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

Delayed Onset Muscle Soreness Clinical Trial

— DOMS  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02113566
• Other study ID #: JBR-001
• Status: Completed
• Phase: Phase 4
• First received: April 6, 2014
• Last updated: December 1, 2015
• Start date: February 2013
• Est. completion date: May 2013

Study information

• Verified date: December 2015
• Source: Jean Brown Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Delayed Onset Muscle Soreness
• Myalgia

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
United States	Jean Brown Research	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Jean Brown Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SPID (Sum Pain Intensity Difference)	The primary efficacy parameter is muscle pain/soreness with movement at 48 hours (SPID 0-48)	0-48 hours	No
Secondary	spontaneous muscle pain/soreness		0-48 hours	No
Secondary	Muscle stiffness with movement		0-48 hours	No
Secondary	Overall evaluation measures		0-48 hours	No