A Study Comparing the Efficacy and Safety of Orally Administered Ibuprofen and Placebo in Delayed Onset Muscle Soreness
- Registration Number
- NCT02113566
- Lead Sponsor
- Jean Brown Research
- Brief Summary
The hypotheses to be tested are: Efficacy: Ibuprofen will be more effective than the Placebo in relieving muscle pain/soreness over 48 hour post-dosing with study medication. Safety: There will be no or minimal increased incidence of adverse events (AEs) with Ibuprofen versus and both will be well tolerated.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria
- are male or female, 18-55 years of age
- are a sexually active female of childbearing potential willing to use a medically acceptable form of birth control throughout the study and for 30 days following the end of study participation
- have a history of experiencing muscle soreness after moderately strenuous exercise
- are in good general health, with a BMI less than or equal to 30, and able to perform the exercise regimen
- are able to read, comprehend, and sign the informed consent form
- develop muscle pain/soreness within 24-48 hours of the end of the exercise regimen and have a baseline muscle pain/soreness with movement of greater than or equal to 5 on the NRS (numerical rating scale) and at least "moderate" on the categorical scale
Exclusion Criteria
- regularly works out or exercises the upper extremities with weights or gym equipment during the past 6 months
- works in an occupation that requires regular heavy lifting or involvement of the upper extremities (eg: mover, construction workers)
- allergy or intolerance to any non-steroidal anti-inflammatory drug (NSAID), aspirin or acetaminophen
- the presence of any medical condition (eg: history of bleeding ulcers or current peptic ulcer disease) that would preclude the subject from safely participating in the study'
- any form of arthritis that requires prescription or over-the-counter (OTC)treatment pregnant or lactating female
- current habituation or history of chronic use of analgesic or drugs or severe chronic pain problems that do not respond to OTC medication and/or requires a prescription analgesic
- currently on chronic NSAID therapy for any reason
- current or recent history of drug or alcohol abuse
- has taken an analgesic medication within 5 half lives of performing the exercise regimen during the run-in period or completing the baseline assessment
- has donated blood within the past 30 days
- is unable to swallow whole or large tablets or capsules
- is unable/unwilling to remain at the study center for the 6 hour inpatient observation period.
- participation in an investigational study within the past 30 days of screening
- prior participation in this trial
- site employee or close relative of a site employee directly involved in the conduct or the study or is an employee or close relative of the study doctor.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Acetaminophen 1000mg 2 capsules identical to comparator, 3 times daily on Day 1 and Day 2. On Day 3 only one dose will be taken. The intervention is Acetaminophen 1000mg. Ibuprofen Acetaminophen 1000mg 2oomg capsules (400 mg per dose), 3 times daily on Day 1 and Day 2. On Day 3 only one dose will be taken. The intervention is Acetaminophen 1000mg.
- Primary Outcome Measures
Name Time Method SPID (Sum Pain Intensity Difference) 0-48 hours The primary efficacy parameter is muscle pain/soreness with movement at 48 hours (SPID 0-48)
- Secondary Outcome Measures
Name Time Method spontaneous muscle pain/soreness 0-48 hours Muscle stiffness with movement 0-48 hours Overall evaluation measures 0-48 hours
Trial Locations
- Locations (1)
Jean Brown Research
🇺🇸Salt Lake City, Utah, United States