Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been terminated.
(The study was terminated due to results in another study (NCT00878501).)
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00976534
First received: September 9, 2009
Last updated: December 21, 2009
Last verified: December 2009

September 9, 2009
December 21, 2009
September 2009
Not Provided
Change from baseline in NRS pain (12 h-recall) [ Time Frame: Morning and evening 12 hour recall ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00976534 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Study to Evaluate Efficacy, Safety, Tolerability and Pharmacokinetics of AZD1386 in Patients With Peripheral Neuropathic Pain
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)

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
  • Pain
  • Neuropathic Pain
  • Drug: AZD1386
    90 mg, capsules, oral, during 3 weeks
  • Drug: Placebo
    capsules, oral, during 3 weeks
  • Experimental: 1
    Intervention: Drug: AZD1386
  • Placebo Comparator: 2
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
90
February 2010
Not Provided

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Canada,   Denmark,   France,   United Kingdom
 
NCT00976534
D5090C00018
No
AstraZeneca Pharmaceuticals, AstraZeneca
AstraZeneca
Not Provided
Study Director: Richard L Leff, md AstraZeneca R&D Wilmington, USA
Study Chair: Rolf Karlsten, MD AstraZeneca R&D Södertälje, Sweden
AstraZeneca
December 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP