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

Pain Clinical Trial

— AVANT  

Official title:

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00976534
• Other study ID #: D5090C00018
• Status: Terminated
• Phase: Phase 2
• First received: September 9, 2009
• Last updated: December 21, 2009
• Start date: September 2009
• Est. completion date: February 2010

Study information

• Verified date: December 2009
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 90
• Est. completion date: February 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neuralgia
• Neuralgia, Postherpetic
• Neuropathic Pain
• Pain

Intervention

Drug:
• AZD1386
90 mg, capsules, oral, during 3 weeks
• Placebo
capsules, oral, during 3 weeks

Locations

Country	Name	City	State
Canada	Research Site	Calgary	Alberta
Canada	Research Site	Halifax	Nova Scotia
Canada	Research Site	Toronto	Ontario
Denmark	Research Site	Alborg
Denmark	Research Site	Arhus C
France	Research Site	Boulogne Billancourt
France	Research Site	Clermont Ferrand
France	Research Site	Nice
United Kingdom	Research Site	Bradford
United Kingdom	Research Site	Glasgow
United Kingdom	Research Site	London
United Kingdom	Research Site	Manchester

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

Canada,  Denmark,  France,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in NRS pain (12 h-recall)		Morning and evening 12 hour recall	No
Secondary	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	No
Secondary	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	No
Secondary	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	No