search
Back to results

AZD2066 Neuropathic Pain - Mechanical Hypersensitivity (NP-MH)

Primary Purpose

Neuropathic Pain, Mechanical Hypersensitivity

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
AZD2066
Placebo
Sponsored by
AstraZeneca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neuropathic Pain focused on measuring Pain, Mechanical Hypersensitivity, Allodynia, Efficacy, analgesia, Neuropathic

Eligibility Criteria

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

Inclusion Criteria:

  • Provision of informed consent prior to any study specific procedures.
  • Male or non-fertile females
  • Painful symptoms due to neuropathic pain for a period of 3 months to 5 years, associated with mechanical allodynia and/or punctate hyperalgesia.

Exclusion Criteria:

  • Other pain that may confound assessment of neuropathic pain.
  • Diagnosis of any severe neurological disease.
  • History of significant psychiatric disease/condition and/or history of psychotic disorders among first degree relatives.

Sites / Locations

  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

A

B

Arm Description

Outcomes

Primary Outcome Measures

Change in Mean Numerical Rating Scale (NRS) Pain Score From Baseline to Last 5 Days on Treatment
Mean pain intensity for 5-day baseline period (morning Day -5 to evening Day-1) and mean pain intensity for last 5 days on treatment (ie, last dose day and the 4 preceding calendar days) was calculated based on the NRS scale (0-10). 0=No pain, 10=Worst pain imaginable.

Secondary Outcome Measures

Patients With ≥30% Reduction From Baseline in NRS Pain Intensity Score (Responder Rate) at Day 28
NRS pain intensity score reduction=(change from baseline at Day 28/baseline)*100 Responder=pain intensity score reduction ≥30% (yes/no)? Responder rate=(no. of responders/total no. of patients)*100
Patients With ≥50% Reduction From Baseline in NRS Pain Intensity Score (Responder Rate) at Day 28
Pain intensity score reduction=(change from baseline Day 28/baseline)*100 Responder=pain intensity score reduction ≥50% (Yes/No)? Responder rate=(no. of responders/total no. of patients)*100
Patients With Patient Global Impression of Change (PGIC) Score of at Least "Much Improved" (Responder Rate) at Day 28
PGIC scale ranges from 1-7 where 1=Very much improved and 7=Very much worse Responder=Patient with a response of " much improved" or "very much improved" Responder rate=(no. of responders/total no. of patients)*100
Change in Short Form McGill Pain Questionnaire (SF-MPQ) Sensory Index From Baseline to Day 28
Sensory index=sum of the intensity scale values of the words chosen for the descriptors 1-11 in the questionnaire. Range of scores for the sensory index=0-33 (higher score represents a worse condition). Change from baseline (measured prior to randomization) to Day 28 was calculated.
Change in SF-MPQ Affective Index From Baseline to Day 28
Affective index=sum of the intensity scale values of the words chosen for the descriptors 12-15 in the questionnaire. Range of scores for the affective index=0-12 (higher score represents a worse condition). Change from baseline (measured prior to randomization) to Day 28 was calculated.
Change in Brief Pain Inventory-Short Form (BPI-SF) Pain Severity From Baseline to Day 28
Change from baseline (measured prior to randomization) to Day 28 was calculated for the pain severity (mean of 4 intensity items). Each intensity item is recorded on a NRS 0-10, where 0=No Pain and 10=Pain as bad as you can imagine.
Change in BPI-SF Pain Interference From Baseline to Day 28
Change from baseline (measured prior to randomization) to Day 28 was calculated for pain interference (mean of 7 interference items). Each interference item is recorded on a NRS 0-10, where 0=No interference and 10=Interferes completely.

Full Information

First Posted
July 13, 2009
Last Updated
August 28, 2012
Sponsor
AstraZeneca
Collaborators
Quintiles, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT00939094
Brief Title
AZD2066 Neuropathic Pain - Mechanical Hypersensitivity
Acronym
NP-MH
Official Title
A Phase IIa, Double-Blind, Randomised, Parallel-Group, Multi-Centre Study to Evaluate the Analgesic Efficacy of 28 Days Oral Administration of AZD2066 Compared to Placebo in Peripheral Neuropathic Pain Patients With Mechanical Hypersensitivity
Study Type
Interventional

2. Study Status

Record Verification Date
August 2012
Overall Recruitment Status
Terminated
Study Start Date
August 2009 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
November 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
Collaborators
Quintiles, Inc.

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to investigate if 28 days of treatment with AZD2066 compared to placebo can relieve the pain arising from the nervous system when the patients are touched by something that should not cause pain or have severe pain when they are touched by something that should only cause a little pain.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuropathic Pain, Mechanical Hypersensitivity
Keywords
Pain, Mechanical Hypersensitivity, Allodynia, Efficacy, analgesia, Neuropathic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
87 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Title
B
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
AZD2066
Intervention Description
Capsule, once daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Capsule, once daily
Primary Outcome Measure Information:
Title
Change in Mean Numerical Rating Scale (NRS) Pain Score From Baseline to Last 5 Days on Treatment
Description
Mean pain intensity for 5-day baseline period (morning Day -5 to evening Day-1) and mean pain intensity for last 5 days on treatment (ie, last dose day and the 4 preceding calendar days) was calculated based on the NRS scale (0-10). 0=No pain, 10=Worst pain imaginable.
Time Frame
Change in mean pain intensity from 5-day baseline to the last 5 days on treatment, measure twice daily with NRS (12-hour recall)
Secondary Outcome Measure Information:
Title
Patients With ≥30% Reduction From Baseline in NRS Pain Intensity Score (Responder Rate) at Day 28
Description
NRS pain intensity score reduction=(change from baseline at Day 28/baseline)*100 Responder=pain intensity score reduction ≥30% (yes/no)? Responder rate=(no. of responders/total no. of patients)*100
Time Frame
28 days
Title
Patients With ≥50% Reduction From Baseline in NRS Pain Intensity Score (Responder Rate) at Day 28
Description
Pain intensity score reduction=(change from baseline Day 28/baseline)*100 Responder=pain intensity score reduction ≥50% (Yes/No)? Responder rate=(no. of responders/total no. of patients)*100
Time Frame
28 days
Title
Patients With Patient Global Impression of Change (PGIC) Score of at Least "Much Improved" (Responder Rate) at Day 28
Description
PGIC scale ranges from 1-7 where 1=Very much improved and 7=Very much worse Responder=Patient with a response of " much improved" or "very much improved" Responder rate=(no. of responders/total no. of patients)*100
Time Frame
28 days
Title
Change in Short Form McGill Pain Questionnaire (SF-MPQ) Sensory Index From Baseline to Day 28
Description
Sensory index=sum of the intensity scale values of the words chosen for the descriptors 1-11 in the questionnaire. Range of scores for the sensory index=0-33 (higher score represents a worse condition). Change from baseline (measured prior to randomization) to Day 28 was calculated.
Time Frame
28 days
Title
Change in SF-MPQ Affective Index From Baseline to Day 28
Description
Affective index=sum of the intensity scale values of the words chosen for the descriptors 12-15 in the questionnaire. Range of scores for the affective index=0-12 (higher score represents a worse condition). Change from baseline (measured prior to randomization) to Day 28 was calculated.
Time Frame
28 days
Title
Change in Brief Pain Inventory-Short Form (BPI-SF) Pain Severity From Baseline to Day 28
Description
Change from baseline (measured prior to randomization) to Day 28 was calculated for the pain severity (mean of 4 intensity items). Each intensity item is recorded on a NRS 0-10, where 0=No Pain and 10=Pain as bad as you can imagine.
Time Frame
28 days
Title
Change in BPI-SF Pain Interference From Baseline to Day 28
Description
Change from baseline (measured prior to randomization) to Day 28 was calculated for pain interference (mean of 7 interference items). Each interference item is recorded on a NRS 0-10, where 0=No interference and 10=Interferes completely.
Time Frame
28 days

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: Provision of informed consent prior to any study specific procedures. Male or non-fertile females Painful symptoms due to neuropathic pain for a period of 3 months to 5 years, associated with mechanical allodynia and/or punctate hyperalgesia. Exclusion Criteria: Other pain that may confound assessment of neuropathic pain. Diagnosis of any severe neurological disease. History of significant psychiatric disease/condition and/or history of psychotic disorders among first degree relatives.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Biljana Lilja
Organizational Affiliation
AstraZeneca R&D Södertälje151 85 Södertälje, Sweden
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Brett Stacey
Organizational Affiliation
Oregon Health and Science University Comprehensive Pain Clinic, Portland, OR 97239, USA
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Site
City
Tucson
State/Province
Arizona
Country
United States
Facility Name
Research Site
City
Los Angeles
State/Province
California
Country
United States
Facility Name
Research Site
City
Sacramento
State/Province
California
Country
United States
Facility Name
Research Site
City
San Francisco
State/Province
California
Country
United States
Facility Name
Research Site
City
Walnut Creek
State/Province
California
Country
United States
Facility Name
Research Site
City
Boulder
State/Province
Colorado
Country
United States
Facility Name
Research Site
City
Atlantis
State/Province
Florida
Country
United States
Facility Name
Research Site
City
Aventura
State/Province
Florida
Country
United States
Facility Name
Research Site
City
Clearwater
State/Province
Florida
Country
United States
Facility Name
Research Site
City
Fort Myers
State/Province
Florida
Country
United States
Facility Name
Research Site
City
Orlando
State/Province
Florida
Country
United States
Facility Name
Research Site
City
Palm Beach Gardens
State/Province
Florida
Country
United States
Facility Name
Research Site
City
Sarasota
State/Province
Florida
Country
United States
Facility Name
Research Site
City
St Petersburg
State/Province
Florida
Country
United States
Facility Name
Research Site
City
Sunrise
State/Province
Florida
Country
United States
Facility Name
Research Site
City
Canton
State/Province
Georgia
Country
United States
Facility Name
Research Site
City
Marietta
State/Province
Georgia
Country
United States
Facility Name
Research Site
City
Evansville
State/Province
Indiana
Country
United States
Facility Name
Research Site
City
New Orleans
State/Province
Louisiana
Country
United States
Facility Name
Research Site
City
Brockton
State/Province
Massachusetts
Country
United States
Facility Name
Research Site
City
Bingham Farms
State/Province
Michigan
Country
United States
Facility Name
Research Site
City
Las Vegas
State/Province
Nevada
Country
United States
Facility Name
Research Site
City
Reno
State/Province
Nevada
Country
United States
Facility Name
Research Site
City
Lumberton
State/Province
New Jersey
Country
United States
Facility Name
Research Site
City
Willingboro
State/Province
New Jersey
Country
United States
Facility Name
Research Site
City
Albuquerque
State/Province
New Mexico
Country
United States
Facility Name
Research Site
City
Jacksonville
State/Province
North Carolina
Country
United States
Facility Name
Research Site
City
Winston-salem
State/Province
North Carolina
Country
United States
Facility Name
Research Site
City
Kettering
State/Province
Ohio
Country
United States
Facility Name
Research Site
City
Portland
State/Province
Oregon
Country
United States
Facility Name
Research Site
City
Bridgeville
State/Province
Pennsylvania
Country
United States
Facility Name
Research Site
City
Philadelphia
State/Province
Pennsylvania
Country
United States
Facility Name
Research Site
City
Austin
State/Province
Texas
Country
United States
Facility Name
Research Site
City
Dallas
State/Province
Texas
Country
United States
Facility Name
Research Site
City
Irving
State/Province
Texas
Country
United States
Facility Name
Research Site
City
Lexington
State/Province
Texas
Country
United States
Facility Name
Research Site
City
Longview
State/Province
Texas
Country
United States
Facility Name
Research Site
City
San Antonio
State/Province
Texas
Country
United States

12. IPD Sharing Statement

Learn more about this trial

AZD2066 Neuropathic Pain - Mechanical Hypersensitivity

We'll reach out to this number within 24 hrs