AZD2066 Neuropathic Pain - Mechanical Hypersensitivity

Neuropathic Pain Clinical Trial

— 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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00939094
• Other study ID #: D0475C00016
• Status: Terminated
• Phase: Phase 2
• First received: July 13, 2009
• Last updated: August 28, 2012
• Start date: August 2009
• Est. completion date: November 2010

Study information

• Verified date: August 2012
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 87
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypersensitivity
• Mechanical Hypersensitivity
• Neuralgia
• Neuropathic Pain

Intervention

Drug:
• AZD2066
Capsule, once daily
• Placebo
Capsule, once daily

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
AstraZeneca	Quintiles, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No