Viewing Study NCT00354094


Ignite Creation Date: 2025-12-25 @ 1:46 AM
Ignite Modification Date: 2025-12-26 @ 3:44 AM
Study NCT ID: NCT00354094
Status: TERMINATED
Last Update Posted: 2007-11-08
First Post: 2006-07-18
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: [S,S]-Reboxetine Long Term Safety Study In Post-Shingles Pain.
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': {'count': 600}}, 'statusModule': {'whyStopped': 'The study was stopped due to business/operational issues.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2006-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-11', 'completionDateStruct': {'date': '2007-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2007-11-07', 'studyFirstSubmitDate': '2006-07-18', 'studyFirstSubmitQcDate': '2006-07-18', 'lastUpdatePostDateStruct': {'date': '2007-11-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-07-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Vital signs'}, {'measure': 'Physical examination'}, {'measure': '12-lead ECG'}, {'measure': 'Hematology/Biochemistry'}, {'measure': 'Adverse events'}], 'secondaryOutcomes': [{'measure': 'Pain Visual Analogue Scale'}, {'measure': 'Patient Global Impression of Change'}, {'measure': 'Neuropathic Pain Symptom Inventory'}, {'measure': 'Modified Brief Pain Inventory - Short Form'}, {'measure': 'SF-12 Health Survey'}, {'measure': 'EQ-5D'}, {'measure': 'Analgesic Treatment Satisfaction Scale'}, {'measure': 'Pain-related Medication Utilization'}]}, 'conditionsModule': {'conditions': ['Pain']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A6061030&StudyName=%5BS%2CS%5D-Reboxetine%20Long%20Term%20Safety%20Study%20In%20Post-Shingles%20Pain.', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the long term (up to 2 years) safety and tolerability of \\[S,S\\]-Reboxetine in patients with pain after shingles.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients must have pain present for more than 3 months after healing of the shingles skin rash.\n* Patients at screening must have a score of \\>/=40mm on the pain visual analogue scale.\n\nExclusion Criteria:\n\n* Patients with significant hepatic impairment.\n* Patients with other severe pain, that may impair the self-assessment of pain due to postherpetic neuralgia (pain after shingles).'}, 'identificationModule': {'nctId': 'NCT00354094', 'briefTitle': '[S,S]-Reboxetine Long Term Safety Study In Post-Shingles Pain.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A Phase 2B Long-Term, Randomized, Open-Label, Safety And Tolerability Trial Comparing [S,S]-Reboxetine (PNU-165442g) With Routine Care In Patients With Postherpetic Neuralgia (PHN).', 'orgStudyIdInfo': {'id': 'A6061030'}}, 'armsInterventionsModule': {'interventions': [{'name': '[S,S]-Reboxetine', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '33606', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '33407', 'city': 'West Palm Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 26.71534, 'lon': -80.05337}}, {'zip': '27401', 'city': 'Greensboro', 'state': 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