AZD2066 Neuropathic Pain - Mechanical Hypersensitivity (NP-MH)

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

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.

Study Overview

• Status: Terminated
• Conditions: Neuropathic Pain; Mechanical Hypersensitivity
• Intervention / Treatment: Drug: AZD2066; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 87
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Tucson, Arizona, United States
      • Research Site
  • California
    • Los Angeles, California, United States
      • Research Site
    • Sacramento, California, United States
      • Research Site
    • San Francisco, California, United States
      • Research Site
    • Walnut Creek, California, United States
      • Research Site
  • Colorado
    • Boulder, Colorado, United States
      • Research Site
  • Florida
    • Atlantis, Florida, United States
      • Research Site
    • Aventura, Florida, United States
      • Research Site
    • Clearwater, Florida, United States
      • Research Site
    • Fort Myers, Florida, United States
      • Research Site
    • Orlando, Florida, United States
      • Research Site
    • Palm Beach Gardens, Florida, United States
      • Research Site
    • Sarasota, Florida, United States
      • Research Site
    • St Petersburg, Florida, United States
      • Research Site
    • Sunrise, Florida, United States
      • Research Site
  • Georgia
    • Canton, Georgia, United States
      • Research Site
    • Marietta, Georgia, United States
      • Research Site
  • Indiana
    • Evansville, Indiana, United States
      • Research Site
  • Louisiana
    • New Orleans, Louisiana, United States
      • Research Site
  • Massachusetts
    • Brockton, Massachusetts, United States
      • Research Site
  • Michigan
    • Bingham Farms, Michigan, United States
      • Research Site
  • Nevada
    • Las Vegas, Nevada, United States
      • Research Site
    • Reno, Nevada, United States
      • Research Site
  • New Jersey
    • Lumberton, New Jersey, United States
      • Research Site
    • Willingboro, New Jersey, United States
      • Research Site
  • New Mexico
    • Albuquerque, New Mexico, United States
      • Research Site
  • North Carolina
    • Jacksonville, North Carolina, United States
      • Research Site
    • Winston-salem, North Carolina, United States
      • Research Site
  • Ohio
    • Kettering, Ohio, United States
      • Research Site
  • Oregon
    • Portland, Oregon, United States
      • Research Site
  • Pennsylvania
    • Bridgeville, Pennsylvania, United States
      • Research Site
    • Philadelphia, Pennsylvania, United States
      • Research Site
  • Texas
    • Austin, Texas, United States
      • Research Site
    • Dallas, Texas, United States
      • Research Site
    • Irving, Texas, United States
      • Research Site
    • Lexington, Texas, United States
      • Research Site
    • Longview, Texas, United States
      • Research Site
    • San Antonio, Texas, United States
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: A	Drug: AZD2066; Capsule, once daily
Placebo Comparator: B	Drug: Placebo; Capsule, once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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 Measures

Outcome Measure	Measure Description	Time Frame
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	28 days
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	28 days
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	28 days
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.	28 days
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.	28 days
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.	28 days
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.	28 days

Collaborators and Investigators

• Sponsor: AstraZeneca
• Collaborators: Quintiles, Inc.
• Investigators: Study Director: Biljana Lilja, AstraZeneca R&D Södertälje151 85 Södertälje, Sweden; Principal Investigator: Brett Stacey, Oregon Health and Science University Comprehensive Pain Clinic, Portland, OR 97239, USA

Study record dates

Study Major Dates

• Study Start: August 1, 2009
• Primary Completion (Actual): November 1, 2010
• Study Completion (Actual): November 1, 2010

Study Registration Dates

• First Submitted: July 13, 2009
• First Submitted That Met QC Criteria: July 13, 2009
• First Posted (Estimate): July 14, 2009

Study Record Updates

• Last Update Posted (Estimate): September 27, 2012
• Last Update Submitted That Met QC Criteria: August 28, 2012
• Last Verified: August 1, 2012

More Information

Terms related to this study

• Keywords: Efficacy; analgesia; Allodynia; Neuropathic; Pain, Mechanical Hypersensitivity
• Additional Relevant MeSH Terms: Nervous System Diseases; Immune System Diseases; Pain; Neurologic Manifestations; Neuromuscular Diseases; Peripheral Nervous System Diseases; Hypersensitivity; Neuralgia
• Other Study ID Numbers: D0475C00016