Ignite Creation Date:
2025-12-25 @ 1:38 AM
Ignite Modification Date:
2025-12-31 @ 5:22 PM
Study NCT ID:
NCT00348894
Status:
TERMINATED
Last Update Posted:
2011-06-01
First Post:
2006-07-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
[S,S]-Reboxetine Long Term Safety Study In Chronic Painful Diabetic Peripheral Neuropathy.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C524178', 'term': 'O-methyl reboxetine'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 136}}, 'statusModule': {'whyStopped': '\\- Study was terminated due to insufficient clinical efficacy observed in previous studies conducted in postherpetic neuralgia.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2006-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-05', 'completionDateStruct': {'date': '2007-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-05-31', 'studyFirstSubmitDate': '2006-07-04', 'studyFirstSubmitQcDate': '2006-07-04', 'lastUpdatePostDateStruct': {'date': '2011-06-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-07-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Vital signs', 'timeFrame': 'duration of study'}, {'measure': 'Physical examination', 'timeFrame': 'duration of study'}, {'measure': '12-lead ECG', 'timeFrame': 'duration of study'}, {'measure': 'Hematology/Biochemistry', 'timeFrame': 'duration of study'}, {'measure': 'Adverse events', 'timeFrame': 'duration of study'}], 'secondaryOutcomes': [{'measure': 'Pain Visual Analogue Scale', 'timeFrame': 'duration of study'}, {'measure': 'Neuropathic Pain Symptom Inventory', 'timeFrame': 'duration of study'}, {'measure': 'Modified Brief Pain Inventory-Short Form', 'timeFrame': 'duration of study'}, {'measure': 'Patient Global Impression of Change', 'timeFrame': 'duration of study'}, {'measure': 'SF-12 Health Survey', 'timeFrame': 'duration of study'}, {'measure': 'EQ-5D', 'timeFrame': 'duration of study'}, {'measure': 'Analgesic Treatment Satisfaction Scale', 'timeFrame': 'duration of study'}, {'measure': 'Pain-related Medication Utilization', 'timeFrame': 'duration of study'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Pain']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A6061031&StudyName=%5BS%2CS%5D-Reboxetine%20Long%20Term%20Safety%20Study%20In%20Chronic%20Painful%20Diabetic%20Peripheral%20Neuropathy.%0A', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to 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