Overview

A Study of Combogesic 325 in Adolescent Patients With Moderate to Severe Postoperative Pain Associated With Orthopedic Surgery

Status:
NOT_YET_RECRUITING

Trial end date:
2026-10-01

Target enrollment:

Participant gender:

Summary

Combogesic 325 contains a combination of ibuprofen and acetaminophen. The purpose of this study is to compare the pain relief effects of Combogesic 325mg and acetaminophen and to evaluate the safety of Combogesic 325mg in adolescents between the ages of 12 and \<18 years. What will the study involve for participants? * Participants will be randomly allocated to one of 3 treatment groups: * 3 tablets of Combogesic 325, * 2 tablets of Combogesic 325 and 1 tablet of placebo or * 2 tablets of acetaminophen1000mg and 1 tablet of placebo * Participants will take 3 tablets every 6 hours with a maximum of 4 doses in 24 hours * Participants and study doctor will be blinded to the treatment group * If pain is not sufficiently controlled, opioids may be used as supplementary pain relief at the discretion of the study doctor. * Participants will complete a patient diary to assess their pain * Participants will rate the study drug at the end of the treatment. It is expected that Combogesic tablets (either 2 or 3 tablets per dose) will provide a greater reduction in pain compared to acetaminophen (1000 mg) treatment.

Phase:

PHASE3

Details

Lead Sponsor:

AFT Pharmaceuticals, Ltd.

Treatments:

Acetaminophen
Ibuprofen