Ignite Creation Date:
2024-05-05 @ 12:07 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00240838
Status:
COMPLETED
Last Update Posted:
2011-06-29
First Post:
2005-10-14
Brief Title:
An Effectiveness and Safety Study Comparing Acetaminophen 3900 mgDay to Ibuprofen 1200 mgDay in the Treatment of Post-Race Muscle Soreness
Sponsor:
Johnson Johnson Consumer and Personal Products Worldwide
Organization:
Johnson Johnson Consumer and Personal Products Worldwide
Study Overview
Official Title:
A Randomized Double-Blind Study Evaluating Acetaminophen Extended Release Caplets 3900 mgDay and Ibuprofen 1200 mgDay in the Treatment of Post-Race Muscle Soreness
Status:
COMPLETED
Status Verified Date:
2011-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 mgday two 650 mg caplets taken three times a day for five days or ibuprofen caplets 1200 mgday 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 mgday is superior to ibuprofen 1200 mgday 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None