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

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

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.

Study Overview

• Status: Completed
• Conditions: Delayed Onset Muscle Soreness
• Intervention / Treatment: Drug: Acetaminophen 1000mg

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Utah
    • Salt Lake City, Utah, United States, 84124
      • Jean Brown Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: 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.	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.; Other Names: Tylenol
Active Comparator: 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.	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.; Other Names: Tylenol

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Jean Brown Research

Study record dates

Study Major Dates

• Study Start: February 1, 2013
• Primary Completion (Actual): May 1, 2013
• Study Completion (Actual): May 1, 2013

Study Registration Dates

• First Submitted: April 6, 2014
• First Submitted That Met QC Criteria: April 10, 2014
• First Posted (Estimate): April 14, 2014

Study Record Updates

• Last Update Posted (Estimate): December 2, 2015
• Last Update Submitted That Met QC Criteria: December 1, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Keywords: Delayed onset muscle soreness; DOMS
• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Diseases; Musculoskeletal Pain; Myalgia; Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Antipyretics; Acetaminophen
• Other Study ID Numbers: JBR-001