD;
             per the Investigator.&#xD;
&#xD;
          5. Ability and willingness to provide informed consent, adhere to the study visit&#xD;
             schedule and complete all study assessments and language specific questionnaires.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Body weight less than 40 kg.&#xD;
&#xD;
          2. Concurrent fissurectomy.&#xD;
&#xD;
          3. Subject is pregnant or breastfeeding. Women of childbearing potential must have a&#xD;
             negative urine pregnancy test at Baseline.&#xD;
&#xD;
          4. Women of childbearing potential disagree to use an acceptable method of contraception&#xD;
             (e.g., hormonal contraceptives, IUD, barrier device or abstinence) throughout the&#xD;
             study.&#xD;
&#xD;
          5. History of hypersensitivity or allergy to amide-type local anesthetics, opioid, or any&#xD;
             ingredient of the medications administered in this study.&#xD;
&#xD;
          6. Subject has a resting respiratory rate less than 8 per minute and blood oxygen&#xD;
             saturation less than 90 mmHg.&#xD;
&#xD;
          7. Use of any NSAIDs, selective COX-2 inhibitors, opioid, acetaminophen, selective&#xD;
             serotonin reuptake inhibitors (SSRI), tricyclic antidepressants (TCA), gabapentin, or&#xD;
             pregabalin within three days of surgery.&#xD;
&#xD;
          8. Chronic use of opioid medications for more than 14 days in the last 3 months, or&#xD;
             non-opioid pain medications more than 5 times per week.&#xD;
&#xD;
          9. Use of any long-acting opioid medication within 3 days of surgery or any opioid&#xD;
             medication within 24 hours of surgery.&#xD;
&#xD;
         10. Current painful physical condition or concurrent surgery requires analgesic treatment&#xD;
             in the postoperative period.&#xD;
&#xD;
         11. Contraindication to epinephrine or any of the pain-control agents planned for&#xD;
             postoperative use.&#xD;
&#xD;
         12. Administration of an investigational drug within the longer of 30 days or 5&#xD;
             elimination half-lives of such investigational drug prior to study drug&#xD;
             administration.&#xD;
&#xD;
         13. Any psychiatric disorder, psychological, medical, or laboratory condition that may&#xD;
             interfere with study assessments or compliance.&#xD;
&#xD;
         14. Significant medical conditions or laboratory results that may indicate an increased&#xD;
             vulnerability to study drugs and procedures, and thus expose the subject to an&#xD;
             unreasonable risk as a result of participating in this clinical trial.&#xD;
&#xD;
         15. Any clinically significant event or condition uncovered during surgery.&#xD;
&#xD;
         16. History of abuse illicit drugs, prescription medicines or alcohol within the past 2&#xD;
             years.&#xD;
&#xD;
         17. Known history of anti-HIV antibody positive .&#xD;
&#xD;
         18. Failure to pass drug and alcohol screen.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Chang-Chieh Wu, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Tri-Service General Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>General Clinical Research Center, Tri-service General Hospital</name>
      <address>
        <city>Taipei city</city>
        <zip>114</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>July 14, 2014</study_first_submitted>
  <study_first_submitted_qc>July 15, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 17, 2014</study_first_posted>
  <last_update_submitted>September 24, 2020</last_update_submitted>
  <last_update_submitted_qc>September 24, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 28, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Analgesic</keyword>
  <keyword>Narcotics</keyword>
  <keyword>Opioids</keyword>
  <keyword>Pain relief after surgery</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Nalbuphine</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT02193620
org study id: PH-CP025
nct id: NCT02193620
lead sponsor: 
has dmc: No
The purpose of this study is to assess the effectiveness, safety and pharmacokinetics of Oral
      Nalbuphine in the treatment of postoperative pain following hemorrhoidectomy.
• Primary Efficacy Endpoint: Pain assessment calculated as the area under the curve of VAS
      pain intensity scores through 48 hours.

      • Secondary Efficacy Endpoints:

        1. Consumption of diclofenac (Day 1-2) via Intramuscular Injection (IM injection).

        2. Time from the end of operation to the first IM injection diclofenac dose

        3. Brief Pain Inventory (BPI).

        4. Patient satisfaction.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: the area under the curve of VAS pain intensity scores
time frame: at 1, 2, 3, 4±0.25, 8±0.5, 12±0.5, 16±0.5, 20±0.5, 24±1, 28±1, 32±2, 36±2, 40±2, 44±2, and 48±2 h after the surgery
description: Pain assessment calculated as the area under the curve of VAS pain intensity scores through 48 hours
measure: Consumption of diclofenac dose
time frame: in 48 hours after surgery
description: Consumption of diclofenac (Day 1-2) via Intramuscular Injection (IM injection)
measure: Time of operation to diclofenac dose
time frame: in 48 hours after surgery
description: Time from the end of operation to the first IM injection diclofenac dose
measure: Brief Pain Inventory (BPI)
time frame: at 24h and 48h after surgery
description: Brief Pain Inventory (BPI)
measure: Patient satisfaction
time frame: at 48h after surgery
description: Patient satisfaction
arm group label: Placebo group
arm group type: Placebo Comparator
description: Placebo soft capsules
arm group label: Study group
arm group type: Experimental
description: PHN131 soft capsule with Nalbuphine HCl 60 mg/cap
intervention type: Drug
intervention name: PHN131 soft capsule with Nalbuphine HCl 60 mg/cap
description: Multiple dose of oral PHN131 soft capsule with Nalbuphine HCl 60 mg/cap, initial dose : 120 mg ( 2 capsules), then 60 mg (1 capsule); t.i.d.
arm group label: Study group
other name: PHN131
intervention type: Drug
intervention name: Placebo soft capsules
description: Multiple dose of oral Placebo soft capsules, initial dose: 2 capsules, then 1 capsule; t.i.d.
arm group label: Placebo group
other name: Placebo
intervention type: Drug
intervention name: Dicofenac
description: All subjects will receive diclofenac by IM injection for analgesia as rescue pain control.
arm group label: Placebo group
arm group label: Study group
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: Chang-Chieh Wu, MD
role: Principal Investigator
affiliation: Tri-Service General Hospital
facility: 
country: Taiwan
responsible party type: Sponsor
mesh term: Nalbuphine