<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/NCT01676493</url>
  </required_header>
  <id_info>
    <org_study_id>CODE-OS+T-(2-17)-SPK-1</org_study_id>
    <nct_id>NCT01676493</nct_id>
  </id_info>
  <brief_title>A Study of Oral Codeine Sulfate in Pediatric Patients With Post-procedural Pain</brief_title>
  <official_title>A Multicenter, Open-Label, Safety and Pharmacokinetic Study of Oral Codeine Sulfate Administration in Pediatric Subjects 2 Years Old Through 17 Years Old With Post-procedural Pain</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Roxane Laboratories</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Quintiles, Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>West-Ward Pharmaceutical</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a multicenter, open-label study to evaluate the safety and PK of oral codeine sulfate&#xD;
      in pediatric subjects with mild to moderate post-procedural pain.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Eligible pediatric subjects will complete all screening procedures within 14 days before the&#xD;
      scheduled procedure. Screening will be permitted on the day of the procedure. At screening,&#xD;
      the subject's parent or guardian will provide written parental permission/informed consent to&#xD;
      participate in the study and subjects will provide assent (if required by the local&#xD;
      Institutional Review Board [IRB]) before any protocol-specified procedures or assessments are&#xD;
      performed.&#xD;
&#xD;
      Subjects may be inpatients, outpatients, or day-surgery patients at the study site who will&#xD;
      undergo procedures expected to result in at least mild to moderate post-procedure pain with&#xD;
      the day of the procedure noted as Day 0, and will be followed until discharge from the study&#xD;
      site.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Decision to stop study due to low recruitment.&#xD;
  </why_stopped>
  <start_date>April 2012</start_date>
  <completion_date type="Actual">August 2012</completion_date>
  <primary_completion_date type="Actual">August 2012</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>tolerability and safety</measure>
    <time_frame>up to 24 hours</time_frame>
    <description>Percentage of subjects who experience any AEs with a causal relationship to the study medication characterized as possible, probable or unknown (unable to judge).&#xD;
Percentage of subjects with SAEs.&#xD;
Percentage of subjects with a UMSS sedation score of 4.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>analyte concentrations from blood samples</measure>
    <time_frame>24 hours</time_frame>
    <description>Initial Dose of Study Drug&#xD;
Immediately (up to 30 minutes) prior to the dose of oral codeine sulfate.&#xD;
1 hour (45 to 75 minutes) after administration of the initial dose of oral codeine sulfate.&#xD;
2 hours (105 to 135 minutes) after administration of the initial dose of oral codeine sulfate.&#xD;
Subsequent Doses&#xD;
Immediately (up to 30 minutes) prior to the dose of oral codeine sulfate.&#xD;
1 hour (45 to 75 minutes) after administration of the dose of oral codeine sulfate.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">31</enrollment>
  <condition>Pain</condition>
  <arm_group>
    <arm_group_label>Codeine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Codeine Sulfate Oral Solution and Tablet</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Codeine</intervention_name>
    <arm_group_label>Codeine</arm_group_label>
    <other_name>Codeine Sulfate Oral Solution and Tablets</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Has a parent or guardian providing written parental permission/informed consent, with&#xD;
             subject assent (if required by local IRB).&#xD;
&#xD;
          2. Is a child 2 years old through 17 years old, inclusive (at the time of informed&#xD;
             consent signing).&#xD;
&#xD;
          3. Has a routine pediatric procedure that is expected to cause at least mild to moderate&#xD;
             pain.&#xD;
&#xD;
          4. Is expected by the investigator to require a minimum of one (1) dose of oral codeine&#xD;
             for the treatment of mild to moderate post-procedural pain.&#xD;
&#xD;
          5. Has the ability to read and understand the study procedures and has the ability to&#xD;
             communicate meaningfully with the study investigator and staff (if the subject is of&#xD;
             preverbal age or cannot read or communicate meaningfully, then the subject's parent or&#xD;
             guardian must meet this criterion).&#xD;
&#xD;
          6. If female subject is of childbearing potential, she must have a negative urine or&#xD;
             serum pregnancy test result on the day of the scheduled procedure prior to the&#xD;
             procedure. In this population, female of childbearing potential is defined by the&#xD;
             onset of menarche, that is, menstruation, whether at irregular or regular intervals&#xD;
             (periods).&#xD;
&#xD;
          7. Must have vascular access to facilitate multiple blood draws.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Is currently lactating.&#xD;
&#xD;
          2. Has significant medical disease(s), laboratory abnormalities, or conditions(s) that in&#xD;
             the investigator's judgment could compromise the subject's welfare, ability to&#xD;
             communicate with study staff, complete study activities, or would otherwise&#xD;
             contraindicate study participation.&#xD;
&#xD;
          3. Weighs less than 10.5 kg. (see Table 4 Maximum Number of Doses of Study Drug by Weight&#xD;
             for details)&#xD;
&#xD;
          4. Has weight ≤ 5th or ≥ 95th percentile for age based on CDC Growth Charts. (see&#xD;
             Appendix 6)&#xD;
&#xD;
          5. Has received codeine, hydrocodone, morphine or oxycodone in any form in the previous&#xD;
             seven (7) days.&#xD;
&#xD;
          6. Has used opioids chronically (e.g., codeine, morphine, oxycodone, hydrocodone, or&#xD;
             hydromorphone) for &gt;7 calendar days within the previous 30 days before surgery.&#xD;
&#xD;
          7. Has known hypersensitivity or contraindication to receiving oral opioid(s).&#xD;
&#xD;
          8. Has an active enteral malabsorption disorder.&#xD;
&#xD;
          9. Has impaired liver function (e.g., alanine aminotransferase [ALT] ≥3 times the upper&#xD;
             limit of normal [ULN], or bilirubin ≥3 times ULN), known active hepatic disease (e.g.,&#xD;
             hepatitis), evidence of clinically significant chronic liver disease or other&#xD;
             conditions affecting the liver (e.g., chronic hepatitis) that may suggest the&#xD;
             potential for an increased susceptibility to hepatic toxicity with oral codeine&#xD;
             exposure. NOTE: Subjects with no previous history of liver function impairment may be&#xD;
             enrolled before results are available from screening laboratory samples.&#xD;
&#xD;
         10. Has significantly impaired renal function or disease, as evidenced by an estimated&#xD;
             glomerular filtration rate (i.e., from creatinine levels using the Schwartz formula)&#xD;
             calculated to be less than one-third (1/3) of normal for the applicable age of this&#xD;
             study population. NOTE: Subjects with no previous history of kidney function&#xD;
             impairment may be enrolled before results are available from screening laboratory&#xD;
             samples.&#xD;
&#xD;
         11. Is undergoing a procedure as treatment for acute burns.&#xD;
&#xD;
         12. Has a history of substance abuse or there is evidence of current substance abuse, in&#xD;
             the investigator's opinion.&#xD;
&#xD;
         13. Has participated in an interventional clinical study (investigational or marketed&#xD;
             product) within 30 days before screening, or plans to participate in another clinical&#xD;
             trial in the next 30 days.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dante Landucci, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Quintiles, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Children's Medical Center Dallas</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75235</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>August 24, 2012</study_first_submitted>
  <study_first_submitted_qc>August 30, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 31, 2012</study_first_posted>
  <last_update_submitted>October 1, 2018</last_update_submitted>
  <last_update_submitted_qc>October 1, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">October 2, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pain, Procedural</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Codeine</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/NCT01676493
org study id: CODE-OS+T-(2-17)-SPK-1
nct id: NCT01676493
lead sponsor: 
collaborator: 
has dmc: No
This is a multicenter, open-label study to evaluate the safety and PK of oral codeine sulfate
      in pediatric subjects with mild to moderate post-procedural pain.
Eligible pediatric subjects will complete all screening procedures within 14 days before the
      scheduled procedure. Screening will be permitted on the day of the procedure. At screening,
      the subject's parent or guardian will provide written parental permission/informed consent to
      participate in the study and subjects will provide assent (if required by the local
      Institutional Review Board [IRB]) before any protocol-specified procedures or assessments are
      performed.

      Subjects may be inpatients, outpatients, or day-surgery patients at the study site who will
      undergo procedures expected to result in at least mild to moderate post-procedure pain with
      the day of the procedure noted as Day 0, and will be followed until discharge from the study
      site.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: tolerability and safety
time frame: up to 24 hours
description: Percentage of subjects who experience any AEs with a causal relationship to the study medication characterized as possible, probable or unknown (unable to judge).
Percentage of subjects with SAEs.
Percentage of subjects with a UMSS sedation score of 4.
measure: analyte concentrations from blood samples
time frame: 24 hours
description: Initial Dose of Study Drug
Immediately (up to 30 minutes) prior to the dose of oral codeine sulfate.
1 hour (45 to 75 minutes) after administration of the initial dose of oral codeine sulfate.
2 hours (105 to 135 minutes) after administration of the initial dose of oral codeine sulfate.
Subsequent Doses
Immediately (up to 30 minutes) prior to the dose of oral codeine sulfate.
1 hour (45 to 75 minutes) after administration of the dose of oral codeine sulfate.
arm group label: Codeine
arm group type: Experimental
description: Codeine Sulfate Oral Solution and Tablet
intervention type: Drug
intervention name: Codeine
arm group label: Codeine
other name: Codeine Sulfate Oral Solution and Tablets
criteria: 
gender: All
minimum age: 2 Years
maximum age: 17 Years
healthy volunteers: No
last name: Dante Landucci, MD
role: Principal Investigator
affiliation: Quintiles, Inc.
facility: 
country: United States
responsible party type: Sponsor
mesh term: Pain, Procedural
mesh term: Codeine