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Efficacy and Safety Study of Pregabalin in the Treatment of Pain on Walking in Patients With Diabetic Peripheral Neuropathy (DPN)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01474772
First received: November 15, 2011
Last updated: November 17, 2014
Last verified: November 2014
Results First Received: May 21, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Diabetic Peripheral Neuropathy
Interventions: Drug: Pregabalin
Other: 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
411 participants were screened, of whom 206 were withdrawn before randomization. 205 were randomized, of whom 2 discontinued before being treated. Participants were randomized at 36 centers in 4 countries: US (25), Sweden (4), South Africa (4), and Czech Republic (3). 11 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 (V1; Screening) to Visit 12 (V12; Follow-up). Participants with a mean pain score ≥ 4 (moderate to severe pain) and those meeting the pain on walking criteria (post-walk pain score ≥ 4, and > the pre-walk pain score at V1 and Visit 2 [V2; Baseline]) were randomized.

Reporting Groups
  Description
Pregabalin/Placebo Participants were randomized to double-blind treatment with pregabalin for 6 weeks (2 week dose titration [starting dose: 150 mg/day] and 4 weeks fixed dose [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 (2 week dose titration [starting dose: 150 mg/day] and 4 weeks fixed dose [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     101 [1]   102 [2]
COMPLETED     89     99  
NOT COMPLETED     12     3  
Adverse Event (AE) Related to Study Drug                 6                 1  
AE not Related to Study Drug                 1                 0  
Withdrawal by Subject                 3                 1  
Lost to Follow-up                 1                 0  
Reason not Specified                 1                 1  
[1] STARTED=treated. In Period 1 a participant discontinued due to an AE and later died due to the AE.
[2] STARTED=treated

Period 2:   Washout
    Pregabalin/Placebo     Placebo/Pregablin  
STARTED     89     99  
COMPLETED     86     97  
NOT COMPLETED     3     2  
AE not Related to Study Drug                 2                 0  
Withdrawal by Subject                 1                 0  
Lost to Follow-up                 0                 1  
Reason not Specified                 0                 1  

Period 3:   Period 2
    Pregabalin/Placebo     Placebo/Pregablin  
STARTED     86     97  
COMPLETED     77     87  
NOT COMPLETED     9     10  
Death                 0                 1  
AE Related to Study Drug                 0                 1  
AE not Related to Study Drug                 4                 1  
Lack of Efficacy                 1                 0  
Withdrawal by Subject                 3                 4  
Lost to Follow-up                 1                 1  
Reason not Specified                 0                 2  

Period 4:   Follow-up
    Pregabalin/Placebo     Placebo/Pregablin  
STARTED     77     87  
COMPLETED     77     86  
NOT COMPLETED     0     1  
AE not Related to Study Drug                 0                 1  



  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.
No text entered.

Reporting Groups
  Description
Pregabalin/Placebo Participants were randomized to double-blind treatment with pregabalin for 6 weeks (2 week dose titration [starting dose: 150 mg/day] and 4 weeks fixed dose [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/Pregabalin Participants were randomized to double-blind treatment with placebo for 6 weeks in period 1 followed by pregabalin in period 2 (2 week dose titration [starting dose: 150 mg/day] and 4 weeks fixed dose [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/Pregabalin     Total  
Number of Participants  
[units: participants]
  101     102     203  
Age  
[units: Years]
Mean ± Standard Deviation
  59.1  ± 8.5     58.4  ± 9.3     58.7  ± 8.9  
Gender  
[units: participants]
     
Female     40     31     71  
Male     61     71     132  



  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 6 and 11) ]

2.  Primary:   DPN Pain on Walking Based on a 11-point NRS of Each Treatment Period (Week 6 of Each Treatment Period)   [ Time Frame: End of Period (includes both Visits 6 and 11) ]

3.  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 6 and 11) ]

4.  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 6 and 11) ]

5.  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 6 and 11) ]

6.  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 6 and 11) ]

7.  Secondary:   BPI-sf Score for Pain-Interference With Walking Ability at the End of Each Treatment Period (Week 6 of Each Treatment Period)   [ Time Frame: End of Period (includes both Visits 6 and 11) ]

8.  Secondary:   Daytime Total Activity Counts Per Day Measured by Actigraphy Over the Last 7 Days of Each Treatment Period (Week 6 of Each Treatment Period)   [ Time Frame: End of Period (includes both Visits 6 and 11) ]

9.  Secondary:   Steps Per Day Measured by Actigraphy Over the Last 7 Days of Each Treatment Period (Week 6 of Each Treatment Period)   [ Time Frame: End of Period (includes both Visits 6 and 11) ]

10.  Secondary:   Walk 12 Questionnaire Over the Last 2 Weeks of Each Treatment Period (Week 6 of Each Treatment Period)   [ Time Frame: End of Period (includes both Visits 6 and 11) ]

11.  Secondary:   Norfolk Quality of Life-Diabetic Neuropathy (Norfolk QOL-DN) Total Quality of Life (TQOL) Score Measured Over the Last 2 Weeks of Each Treatment Period (Week 6 of Each Treatment Period)   [ Time Frame: End of Period (includes both Visits 6 and 11) ]

12.  Secondary:   Norfolk QOL-DN Symptoms Domain Score Measured Over the Last 2 Weeks of Each Treatment Period (Week 6 of Each Treatment Period)   [ Time Frame: End of Period (includes both Visits 6 and 11) ]

13.  Secondary:   Norfolk QOL-DN Activities of Daily Living Domain Score Measured Over the Last 2 Weeks of Each Treatment Period (Week 6 of Each Treatment Period)   [ Time Frame: End of Period (includes both Visits 6 and 11) ]

14.  Secondary:   Norfolk QOL-DN Physical Functioning / Large Fiber Domain Score Measured Over the Last 2 Weeks of Each Treatment Period (Week 6 of Each Treatment Period)   [ Time Frame: End of Period (includes both Visits 6 and 11) ]

15.  Secondary:   Norfolk QOL-DN Small Fiber Domain Score Measured Over the Last 2 Weeks of Each Treatment Period (Week 6 of Each Treatment Period)   [ Time Frame: End of Period (includes both Visits 6 and 11) ]

16.  Secondary:   Norfolk QOL-DN Autonomic Domain Score Measured Over the Last 2 Weeks of Each Treatment Period (Week 6 of Each Treatment Period)   [ Time Frame: End of Period (includes both Visits 6 and 11) ]

17.  Secondary:   Percentage of Participants With Patient Global Impression of Change (PGIC) Score From Baseline at the End of Period 1 (Week 6)   [ Time Frame: End of Period 1 (V6) ]

18.  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 6 and 11) ]

19.  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 6 and 11) ]

20.  Secondary:   Hospital Anxiety and Depression Scale - Depression (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 6 and 11) ]

21.  Secondary:   Euro QoL-5 Dimensions (EQ-5D) - Health State Profile Utility Scores at the End of Each Treatment Period (Week 6 of Each Treatment Period)   [ Time Frame: End of Period (includes both Visits 6 and 11) ]

22.  Post-Hoc:   Average Weekly DPN Pain Based on a NRS (Baseline, 6 Weeks in Period 1, 2 Weeks Washout and 6 Weeks in Period 2)   [ Time Frame: Baseline, 6 weeks in Period 1, 2 weeks washout and 6 weeks in Period 2 ]


  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
No text entered.


  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: NCT01474772     History of Changes
Other Study ID Numbers: A0081269, 2011-003266-32
Study First Received: November 15, 2011
Results First Received: May 21, 2014
Last Updated: November 17, 2014
Health Authority: United States: Food and Drug Administration