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)

AstraZeneca1 site in 1 country90 target enrollmentSeptember 2009

ConditionsPain Neuropathic Pain

InterventionsAZD1386 Placebo

DrugsAZD1386 Placebo

Overview

Phase: Phase 2
Intervention: AZD1386
Conditions: Pain
Sponsor: AstraZeneca
Enrollment: 90
Locations: 1
Primary Endpoint: Change from baseline in NRS pain (12 h-recall)
Status: Terminated
Last Updated: 16 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

September 2009

End Date

February 2010

Last Updated

16 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

AstraZeneca

Eligibility Criteria

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

Arms & Interventions

1

Intervention: AZD1386

2

Intervention: Placebo

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(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)