Ignite Creation Date:
2025-12-25 @ 3:03 AM
Ignite Modification Date:
2025-12-31 @ 2:49 AM
Study NCT ID:
NCT00372333
Status:
COMPLETED
Last Update Posted:
2009-03-20
First Post:
2006-09-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
IDEA-033 Open Label Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018771', 'term': 'Arthralgia'}, {'id': 'D059352', 'term': 'Musculoskeletal Pain'}], 'ancestors': [{'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal 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': 'D009135', 'term': 'Muscular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 491}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-03', 'completionDateStruct': {'date': '2008-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-03-19', 'studyFirstSubmitDate': '2006-09-04', 'studyFirstSubmitQcDate': '2006-09-05', 'lastUpdatePostDateStruct': {'date': '2009-03-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-09-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'description of AE profile'}, {'measure': 'changes in laboratory values'}, {'measure': 'IDEA-033 plasma levels'}, {'measure': 'visual assessment of skin at target area(s)'}, {'measure': 'physical exam'}, {'measure': 'vital signs'}], 'secondaryOutcomes': [{'measure': 'evaluation of efficacy by real time feedback'}]}, 'conditionsModule': {'keywords': ['musculoskeletal pain; soft tissue inflammation; IDEA-033'], 'conditions': ['Joint Pain', 'Musculoskeletal Pain', 'Stiffness', 'Soft Tissue Inflammation in Designated Target Area(s)']}, 'descriptionModule': {'briefSummary': 'The main aim of the study is to evaluate safety, efficacy, compliance, and usage of epicutaneously applied IDEA-033 in joint / musculoskeletal pain or soft tissue inflammation.', 'detailedDescription': 'Multi-centre, one arm, multiple dose, open-label, at home usage study. Adult volunteers experiencing joint pain, musculoskeletal pain, stiffness, or soft tissue inflammation will be screened for study participation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* at least 18 years or older\n* agree to refrain from chronic usage of NSAIDs or any other analgesics or anti-inflammatory drugs other than those provided during the course of the study or documented sporadic concomitant analgesics\n* joint pain, musculoskeletal pain, stiffness, or soft tissue inflammation in designated target area(s) that are appropriate for self-treatment with a topical analgesic or where availability of a second person can be guaranteed in case self-treatment is not possible\n* healthy skin in the target area(s)\n\nExclusion Criteria:\n\n* known hypersensitivity to IDEA-033 or other NSAIDs\n* history of coagulation disorders\n* history of peptic ulcers or gastric intolerance with NSAIDs\n* urinary tract infection\n* clinically significant renal, hepatic, or gastric disease\n* acute or chronic coexisting illness qualifying for exclusion according to clinical judgement of the investigator\n* clinical laboratory values outside normal range deemed clinically significant by the investigator\n* Narcotics-containing products within 7 days of administering IMP\n* Malignancy within the past 2 years'}, 'identificationModule': {'nctId': 'NCT00372333', 'briefTitle': 'IDEA-033 Open Label Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'IDEA AG'}, 'officialTitle': 'A Multiple-Dose, Open-Label Safety, Compliance, and Usage Evaluation Study of Epicutaneously Applied IDEA-033 in Joint / Musculoskeletal Pain or Soft Tissue Inflammation', 'orgStudyIdInfo': {'id': 'CL-033-III-01'}}, 'armsInterventionsModule': {'interventions': [{'name': 'IDEA-033', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '82166', 'city': 'Gräfelfing', 'state': 'Bavaria', 'country': 'Germany', 'facility': 'X-pert med GmbH / Ilka Rother', 'geoPoint': {'lat': 48.11878, 'lon': 11.42939}}], 'overallOfficials': [{'name': 'Ilka Rother', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'X-pert-med GmbH Munich'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'IDEA AG', 'class': 'INDUSTRY'}}}}