Study Results
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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COMPLETED
PHASE4
31 participants
INTERVENTIONAL
2017-04-10
2017-07-31
Brief Summary
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Detailed Description
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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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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
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.
Ibuprofen 400 mg
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.
Placebo
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.
Placebo
Subjects will receive 4 doses of placebo over a 24 hour period.
Eligibility Criteria
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Exclusion Criteria
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).
18 Years
55 Years
ALL
Yes
Sponsors
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Jean Brown Research
OTHER
Responsible Party
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Derek Muse
Principal Investigator
Locations
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Jean Brown Research
Salt Lake City, Utah, United States
Countries
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Related Links
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Company Website
Other Identifiers
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JBR-002
Identifier Type: -
Identifier Source: org_study_id
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