Ibuprofen Versus Placebo For Muscle Soreness

NCT03228992 | Completed Phase 4 FDA Drug

• 1 other identifier: JBR-002
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

The study will assess the sensitivity of the Delayed Onset Muscle Soreness Model by comparing the safety and efficacy of oral ibuprofen to placebo over 24 hours.

Conditions

Muscle Soreness

Outcome Measures

Primary Outcomes (1)

• Model Sensitivity

  Assess whether ibuprofen provides more relief than placebo in the DOMS model.

  24 hours

Study Arms (2)

Ibuprofen

ACTIVE COMPARATOR

Subjects will receive a total of 4 doses of oral ibuprofen 400 mg over a 24 hour period.

Drug: Ibuprofen 400 mg

Placebo

PLACEBO COMPARATOR

Subjects will receive a total of 4 doses of oral placebo over a 24 hour period.

Other: Placebo

Interventions

Ibuprofen 400 mg DRUG

Subjects will receive 4 doses of oral ibuprofen over a 24 hour period.

Ibuprofen

Placebo OTHER

Subjects will receive 4 doses of placebo over a 24 hour period.

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

Subjects must meet the following criteria to be included in the study: 1. Male or female subjects aged 18-55 years; 2. In good general health; 3. Non-pregnant, non-lactating female subjects must be: 1. physically incapable of childbearing potential (postmenopausal for more than 1 year or surgically sterile) or 2. practicing an acceptable method of contraception (hormonal, barrier with spermicide, intrauterine device, vasectomized or same sex partner, or abstinence). Subjects using hormonal birth control must have been on a stable dose of treatment for at least 30 days and received at least 1 cycle of treatment prior to randomization. 4. History of experiencing muscle pain/soreness after moderately strenuous exercise; Subjects are excluded from the study if any of the following criteria apply: 1. Currently participating in an exercise regimen. 2. Have an allergy or intolerance to any NSAID, aspirin, acetaminophen or lactose; 3. History of rhabdomyolysis; 4. Have participated in an investigational study within the past 30 days of screening; 5. Are an employee or relative of an employee of the study site (directly involved with the study).

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Jean Brown Research: lead

Study Sites (1)

Jean Brown Research

Salt Lake City, Utah, 84124, United States

Location

Related Links

• Company Website

MeSH Terms

Conditions

Myalgia

Interventions

Ibuprofen

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Musculoskeletal Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 16, 2017
• First Posted: July 25, 2017
• Study Start: April 10, 2017
• Primary Completion: July 31, 2017
• Study Completion: July 31, 2017
• Last Updated: August 4, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)