Ignite Creation Date:
2024-05-05 @ 12:06 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00240851
Status:
COMPLETED
Last Update Posted:
2015-06-19
First Post:
2005-10-14
Brief Title:
An Effectiveness and Safety Study of Acetaminophen Extended Release Caplets in Treating Muscle Aches and Soreness That Occur After a Marathon Race
Sponsor:
Johnson Johnson Consumer and Personal Products Worldwide
Organization:
Johnson Johnson Consumer and Personal Products Worldwide
Study Overview
Official Title:
A Randomized Double-Blind Placebo-Controlled Study Evaluating Acetaminophen Extended Release Caplets 3900 mgDay in the Treatment of Post-Race Muscle Aching and Pain Soreness
Status:
COMPLETED
Status Verified Date:
2015-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
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 of acetaminophen extended release caplets to placebo in treating the muscle aching and pain soreness that occurs after a marathon
Detailed Description:
This is a randomized double-blind placebo-controlled study to compare the effectiveness and safety of acetaminophen and placebo in treating muscle aching and pain 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 four days or placebo two placebo caplets taken three times a day for four days The primary measurement of efficacy is the average change from baseline in muscle soreness on Day 1 the day of the marathon Safety assessments consist of monitoring adverse events and a physical examination at the screening visit including vital signs weight a medical history review and a urine pregnancy test for females of childbearing potential The hypothesis of the study is that acetaminophen is more effective than placebo in the relief of post-race muscle aching and pain soreness score on the evening of the race Two acetaminophen 650 mg extended release caplets taken by mouth three times a day over a four day period or two placebo caplets taken by mouth three times a day over a four day period
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