A Study Comparing the Efficacy and Safety of Orally Administered Ibuprofen and Placebo in Delayed Onset Muscle Soreness

Study Overview
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Brief Summary
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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.

Official Title
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A Double-Blind, Repeat-Dose, Parallel Group Study Comparing the Efficacy and Safety of Orally Administered Ibuprofen and Placebo in Delayed Onset Muscle Soreness.

Conditions
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Delayed Onset Muscle Soreness

Intervention / Treatment
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* Drug: Acetaminophen 1000mg


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>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. | Drug: Acetaminophen 1000mg<br>* Subjects 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.<br>* Other names: Tylenol;|
| Active Comparator: Ibuprofen<br>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. | Drug: Acetaminophen 1000mg<br>* Subjects 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.<br>* Other names: Tylenol;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SPID (Sum Pain Intensity Difference) | The primary efficacy parameter is muscle pain/soreness with movement at 48 hours (SPID 0-48) | 0-48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| spontaneous muscle pain/soreness |  | 0-48 hours | 
| Muscle stiffness with movement |  | 0-48 hours | 
| Overall evaluation measures |  | 0-48 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Delayed onset muscle soreness, DOMS