Delayed Onset Muscle Soreness | A Study Comparing the Efficacy and Safety of Orally Administered Ibuprofen and Placebo in Delayed Onset Muscle Soreness
Delayed Onset Muscle Soreness research study
What is the primary objective of this study?
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.
Who is eligible to participate?
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.
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Delayed Onset Muscle Soreness
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:Acetaminophen 1000mgSubjects who require rescue medication between hours 4 and 6 will be allowed to take Dose 2 of the study medication. If the subject chooses to take a rescue analgesic (acetaminophen 1000mg), they will be considered a treatment failure. This intervention will be use for the placebo and Ibuprofen arm.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Placebo2 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.
Ibuprofen2oomg 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.
Start Date: February 2013
Completed Date: May 2013
Phase: Phase 4
Primary Outcome: SPID (Sum Pain Intensity Difference)
Secondary Outcome: spontaneous muscle pain/soreness
Study sponsors, principal investigator, and references
Principal Investigator: Derek Muse, MD
Lead Sponsor: Jean Brown Research