Back to resultsIbuprofen Versus Placebo For Muscle Soreness
Primary Purpose
Muscle Soreness
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Ibuprofen 400 mg
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Muscle Soreness
Eligibility Criteria
Subjects must meet the following criteria to be included in the study:
- Male or female subjects aged 18-55 years;
- In good general health;
Non-pregnant, non-lactating female subjects must be:
- physically incapable of childbearing potential (postmenopausal for more than 1 year or surgically sterile) or
- practicing an acceptable method of contraception (hormonal, barrier with spermicide, intrauterine device, vasectomized or same sex partner, or abstinence). Subjects using hormonal birth control must have been on a stable dose of treatment for at least 30 days and received at least 1 cycle of treatment prior to randomization.
- History of experiencing muscle pain/soreness after moderately strenuous exercise;
Subjects are excluded from the study if any of the following criteria apply:
- Currently participating in an exercise regimen.
- Have an allergy or intolerance to any NSAID, aspirin, acetaminophen or lactose;
- History of rhabdomyolysis;
- Have participated in an investigational study within the past 30 days of screening;
- Are an employee or relative of an employee of the study site (directly involved with the study).
Sites / Locations
- Jean Brown Research
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Ibuprofen
Placebo
Arm Description
Subjects will receive a total of 4 doses of oral ibuprofen 400 mg over a 24 hour period.
Subjects will receive a total of 4 doses of oral placebo over a 24 hour period.
Outcomes
Primary Outcome Measures
Model Sensitivity
Assess whether ibuprofen provides more relief than placebo in the DOMS model.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03228992
Brief Title
Ibuprofen Versus Placebo For Muscle Soreness
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
April 10, 2017 (Actual)
Primary Completion Date
July 31, 2017 (Actual)
Study Completion Date
July 31, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Jean Brown Research
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The study will assess the sensitivity of the Delayed Onset Muscle Soreness Model by comparing the safety and efficacy of oral ibuprofen to placebo over 24 hours.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Muscle Soreness
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
31 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ibuprofen
Arm Type
Active Comparator
Arm Description
Subjects will receive a total of 4 doses of oral ibuprofen 400 mg over a 24 hour period.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Subjects will receive a total of 4 doses of oral placebo over a 24 hour period.
Intervention Type
Drug
Intervention Name(s)
Ibuprofen 400 mg
Intervention Description
Subjects will receive 4 doses of oral ibuprofen over a 24 hour period.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Subjects will receive 4 doses of placebo over a 24 hour period.
Primary Outcome Measure Information:
Title
Model Sensitivity
Description
Assess whether ibuprofen provides more relief than placebo in the DOMS model.
Time Frame
24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Subjects must meet the following criteria to be included in the study:
Male or female subjects aged 18-55 years;
In good general health;
Non-pregnant, non-lactating female subjects must be:
physically incapable of childbearing potential (postmenopausal for more than 1 year or surgically sterile) or
practicing an acceptable method of contraception (hormonal, barrier with spermicide, intrauterine device, vasectomized or same sex partner, or abstinence). Subjects using hormonal birth control must have been on a stable dose of treatment for at least 30 days and received at least 1 cycle of treatment prior to randomization.
History of experiencing muscle pain/soreness after moderately strenuous exercise;
Subjects are excluded from the study if any of the following criteria apply:
Currently participating in an exercise regimen.
Have an allergy or intolerance to any NSAID, aspirin, acetaminophen or lactose;
History of rhabdomyolysis;
Have participated in an investigational study within the past 30 days of screening;
Are an employee or relative of an employee of the study site (directly involved with the study).
Facility Information:
Facility Name
Jean Brown Research
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84124
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
http://jeanbrownresearch.com
Description
Company Website
Learn more about this trial
Ibuprofen Versus Placebo For Muscle Soreness
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