Study to Evaluate Efficacy, Safety, Tolerability and Pharmacokinetics of AZD1386 in Patients With Peripheral Neuropathic Pain

Phase 2TerminatedNCT00976534

AstraZeneca90 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Pain Neuropathic Pain

Interventions

AZD1386DRUG

90 mg, capsules, oral, during 3 weeks

PlaceboDRUG

capsules, oral, during 3 weeks

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (12)

Research Site

Calgary, Alberta, Canada

Research Site

Halifax, Nova Scotia, Canada

Research Site

Toronto, Ontario, Canada

Research Site

Aalborg, Denmark

Outcomes

Primary Outcomes

Change from baseline in NRS pain (12 h-recall)

Time frame: Morning and evening 12 hour recall

Secondary Outcomes

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

Time frame: 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

Time frame: 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

Time frame: Day 1 and 22

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.