NCT07225140

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

A Multicenter, Double-blind, Randomized, Parallel Group, Active-controlled, Dose-ranging Study to Assess Efficacy, Safety, and Pharmacokinetics of Combogesic® 325 in Adolescent Patients (Aged 12 to Less Than 18 Years) With Moderate to Severe Postoperative Pain Associated With Orthopedic Surgery

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 180 (estimated)
• Sponsor: AFT Pharmaceuticals, Ltd. · Industry
• Sex: All
• Age: 12 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Post Operative Pain, Acute

Interventions

Type	Name	Description
DRUG	Combogesic® tablets	The active ingredients of Combogesic® tablets are acetaminophen 325 mg and ibuprofen 97.5 mg.
DRUG	Acetaminophen 500mg	Each tablet contains acetaminophen 500mg.
DRUG	Placebo	Placebo tablets do not contain any active ingredients

Timeline

• Start date: 2026-02-01
• Primary completion: 2026-10-01
• Completion: 2026-10-01
• First posted: 2025-11-05
• Last updated: 2025-11-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study