Pain
Conditions
Keywords
muscle soreness, pain, acetaminophen, ibuprofen
Brief summary
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.
Detailed description
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.
Interventions
DRUGacetaminophen extended release caplets
Sponsors
Johnson & Johnson Consumer and Personal Products Worldwide
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Average change in muscle soreness from baseline for both morning and evening assessments. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Outcome results
None listed