A Study of Oral Codeine Sulfate in Pediatric Patients With Post-procedural Pain

NCT01676493 | Terminated Phase 3

• 1 other identifier: CODE-OS+T-(2-17)-SPK-1
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pain

Outcome Measures

Primary Outcomes (2)

• tolerability and safety

  * 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.

  up to 24 hours

• analyte concentrations from blood samples

  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.

  24 hours

Study Arms (1)

Codeine

EXPERIMENTAL

Codeine Sulfate Oral Solution and Tablet

Drug: Codeine

Interventions

Codeine DRUG

Also known as: Codeine Sulfate Oral Solution and Tablets

Codeine

Eligibility Criteria

• Age: 2 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Has a parent or guardian providing written parental permission/informed consent, with subject assent (if required by local IRB).
• Is a child 2 years old through 17 years old, inclusive (at the time of informed consent signing).
• Has a routine pediatric procedure that is expected to cause at least mild to moderate pain.
• Is expected by the investigator to require a minimum of one (1) dose of oral codeine for the treatment of mild to moderate post-procedural pain.
• Has the ability to read and understand the study procedures and has the ability to communicate meaningfully with the study investigator and staff (if the subject is of preverbal age or cannot read or communicate meaningfully, then the subject's parent or guardian must meet this criterion).
• If female subject is of childbearing potential, she must have a negative urine or serum pregnancy test result on the day of the scheduled procedure prior to the procedure. In this population, female of childbearing potential is defined by the onset of menarche, that is, menstruation, whether at irregular or regular intervals (periods).
• Must have vascular access to facilitate multiple blood draws.

You may not qualify if:

• Is currently lactating.
• Has significant medical disease(s), laboratory abnormalities, or conditions(s) that in the investigator's judgment could compromise the subject's welfare, ability to communicate with study staff, complete study activities, or would otherwise contraindicate study participation.
• Weighs less than 10.5 kg. (see Table 4 Maximum Number of Doses of Study Drug by Weight for details)
• Has weight ≤ 5th or ≥ 95th percentile for age based on CDC Growth Charts. (see Appendix 6)
• Has received codeine, hydrocodone, morphine or oxycodone in any form in the previous seven (7) days.
• Has used opioids chronically (e.g., codeine, morphine, oxycodone, hydrocodone, or hydromorphone) for \>7 calendar days within the previous 30 days before surgery.
• Has known hypersensitivity or contraindication to receiving oral opioid(s).
• Has an active enteral malabsorption disorder.
• Has impaired liver function (e.g., alanine aminotransferase \[ALT\] ≥3 times the upper limit of normal \[ULN\], or bilirubin ≥3 times ULN), known active hepatic disease (e.g., hepatitis), evidence of clinically significant chronic liver disease or other conditions affecting the liver (e.g., chronic hepatitis) that may suggest the potential for an increased susceptibility to hepatic toxicity with oral codeine exposure. NOTE: Subjects with no previous history of liver function impairment may be enrolled before results are available from screening laboratory samples.
• Has significantly impaired renal function or disease, as evidenced by an estimated glomerular filtration rate (i.e., from creatinine levels using the Schwartz formula) calculated to be less than one-third (1/3) of normal for the applicable age of this study population. NOTE: Subjects with no previous history of kidney function impairment may be enrolled before results are available from screening laboratory samples.
• Is undergoing a procedure as treatment for acute burns.
• Has a history of substance abuse or there is evidence of current substance abuse, in the investigator's opinion.
• Has participated in an interventional clinical study (investigational or marketed product) within 30 days before screening, or plans to participate in another clinical trial in the next 30 days.

Sponsors & Collaborators

• Roxane Laboratories: lead
• Quintiles, Inc.: collaborator

Study Sites (1)

Children's Medical Center Dallas

Dallas, Texas, 75235, United States

Location

MeSH Terms

Conditions

Pain

Interventions

Codeine; Tablets

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Dante Landucci, MD

  Quintiles, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2012
• First Posted: August 31, 2012
• Study Start: April 1, 2012
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: October 2, 2018

Record last verified: 2018-10

Locations

US (1)