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Placebo-controlled Safety and Efficacy Study of Pregabalin in Subjects With Post-traumatic Peripheral Neuropathic Pain

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01701362
First received: October 3, 2012
Last updated: May 4, 2017
Last verified: April 2017
Results First Received: July 20, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition: Neuropathic Pain
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

A total of 187 centers participated in the study in 14 countries.

During screening, with the exception of daily pain score data that was collected to determine participants eligibility, no participants were treated with active drug and no efficacy data were collected. Only safety and no efficacy data was collected during the taper period.


Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants had clinic visits at screening, randomization, and during the treatment period, and a phone contact for follow-up after the last taper dose. All the eligible participants were randomly assigned (1:1) to 15 weeks of treatment with Pregabalin or Placebo.

Reporting Groups
  Description
Pregabalin Participants randomized to receive pregabalin: a 3-week dose optimization phase followed by 150 mg, 300 mg, 450 mg or 600 mg per day dosing 12-week maintenance phase.
Placebo Participants randomized to receive placebo

Participant Flow:   Overall Study
    Pregabalin   Placebo
STARTED   275   267 
TREATED   274   265 
COMPLETED   233   211 
NOT COMPLETED   42   56 
Adverse events not related to study drug                1                6 
Adverse events related to study drug                12                10 
Protocol Violation                5                3 
No longer willing to participate                8                14 
Lost to Follow-up                6                9 
Insufficient clinical response                6                6 
Death                0                1 
Randomized but not treated                1                2 
Reasons other than those mentioned above                3                5 



  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 Participants randomized to receive pregabalin: a 3-week dose optimization phase followed by 150 mg, 300 mg, 450 mg or 600 mg per day dosing 12-week maintenance phase.
Placebo Participants randomized to receive placebo
Total Total of all reporting groups

Baseline Measures
   Pregabalin   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 274   265   539 
Age 
[Units: Years]
Mean (Standard Deviation)
 52.8  (12.9)   53.4  (12.7)   53.1  (12.8) 
Age, Customized 
[Units: Participants]
     
18 - 44 years   59   61   120 
45 - 64 years   163   154   317 
>=65 years   52   50   102 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      132  48.2%      134  50.6%      266  49.4% 
Male      142  51.8%      131  49.4%      273  50.6% 


  Outcome Measures
  Show All Outcome Measures

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

2.  Primary:   Change From Baseline to Week 15 in Weekly Mean Pain Score   [ Time Frame: up to Week 15 ]

3.  Secondary:   Patient Global Impression of Change (PGIC) at Week 15   [ Time Frame: Week 15 ]

4.  Secondary:   Change From Baseline in Overall Weekly Mean Sleep Interference Score (SIRS)   [ Time Frame: up to Week 15 ]

5.  Secondary:   Change From Baseline in Pain Severity Index (Brief Pain Inventory-short Form [BPI-sf])   [ Time Frame: Week 15 ]

6.  Secondary:   Change From Baseline in Pain Interference Index (BPI-sf)   [ Time Frame: Week 15 ]

7.  Secondary:   Change From Baseline to Endpoint in Quality of Life Using EuroQol (EQ-5D) Health State Profile Scores   [ Time Frame: Week 15 ]

8.  Secondary:   Baseline Scores in the Medical Outcomes Study Sleep Scale (MOS-SS) - Sub-domain Score.   [ Time Frame: Baseline ]

9.  Secondary:   Mean Change From Baseline in the Medical Outcomes Study Sleep Scale (MOS-SS) - Sub-domain Score.   [ Time Frame: Week 15 ]

10.  Secondary:   Percentage of Participants in MOS-SS With Optimal Sleep Status.   [ Time Frame: Week 15 ]

11.  Secondary:   Percentage of Responders to Treatment With Pregabalin Measured as Reduction in Mean Pain Score of ≥30%.   [ Time Frame: Week 15 ]

12.  Secondary:   Percentage of Responders to Treatment With Pregabalin Measured as Reduction in Mean Pain Score of ≥50%   [ Time Frame: Week 15 ]


  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 Clinical Trials.gov Call Center
Organization: Pfizer, Inc
phone: 1-800-718-1021
e-mail: ClinicalTrials.gov_Inquiries@pfizer.com



Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01701362     History of Changes
Other Study ID Numbers: A0081279
2012-003304-12 ( EudraCT Number )
Study First Received: October 3, 2012
Results First Received: July 20, 2016
Last Updated: May 4, 2017