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

NCT07225140 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2025-11-05

No results posted yet for this study

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

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

Sponsors & Collaborators

  • AFT Pharmaceuticals, Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2026-02-28
Primary Completion
2026-10-31
Completion
2026-10-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs

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 NCT07225140 on ClinicalTrials.gov