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

Conditions

• Post Operative Pain, Acute

Eligibility Criteria

Sex

ALL

Age

12 Years - 17 Years

Healthy Volunteers

Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date

Feb 28, 2026

Status verified

Nov 2025

Primary completion

Oct 31, 2026

Completion

Oct 31, 2026

Study Design

Enrollment

180 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Treatment A- 3 tablets of Combogesic® tablets
  3 tablets of Combogesic® (acetaminophen 975mg + ibuprofen 292.5 mg, total per dose) will be administered every 6 hours up to a maximum of 4 doses in 24 hours.
• Experimental: Treatment B- 2 tablets of Combogesic® + 1 tablets of placebo
  2 tablets of Combogesic® (acetaminophen 650 mg + ibuprofen 195 mg, total per dose) and 1 tablet of placebo will be administered every 6 hours up to a maximum of 4 doses in 24 hours.
• Active Comparator: Treatment C - 2 tablets of acetaminophen and 1 tablet of placebo
  2 tablets of acetaminophen (1000 mg total per dose) + 1 tablet of placebo will be administered every 6 hours up to a maximum of 4 doses in 24 hours.

Primary Outcome Measure

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 [ Time Frame: From start of exposure to study drug until 6 hours after first dose ]

Central Contacts

• Laura Boddington
  +64 9 488 0232 ext 735
  [email protected]

Locations (1)

Find similar trials in Orlando, FL

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