A Study of Combogesic® 325 in Adolescent Patients With Moderate to Severe Postoperative Pain Associated With Orthopedic Surgery
Public ClinicalTrials.gov record NCT07225140. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT07225140
- Recruitment status
- Not yet recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 180 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 12 Years to 17 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 30, 2026
- Primary completion
- Sep 30, 2027
- Completion
- Sep 30, 2027
- Last update posted
- Jun 30, 2026
2026 – 2027
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Nemours Children's Health | Orlando | Florida | 32827 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07225140, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 30, 2026 · Synced Sep 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT07225140 live on ClinicalTrials.gov.