Study To Evaluate Efficacy, Safety And Tolerability Of Lyrica In Patients With Painful Diabetic Peripheral Neuropathy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01332149
First received: April 7, 2011
Last updated: June 1, 2015
Last verified: June 2015
Results First Received: March 23, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Diabetic Neuropathy, Painful
Interventions: Drug: Pregabalin
Drug: Placebo matched with pregabalin

  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
All participants were Chinese. 626 participants were randomized initially, as originally stated on clinicaltrials.gov. However, 3 participants discontinued right after randomization without any treatment information. As such, the actual number of participants randomized and assigned to treatment was 623 as stated in the “Started” Row below.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Pregabalin Participants received 1 placebo capsule matched to pregabalin twice a day for 1 week (run-in period), followed by a 9-week double-blind treatment phase (1-week dose-escalation phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg twice a day and an 8-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg twice a day), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg twice a day).
Placebo Participants received matching placebo capsule(s) for a period of 11 weeks, which consisted of a 1-week run-in period, 9-week double-blind treatment phase and 1-week taper-off period.

Participant Flow:   Overall Study
    Pregabalin     Placebo  
STARTED     314 [1]   309 [1]
Treated     313     307  
COMPLETED     284     271  
NOT COMPLETED     30     38  
Adverse Event                 11                 9  
Other unspecified                 5                 7  
Protocol Violation                 1                 3  
Withdrawal by Subject                 4                 5  
Lost to Follow-up                 1                 1  
Insufficient clinical response                 4                 7  
Did not meet entrance criteria                 3                 4  
Randomized but not treated                 1                 2  
[1] Assigned to study treatment.



  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.
The Full Analysis Set (FAS) was defined as all randomized participants who received at least 1 dose of study medication.

Reporting Groups
  Description
Pregabalin Participants received 1 placebo capsule matched to pregabalin twice a day for 1 week (run-in period), followed by a 9-week double-blind treatment phase (1-week dose-escalation phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg twice a day and an 8-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg twice a day), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg twice a day).
Placebo Participants received matching placebo capsule(s) for a period of 11 weeks, which consisted of a 1-week run-in period, 9-week double-blind treatment phase and 1-week taper-off period.
Total Total of all reporting groups

Baseline Measures
    Pregabalin     Placebo     Total  
Number of Participants  
[units: participants]
  313     307     620  
Age, Customized  
[units: participants]
     
18-44 years     25     15     40  
45-64 years     172     178     350  
More than or equal to (>=) 65 years     116     114     230  
Gender  
[units: participants]
     
Female     159     168     327  
Male     154     139     293  



  Outcome Measures
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1.  Primary:   Baseline Mean Pain Score   [ Time Frame: Baseline ]

2.  Primary:   Change From Baseline in Mean Pain Score at Endpoint   [ Time Frame: Baseline and end of fixed dose phase (Day 63/Week 9)/Early Termination (Study Endpoint) ]

3.  Secondary:   Change From Baseline in Weekly Mean Pain Score at Weeks 1 to 9   [ Time Frame: Baseline and weekly from Weeks 1 to 9 ]

4.  Secondary:   Baseline Mean Sleep Interference Score   [ Time Frame: Baseline ]

5.  Secondary:   Change From Baseline in Mean Sleep Interference Score at Endpoint   [ Time Frame: Baseline and end of fixed dose phase (Day 63/Week 9)/Early Termination (Study Endpoint) ]

6.  Secondary:   Change From Baseline in Weekly Mean Sleep Interference Score at Weeks 1 to 9   [ Time Frame: Baseline and weekly from Weeks 1 to 9 ]

7.  Secondary:   Percentage of 30 Percent (%) Responders at Endpoint   [ Time Frame: End of fixed dose phase (Day 63/Week 9)/Early Termination (Study Endpoint) ]

8.  Secondary:   Change From Baseline in Short Form McGill Pain Questionnaire (SF-MPQ) Score at Weeks 1, 5, and 9   [ Time Frame: Baseline; Weeks 1, 5, and 9 ]

9.  Secondary:   Baseline Pain Visual Analogue Scale (VAS) and Present Pain Intensity (PPI) Scale   [ Time Frame: Baseline ]

10.  Secondary:   Change From Baseline in Pain VAS From the SF-MPQ at Endpoint   [ Time Frame: Baseline and Day 63 (Week 9)/Early Termination (Study Endpoint) ]

11.  Secondary:   Change From Baseline in PPI Scale From the SF-MPQ at Endpoint   [ Time Frame: Baseline and Day 63 (Week 9)/Early Termination (Study Endpoint) ]

12.  Secondary:   Baseline Medical Outcomes Study (MOS)-Sleep Scale Scores   [ Time Frame: Baseline ]

13.  Secondary:   Change From Baseline in MOS-Sleep Scale, Sleep Disturbance Score at Endpoint   [ Time Frame: Baseline and Day 63 (Week 9)/Early Termination (Study Endpoint) ]

14.  Secondary:   Change From Baseline in MOS-Sleep Scale, Snoring Score at Endpoint   [ Time Frame: Baseline and Day 63 (Week 9)/Early Termination (Study Endpoint) ]

15.  Secondary:   Change From Baseline in MOS-Sleep Scale, Awaken Short of Breath Score at Endpoint   [ Time Frame: Baseline and Day 63 (Week 9)/Early Termination (Study Endpoint) ]

16.  Secondary:   Change From Baseline in MOS-Sleep Scale, Quantity of Sleep Score at Endpoint   [ Time Frame: Baseline and Day 63 (Week 9)/Early Termination (Study Endpoint) ]

17.  Secondary:   Percentage of Participants Who Had Optimal Sleep at Endpoint   [ Time Frame: Day 63 (Week 9)/Early Termination (Study Endpoint) ]

18.  Secondary:   Change From Baseline in MOS-Sleep Scale, Sleep Adequacy Score at Endpoint   [ Time Frame: Baseline and Day 63 (Week 9)/Early Termination (Study Endpoint) ]

19.  Secondary:   Change From Baseline in MOS-Sleep Scale, Somnolence Score at Endpoint   [ Time Frame: Baseline and Day 63 (Week 9)/Early Termination (Study Endpoint) ]

20.  Secondary:   Change From Baseline in MOS-Sleep Scale, Sleep Problems Index Score at Endpoint   [ Time Frame: Baseline and Day 63 (Week 9)/Early Termination (Study Endpoint) ]

21.  Secondary:   Clinical Global Impression of Change (CGIC) at Endpoint   [ Time Frame: Day 63 (Week 9)/Early Termination (Study Endpoint) ]

22.  Secondary:   Patient Global Impression of Change (PGIC) Score at Endpoint   [ Time Frame: Day 63 (Week 9)/Early Termination (Study Endpoint) ]

23.  Secondary:   Baseline Hospital Anxiety and Depression Scale (HADS) Scores   [ Time Frame: Baseline ]

24.  Secondary:   Change From Baseline in HADS Anxiety Total Score at Endpoint   [ Time Frame: Baseline and Day 63 (Week 9)/Early Termination (Study Endpoint) ]

25.  Secondary:   Change From Baseline in HADS Depression Total Score at Endpoint   [ Time Frame: Baseline and Day 63 (Week 9)/Early Termination (Study Endpoint) ]


  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: NCT01332149     History of Changes
Other Study ID Numbers: A0081265
Study First Received: April 7, 2011
Results First Received: March 23, 2015
Last Updated: June 1, 2015
Health Authority: United States: Food and Drug Administration