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

Sponsor:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00976534

Purpose

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.

Condition	Intervention	Phase
Pain Neuropathic Pain	Drug: AZD1386 Drug: Placebo	Phase 2

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

Resource links provided by NLM:

MedlinePlus related topics: Shingles

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Change from baseline in NRS pain (12 h-recall) [ Time Frame: Morning and evening 12 hour recall ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]

Estimated Enrollment:	90
Study Start Date:	September 2009
Estimated Study Completion Date:	February 2010

Arms	Assigned Interventions
Experimental: 1	Drug: AZD1386 90 mg, capsules, oral, during 3 weeks
Placebo Comparator: 2	Drug: Placebo capsules, oral, during 3 weeks

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00976534

Locations

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

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:	Richard L Leff, md	AstraZeneca R&D Wilmington, USA
Study Chair:	Rolf Karlsten, MD	AstraZeneca R&D Södertälje, Sweden

More Information

No publications provided

Responsible Party:	AstraZeneca Pharmaceuticals, AstraZeneca
ClinicalTrials.gov Identifier:	NCT00976534 History of Changes
Other Study ID Numbers:	D5090C00018
Study First Received:	September 9, 2009
Last Updated:	December 21, 2009
Health Authority:	United States: Food and Drug Administration

Keywords provided by AstraZeneca:

Analgesic effect
Peripheral Neuropathic pain
Posttraumatic Neuralgia (PTN)
Postherpetic Neuralgia (PHN)

Additional relevant MeSH terms:

Neuralgia
Neuralgia, Postherpetic
Pain
Neurologic Manifestations

Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on May 23, 2012