Official Title: “A Randomized, Double-Blind Study Evaluating Acetaminophen Extended Release Caplets (3900 mg/Day) and Ibuprofen (1200 mg/Day) in the Treatment of Post-Race Muscle Soreness.”

The purpose of this study is to compare the effectiveness and safety of acetaminophen extended release caplets and ibuprofen in relieving the muscle soreness that occurs after a marathon.

Study Type: Interventional

Study Design: Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study

The objective of this randomized, double-blind study is to compare the effectiveness and safety of acetaminophen extended release caplets and ibuprofen in relieving the muscle soreness that occurs in subjects who complete a marathon. Subjects are randomized to receive acetaminophen extended release caplets, 3900 mg/day (two 650 mg caplets taken three times a day, for five days) or ibuprofen caplets, 1200 mg/day (two 200 mg caplets taken three times a day, for five days). The primary measurement of efficacy is the average change in muscle soreness from baseline for both the morning and evening assessments. Safety assessments consist of monitoring adverse events, and a physical examination including vital signs, weight, a review of concomitant medications, and a urine pregnancy test for female subjects.

Two hypotheses are examined in a step-down approach. The first hypothesis is that acetaminophen extended release is not inferior to ibuprofen in relieving the muscle soreness that occurs after a marathon. If acetaminophen extended release is not inferior to ibuprofen in relieving the muscle soreness that occurs after a marathon, the second hypothesis is that acetaminophen extended release (3900 mg/day) is superior to ibuprofen (1200 mg/day) in relieving the muscle soreness that occurs after a marathon.

Two acetaminophen 650 mg extended release caplets, taken by mouth, three times a day for five days or two ibuprophen 200 mg caplets, taken by mouth, three times a day for five days.

Primary:

• Average change in muscle soreness from baseline for both morning and evening assessments.

Secondary:

• Average change in muscle soreness from baseline for morning assessments; Average change in muscle soreness from baseline for evening assessments; Average ratings of interference with 1) sleep; 2) morning activity; 3) ability to go for a run

Inclusion Criteria:

• Patients must complete the marathon
• Be able to swallow the study medication
• Comply with study requirements regarding the use of any other pain medications before, during or after the marathon
• Rate their muscle soreness on the evening after the marathon as at least a 4, on a zero-to-ten point scale
• If female, must not be pregnant or breastfeeding, and must be using an acceptable form of contraception

Exclusion Criteria:

• Previous diagnosis of osteoarthritis requiring pain medication therapy
• Currently have a major medical illness
• Have a history of cardiovascular disease, heat injury (heat exhaustion or heat stroke) or collapse during a running or endurance event
• Known hypersensitivity to acetaminophen or ibuprofen

Lead Sponsor: McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.

Overall Clinical Trial Officials and Contacts

McNeil Consumer & Specialty Pharmaceuticals Clinical Trial Study Director McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.  

Information obtained from ClinicalTrials.gov on July 23, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00240838

Study ID Number: CR002866

ClinicalTrials.gov Identifier: NCT00240838

Health Authority: United States: Food and Drug Administration

An Effectiveness and Safety Study comparing Acetaminophen (3900 mg/day) to Ibuprofen (1200 mg/day) in the Treatment of Post-Race Muscle Soreness.