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

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ClinicalTrials.gov Identifier: NCT00857623
Recruitment Status : Completed
First Posted : March 6, 2009
Results First Posted : October 29, 2012
Last Update Posted : November 12, 2012
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Pain
Diabetic Neuropathy
Interventions Drug: AZD2066
Drug: Placebo
Enrollment 127

Recruitment Details This multicenter study was conducted between February 2009 and August 2009in the United States.
Pre-assignment Details The study consisted of a 42-day enrollment phase (including washout and baseline period), a 28-day treatment phase (10-day inpatient and 18-day outpatient) where patients were randomized to AZD2066 or placebo, and a 7-day follow-up phase. Patients randomized to treatment with AZD2066 received 12 mg from Days 1 to 4 and 18 mg from Days 5 to 28.
Arm/Group Title AZD2066 Placebo
Hide Arm/Group Description Capsule, once daily. 12 mg AZD2066 day 1-4 and 18 mg AZD2066 day 5-28. Capsule, once daily
Period Title: Overall Study
Started 62 65
Completed 48 55
Not Completed 14 10
Reason Not Completed
Adverse Event             5             2
Study-specific discontinuation criteria             5             3
Withdrawal by Subject             2             1
Lack of Efficacy             1             1
Severe non-compliance to protocol             1             1
Intake of prohibited medication             0             1
Positive for HEP C             0             1
Arm/Group Title AZD2066 Placebo Total
Hide Arm/Group Description Capsule, once daily 12 mg AZD2066 day 1-4 and 18 mg AZD2066 day 5-28 Capsule, once daily Total of all reporting groups
Overall Number of Baseline Participants 62 65 127
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 62 participants 65 participants 127 participants
59.2  (9.2) 57.0  (8.7) 58.1  (8.95)
[1]
Measure Description: All randomized patients.
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 62 participants 65 participants 127 participants
Female
26
  41.9%
31
  47.7%
57
  44.9%
Male
36
  58.1%
34
  52.3%
70
  55.1%
[1]
Measure Description: All randomized patients.
1.Primary Outcome
Title Change in Mean Numerical Rating Scale (NRS) Score From Baseline to Last 5 Days of Treatment
Hide Description

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.

Time Frame From baseline to day 28
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Per Protocol population (PP)
Arm/Group Title AZD2066 Placebo
Hide Arm/Group Description:
Capsule, once daily 12 mg AZD2066 day 1-4 and 18 mg AZD2066 day 5-28
Capsule, once daily
Overall Number of Participants Analyzed 46 51
Least Squares Mean (Standard Error)
Unit of Measure: Scores on a scale
-2.33  (0.37) -2.52  (0.36)
2.Secondary Outcome
Title Daily Numerical Rating Scale (NRS) Pain Scores and Change From Baseline Over Time to Day 28.
Hide Description 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.
Time Frame From baseline to 28 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Per Protocol population (PP)
Arm/Group Title AZD2066 Placebo
Hide Arm/Group Description:
Capsule, once daily 12 mg AZD2066 day 1-4 and 18 mg AZD2066 day 5-28
Capsule, once daily
Overall Number of Participants Analyzed 46 51
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
-2.3  (2.2) -2.5  (2.3)
3.Secondary Outcome
Title Number of Patients With >=30% Reduction From Baseline in Numerical Rating Scale (NRS) Pain Intensity Score at Day 28
Hide Description 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
Time Frame 28 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Per Protocol population (PP)
Arm/Group Title AZD2066 Placebo
Hide Arm/Group Description:
Capsule, once daily 12 mg AZD2066 day 1-4 and 18 mg AZD2066 day 5-28
Capsule, once daily
Overall Number of Participants Analyzed 46 51
Measure Type: Number
Unit of Measure: Participants
23 25
4.Secondary Outcome
Title Number of Patients With >=50% Reduction From Baseline in Numerical Rating Scale (NRS) Pain Intensity Score at Day 28
Hide Description 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
Time Frame 28 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Per Protocol population (PP)
Arm/Group Title AZD2066 Placebo
Hide Arm/Group Description:
Capsule, once daily 12 mg AZD2066 day 1-4 and 18 mg AZD2066 day 5-28
Capsule, once daily
Overall Number of Participants Analyzed 46 51
Measure Type: Number
Unit of Measure: Participants
15 15
5.Secondary Outcome
Title Number of Patients With Patient Global Impression of Change (PGIC) Score of at Least “Much Improved” at Day 28.
Hide Description

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

Time Frame 28 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Per Protocol population (PP)
Arm/Group Title AZD2066 Placebo
Hide Arm/Group Description:
Capsule, once daily 12 mg AZD2066 day 1-4 and 18 mg AZD2066 day 5-28
Capsule, once daily
Overall Number of Participants Analyzed 46 51
Measure Type: Number
Unit of Measure: Participants
20 28
6.Secondary Outcome
Title Change in McGill Pain Questionnaire Short Form (MPQ-SF) Sensory Index From Baseline to Day 28.
Hide Description

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.

Time Frame From baseline to day 28.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Per Protocol population (PP)
Arm/Group Title AZD2066 Placebo
Hide Arm/Group Description:
Capsule, once daily 12 mg AZD2066 day 1-4 and 18 mg AZD2066 day 5-28
Capsule, once daily
Overall Number of Participants Analyzed 46 51
Least Squares Mean (Standard Error)
Unit of Measure: Scores on a scale
-6.87  (0.93) -7.68  (0.88)
7.Secondary Outcome
Title Change in McGill Pain Questionnaire Short Form (MPQ-SF) Affective Index From Baseline to Day 28.
Hide Description

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.

Time Frame From baseline to day 28.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Per Protocol population (PP)
Arm/Group Title AZD2066 Placebo
Hide Arm/Group Description:
Capsule, once daily 12 mg AZD2066 day 1-4 and 18 mg AZD2066 day 5-28
Capsule, once daily
Overall Number of Participants Analyzed 46 51
Least Squares Mean (Standard Error)
Unit of Measure: Scores on a scale
-1.87  (0.35) -2.06  (0.34)
8.Secondary Outcome
Title Change in Brief Pain Inventory-Short Form (BPI-SF) Pain Severity From Baseline to Day 28.
Hide Description 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.
Time Frame From baseline to day 28..
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Per Protocol population (PP)
Arm/Group Title AZD2066 Placebo
Hide Arm/Group Description:
Capsule, once daily 12 mg AZD2066 day 1-4 and 18 mg AZD2066 day 5-28
Capsule, once daily
Overall Number of Participants Analyzed 46 51
Least Squares Mean (Standard Error)
Unit of Measure: Scores on a scale
-1.99  (0.35) -2.19  (0.34)
9.Secondary Outcome
Title Change in Brief Pain Inventory-Short Form (BPI-SF) Pain Interference From Baseline to Day 28.
Hide Description 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.
Time Frame From baseline to 28 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Per Protocol population (PP)
Arm/Group Title AZD2066 Placebo
Hide Arm/Group Description:
Capsule, once daily 12 mg AZD2066 day 1-4 and 18 mg AZD2066 day 5-28
Capsule, once daily
Overall Number of Participants Analyzed 46 51
Least Squares Mean (Standard Error)
Unit of Measure: Scores on a scale
-2.13  (0.31) -2.13  (0.30)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title AZD2066 Placebo
Hide Arm/Group Description Capsule, once daily 12 mg AZD2066 day 1-4 and 18 mg AZD2066 day 5-28 Capsule, once daily
All-Cause Mortality
AZD2066 Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
AZD2066 Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   1/62 (1.61%)   1/65 (1.54%) 
Cardiac disorders     
Cardiac failure congestive; Myocardial infarction  0/62 (0.00%)  1/65 (1.54%) 
Injury, poisoning and procedural complications     
Hip fracture  1/62 (1.61%)  0/65 (0.00%) 
1
Term from vocabulary, MedDRA 12.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
AZD2066 Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   19/62 (30.65%)   20/65 (30.77%) 
Gastrointestinal disorders     
Diarrhea  5/62 (8.06%)  6/65 (9.23%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  4/62 (6.45%)  2/65 (3.08%) 
Nervous system disorders     
Headache  9/62 (14.52%)  11/65 (16.92%) 
Dizziness  7/62 (11.29%)  4/65 (6.15%) 
1
Term from vocabulary, MedDRA 12.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
 
Results Point of Contact
Name/Title: Gerard Lynch
Organization: AstraZeneca
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00857623     History of Changes
Other Study ID Numbers: D0475C00009
First Submitted: February 27, 2009
First Posted: March 6, 2009
Results First Submitted: September 28, 2012
Results First Posted: October 29, 2012
Last Update Posted: November 12, 2012