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

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

Official Title
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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

Conditions
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Pain, Diabetic Neuropathy

Intervention / Treatment
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* Drug: AZD2066
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: AZD2066<br>* Capsule, once daily, 12 mg AZD2066 day 1-4 and 18 mg AZD2066 day 5-28.<br>|
| Placebo Comparator: 2<br> | Drug: Placebo<br>* Capsule, once daily<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pain, Diabetic Neuropathy, PDN, Analgesia, Efficacy