Pregabalin Treatment Of Peripheral Neuropathic Pain Associated With Diabetic Peripheral NeP (DPN), Postherpetic Neuralgia (PHN), HIV-related NeP (HIV), and Chemotherapy Induced NeP

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00407511
First received: December 1, 2006
Last updated: October 8, 2009
Last verified: October 2009
Results First Received: June 18, 2009  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Diabetic Peripheral Neuropathic Pain (DPN)
Postherpetic Neuralgia (PHN)
HIV-related Neuropathic Pain (HIV)
Chemotherapy Induced Neuropathic Pain
Intervention: Drug: 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
Subjects were recruited at 13 medical centers in Latin America and participated between January 2007 and July 2008.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
160 subjects were screened and evaluated for inclusion/exclusion criteria; 121 were assigned to open-label treatment.

Reporting Groups
  Description
Pregabalin Dose adjustment phase: Week 1: 75mg BID (150 mg/day) all subjects; Week 2 through Week 4: subjects were assessed on a weekly basis for dose adjustment from 75 mg BID (150 mg/day) to 150 mg BID (300 mg/day), and to 300 mg BID (600 mg/day) if needed based on pain relief and tolerability. 8 week dose maintenance phase (Week 5 to Week 12): subjects continued with their final pregabalin dosage: 75mg BID (150 mg/day) to 300 mg BID (600 mg/day) based on individual pain response and tolerability.

Participant Flow:   Overall Study
    Pregabalin  
STARTED     121  
COMPLETED     99  
NOT COMPLETED     22  
Adverse Event                 9  
Lost to Follow-up                 4  
unknown                 5  
Withdrawal by Subject                 4  



  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 Dose adjustment phase: Week 1: 75mg BID (150 mg/day) all subjects; Week 2 through Week 4: subjects were assessed on a weekly basis for dose adjustment from 75 mg BID (150 mg/day) to 150 mg BID (300 mg/day), and to 300 mg BID (600 mg/day) if needed based on pain relief and tolerability. 8 week dose maintenance phase (Week 5 to Week 12): subjects continued with their final pregabalin dosage: 75mg BID (150 mg/day) to 300 mg BID (600 mg/day) based on individual pain response and tolerability.

Baseline Measures
    Pregabalin  
Number of Participants  
[units: participants]
  121  
Age, Customized  
[units: participants]
 
Between 18 to 44 years     15  
Between 45 to 64 years     76  
>= 65 years     30  
Gender  
[units: participants]
 
Female     83  
Male     38  



  Outcome Measures
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1.  Primary:   Change From Baseline to End of Treatment (EOT) in Weekly Mean Pain Score on the Daily Pain Rating Scale (DPRS)   [ Time Frame: Baseline, End of Treatment ]

2.  Secondary:   Change From Baseline in Mean Pain Score on the Daily Pain Rating Scale (DPRS)   [ Time Frame: Week 4, Week 8, Week 12 ]

3.  Secondary:   Change From Baseline (BL) in Modified Brief Pain Inventory-Short Form (m-BPI-sf): Pain Severity Index Scores   [ Time Frame: Baseline, Week 8, Week 12, EOT/LOCF ]

4.  Secondary:   Change From Baseline in Modified Brief Pain Inventory-Short Form (m-BPI-sf): Pain Interference Index Scores   [ Time Frame: Baseline, Week 8, Week 12, End of Treatment/Last Observation Carried Forward (EOT/LOCF) ]

5.  Secondary:   Pain Treatment Satisfaction Scale (PTSS): Impact of Current Pain Medication   [ Time Frame: Baseline, Week 8, Week 12, EOT/LOCF ]

6.  Secondary:   Pain Treatment Satisfaction Scale (PTSS): Satisfaction With Current Pain Medication   [ Time Frame: Baseline, Week 8, Week 12, EOT/LOCF ]

7.  Secondary:   Change From Baseline in Visual Analogue Scale for Pain (VAS-pain)   [ Time Frame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 8, Week 12, EOT/LOCF ]

8.  Secondary:   Change From Baseline in Global Anxiety Visual Analogue Scale (GA-VAS)   [ Time Frame: Baseline, Week 8, Week 12, EOT/LOCF ]

9.  Secondary:   Change From Baseline in Mean Daily Sleep Interference Score (DSIS)   [ Time Frame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11, Week 12, EOT/LOCF ]

10.  Secondary:   Patient Global Impression of Change (PGIC)   [ Time Frame: End of Treatment/ Last Observation Carried Forward (Week 12 or last post-baseline assessment) ]

11.  Secondary:   Clinical Global Impression of Change (CGIC)   [ Time Frame: End of Treatment/ Last Observation Carried Forward (Week 12 or last post-baseline assessment) ]


  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.govCallCenter@pfizer.com


No publications provided by Pfizer

Publications automatically indexed to this study:

Responsible Party: Director, Clinical Trials Disclosure Group, Pfizer Inc.
ClinicalTrials.gov Identifier: NCT00407511     History of Changes
Other Study ID Numbers: A0081097
Study First Received: December 1, 2006
Results First Received: June 18, 2009
Last Updated: October 8, 2009
Health Authority: Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos