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

Jean Brown Research

Status and phase

Completed

Phase 4

Conditions

Delayed Onset Muscle Soreness

Treatments

Drug: Acetaminophen 1000mg

Study type

Interventional

Funder types

Other

Identifiers

NCT02113566

JBR-001

Details and patient eligibility

About

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.

Enrollment

60 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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.