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Safety And Efficacy Study Of Once Daily Controlled Release Pregabalin In The Treatment Of Patients With Postherpetic Neuralgia

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ClinicalTrials.gov Identifier: NCT01270828
Recruitment Status : Completed
First Posted : January 5, 2011
Results First Posted : January 13, 2016
Last Update Posted : January 13, 2016
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition: Post Herpetic Neuralgia
Interventions: Drug: Pregabalin
Drug: placebo

  Participant Flow

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 129 centers in 17 countries screened subjects for the study, including 68 in the US, 6 in Bulgaria, 6 in Poland, 6 in Russia, 6 in the Ukraine, 5 in India, 5 in South Africa, 5 in Sweden, 4 in Slovakia, 3 in Colombia, 3 in Croatia, 3 in Germany, 2 in Denmark, 2 in Hong Kong, 2 in Serbia, 2 in Taiwan, and 1 in the Czech Republic.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The study consisted of 4 phases: Baseline (1 week [wk]): to determine study entry criteria; Single Blind (SB) (6 wks): to determine optimized dose; Double Blind (DB) (13 wks): responders with at least 50% improvement in pain at SB were considered and randomized to pregabalin or matching placebo; and DB taper phase (1 wk).

Reporting Groups
  Description
Pregabalin Controlled Release (CR) DB Possible doses for participants with normal creatinine clearance (CLcr) (≥60 mL/min) during the DB fixed dose phase were pregabalin CR 165 mg/day, 330 mg/day, 495 mg/day CR or 660 mg/day CR. Doses for participants with low CLcr (>30 - <60 mL/min) were pregabalin 82.5 mg/day, 165 mg/day, 247.5 mg/day, or 330 mg/day CR.
Placebo DB Participants received matching placebo
Pregabalin CR SB The participants with normal CLcr (≥60 mL/min) were treated with pregabalin 165 mg/day CR; those with low CLcr (>30 - <60 mL/min) received 82.5 mg/day pregabalin CR. Subsequently, the pregabalin doses were increased based on efficacy and tolerability at each weekly visit.

Participant Flow for 2 periods

Period 1:   Pregabalin CR SB
    Pregabalin Controlled Release (CR) DB   Placebo DB   Pregabalin CR SB
STARTED   0   0   806 
COMPLETED   0   0   660 
NOT COMPLETED   0   0   146 
Reason Unspecified                0                0                8 
Enrolled but not treated                0                0                5 
Related adverse event                0                0                46 
Lack of Efficacy                0                0                32 
Withdrawal by Subject                0                0                29 
Lost to Follow-up                0                0                10 
Unrelated AE                0                0                8 
Protocol Violation                0                0                8 

Period 2:   Double Blind Phase
    Pregabalin Controlled Release (CR) DB   Placebo DB   Pregabalin CR SB
STARTED   208   205   0 
COMPLETED   182   160   0 
NOT COMPLETED   26   45   0 
Death                0                1                0 
Protocol Violation                0                1                0 
Protocol and GCP non-compliance                4                3                0 
Reason Unspecified                7                4                0 
Withdrawal by Subject                6                15                0 
Lost to Follow-up                1                2                0 
Lack of Efficacy                2                11                0 
Adverse event not related to study drug                1                1                0 
Adverse event related to study drug                5                7                0 



  Baseline Characteristics

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.
Baseline analysis population description consisted of all participants randomized to the DB phase who received at least 1 dose of study medication in the DB phase (full analysis set).

Reporting Groups
  Description
Pregabalin CR DB Possible doses for participants with normal creatinine clearance (CLcr) (≥60 mL/min) during the DB fixed dose phase were pregabalin CR 165 mg/day, 330 mg/day, 495 mg/day CR or 660 mg/day CR. Doses for participants with low CLcr (>30 - <60 mL/min) were pregabalin 82.5 mg/day, 165 mg/day, 247.5 mg/day, or 330 mg/day CR.
Placebo DB Participants received matching placebo
Total Total of all reporting groups

Baseline Measures
   Pregabalin CR DB   Placebo DB   Total 
Overall Participants Analyzed 
[Units: Participants]
 208   205   413 
Age, Customized 
[Units: Participants]
     
<18 years   0   0   0 
18-44 years   26   24   50 
45-64 years   86   78   164 
≥65 years   96   103   199 
Gender 
[Units: Participants]
     
Female   134   122   256 
Male   74   83   157 


  Outcome Measures

1.  Primary:   Number of Participants With Loss of Therapeutic Response.   [ Time Frame: 13 Weeks ]

2.  Secondary:   Participants With Secondary LTR Based on 5 Day Rolling Average Diary Results   [ Time Frame: 13 Weeks ]

3.  Secondary:   Percentage of Participants With 30% Reduction in the Mean Pain Score.   [ Time Frame: 13 Weeks ]

4.  Secondary:   Percentage of Participants With 50% Reduction in the Mean Pain Score.   [ Time Frame: 13 Weeks ]

5.  Secondary:   Change From Baseline to Endpoint in Weekly Mean Pain Score.   [ Time Frame: SB Baseline (Enrollment) to Week 19 and DB Baseline (Week 6) to Week 19 ]

6.  Secondary:   Change in the Weekly NRS-Pain (1-Week Recall).   [ Time Frame: SB Baseline (Enrollment) to Week 19 and DB Baseline (Week 6) to Week 19 ]

7.  Secondary:   Change in the Medical Outcomes Study-Sleep Scale (MOS-SS).   [ Time Frame: SB Baseline (BL) (Enrollment) to Week 19 and DB Baseline (Week 6) to Week 19 ]

8.  Secondary:   Change in the MOS-SS-Quantity of Sleep.   [ Time Frame: SB Baseline (BL) (Enrollment) to Week 19 and DB Baseline (Week 6) to Week 19 ]

9.  Secondary:   The MOS-SS-Optimal Sleep.   [ Time Frame: Week 6 and Week 19 ]

10.  Secondary:   Percentage of Participants With Change in the Patient Global Impression of Change (PGIC) Score   [ Time Frame: Week 19 ]

11.  Secondary:   Change in the Short Form 36 Health Survey (SF-36)   [ Time Frame: Week 19 ]

12.  Secondary:   Change in Mean Daily Sleep Interference Scores   [ Time Frame: Week 19 ]

13.  Secondary:   Change in Hospital Anxiety and Depression Scales (HADS)   [ Time Frame: Week 19 ]

14.  Secondary:   Change in the Brief Pain Inventory (BPI-sf)   [ Time Frame: Week 19 ]

15.  Secondary:   Percentage of Participants With Benefit From Treatment, Satisfaction With Treatment and Willingness to Continue Treatement (BSW)   [ Time Frame: Week 19 ]

16.  Secondary:   Number of Participants With Adverse Events   [ Time Frame: Baseline to Week 20 ]

17.  Secondary:   Percentage of Participants With Suicidal Behaviour/Ideation   [ Time Frame: Baseline, Weeks 6, 11, 15, 19 and 20 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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

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



Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01270828     History of Changes
Other Study ID Numbers: A0081224
2009-016766-86 ( EudraCT Number )
First Submitted: January 4, 2011
First Posted: January 5, 2011
Results First Submitted: October 1, 2015
Results First Posted: January 13, 2016
Last Update Posted: January 13, 2016