Study to Evaluate the Analgesic Efficacy of 28 Days' Oral Administration of AZD2066 Compared With Placebo in Patients With Painful Diabetic Neuropathy
- Registration Number
- NCT00857623
- Lead Sponsor
- AstraZeneca
- Brief Summary
The purpose of this study is to investigate if AZD2066 can relieve the pain arising from painful diabetic neuropathy compared to placebo.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 127
- Provision of informed consent prior to any study specific procedures.
- Clinical diagnosis of painful diabetic neuropathy.
- non-fertile females
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 AZD2066 - 2 Placebo -
- Primary Outcome Measures
Name Time Method Change in Mean Numerical Rating Scale (NRS) Score From Baseline to Last 5 Days of Treatment From baseline to day 28 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.
- Secondary Outcome Measures
Name Time Method Daily Numerical Rating Scale (NRS) Pain Scores and Change From Baseline Over Time to Day 28. From baseline to 28 days 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.
Number of Patients With >=30% Reduction From Baseline in Numerical Rating Scale (NRS) Pain Intensity Score at Day 28 28 days 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
Number of Patients With >=50% Reduction From Baseline in Numerical Rating Scale (NRS) Pain Intensity Score at Day 28 28 days 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
Number of Patients With Patient Global Impression of Change (PGIC) Score of at Least "Much Improved" at Day 28. 28 days 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)\*100Change in McGill Pain Questionnaire Short Form (MPQ-SF) Sensory Index From Baseline to Day 28. 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.Change in McGill Pain Questionnaire Short Form (MPQ-SF) Affective Index From Baseline to Day 28. 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.Change in Brief Pain Inventory-Short Form (BPI-SF) Pain Severity From Baseline to Day 28. 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.
Change in Brief Pain Inventory-Short Form (BPI-SF) Pain Interference From Baseline to Day 28. From baseline to 28 days 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.
Trial Locations
- Locations (3)
Reasearch Site
🇺🇸Albany, New York, United States
Reserach Site
🇺🇸Bella Vista, Arkansas, United States
Research Site
🇺🇸San Antonio, Texas, United States