Ibuprofen Versus Placebo For Muscle Soreness
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03228992|
Recruitment Status : Completed
First Posted : July 25, 2017
Last Update Posted : August 4, 2017
|Condition or disease||Intervention/treatment||Phase|
|Muscle Soreness||Drug: Ibuprofen 400 mg Other: Placebo||Phase 4|
This is a double-blind, randomized, placebo controlled, parallel group, pilot safety and efficacy study. Healthy male or female subjects who have a history of occasional muscle soreness and are not currently exercising will be asked to volunteer for the study. All subjects will complete an informed consent process prior to study procedures.
The study duration is anticipated to be approximately 4 months. Each subject may be in the study for up to 45 days including screening, run-in, inpatient and outpatient dosing and assessments, follow-up visit and follow-up telephone contact.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||31 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||A DOUBLE-BLIND, REPEAT-DOSE, PARALLEL GROUP, PILOT STUDY COMPARING THE EFFICACY AND SAFETY OF ORALLY ADMINISTERED IBUPROFEN AND PLACEBO IN DELAYED ONSET MUSCLE SORENESS|
|Actual Study Start Date :||April 10, 2017|
|Actual Primary Completion Date :||July 31, 2017|
|Actual Study Completion Date :||July 31, 2017|
Active Comparator: Ibuprofen
Subjects will receive a total of 4 doses of oral ibuprofen 400 mg over a 24 hour period.
Drug: Ibuprofen 400 mg
Subjects will receive 4 doses of oral ibuprofen over a 24 hour period.
Placebo Comparator: Placebo
Subjects will receive a total of 4 doses of oral placebo over a 24 hour period.
Subjects will receive 4 doses of placebo over a 24 hour period.
- Model Sensitivity [ Time Frame: 24 hours ]Assess whether ibuprofen provides more relief than placebo in the DOMS model.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03228992
|United States, Utah|
|Jean Brown Research|
|Salt Lake City, Utah, United States, 84124|