Study to Evaluate the Analgesic Efficacy of 28 Days' Oral Administration of AZD2066 Compared With Placebo in Patients With Painful Diabetic Neuropathy

Pain Clinical Trial

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 With Placebo in Patients With Painful Diabetic Neuropathy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00857623
• Other study ID #: D0475C00009
• Status: Completed
• Phase: Phase 2
• First received: February 27, 2009
• Last updated: November 8, 2012
• Start date: February 2009
• Est. completion date: August 2009

Study information

• Verified date: November 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 AZD2066 can relieve the pain arising from painful diabetic neuropathy compared to placebo.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 127
• Est. completion date: August 2009
• Est. primary completion date: August 2009
• 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.

• Clinical diagnosis of painful diabetic neuropathy.

• non-fertile females

Exclusion Criteria:

• Other pain that may confound assessment of neuropathic pain.

• Ongoing significant peripheral arterial diseases, skin ulcers, or amputation in the lower extremities.

• 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

• Diabetic Neuropathies
• Diabetic Neuropathy
• Pain

Intervention

Drug:
• AZD2066
Capsule, once daily, 12 mg AZD2066 day 1-4 and 18 mg AZD2066 day 5-28.
• Placebo
Capsule, once daily

Locations

Country	Name	City	State
United States	Reasearch Site	Albany	New York
United States	Reserach Site	Bella Vista	Arkansas
United States	Research Site	Bingham Farms	Michigan
United States	Research Site	Clearwater	Florida
United States	Research Site	Deland	Florida
United States	Research Site	Houston	Texas
United States	Research Site	Indiana	Pennsylvania
United States	Research Site	Lauderdale Lakes	Florida
United States	Research Site	Madisonville	Kentucky
United States	Research Site	Miami	Florida
United States	Research Site	National City	California
United States	Research Site	Orlando	Florida
United States	Research Site	Owing Mills	Maryland
United States	Research Site	Pembroke Pines	Florida
United States	Research Site	Philadelphia	Pennsylvania
United States	Research Site	San Antonio	Texas
United States	Research Site	Walnut Creek	California
United States	Research Site	Willingboro	New Jersey
United States	Research Site	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Mean Numerical Rating Scale (NRS) Score From Baseline to Last 5 Days of Treatment	Change of mean pain intensity from 5-day baseline to the last 5 days of treatment, measured twice daily with NRS (12 hours recall).; Mean pain intensity for 5-day baseline period (evening Day -6 to moning 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 numerical rating scale (NRS)(0-10). 0=No pain, 10=Worst pain imaginable.	From baseline to day 28	No
Secondary	Daily Numerical Rating Scale (NRS) Pain Scores and Change From Baseline Over Time to Day 28.	Mean pain intensity per day (mean of morning and evening NRS values) and change from baseline were calculated for each study day. Baseline value= mean pain intensity for the 5-day baseline period. NRS scale (0- 10) where 0= No pain and 10= Worst pain imaginable.	From baseline to 28 days	No
Secondary	Number of Patients With >=30% Reduction From Baseline in Numerical Rating Scale (NRS) Pain Intensity Score at Day 28	Pain intensity score reduction=(change from baseline at D28/baseline)*100 Responder= pain intensity score reduction =30% (yes/no)? Responder rate= (no. of responders/total no. of patients)*100	28 days	No
Secondary	Number of Patients With >=50% Reduction From Baseline in Numerical Rating Scale (NRS) Pain Intensity Score at Day 28	Pain intensity score reduction= (change from baseline D28/baseline)*100 Responder=pain intensity score reduction =50% (Yes/No)? Responder rate= (no. of responders/total no. of patients)*100	28 days	No
Secondary	Number of Patients With Patient Global Impression of Change (PGIC) Score of at Least "Much Improved" at Day 28.	Patient Global Impression of Change (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 McGill Pain Questionnaire Short Form (MPQ-SF) 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.	From baseline to day 28.	No
Secondary	Change in McGill Pain Questionnaire Short Form (MPQ-SF) 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.	From baseline to day 28.	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 Numerical rating Scale (NRS) 0-10, where 0=No pain and 10= The worst pain.	From baseline to day 28..	No
Secondary	Change in Brief Pain Inventory-Short Form (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 Numerical Rating Scale (NRS 0-10), where 0= No interference and 10= Interferes completely.	From baseline to 28 days	No