Clinical trial NCT02113566: A Study Comparing the Efficacy and Safety of Orally Administered Ibuprofen and Placebo in Delayed Onset Muscle Soreness
Official title: A Double-Blind, Repeat-Dose, Parallel Group Study Comparing the Efficacy and Safety of Orally Administered Ibuprofen and Placebo in Delayed Onset Muscle Soreness.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Delayed Onset Muscle Soreness
Keywords: Delayed onset muscle soreness
DOMS
Lead sponsor: Jean Brown Research
Sponsor class: OTHER
First posted: 2014-04-14
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: SPID (Sum Pain Intensity Difference)
timeFrame: 0-48 hours
Secondary outcomes:
measure: spontaneous muscle pain/soreness
timeFrame: 0-48 hours
measure: Muscle stiffness with movement
timeFrame: 0-48 hours
measure: Overall evaluation measures
timeFrame: 0-48 hours
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: Jean Brown Research
state: Utah
Study officials:
affiliation: Jean Brown Research
name: Derek Muse, MD
role: PRINCIPAL_INVESTIGATOR
References: