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Study Of Pregabalin (Lyrica) In Patients With Painful Diabetic Peripheral Neuropathy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01057693
First received: January 26, 2010
Last updated: January 18, 2013
Last verified: January 2013
Results First Received: January 18, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Diabetic Neuropathy, Painful
Interventions: Drug: pregabalin (Lyrica)
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Pregabalin SB Participants who were inadequately controlled on their current diabetic peripheral neuropathy (DPN) treatment were switched to single-blind (SB) pregabalin capsules at a starting dose of 150 milligram per day (mg/day) and increased to 300 mg/day, administered three times daily up to Week 6. Participants who experienced greater than or equal to (>=) 30 percent (%) pain reduction from baseline to Week 6 were eligible for double-blind (DB) treatment phase.
Pregabalin DB Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received pregabalin capsules 150 mg/day or 300 mg/day, administered three times daily up to Week 19 during DB treatment phase.
Placebo Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received matching placebo capsules, administered three times daily up to Week 19 during DB treatment phase.

Participant Flow for 3 periods

Period 1:   Single-Blind Phase (Up to Week 6)
    Pregabalin SB     Pregabalin DB     Placebo  
STARTED     665     0     0  
COMPLETED     566     0     0  
NOT COMPLETED     99     0     0  
Adverse Event                 45                 0                 0  
Lack of Efficacy                 7                 0                 0  
Lost to Follow-up                 14                 0                 0  
Protocol Violation                 9                 0                 0  
Withdrawal by Subject                 22                 0                 0  
Unspecified                 2                 0                 0  

Period 2:   Between Single-Blind and Double-Blind
    Pregabalin SB     Pregabalin DB     Placebo  
STARTED     566     0     0  
COMPLETED     296     0     0  
NOT COMPLETED     270     0     0  
Adverse Event                 5                 0                 0  
Lack of Efficacy                 247                 0                 0  
Lost to Follow-up                 1                 0                 0  
Protocol Violation                 7                 0                 0  
Withdrawal by Subject                 4                 0                 0  
Unspecified                 6                 0                 0  

Period 3:   Double-Blind Phase (Week 7 to Week 19)
    Pregabalin SB     Pregabalin DB     Placebo  
STARTED     0     147     149  
Treated     0     147     147  
COMPLETED     0     125     113  
NOT COMPLETED     0     22     36  
Adverse Event                 0                 8                 11  
Lack of Efficacy                 0                 3                 8  
Lost to Follow-up                 0                 2                 5  
Protocol Violation                 0                 0                 4  
Withdrawal by Subject                 0                 8                 6  
Unspecified                 0                 1                 0  
Randomized, Not Treated                 0                 0                 2  



  Baseline Characteristics
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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.
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Reporting Groups
  Description
Pregabalin SB Participants who were inadequately controlled on their current DPN treatment were switched to SB pregabalin capsules at a starting dose of 150 mg/day and increased to 300 mg/day, administered three times daily up to Week 6. Participants who experienced >=30% pain reduction from baseline to Week 6 were eligible for DB treatment phase.

Baseline Measures
    Pregabalin SB  
Number of Participants  
[units: participants]
  665  
Age, Customized  
[units: participants]
 
18 to 44 Years     58  
45 to 64 Years     417  
>=65 Years     190  
Gender  
[units: participants]
 
Female     302  
Male     363  



  Outcome Measures
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1.  Primary:   Change From Single-Blind Baseline in Mean Pain Score at Week 19 During Double-Blind Phase   [ Time Frame: SB Baseline, Week 19 (DB Phase) ]

2.  Secondary:   Time to Loss of Pain Response (Double-Blind Phase)   [ Time Frame: SB Baseline up to Week 19 ]

3.  Secondary:   Change From Single-Blind Baseline in Mean Pain Score at Week 6 During Single-Blind Phase   [ Time Frame: SB Baseline, Week 6 (SB Phase) ]

4.  Secondary:   Weekly Mean Pain Scores (Single-Blind Phase)   [ Time Frame: Week 1, 2, 3, 4, 5, 6 ]

5.  Secondary:   Weekly Mean Pain Scores (Double-Blind Phase)   [ Time Frame: DB Baseline, Week 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19 ]

6.  Secondary:   Percentage of Participants With At Least 30 Percent and 50 Percent Reduction in Mean Pain Score (Single-Blind Phase)   [ Time Frame: Week 6 ]

7.  Secondary:   Percentage of Participants With At Least 30 Percent and 50 Percent Reduction in Mean Pain Score (Double-Blind Phase)   [ Time Frame: Week 19 ]

8.  Secondary:   Patient Global Impression of Change (PGIC) (Single-Blind Phase)   [ Time Frame: Week 6 ]

9.  Secondary:   Patient Global Impression of Change (PGIC) (Double-Blind Phase)   [ Time Frame: Week 19 ]

10.  Secondary:   Medical Outcomes Study -Sleep Scale (MOS-SS) (Single-Blind Phase)   [ Time Frame: SB Baseline, Week 6 ]

11.  Secondary:   Medical Outcomes Study -Sleep Scale (MOS-SS) (Double-Blind Phase)   [ Time Frame: Week 19 ]

12.  Secondary:   Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study-Sleep Scale (MOS-SS) (Single-Blind Phase)   [ Time Frame: SB Baseline, Week 6 ]

13.  Secondary:   Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study-Sleep Scale (MOS-SS) (Double-Blind Phase)   [ Time Frame: Week 19 ]

14.  Secondary:   Weekly Mean Sleep Interference Score (Single-Blind Phase)   [ Time Frame: SB Baseline, Week 1, 2, 3, 4, 5, 6 ]

15.  Secondary:   Weekly Mean Sleep Interference Score (Double-Blind Phase)   [ Time Frame: DB Baseline, Week 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19 ]

16.  Secondary:   Endpoint Mean Sleep Interference Score (Single-Blind Phase)   [ Time Frame: Week 6 ]

17.  Secondary:   Endpoint Mean Sleep Interference Score (Double-Blind Phase)   [ Time Frame: Week 19 ]

18.  Secondary:   Quality of Life Questionnaire– Diabetic Neuropathy (QOL-DN) (Single-Blind Phase)   [ Time Frame: SB Baseline, Week 6 ]

19.  Secondary:   Quality of Life Questionnaire– Diabetic Neuropathy (QOL-DN) (Double-Blind Phase)   [ Time Frame: Week 19 ]

20.  Secondary:   Pain Visual Analog Scale (VAS) (Single-Blind Phase)   [ Time Frame: SB Baseline, Week 6 ]

21.  Secondary:   Pain Visual Analog Scale (VAS) (Double-Blind Phase)   [ Time Frame: Week 19 ]

22.  Secondary:   Brief Pain Inventory-Short Form (BPI-sf) (Single-Blind Phase)   [ Time Frame: SB Baseline, Week 6 ]

23.  Secondary:   Brief Pain Inventory-Short Form (BPI-sf) (Double-Blind Phase)   [ Time Frame: Week 19 ]

24.  Secondary:   Hospital Anxiety and Depression Scale (HADS) (Single-Blind Phase)   [ Time Frame: SB Baseline, Week 6 ]

25.  Secondary:   Hospital Anxiety and Depression Scale (HADS) (Double-Blind Phase)   [ Time Frame: Week 19 ]

26.  Secondary:   Patient Global Evaluation of Study Medication (GESM) (Single-Blind Phase)   [ Time Frame: Week 6 ]

27.  Secondary:   Patient Global Evaluation of Study Medication (GESM) (Double-Blind Phase)   [ Time Frame: Week 19 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  More Information
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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: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.gov_Inquiries@pfizer.com


No publications provided


Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01057693     History of Changes
Other Study ID Numbers: A0081242
Study First Received: January 26, 2010
Results First Received: January 18, 2013
Last Updated: January 18, 2013
Health Authority: United States: Food and Drug Administration