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

NCT ID: NCT02113566

Last Updated: 2015-12-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-02-28
• Study Completion Date: 2013-05-31

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.

Conditions

Delayed Onset Muscle Soreness

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Placebo

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.

Group Type: PLACEBO_COMPARATOR

Acetaminophen 1000mg

Intervention Type: DRUG

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.

Ibuprofen

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.

Group Type: ACTIVE_COMPARATOR

Acetaminophen 1000mg

Intervention Type: DRUG

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.

Interventions

Acetaminophen 1000mg

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.

Intervention Type: DRUG

Other Intervention Names

Tylenol

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Jean Brown Research

OTHER

Sponsor Role: lead

Responsible Party

Derek Muse

Derek Muse, MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Derek Muse, MD

Role: PRINCIPAL_INVESTIGATOR

Jean Brown Research

Locations

Jean Brown Research

Salt Lake City, Utah, United States

Countries

United States

Other Identifiers

JBR-001

Identifier Type: -

Identifier Source: org_study_id