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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00976534
Recruitment Status : Terminated (The study was terminated due to results in another study (NCT00878501).)
First Posted : September 14, 2009
Last Update Posted : December 23, 2009
Information provided by:

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.

Condition or disease Intervention/treatment Phase
Pain Neuropathic Pain Drug: AZD1386 Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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)
Study Start Date : September 2009
Estimated Study Completion Date : February 2010

Arm Intervention/treatment
Experimental: 1 Drug: AZD1386
90 mg, capsules, oral, during 3 weeks

Placebo Comparator: 2 Drug: Placebo
capsules, oral, during 3 weeks

Primary Outcome Measures :
  1. Change from baseline in NRS pain (12 h-recall) [ Time Frame: Morning and evening 12 hour recall ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00976534

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Canada, Alberta
Research Site
Calgary, Alberta, Canada
Canada, Nova Scotia
Research Site
Halifax, Nova Scotia, Canada
Canada, Ontario
Research Site
Toronto, Ontario, Canada
Research Site
Alborg, Denmark
Research Site
Arhus C, Denmark
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
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Study Director: Richard L Leff, md AstraZeneca R&D Wilmington, USA
Study Chair: Rolf Karlsten, MD AstraZeneca R&D Södertälje, Sweden

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Responsible Party: AstraZeneca Pharmaceuticals, AstraZeneca Identifier: NCT00976534     History of Changes
Other Study ID Numbers: D5090C00018
First Posted: September 14, 2009    Key Record Dates
Last Update Posted: December 23, 2009
Last Verified: December 2009

Keywords provided by AstraZeneca:
Analgesic effect
Peripheral Neuropathic pain
Posttraumatic Neuralgia (PTN)
Postherpetic Neuralgia (PHN)

Additional relevant MeSH terms:
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Neuralgia, Postherpetic
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms