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

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.

Eligibility

Age range

12–17 years

Sex

All

Healthy volunteers

No

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

Location