Ignite Creation Date:
2025-12-24 @ 5:53 PM
Ignite Modification Date:
2026-02-20 @ 6:24 PM
Study NCT ID:
NCT00991068
Status:
COMPLETED
Last Update Posted:
2012-03-16
First Post:
2009-10-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Open-Label Study Evaluating Synera® in the Treatment of Patients With Carpal Tunnel Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002349', 'term': 'Carpal Tunnel Syndrome'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D020423', 'term': 'Median Neuropathy'}, {'id': 'D020422', 'term': 'Mononeuropathies'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009408', 'term': 'Nerve Compression Syndromes'}, {'id': 'D012090', 'term': 'Cumulative Trauma Disorders'}, {'id': 'D013180', 'term': 'Sprains and Strains'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008012', 'term': 'Lidocaine'}, {'id': 'D013748', 'term': 'Tetracaine'}, {'id': 'D057968', 'term': 'Transdermal Patch'}], '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'}, {'id': 'D062366', 'term': 'para-Aminobenzoates'}, {'id': 'D062365', 'term': 'Aminobenzoates'}, {'id': 'D001565', 'term': 'Benzoates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-03', 'dispFirstSubmitDate': '2012-03-14', 'completionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-03-14', 'studyFirstSubmitDate': '2009-10-06', 'dispFirstSubmitQcDate': '2012-03-14', 'studyFirstSubmitQcDate': '2009-10-06', 'dispFirstPostDateStruct': {'date': '2012-03-16', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2012-03-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-10-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain intensity', 'timeFrame': 'Screening/Day 1, Day 8, and Day 15 or early withdrawal'}], 'secondaryOutcomes': [{'measure': 'Pain interference with activities (general, normal work, sleep)', 'timeFrame': 'Screening/Day 1, Day 8, and Day 15 or early withdrawal'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Pain', 'Mild to moderate Carpal Tunnel Syndrome'], 'conditions': ['Carpal Tunnel Syndrome']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to explore the potential usefulness of Synera for the treatment of pain associated with mild to moderate carpal tunnel syndrome.', 'detailedDescription': 'ZARS Pharma, Inc. has developed Synera® (lidocaine 70 mg and tetracaine 70 mg topical patch), a drug delivery patch that utilizes controlled heat to enhance the delivery of a local anesthetic formulation consisting of a eutectic mixture of lidocaine and tetracaine. Synera was approved by the Food and Drug Administration (FDA) on June 23, 2005 and is indicated for use on intact skin to provide local dermal analgesia for superficial venous access and superficial dermatological procedures such as excision, electrodesiccation, and shave biopsy of skin lesions.\n\nThe purpose of this single center, 2-week open-label pilot study is to explore the potential usefulness of Synera for the treatment of pain associated with mild to moderate CTS.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pain associated with mild to moderate carpal tunnel syndrome in a single wrist\n* Have recent (within 3 months) electrodiagnostic evidence of carpal tunnel syndrome (CTS)\n\nExclusion Criteria:\n\n* Have bilateral carpal tunnel syndrome\n* Have another peripheral neuropathy in the affected limb\n* Have had an injection into the carpal tunnel within 8 weeks\n* Have had surgical release of the target wrist within previous 6 months\n* Have electrodiagnostic evidence of severe CTS\n\nOther protocol-defined inclusion/exclusion criteria may apply'}, 'identificationModule': {'nctId': 'NCT00991068', 'briefTitle': 'Open-Label Study Evaluating Synera® in the Treatment of Patients With Carpal Tunnel Syndrome', 'organization': {'class': 'INDUSTRY', 'fullName': 'ZARS Pharma Inc.'}, 'officialTitle': 'An Open-Label Pilot Study Evaluating Synera® in the Treatment of Patients With Carpal Tunnel Syndrome', 'orgStudyIdInfo': {'id': 'SC-201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Synera', 'description': 'Synera topical patch', 'interventionNames': ['Drug: Synera (lidocaine 70 mg and tetracaine 70 mg) topical patch']}], 'interventions': [{'name': 'Synera (lidocaine 70 mg and tetracaine 70 mg) topical patch', 'type': 'DRUG', 'description': 'Patients will apply a single Synera patch to the target wrist for 2 hours twice a day (ie, morning and evening applications) for 14 days.', 'armGroupLabels': ['Synera']}]}, 'contactsLocationsModule': {'locations': [{'zip': '66211', 'city': 'Overland Park', 'state': 'Kansas', 'country': 'United States', 'facility': 'International Clinical Research Institute', 'geoPoint': {'lat': 38.98223, 'lon': -94.67079}}], 'overallOfficials': [{'name': 'Srinivas Nalamachu, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'International Clinical Research Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ZARS Pharma Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}