Ignite Creation Date:
2025-12-24 @ 4:40 PM
Ignite Modification Date:
2026-03-28 @ 12:58 PM
Study NCT ID:
NCT02113566
Status:
COMPLETED
Last Update Posted:
2015-12-02
First Post:
2014-04-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study Comparing the Efficacy and Safety of Orally Administered Ibuprofen and Placebo in Delayed Onset Muscle Soreness
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000082', 'term': 'Acetaminophen'}], 'ancestors': [{'id': 'D000083', 'term': 'Acetanilides'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-12', 'completionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-12-01', 'studyFirstSubmitDate': '2014-04-06', 'studyFirstSubmitQcDate': '2014-04-10', 'lastUpdatePostDateStruct': {'date': '2015-12-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-04-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'SPID (Sum Pain Intensity Difference)', 'timeFrame': '0-48 hours', 'description': 'The primary efficacy parameter is muscle pain/soreness with movement at 48 hours (SPID 0-48)'}], 'secondaryOutcomes': [{'measure': 'spontaneous muscle pain/soreness', 'timeFrame': '0-48 hours'}, {'measure': 'Muscle stiffness with movement', 'timeFrame': '0-48 hours'}, {'measure': 'Overall evaluation measures', 'timeFrame': '0-48 hours'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Delayed onset muscle soreness', 'DOMS'], 'conditions': ['Delayed Onset Muscle Soreness']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* are male or female, 18-55 years of age\n* 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\n* have a history of experiencing muscle soreness after moderately strenuous exercise\n* are in good general health, with a BMI less than or equal to 30, and able to perform the exercise regimen\n* are able to read, comprehend, and sign the informed consent form\n* 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\n\nExclusion Criteria:\n\n* regularly works out or exercises the upper extremities with weights or gym equipment during the past 6 months\n* works in an occupation that requires regular heavy lifting or involvement of the upper extremities (eg: mover, construction workers)\n* allergy or intolerance to any non-steroidal anti-inflammatory drug (NSAID), aspirin or acetaminophen\n* 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\'\n* any form of arthritis that requires prescription or over-the-counter (OTC)treatment pregnant or lactating female\n* 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\n* currently on chronic NSAID therapy for any reason\n* current or recent history of drug or alcohol abuse\n* has taken an analgesic medication within 5 half lives of performing the exercise regimen during the run-in period or completing the baseline assessment\n* has donated blood within the past 30 days\n* is unable to swallow whole or large tablets or capsules\n* is unable/unwilling to remain at the study center for the 6 hour inpatient observation period.\n* participation in an investigational study within the past 30 days of screening\n* prior participation in this trial\n* 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.'}, 'identificationModule': {'nctId': 'NCT02113566', 'acronym': 'DOMS', 'briefTitle': 'A Study Comparing the Efficacy and Safety of Orally Administered Ibuprofen and Placebo in Delayed Onset Muscle Soreness', 'organization': {'class': 'OTHER', 'fullName': 'Jean Brown Research'}, 'officialTitle': 'A Double-Blind, Repeat-Dose, Parallel Group Study Comparing the Efficacy and Safety of Orally Administered Ibuprofen and Placebo in Delayed Onset Muscle Soreness.', 'orgStudyIdInfo': {'id': 'JBR-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': '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.', 'interventionNames': ['Drug: Acetaminophen 1000mg']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Ibuprofen', 'description': '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.', 'interventionNames': ['Drug: Acetaminophen 1000mg']}], 'interventions': [{'name': 'Acetaminophen 1000mg', 'type': 'DRUG', 'otherNames': ['Tylenol'], 'description': '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.', 'armGroupLabels': ['Ibuprofen', 'Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '84124', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'Jean Brown Research', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}], 'overallOfficials': [{'name': 'Derek Muse, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Jean Brown Research'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jean Brown Research', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Derek Muse, MD', 'investigatorFullName': 'Derek Muse', 'investigatorAffiliation': 'Jean Brown Research'}}}}