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

Primary Purpose

Pain, Neuropathic Pain

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
AZD1386
Placebo
Sponsored by
AstraZeneca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain focused on measuring Analgesic effect, Peripheral Neuropathic pain, Posttraumatic Neuralgia (PTN), Postherpetic Neuralgia (PHN)

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Research Site
  • Research Site
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  • Research Site
  • Research Site
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Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

Outcomes

Primary Outcome Measures

Change from baseline in NRS pain (12 h-recall)

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
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
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

Full Information

First Posted
September 9, 2009
Last Updated
December 21, 2009
Sponsor
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT00976534
Brief Title
Study to Evaluate Efficacy, Safety, Tolerability and Pharmacokinetics of AZD1386 in Patients With Peripheral Neuropathic Pain
Acronym
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)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2009
Overall Recruitment Status
Terminated
Why Stopped
The study was terminated due to results in another study (NCT00878501).
Study Start Date
September 2009 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
AstraZeneca

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Neuropathic Pain
Keywords
Analgesic effect, Peripheral Neuropathic pain, Posttraumatic Neuralgia (PTN), Postherpetic Neuralgia (PHN)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
AZD1386
Intervention Description
90 mg, capsules, oral, during 3 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
capsules, oral, during 3 weeks
Primary Outcome Measure Information:
Title
Change from baseline in NRS pain (12 h-recall)
Time Frame
Morning and evening 12 hour recall
Secondary Outcome Measure Information:
Title
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
Title
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
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard L Leff, md
Organizational Affiliation
AstraZeneca R&D Wilmington, USA
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Rolf Karlsten, MD
Organizational Affiliation
AstraZeneca R&D Södertälje, Sweden
Official's Role
Study Chair
Facility Information:
Facility Name
Research Site
City
Calgary
State/Province
Alberta
Country
Canada
Facility Name
Research Site
City
Halifax
State/Province
Nova Scotia
Country
Canada
Facility Name
Research Site
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
Research Site
City
Alborg
Country
Denmark
Facility Name
Research Site
City
Arhus C
Country
Denmark
Facility Name
Research Site
City
Boulogne Billancourt
Country
France
Facility Name
Research Site
City
Clermont Ferrand
Country
France
Facility Name
Research Site
City
Nice
Country
France
Facility Name
Research Site
City
Bradford
Country
United Kingdom
Facility Name
Research Site
City
Glasgow
Country
United Kingdom
Facility Name
Research Site
City
London
Country
United Kingdom
Facility Name
Research Site
City
Manchester
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

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