Ibuprofen Versus Placebo For Muscle Soreness

NCT ID: NCT03228992

Last Updated: 2017-08-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-10

Study Completion Date

2017-07-31

Brief Summary

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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.

Detailed Description

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This is a double-blind, randomized, placebo controlled, parallel group, pilot safety and efficacy study. Healthy male or female subjects who have a history of occasional muscle soreness and are not currently exercising will be asked to volunteer for the study. All subjects will complete an informed consent process prior to study procedures.

The study duration is anticipated to be approximately 4 months. Each subject may be in the study for up to 45 days including screening, run-in, inpatient and outpatient dosing and assessments, follow-up visit and follow-up telephone contact.

Conditions

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Muscle Soreness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Ibuprofen

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

Group Type ACTIVE_COMPARATOR

Ibuprofen 400 mg

Intervention Type DRUG

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

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

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

Interventions

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Ibuprofen 400 mg

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

Intervention Type DRUG

Placebo

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

Intervention Type OTHER

Eligibility Criteria

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Exclusion Criteria

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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Jean Brown Research

OTHER

Sponsor Role lead

Responsible Party

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Derek Muse

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Jean Brown Research

Salt Lake City, Utah, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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JBR-002

Identifier Type: -

Identifier Source: org_study_id

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