Ignite Creation Date:
2025-12-25 @ 4:54 AM
Ignite Modification Date:
2026-01-25 @ 12:51 AM
Study NCT ID:
NCT01438918
Status:
WITHDRAWN
Last Update Posted:
2012-01-25
First Post:
2011-09-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
X-Ray Study Investigating The Safety And Efficacy Of SD-6010 In Subjects With Osteoarthritis Of The Knee
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020370', 'term': 'Osteoarthritis, Knee'}, {'id': 'D010003', 'term': 'Osteoarthritis'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C578791', 'term': 'cindunistat'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2012-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-01', 'completionDateStruct': {'date': '2015-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-01-24', 'studyFirstSubmitDate': '2011-09-13', 'studyFirstSubmitQcDate': '2011-09-20', 'lastUpdatePostDateStruct': {'date': '2012-01-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-09-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To assess the progression rate of joint space narrowing in the study knee of subjects with knee OA over a 24-month period', 'timeFrame': '24 months'}], 'secondaryOutcomes': [{'measure': 'Clinical benefit of SD 6010 will be measured from changes in response from baseline to 24 months in 7 patient reported outcomes (PRO), including, but not limited to, WOMAC, pain VAS, ICOAP, KOOS.', 'timeFrame': '24 months'}, {'measure': 'Total analgesic medication burden for OA in the study knee will be compared back to baseline of an increased, sustained use of standard background and/or rescue medication for more than 30 days as measured at the Month 12 and 24 visits', 'timeFrame': '24 months'}, {'measure': 'Safety: Change from baseline to M24 in vital signs (blood pressure, heart rate) measurements will be assessed', 'timeFrame': '24 months'}, {'measure': 'Safety: Change from baseline to M24 in ECG abnormalities', 'timeFrame': '24 months'}, {'measure': 'Safety: In a subset of subjects: Change from baseline on average as assessed by 24-h ambulatory blood pressure monitoring (ABPM) at months 3 and 6', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Knee', 'Osteoarthritis', 'X-ray', 'Joint Space Narrowing'], 'conditions': ['Knee Osteoarthritis']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A6171017&StudyName=X-Ray%20Study%20Investigating%20The%20Safety%20And%20Efficacy%20Of%20SD-6010%20In%20Subjects%20With%20Osteoarthritis%20Of%20The%20Knee', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'The objective of this 2-year study is to evaluate the safety, tolerability and disease modifying efficacy of SD 6010, an inhibitor of inducible nitric oxide synthase (iNOS). The efficacy of SD-6010 will be evaluated by radiography using joint space narrowing in the medial tibiofemoral compartment of the study knee as the primary endpoint.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nSubjects aged \\>= 40 years Diagnosed with knee OA (ACR definition of OA) Radiographic evidence of OA in the study knee\n\nExclusion Criteria:\n\nA diagnosis of any other rheumatic disease Current conditions in the study knee that would confound efficacy Selected, traditional clinical safety and laboratory parameters'}, 'identificationModule': {'nctId': 'NCT01438918', 'briefTitle': 'X-Ray Study Investigating The Safety And Efficacy Of SD-6010 In Subjects With Osteoarthritis Of The Knee', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A Long-term, Confirmatory, Phase 3, Randomized, Double-Blind, Parallel Group, Placebo-Controlled Study To Investigate The Safety And Efficacy Of Orally Administered Sd-6010 In Subjects With Symptomatic Osteoarthritis Of The Knee', 'orgStudyIdInfo': {'id': 'A6171017'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '200 mg', 'description': 'High dose active comparator', 'interventionNames': ['Drug: SD-6010']}, {'type': 'ACTIVE_COMPARATOR', 'label': '50 mg', 'description': 'Low dose active comparator', 'interventionNames': ['Drug: SD-6010']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo comparator to be used for control purposes', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'SD-6010', 'type': 'DRUG', 'description': '200 mg tablets once a day for 2 years', 'armGroupLabels': ['200 mg']}, {'name': 'SD-6010', 'type': 'DRUG', 'description': '50 mg tablets once a day for 2 years', 'armGroupLabels': ['50 mg']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo tablets once a day for 2 years', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}