Study to Evaluate Efficacy, Safety, Tolerability and Pharmacokinetics of AZD1386 in Patients With Peripheral Neuropathic Pain
- Registration Number
- NCT00976534
- Lead Sponsor
- AstraZeneca
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 90
Inclusion Criteria
- Patients with painful symptoms due to neuropathic pain
- Provision of signed informed consent
- Non pregnant females
Exclusion Criteria
- Other pain conditions that may confound assessment of neuropathic pain, as judged by the investigator
- History, and/or presence of somatic disease, which may interfere with the objectives of the study as judged by the investigator
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 AZD1386 - 2 Placebo -
- Primary Outcome Measures
Name Time Method Change from baseline in NRS pain (12 h-recall) Morning and evening 12 hour recall
- Secondary Outcome Measures
Name Time Method 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 Morning and evening 12 hour recall 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 Day 8, 15 and 22 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 Day 1 and 22
Trial Locations
- Locations (1)
Research Site
🇬🇧Manchester, United Kingdom