Effect Of Pregabalin Treatment In Patients With Diabetic Nerve Pain Who Currently Use A Non-Steroid Anti-Inflammatory Drug (NSAID) For Another Pain

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01455415
First received: October 17, 2011
Last updated: April 22, 2015
Last verified: April 2015
Results First Received: October 30, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Painful Diabetic Peripheral Neuropathy
Interventions: Drug: pregabalin
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
501 participants were screened, of whom 197 were withdrawn before randomization. 304 were randomized, of whom 3 discontinued before being treated. Participants were randomized at 47 centers in 3 countries: US (43), Czech Republic (3), and Italy (1). 4 centers received study drug but did not randomize participants.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants completed daily pain and sleep diary from Visit 1 (Screening) to Visit 9. Participants with a mean pain score ≥ 4 (moderate to severe pain) and those having completed ≥ 4 daily pain dairies over past 7 days and having a mean score of ≥ 4 at Visit 2 (Baseline) were randomized.

Reporting Groups
  Description
Pregabalin/Placebo Participants were randomized to double-blind treatment with pregabalin for 6 weeks (150 - 300 mg/day) in period 1 followed by placebo in period 2. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
Placebo/Pregablin Participants were randomized to double-blind treatment with placebo for 6 weeks in period 1 followed by pregabalin in period 2 (150 - 300 mg/day). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.

Participant Flow for 4 periods

Period 1:   Period 1
    Pregabalin/Placebo     Placebo/Pregablin  
STARTED     154 [1]   147 [1]
COMPLETED     135     123  
NOT COMPLETED     19     24  
Adverse Event (AE) Related to Study Drug                 9                 6  
Lost To Follow-up Related to Study Drug                 3                 3  
Drug Error not Associated to AE                 0                 1  
AE Not Related to Study Drug                 2                 6  
Withdrawal by Subject                 4                 5  
Unspecified Reason                 1                 1  
Protocol Violation                 0                 2  
[1] Started=Treated

Period 2:   Washout
    Pregabalin/Placebo     Placebo/Pregablin  
STARTED     135     123  
COMPLETED     127     116  
NOT COMPLETED     8     7  
AE Related to Study Drug                 2                 0  
Lost to Follow-up                 1                 0  
Drug Error not Associated to AE                 2                 1  
AE Not Related to Study Drug                 2                 3  
Unspecified Reason                 1                 2  
Protocol Violation                 0                 1  

Period 3:   Period 2
    Pregabalin/Placebo     Placebo/Pregablin  
STARTED     127     116  
COMPLETED     114     106  
NOT COMPLETED     13     10  
AE Related to Study Drug                 1                 2  
Lost to Follow-up                 2                 1  
AE Not Related to Study Drug                 2                 1  
Lack of Efficacy                 2                 0  
Withdrawal by Subject                 2                 3  
Unspecified Reason                 2                 3  
Protocol Violation                 2                 0  

Period 4:   Follow-up
    Pregabalin/Placebo     Placebo/Pregablin  
STARTED     114     106  
COMPLETED     111     104  
NOT COMPLETED     3     2  
AE Related to Study Drug                 0                 1  
Lack of Efficacy                 0                 1  
Withdrawal by Subject                 2                 0  
Unspecified Reason                 1                 0  



  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.
Intent-to-Treat Population (ITT) included all randomized participants with at least one dose of study drug. The ITT population was analyzed according to what the randomization schedule intended for the participants to take in each period.

Reporting Groups
  Description
Pregabalin/Placebo Participants were randomized to double-blind treatment with pregabalin for 6 weeks (150 - 300 mg/day) in period 1 followed by placebo in period 2. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
Placebo/Pregablin Participants were randomized to double-blind treatment with placebo for 6 weeks in period 1 followed by pregabalin in period 2 (150 - 300 mg/day). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
Total Total of all reporting groups

Baseline Measures
    Pregabalin/Placebo     Placebo/Pregablin     Total  
Number of Participants  
[units: participants]
  154     147     301  
Age  
[units: years]
Mean ± Standard Deviation
  59.4  ± 9.8     58.4  ± 9.5     58.9  ± 9.7  
Gender  
[units: participants]
     
Female     65     72     137  
Male     89     75     164  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Average Diabetic Peripheral Neuropathy (DPN) Pain Based on a Numeric Rating Scale (NRS) Over the Last 7 Days of Each Treatment Period (Week 6 of Each Treatment Period)   [ Time Frame: End of Period (includes both Visits 5 and 9) ]

2.  Secondary:   Percentage of Participants Achieving 30% Reduction in Mean DPN Pain Score From Baseline at the End of Each Treatment Period (Week 6 of Each Treatment Period)   [ Time Frame: End of Period (includes both Visits 5 and 9) ]

3.  Secondary:   Percentage of Participants Achieving 50% Reduction in Mean DPN Pain Score From Baseline at the End of Each Treatment Period (Week 6 of Each Treatment Period)   [ Time Frame: End of Period (includes both Visits 5 and 9) ]

4.  Secondary:   Brief Pain Inventory-Short Form (BPI-sf) Score for Pain-Severity Domain at the End of Each Treatment Period (Week 6 of Each Treatment Period)   [ Time Frame: End of Period (includes both Visits 5 and 9) ]

5.  Secondary:   BPI-sf Score for Pain-Interference Domain at the End of Each Treatment Period (Week 6 of Each Treatment Period)   [ Time Frame: End of Period (includes both Visits 5 and 9) ]

6.  Secondary:   Mean Sleep Interference Rating Score at the End of Each Treatment Period (Week 6 of Each Treatment Period)   [ Time Frame: End of Period (includes both Visits 5 and 9) ]

7.  Secondary:   Hospital Anxiety and Depression Scale - Anxiety (HADS-A) Total Score at the End of Each Treatment Period (Week 6 of Each Treatment Period)   [ Time Frame: End of Period (includes both Visits 5 and 9) ]

8.  Secondary:   HADS-D Total Score at the End of Each Treatment Period (Week 6 of Each Treatment Period)   [ Time Frame: End of Period (includes both Visits 5 and 9) ]

9.  Secondary:   Norfolk Quality of Life-Diabetic Neuropathy (Norfolk QOL-DN) Total Quality of Life (TQOL) Score at the End of Each Treatment Period (Week 6 of Each Treatment Period)   [ Time Frame: End of Period (includes both Visits 5 and 9) ]

10.  Secondary:   Norfolk QOL-DN Symptoms Domain Score at the End of Each Treatment Period (Week 6 of Each Treatment Period)   [ Time Frame: End of Period (includes both Visits 5 and 9) ]

11.  Secondary:   Norfolk QOL-DN Activities of Daily Living Domain Score at the End of Each Treatment Period (Week 6 of Each Treatment Period)   [ Time Frame: End of Period (includes both Visits 5 and 9) ]

12.  Secondary:   Norfolk QOL-DN Physical Functioning / Large Fiber Domain Score at the End of Each Treatment Period (Week 6 of Each Treatment Period)   [ Time Frame: End of Period (includes both Visits 5 and 9) ]

13.  Secondary:   Norfolk QOL-DN Small Fiber Domain Score at the End of Each Treatment Period (Week 6 of Each Treatment Period)   [ Time Frame: End of Period (includes both Visits 5 and 9) ]

14.  Secondary:   Norfolk QOL-DN Autonomic Domain Score at the End of Each Treatment Period (Week 6 of Each Treatment Period)   [ Time Frame: End of Period (includes both Visits 5 and 9) ]

15.  Secondary:   Euro QoL-5 Dimensions (EQ-5D) Mobility Domain Score at the End of Each Treatment Period (Week 6 of Each Treatment Period)   [ Time Frame: End of Period (includes both Visits 5 and 9) ]

16.  Secondary:   EQ-5D Self-Care Domain Score at the End of Each Treatment Period (Week 6 of Each Treatment Period)   [ Time Frame: End of Period (includes both Visits 5 and 9) ]

17.  Secondary:   EQ-5D Usual Activities Domain Score at the End of Each Treatment Period (Week 6 of Each Treatment Period)   [ Time Frame: End of Period (includes both Visits 5 and 9) ]

18.  Secondary:   EQ-5D Pain / Discomfort Domain Score at the End of Each Treatment Period (Week 6 of Each Treatment Period)   [ Time Frame: End of Period (includes both Visits 5 and 9) ]

19.  Secondary:   EQ-5D Anxiety / Depression Domain Score at the End of Each Treatment Period (Week 6 of Each Treatment Period)   [ Time Frame: End of Period (includes both Visits 5 and 9) ]

20.  Secondary:   EQ-5D Dolan 1997 Index Summary Score at the End of Each Treatment Period (Week 6 of Each Treatment Period)   [ Time Frame: End of Period (includes both Visits 5 and 9) ]

21.  Secondary:   EQ-5D Dolan 2002 Index Summary Score at the End of Each Treatment Period (Week 6 of Each Treatment Period)   [ Time Frame: End of Period (includes both Visits 5 and 9) ]

22.  Secondary:   Patient Global Impression of Change (PGIC) Score at the End of Period 1 (Week 6) - Original Scores   [ Time Frame: End of Period 1 (V5) ]

23.  Secondary:   PGIC Score at the End of Period 1 (Week 6) - Categorized Scores   [ Time Frame: End of Period 1 (V5) ]


  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: NCT01455415     History of Changes
Other Study ID Numbers: A0081268, 2011-002743-10
Study First Received: October 17, 2011
Results First Received: October 30, 2014
Last Updated: April 22, 2015
Health Authority: United States: Food and Drug Administration