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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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
This multicenter study was conducted between February 2009 and August 2009in the United States.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
AZD2066 Capsule, once daily. 12 mg AZD2066 day 1-4 and 18 mg AZD2066 day 5-28.
Placebo Capsule, once daily

Participant Flow:   Overall Study
    AZD2066   Placebo
STARTED   62   65 
COMPLETED   48   55 
NOT COMPLETED   14   10 
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 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
AZD2066 Capsule, once daily 12 mg AZD2066 day 1-4 and 18 mg AZD2066 day 5-28
Placebo Capsule, once daily
Total Total of all reporting groups

Baseline Measures
   AZD2066   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 62   65   127 
Age [1] 
[Units: Years]
Mean (Standard Deviation)
 59.2  (9.2)   57.0  (8.7)   58.1  (8.95) 
[1] All randomized patients.
Gender [1] 
[Units: Participants]
     
Female   26   31   57 
Male   36   34   70 
[1] All randomized patients.


  Outcome Measures

1.  Primary:   Change in Mean Numerical Rating Scale (NRS) Score From Baseline to Last 5 Days of Treatment   [ Time Frame: From baseline to day 28 ]

2.  Secondary:   Daily Numerical Rating Scale (NRS) Pain Scores and Change From Baseline Over Time to Day 28.   [ Time Frame: From baseline to 28 days ]

3.  Secondary:   Number of Patients With >=30% Reduction From Baseline in Numerical Rating Scale (NRS) Pain Intensity Score at Day 28   [ Time Frame: 28 days ]

4.  Secondary:   Number of Patients With >=50% Reduction From Baseline in Numerical Rating Scale (NRS) Pain Intensity Score at Day 28   [ Time Frame: 28 days ]

5.  Secondary:   Number of Patients With Patient Global Impression of Change (PGIC) Score of at Least “Much Improved” at Day 28.   [ Time Frame: 28 days ]

6.  Secondary:   Change in McGill Pain Questionnaire Short Form (MPQ-SF) Sensory Index From Baseline to Day 28.   [ Time Frame: From baseline to day 28. ]

7.  Secondary:   Change in McGill Pain Questionnaire Short Form (MPQ-SF) Affective Index From Baseline to Day 28.   [ Time Frame: From baseline to day 28. ]

8.  Secondary:   Change in Brief Pain Inventory-Short Form (BPI-SF) Pain Severity From Baseline to Day 28.   [ Time Frame: From baseline to day 28.. ]

9.  Secondary:   Change in Brief Pain Inventory-Short Form (BPI-SF) Pain Interference From Baseline to Day 28.   [ Time Frame: From baseline to 28 days ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Gerard Lynch
Organization: AstraZeneca
e-mail: aztrial_results_posting@astrazeneca.com



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