Clinical trial NCT00939094: AZD2066 Neuropathic Pain - Mechanical Hypersensitivity
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
Overall status: TERMINATED
Phase: PHASE2
Conditions: Neuropathic Pain
Mechanical Hypersensitivity
Keywords: Pain, Mechanical Hypersensitivity
Allodynia
Efficacy
analgesia
Neuropathic
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: Quintiles, Inc.
First posted: 2009-07-14
Enrollment: 87
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Change in Mean Numerical Rating Scale (NRS) Pain Score From Baseline to Last 5 Days on Treatment
timeFrame: 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:
measure: Patients With ≥30% Reduction From Baseline in NRS Pain Intensity Score (Responder Rate) at Day 28
timeFrame: 28 days
measure: Patients With ≥50% Reduction From Baseline in NRS Pain Intensity Score (Responder Rate) at Day 28
timeFrame: 28 days
measure: Patients With Patient Global Impression of Change (PGIC) Score of at Least "Much Improved" (Responder Rate) at Day 28
timeFrame: 28 days
measure: Change in Short Form McGill Pain Questionnaire (SF-MPQ) Sensory Index From Baseline to Day 28
timeFrame: 28 days
measure: Change in SF-MPQ Affective Index From Baseline to Day 28
timeFrame: 28 days
measure: Change in Brief Pain Inventory-Short Form (BPI-SF) Pain Severity From Baseline to Day 28
timeFrame: 28 days
measure: Change in BPI-SF Pain Interference From Baseline to Day 28
timeFrame: 28 days
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Research Site
state: Arizona
city: Los Angeles
country: United States
facility: Research Site
state: California
city: Sacramento
country: United States
facility: Research Site
state: California
city: San Francisco
country: United States
facility: Research Site
state: California
city: Walnut Creek
country: United States
facility: Research Site
state: California
city: Boulder
country: United States
facility: Research Site
state: Colorado
city: Atlantis
country: United States
facility: Research Site
state: Florida
city: Aventura
country: United States
facility: Research Site
state: Florida
city: Clearwater
country: United States
facility: Research Site
state: Florida
city: Fort Myers
country: United States
facility: Research Site
state: Florida
city: Orlando
country: United States
facility: Research Site
state: Florida
city: Palm Beach Gardens
country: United States
facility: Research Site
state: Florida
city: Sarasota
country: United States
facility: Research Site
state: Florida
city: St Petersburg
country: United States
facility: Research Site
state: Florida
city: Sunrise
country: United States
facility: Research Site
state: Florida
city: Canton
country: United States
facility: Research Site
state: Georgia
city: Marietta
country: United States
facility: Research Site
state: Georgia
city: Evansville
country: United States
facility: Research Site
state: Indiana
city: New Orleans
country: United States
facility: Research Site
state: Louisiana
city: Brockton
country: United States
facility: Research Site
state: Massachusetts
city: Bingham Farms
country: United States
facility: Research Site
state: Michigan
city: Las Vegas
country: United States
facility: Research Site
state: Nevada
city: Reno
country: United States
facility: Research Site
state: Nevada
city: Lumberton
country: United States
facility: Research Site
state: New Jersey
city: Willingboro
country: United States
facility: Research Site
state: New Jersey
city: Albuquerque
country: United States
facility: Research Site
state: New Mexico
city: Jacksonville
country: United States
facility: Research Site
state: North Carolina
city: Winston-salem
country: United States
facility: Research Site
state: North Carolina
city: Kettering
country: United States
facility: Research Site
state: Ohio
city: Portland
country: United States
facility: Research Site
state: Oregon
city: Bridgeville
country: United States
facility: Research Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: Research Site
state: Pennsylvania
city: Austin
country: United States
facility: Research Site
state: Texas
city: Dallas
country: United States
facility: Research Site
state: Texas
city: Irving
country: United States
facility: Research Site
state: Texas
city: Lexington
country: United States
facility: Research Site
state: Texas
city: Longview
country: United States
facility: Research Site
state: Texas
city: San Antonio
country: United States
facility: Research Site
state: Texas
Study officials:
affiliation: AstraZeneca R&D Södertälje151 85 Södertälje, Sweden
name: Biljana Lilja
role: STUDY_DIRECTOR
affiliation: Oregon Health and Science University Comprehensive Pain Clinic, Portland, OR 97239, USA
name: Brett Stacey
role: PRINCIPAL_INVESTIGATOR
References: