Ignite Creation Date:
2025-12-26 @ 10:56 AM
Ignite Modification Date:
2026-02-25 @ 8:31 PM
Study NCT ID:
NCT00576108
Status:
COMPLETED
Last Update Posted:
2008-07-22
First Post:
2007-12-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A 2 Week Study of Topical KD7040 in the Treatment of Postherpetic Neuralgia (PHN)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051474', 'term': 'Neuralgia, Postherpetic'}, {'id': 'D006562', 'term': 'Herpes Zoster'}, {'id': 'D009437', 'term': 'Neuralgia'}], 'ancestors': [{'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D000073618', 'term': 'Varicella Zoster Virus Infection'}, {'id': 'D006566', 'term': 'Herpesviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-07', 'completionDateStruct': {'date': '2008-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-07-18', 'studyFirstSubmitDate': '2007-12-14', 'studyFirstSubmitQcDate': '2007-12-17', 'lastUpdatePostDateStruct': {'date': '2008-07-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-12-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Worst daily pain', 'timeFrame': 'Once daily'}], 'secondaryOutcomes': [{'measure': 'Average daily pain', 'timeFrame': 'Once daily'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Postherpetic Neuralgia', 'Shingles', 'Herpes Zoster', 'Neuropathic Pain']}, 'descriptionModule': {'briefSummary': 'This study will evaluate the safety and efficacy of 2 weeks of topical KD7040 versus placebo in the treatment of postherpetic neuralgia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male or female subjects ages 18-85 years\n* Previous diagnosis of Shingles (Herpes Zoster) with pain persisting for at least 3 months, but not longer than 5 years, after healing of rash\n* Subject with intact skin in the targeted treatment area\n* Female subjects of childbearing potential must have a negative serum pregnancy test at screening, a negative urine human chorionic gonadotropin (hCG) test prior to randomization, and must use medically acceptable methods of birth control. All subjects must agree to take every precaution to ensure that pregnancy will not occur during the study.\n* Subject must be willing and able to complete screening and study procedures as described int he protocol.\n* Subject must voluntarily provide written Informed Consent prior to participation.\n\nExclusion Criteria:\n\n* Subjects with known hypersensitivity to KD7040 or methylparaben, or previous exposure to KD7040.\n* Subjects pregnant, nursing or planning to become pregnant.\n* Subjects who are immunocompromised or have clinically significant hematological abnormalities.\n* Subjects with system dermatological conditions (e.g., psoriasis, atopic dermatitis) or impaired wound healing.\n* Subjects who have had local anesthetic nerve blocks within 48 hours of study entry.\n* Subjects having other sever pain which may confound assessment of PHN.\n* Subjects who have serious, unstable, or clinically significant medical or psychological conditions, which, in the opinion of the Investigator(s) would compromise the subjects' participation in the study."}, 'identificationModule': {'nctId': 'NCT00576108', 'briefTitle': 'A 2 Week Study of Topical KD7040 in the Treatment of Postherpetic Neuralgia (PHN)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Kalypsys, Inc.'}, 'orgStudyIdInfo': {'id': 'KD7040-NP02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'KD7040 topical gel', 'interventionNames': ['Drug: KD7040 Topical Gel']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo gel', 'interventionNames': ['Drug: Placebo gel']}], 'interventions': [{'name': 'KD7040 Topical Gel', 'type': 'DRUG', 'description': 'KD7040 topical gel', 'armGroupLabels': ['KD7040 topical gel']}, {'name': 'Placebo gel', 'type': 'DRUG', 'description': 'Placebo gel', 'armGroupLabels': ['Placebo gel']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': 'United Bioscience Corporation', 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kalypsys, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Kalypsys, Inc.', 'oldOrganization': 'Kalypsys, Inc.'}}}}