A Phase 4 interventional study of acetaminophen extended release caplets in Pain, sponsored by Johnson & Johnson Consumer and Personal Products Worldwide. Completed. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-06-29.
Sponsored by Johnson & Johnson Consumer and Personal Products Worldwide · Phase 4, Interventional, and Treatment
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.
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 ibuprofen 200 mg caplets, taken by mouth, three times a day for five days.
282 studies on the registry are indexed under Myalgia; 43 are open to participants now.
This study's enrollment of 483 is above the median of 44 across 241 interventional studies indexed under Myalgia.
Browse Myalgia studies →Johnson & Johnson Consumer and Personal Products Worldwide is the lead sponsor of 58 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Average change in muscle soreness from baseline for both morning and evening assessments.
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
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This study is completed, as verified in Jun 2011. You cannot join it, but the record below documents what was studied.
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Johnson & Johnson Consumer and Personal Products Worldwide