Ignite Creation Date:
2025-12-25 @ 2:50 AM
Ignite Modification Date:
2026-03-06 @ 5:54 AM
Study NCT ID:
NCT00625833
Status:
TERMINATED
Last Update Posted:
2019-12-13
First Post:
2008-02-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Trial Of [S,S]-Reboxetine In Patients With Chronic Painful Diabetic Peripheral Neuropathy.
Sponsor:
Organization:
Raw JSON
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Some evidence for the effectiveness of \\[S,S\\]- Reboxetine in relieving chronic pain has been seen in 3 completed trials.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female of any race at least 18 years of age\n* Diagnosis of painful, distal, symmetrical, sensory-motor polyneuropathy, which is due to diabetes, for at least 1 year\n* Patients at Visit 1 must have a score ≥40 mm on the Pain Visual Analogue Scale\n\nExclusion Criteria:\n\n* Patients with significant hepatic impairment\n* Neurological disorders unrelated to diabetic neuropathy that may confuse the assessment of neuropathic pain\n* Any pain or other condition that may confound assessment or self-evaluation of the pain due to diabetic neuropathy\n* Amputations other than toes\n* A current or recent diagnosis (past 6 months) or episode of major depressive disorder and/or uncontrolled depression\n* History of transient ischemic attack or stroke\n* Myocardial infarction or unstable angina within the past three months'}, 'identificationModule': {'nctId': 'NCT00625833', 'briefTitle': 'A Trial Of [S,S]-Reboxetine In Patients With Chronic Painful Diabetic Peripheral Neuropathy.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A Randomized, Double-Blind Placebo Controlled Trial Of [S,S]-Reboxetine In Patients With Chronic Painful Diabetic Peripheral Neuropathy.', 'orgStudyIdInfo': {'id': 'A6061037'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': '2', 'interventionNames': ['Drug: [S,S]-Reboxetine']}], 'interventions': [{'name': 'Placebo', 'type': 'DRUG', 'description': 'Oral tablet once a day dosing for 10 weeks.', 'armGroupLabels': ['Placebo']}, {'name': '[S,S]-Reboxetine', 'type': 'DRUG', 'description': 'Oral tablet 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