Ignite Creation Date:
2025-12-24 @ 4:03 PM
Ignite Modification Date:
2025-12-27 @ 4:59 AM
Study NCT ID:
NCT00931866
Status:
COMPLETED
Last Update Posted:
2010-08-16
First Post:
2009-06-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Diclofenac Patch for Treatment of Acute Pain Due to Mild to Moderate Soft Tissue Injuries (TAPED)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059787', 'term': 'Acute Pain'}, {'id': 'D017695', 'term': 'Soft Tissue Injuries'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004008', 'term': 'Diclofenac'}], 'ancestors': [{'id': 'D010648', 'term': 'Phenylacetates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 407}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-08', 'completionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-08-12', 'studyFirstSubmitDate': '2009-06-29', 'studyFirstSubmitQcDate': '2009-06-30', 'lastUpdatePostDateStruct': {'date': '2010-08-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-07-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in average pain during daily activity at Day 7', 'timeFrame': 'Day 7'}], 'secondaryOutcomes': [{'measure': 'Change in average pain during daily activity at Day 14', 'timeFrame': 'Day 14'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['diclofenac', 'acute pain', 'topical', 'patch', 'Acute Pain due to Mild to Moderate Soft Tissue Injury'], 'conditions': ['Acute Pain', 'Soft Tissue Injury']}, 'descriptionModule': {'briefSummary': 'The primary purpose of this study is to assess the effectiveness of once daily application of a diclofenac sodium topical patch in reducing mild to moderate soft tissue injuries when applied to the painful area.', 'detailedDescription': 'This randomized, double-blind, placebo-controlled, parallel group study will be conducted in patients with mild to moderate soft tissue injuries.\n\nEligible patients will be randomized (in a 1:1 ratio) to receive double-blind treatment with either the diclofenac topical patch or a matching placebo patch to be applied once daily for 14 days. Patients will return to the clinic for assessments on Day 3, Day 7 and Day 14; a follow-up assessment will be conducted on Day 21. Patients will complete an electronic diary in which assessments including pain intensity and pain relief will be recorded twice daily. Functional disability and global impression of change will be recorded in the diary at study visits, ratings of the quality of sleep will be recorded in the diary each morning, and the use of study treatment and rescue medication will be recorded in the diary each day.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and female subjects 18-75 years of age\n* Sustained recent, painful unilateral mild to moderate soft tissue injury (between the mid-bicep to wrist or mid-thigh to ankle)\n* Meet baseline pain criterion\n\nExclusion Criteria:\n\n* Open wound or infection at site of injury\n* Evidence of severe injury, including fracture or nerve injury\n* Use of oral NSAIDs or opioids within 12-24 hours of injury\n* Presence or history of peptic ulcers or GI bleeding\n* A history of intolerance to NSAIDs, acetaminophen, adhesives\n* Positive pregnancy test\n* Positive drug screen'}, 'identificationModule': {'nctId': 'NCT00931866', 'briefTitle': 'Diclofenac Patch for Treatment of Acute Pain Due to Mild to Moderate Soft Tissue Injuries (TAPED)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Cerimon Pharmaceuticals'}, 'officialTitle': 'A Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of a Diclofenac Sodium Patch for the Topical Treatment of Acute Pain Due to Mild to Moderate Soft Tissue Injuries', 'orgStudyIdInfo': {'id': 'DCF-006'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Diclofenac Sodium Patch', 'interventionNames': ['Drug: Diclofenac Sodium']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Topical Placebo Patch', 'interventionNames': ['Drug: Matching Placebo Patch']}], 'interventions': [{'name': 'Diclofenac Sodium', 'type': 'DRUG', 'description': 'Topical diclofenac patch applied once daily to area of pain', 'armGroupLabels': ['Diclofenac Sodium Patch']}, {'name': 'Matching Placebo Patch', 'type': 'DRUG', 'description': 'Matching placebo patch, containing identical constituents to the active comparator except for diclofenac sodium; applied once daily', 'armGroupLabels': ['Topical Placebo Patch']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'PPD', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cerimon Pharmaceuticals', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'PPD Development, LP', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Shaily J. Reichert, V.P. of Clinical Development', 'oldOrganization': 'Cerimon Pharmaceuticals'}}}}