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

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

The purpose of this study is to investigate if AZD2066 can relieve the pain arising from painful diabetic neuropathy compared to placebo.

Study Overview

• Status: Completed
• Conditions: Pain; Diabetic Neuropathy
• Intervention / Treatment: Drug: Placebo; Drug: AZD2066

• Study Type: Interventional
• Enrollment (Actual): 127
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • Bella Vista, Arkansas, United States
      • Reserach Site
  • California
    • National City, California, United States
      • Research Site
    • Walnut Creek, California, United States
      • Research Site
  • Florida
    • Clearwater, Florida, United States
      • Research Site
    • Deland, Florida, United States
      • Research Site
    • Lauderdale Lakes, Florida, United States
      • Research Site
    • Miami, Florida, United States
      • Research Site
    • Orlando, Florida, United States
      • Research Site
    • Pembroke Pines, Florida, United States
      • Research Site
  • Kentucky
    • Madisonville, Kentucky, United States
      • Research Site
  • Maryland
    • Owing Mills, Maryland, United States
      • Research Site
  • Michigan
    • Bingham Farms, Michigan, United States
      • Research Site
  • New Jersey
    • Willingboro, New Jersey, United States
      • Research Site
  • New York
    • Albany, New York, United States
      • Reasearch Site
  • North Carolina
    • Winston-Salem, North Carolina, United States
      • Research Site
  • Pennsylvania
    • Indiana, Pennsylvania, United States
      • Research Site
    • Philadelphia, Pennsylvania, United States
      • Research Site
  • Texas
    • Houston, 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.
• 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 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: 1	Drug: AZD2066; Capsule, once daily, 12 mg AZD2066 day 1-4 and 18 mg AZD2066 day 5-28.
Placebo Comparator: 2	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) 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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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.
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.
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..
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

Collaborators and Investigators

• Sponsor: AstraZeneca
• Investigators: Study Director: Biljana Lilja, AstraZeneca R&D Södertälje151 85 Södertälje, Sweden; Principal Investigator: Charles E Argoff, MD, Albany Medical , NY 12208, USA

Study record dates

Study Major Dates

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

Study Registration Dates

• First Submitted: February 27, 2009
• First Submitted That Met QC Criteria: March 5, 2009
• First Posted (Estimate): March 6, 2009

Study Record Updates

• Last Update Posted (Estimate): November 12, 2012
• Last Update Submitted That Met QC Criteria: November 8, 2012
• Last Verified: November 1, 2012

More Information

Terms related to this study

• Keywords: Pain; Efficacy; Analgesia; Diabetic Neuropathy; PDN
• Additional Relevant MeSH Terms: Nervous System Diseases; Endocrine System Diseases; Diabetes Complications; Diabetes Mellitus; Neuromuscular Diseases; Peripheral Nervous System Diseases; Diabetic Neuropathies
• Other Study ID Numbers: D0475C00009