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
1 other identifier
interventional
87
1 country
38
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Aug 2009
Shorter than P25 for phase_2
38 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 13, 2009
CompletedFirst Posted
Study publicly available on registry
July 14, 2009
CompletedStudy Start
First participant enrolled
August 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2010
CompletedResults Posted
Study results publicly available
September 27, 2012
CompletedSeptember 27, 2012
August 1, 2012
1.3 years
July 13, 2009
August 28, 2012
August 28, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (7)
Patients With ≥30% Reduction From Baseline in NRS Pain Intensity Score (Responder Rate) at Day 28
28 days
Patients With ≥50% Reduction From Baseline in NRS Pain Intensity Score (Responder Rate) at Day 28
28 days
Patients With Patient Global Impression of Change (PGIC) Score of at Least "Much Improved" (Responder Rate) at Day 28
28 days
Change in Short Form McGill Pain Questionnaire (SF-MPQ) Sensory Index From Baseline to Day 28
28 days
Change in SF-MPQ Affective Index From Baseline to Day 28
28 days
- +2 more secondary outcomes
Study Arms (2)
A
EXPERIMENTALB
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
- Quintiles, Inc.collaborator
Study Sites (38)
Research Site
Tucson, Arizona, United States
Research Site
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
Boulder, Colorado, United States
Research Site
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
Canton, Georgia, United States
Research Site
Marietta, Georgia, United States
Research Site
Evansville, Indiana, United States
Research Site
New Orleans, Louisiana, United States
Research Site
Brockton, Massachusetts, United States
Research Site
Bingham Farms, Michigan, United States
Research Site
Las Vegas, Nevada, United States
Research Site
Reno, Nevada, United States
Research Site
Lumberton, New Jersey, United States
Research Site
Willingboro, New Jersey, United States
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Albuquerque, New Mexico, United States
Research Site
Jacksonville, North Carolina, United States
Research Site
Winston-Salem, North Carolina, United States
Research Site
Kettering, Ohio, United States
Research Site
Portland, Oregon, United States
Research Site
Bridgeville, Pennsylvania, United States
Research Site
Philadelphia, Pennsylvania, United States
Research Site
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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Early termination of study for safety reasons leading to fewer subjects analyzed than originally planned.
Results Point of Contact
- Title
- Gerard Lynch
- Organization
- AstraZeneca
Study Officials
- 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
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 13, 2009
First Posted
July 14, 2009
Study Start
August 1, 2009
Primary Completion
November 1, 2010
Study Completion
November 1, 2010
Last Updated
September 27, 2012
Results First Posted
September 27, 2012
Record last verified: 2012-08