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

NCT01676493 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2018-10-02

No results posted yet for this study

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

Interventions

DRUG

Codeine

Sponsors & Collaborators

  • Quintiles, Inc.

    collaborator INDUSTRY

  • Roxane Laboratories

    lead INDUSTRY

Principal Investigators

  • Dante Landucci, MD · Quintiles, Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
2 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-04-30
Primary Completion
2012-08-31
Completion
2012-08-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01676493 on ClinicalTrials.gov