Ignite Creation Date:
2025-12-25 @ 2:27 AM
Ignite Modification Date:
2026-02-10 @ 1:36 AM
Study NCT ID:
NCT00976534
Status:
TERMINATED
Last Update Posted:
2009-12-23
First Post:
2009-09-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Evaluate Efficacy, Safety, Tolerability and Pharmacokinetics of AZD1386 in Patients With Peripheral Neuropathic Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009437', 'term': 'Neuralgia'}, {'id': 'D051474', 'term': 'Neuralgia, Postherpetic'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C574562', 'term': 'AZD1386'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'whyStopped': 'The study was terminated due to results in another study (NCT00878501).', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2009-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-12', 'completionDateStruct': {'date': '2010-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2009-12-21', 'studyFirstSubmitDate': '2009-09-09', 'studyFirstSubmitQcDate': '2009-09-11', 'lastUpdatePostDateStruct': {'date': '2009-12-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-09-14', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in NRS pain (12 h-recall)', 'timeFrame': 'Morning and evening 12 hour recall'}], 'secondaryOutcomes': [{'measure': 'Response rate, defined as any of the following:NRS (12 h recall) reduced by 30% compared to baseline and NRS (12 h recall) reduced by 50% compared to baseline', 'timeFrame': 'Morning and evening 12 hour recall'}, {'measure': 'Response rate, defined as any of the following: At least "much improved" on Patient Global Impression of Change global and at least "much improved" on PGIC pain', 'timeFrame': 'Day 8, 15 and 22'}, {'measure': 'Response rate, defined as any of the following: Change from baseline in Brief Pain Inventory Short Form and Change from baseline in Pain Quality Assessment Scale', 'timeFrame': 'Day 1 and 22'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Analgesic effect', 'Peripheral Neuropathic pain', 'Posttraumatic Neuralgia (PTN)', 'Postherpetic Neuralgia (PHN)'], 'conditions': ['Pain', 'Neuropathic Pain']}, 'descriptionModule': {'briefSummary': 'The primary aim of this study is to investigate if AZD1386 is efficacious as an analgesic in patients with peripheral neuropathic pain. This will be done by comparing the effect of AZD1386 to placebo ("inactive substance") on pain.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with painful symptoms due to neuropathic pain\n* Provision of signed informed consent\n* Non pregnant females\n\nExclusion Criteria:\n\n* Other pain conditions that may confound assessment of neuropathic pain, as judged by the investigator\n* History, and/or presence of somatic disease, which may interfere with the objectives of the study as judged by the investigator'}, 'identificationModule': {'nctId': 'NCT00976534', 'acronym': 'AVANT', 'briefTitle': 'Study to Evaluate Efficacy, Safety, Tolerability and Pharmacokinetics of AZD1386 in Patients With Peripheral Neuropathic Pain', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A Phase IIa Randomised, Double-blind, Placebo Controlled, Parallel Group, Multicentre Study Evaluating the Efficacy, Safety, Tolerability and Pharmacokinetics of AZD1386 After 3 Weeks of Treatment in Patients With Posttraumatic Neuralgia (PTN) and Postherpetic Neuralgia (PHN)', 'orgStudyIdInfo': {'id': 'D5090C00018'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Drug: AZD1386']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'AZD1386', 'type': 'DRUG', 'description': '90 mg, capsules, oral, during 3 weeks', 'armGroupLabels': ['1']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'capsules, oral, during 3 weeks', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Calgary', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Research Site', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}, {'city': 'Halifax', 'state': 'Nova Scotia', 'country': 'Canada', 'facility': 'Research Site', 'geoPoint': {'lat': 44.64269, 'lon': -63.57688}}, {'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Research Site', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'city': 'Aalborg', 'country': 'Denmark', 'facility': 'Research Site', 'geoPoint': {'lat': 57.048, 'lon': 9.9187}}, {'city': 'Arhus C', 'country': 'Denmark', 'facility': 'Research Site'}, {'city': 'Boulogne-Billancourt', 'country': 'France', 'facility': 'Research Site', 'geoPoint': {'lat': 48.83545, 'lon': 2.24128}}, {'city': 'Clermont-Ferrand', 'country': 'France', 'facility': 'Research Site', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}, {'city': 'Nice', 'country': 'France', 'facility': 'Research Site', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}, {'city': 'Bradford', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 53.79391, 'lon': -1.75206}}, {'city': 'Glasgow', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 55.86515, 'lon': -4.25763}}, {'city': 'London', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'city': 'Manchester', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}], 'overallOfficials': [{'name': 'Richard L Leff, md', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AstraZeneca R&D Wilmington, USA'}, {'name': 'Rolf Karlsten, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'AstraZeneca R&D Södertälje, Sweden'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'AstraZeneca Pharmaceuticals', 'oldOrganization': 'AstraZeneca'}}}}