A Study of Combogesic® 325 in Adolescent Patients With Moderate to Severe Postoperative Pain Asso… (NCT07225140) | Clinical Trial Compass
Not Yet RecruitingPhase 3
A Study of Combogesic® 325 in Adolescent Patients With Moderate to Severe Postoperative Pain Associated With Orthopedic Surgery
United States180 participantsStarted 2026-02
Plain-language 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.
Who can participate
Age range
12 Years – 17 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Provide written informed consent or consent be provided from parents/legal guardians and assent from participants (where appropriate).
* Be males and females aged at least 12 years and less than 18 years old on both the day of consent and throughout the 24 hour study period.
* Be undergoing planned orthopedic surgery which requires at least 24 hours of hospital inpatient stay.
* Have a clinical indication of acute moderate or severe pain (at least ≥ 50 mm on the VAS scale\*) within 6 hours after the completion of surgery associated with orthopedic surgery.
* using a 100mm VAS scale with 0 = no pain and 100 = worst pain imaginable, patients should have a resting VAS pain intensity score of ≥ 50 mm for inclusion. For this study, moderate pain is defined as ≥ 40 mm to ≤ 69 mm and severe pain is defined as a resting VAS of ≥ 70 mm to ≤ 100 mm.
* Have negative HIV and hepatitis B \& C test results.
Exclusion Criteria:
* Has taken any NSAID or acetaminophen containing drug products within 5 half-lives prior to the initial dose of study drug.
* Hypersensitivity to opioids, NSAIDs or acetaminophen or a history of severe/serious drug reaction to NSAIDs or acetaminophen.
* Pregnant or lactating females Known to be pregnant or possibly pregnant.
* Sexually active females of childbearing potential not using adequate contraception\* and sexually active males not using adequate contraception\*\*
* Women of childbearing potential who are unwilling to take adequate c…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Time-adjusted summed pain intensity difference (SPID) calculated from the visual analogue scale (VAS) pain intensity scores 6 hours after first dose of study medication
Timeframe: From start of exposure to study drug until 6 hours after first dose