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A Long-Term Study To Evaluate Safety And Efficacy Of Pregabalin For Postherpetic Neuralgia

Primary Purpose

Neuralgia, Postherpetic

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
pregabalin
Sponsored by
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neuralgia, Postherpetic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients who completed the 13-week treatment of postherpetic neuralgia in Study A0081120.
  • Patients must be able to understand and cooperate with study procedures and have signed a written informed consent prior to entering the study.

Exclusion Criteria:

  • Patients who experienced serious adverse events in the preceding study (A0081120) that were determined by the investigator or the study sponsor to be causally related to the study medication.
  • Patients exhibiting treatment non-compliance in the preceding study (A0081120)

Sites / Locations

  • National Hospital Organization Nagoya Medical Center
  • Kobayashi Clinic
  • Okabe Hospital
  • Gunma Pain Clinic Hospital
  • Takasaki Pain Clinic
  • Asahikawa Pain Clinic Hospital
  • Kamui Pain Clinic
  • Sapporo Asabu Clinic
  • Higashi Sapporo Hospital
  • Seimei Clinic
  • Uchida Pain Relief Clinic
  • National Hospital Organization Himeji Medical Center
  • National Hospital Organization Kobe Medical Center
  • Nakamura Clinic
  • National Hospital Organization Sagamihara National Hospital
  • Suzuki Pain Clinic
  • Hajiri Pain Clinic
  • National Hospital Organization Yokohama Medical Center
  • Sendai Pain Clinic
  • Nakamura Hospital
  • Kawaguchi Kogyo General Hospital
  • Kinoshita Clinic
  • Tokyo Women's Medical University Center East
  • Juntendo University Hospital
  • Mitaka Pain Clinic
  • Toriumi Pain Clinic
  • Kanto Medical NTT East Corporation
  • Naganuma Pain Clinic
  • Tokyo Women's Medical University Hospital
  • Mukai Clinic
  • KM Pain Clinic
  • Otsuki Sleep Clinic
  • Hasumi Pain Clinic

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

pregabalin

Arm Description

Outcomes

Primary Outcome Measures

Summary of Adverse Events
Number of subjects with all causality adverse events, serious adverse events, severe adverse events, adverse events resulted in discontinuation, dose reduced or temporary discontinuation. Subjects are counted only once per treatment in each row.

Secondary Outcome Measures

Short-Form McGill Pain Questionnaire the Efficacy of Change: Sensory Score
Score ranges: 0-33. Higher scores indicate more severe pain. Baseline: The last evaluation on or before Day 1 of double-blind for subjects that took pregabalin in double-blind and last visit <= Day 1 of open-label for subjects that took placebo in double-blind. Endpoint: The last evaluation during dose adjustment/maintenance step of open-label.
Short-Form McGill Pain Questionnaire the Efficacy of Change: Affective Score
Score ranges: 0-12. Higher scores indicate more severe pain. Baseline: The last evaluation on or before Day 1 of double-blind for subjects that took pregabalin in double-blind and last visit <= Day 1 of open-label for subjects that took placebo in double-blind. Endpoint: The last evaluation during dose adjustment/maintenance step of open-label.
Short-Form McGill Pain Questionnaire the Efficacy of Change: Total Score
Score ranges: 0-45. Higher scores indicate more severe pain. Baseline: The last evaluation on or before Day 1 of double-blind for subjects that took pregabalin in double-blind and last visit <= Day 1 of open-label for subjects that took placebo in double-blind. Endpoint: The last evaluation during dose adjustment/maintenance step of open-label.
Short-Form McGill Pain Questionnaire the Efficacy of Change: Present Pain Intensity
Score ranges: 0-5. Higher scores indicate more severe pain. Baseline: The last evaluation on or before Day 1 of double-blind for subjects that took pregabalin in double-blind and last visit <= Day 1 of open-label for subjects that took placebo in double-blind. Endpoint: The last evaluation during dose adjustment/maintenance step of open-label.
Short-Form McGill Pain Questionnaire the Efficacy of Change: Visual Analog Scale
Ranges: 0-100 mm. Larger scale indicate more severe pain. Baseline: The last evaluation on or before Day 1 of double-blind for subjects that took pregabalin in double-blind and last visit <= Day 1 of open-label for subjects that took placebo in double-blind. Endpoint: The last evaluation during dose adjustment/maintenance step of open-label.

Full Information

First Posted
January 18, 2007
Last Updated
July 30, 2021
Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00424372
Brief Title
A Long-Term Study To Evaluate Safety And Efficacy Of Pregabalin For Postherpetic Neuralgia
Official Title
A LONG-TERM STUDY TO EVALUATE SAFETY AND EFFICACY STUDY OF PREGABALIN IN THE TREATMENT OF POSTHERPETIC NEURALGIA.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
January 12, 2007 (Actual)
Primary Completion Date
August 19, 2008 (Actual)
Study Completion Date
August 19, 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
To evaluate the safety of the long-term use of pregabalin.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuralgia, Postherpetic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
126 (Actual)

8. Arms, Groups, and Interventions

Arm Title
pregabalin
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
pregabalin
Intervention Description
Dosage: 150-600 mg/day (75-300 mg bid), oral administration, Treatment duration: 52 weeks
Primary Outcome Measure Information:
Title
Summary of Adverse Events
Description
Number of subjects with all causality adverse events, serious adverse events, severe adverse events, adverse events resulted in discontinuation, dose reduced or temporary discontinuation. Subjects are counted only once per treatment in each row.
Time Frame
52 weeks
Secondary Outcome Measure Information:
Title
Short-Form McGill Pain Questionnaire the Efficacy of Change: Sensory Score
Description
Score ranges: 0-33. Higher scores indicate more severe pain. Baseline: The last evaluation on or before Day 1 of double-blind for subjects that took pregabalin in double-blind and last visit <= Day 1 of open-label for subjects that took placebo in double-blind. Endpoint: The last evaluation during dose adjustment/maintenance step of open-label.
Time Frame
52 weeks
Title
Short-Form McGill Pain Questionnaire the Efficacy of Change: Affective Score
Description
Score ranges: 0-12. Higher scores indicate more severe pain. Baseline: The last evaluation on or before Day 1 of double-blind for subjects that took pregabalin in double-blind and last visit <= Day 1 of open-label for subjects that took placebo in double-blind. Endpoint: The last evaluation during dose adjustment/maintenance step of open-label.
Time Frame
52 weeks
Title
Short-Form McGill Pain Questionnaire the Efficacy of Change: Total Score
Description
Score ranges: 0-45. Higher scores indicate more severe pain. Baseline: The last evaluation on or before Day 1 of double-blind for subjects that took pregabalin in double-blind and last visit <= Day 1 of open-label for subjects that took placebo in double-blind. Endpoint: The last evaluation during dose adjustment/maintenance step of open-label.
Time Frame
52 weeks
Title
Short-Form McGill Pain Questionnaire the Efficacy of Change: Present Pain Intensity
Description
Score ranges: 0-5. Higher scores indicate more severe pain. Baseline: The last evaluation on or before Day 1 of double-blind for subjects that took pregabalin in double-blind and last visit <= Day 1 of open-label for subjects that took placebo in double-blind. Endpoint: The last evaluation during dose adjustment/maintenance step of open-label.
Time Frame
52 weeks
Title
Short-Form McGill Pain Questionnaire the Efficacy of Change: Visual Analog Scale
Description
Ranges: 0-100 mm. Larger scale indicate more severe pain. Baseline: The last evaluation on or before Day 1 of double-blind for subjects that took pregabalin in double-blind and last visit <= Day 1 of open-label for subjects that took placebo in double-blind. Endpoint: The last evaluation during dose adjustment/maintenance step of open-label.
Time Frame
52 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients who completed the 13-week treatment of postherpetic neuralgia in Study A0081120. Patients must be able to understand and cooperate with study procedures and have signed a written informed consent prior to entering the study. Exclusion Criteria: Patients who experienced serious adverse events in the preceding study (A0081120) that were determined by the investigator or the study sponsor to be causally related to the study medication. Patients exhibiting treatment non-compliance in the preceding study (A0081120)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
National Hospital Organization Nagoya Medical Center
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
460-0001
Country
Japan
Facility Name
Kobayashi Clinic
City
Urayasu
State/Province
Chiba
ZIP/Postal Code
279-0012
Country
Japan
Facility Name
Okabe Hospital
City
Kasuya-gun
State/Province
Fukuoka
ZIP/Postal Code
811-2122
Country
Japan
Facility Name
Gunma Pain Clinic Hospital
City
Maebashi
State/Province
Gunma
ZIP/Postal Code
379-2147
Country
Japan
Facility Name
Takasaki Pain Clinic
City
Takasaki
State/Province
Gunma
ZIP/Postal Code
370-0035
Country
Japan
Facility Name
Asahikawa Pain Clinic Hospital
City
Asahikawa
State/Province
Hokkaido
ZIP/Postal Code
070-0034
Country
Japan
Facility Name
Kamui Pain Clinic
City
Asahikawa
State/Province
Hokkaido
ZIP/Postal Code
070-8013
Country
Japan
Facility Name
Sapporo Asabu Clinic
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
001-0045
Country
Japan
Facility Name
Higashi Sapporo Hospital
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
003-8585
Country
Japan
Facility Name
Seimei Clinic
City
Akashi
State/Province
Hyogo
ZIP/Postal Code
673-0016
Country
Japan
Facility Name
Uchida Pain Relief Clinic
City
Amagasaki
State/Province
Hyogo
ZIP/Postal Code
661-0012
Country
Japan
Facility Name
National Hospital Organization Himeji Medical Center
City
Himeji
State/Province
Hyogo
ZIP/Postal Code
670-8520
Country
Japan
Facility Name
National Hospital Organization Kobe Medical Center
City
Kobe
State/Province
Hyogo
ZIP/Postal Code
654-0155
Country
Japan
Facility Name
Nakamura Clinic
City
Kobe
State/Province
Hyogo
ZIP/Postal Code
655-0854
Country
Japan
Facility Name
National Hospital Organization Sagamihara National Hospital
City
Sagamihara
State/Province
Kanagawa
ZIP/Postal Code
228-8522
Country
Japan
Facility Name
Suzuki Pain Clinic
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
227-0043
Country
Japan
Facility Name
Hajiri Pain Clinic
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
236-0037
Country
Japan
Facility Name
National Hospital Organization Yokohama Medical Center
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
245-8575
Country
Japan
Facility Name
Sendai Pain Clinic
City
Sendai
State/Province
Miyagi
ZIP/Postal Code
983-0036
Country
Japan
Facility Name
Nakamura Hospital
City
Beppu
State/Province
Ohita
ZIP/Postal Code
874-0937
Country
Japan
Facility Name
Kawaguchi Kogyo General Hospital
City
Kawaguchi
State/Province
Saitama
ZIP/Postal Code
332-0031
Country
Japan
Facility Name
Kinoshita Clinic
City
Tokorozawa
State/Province
Saitama
ZIP/Postal Code
359-0038
Country
Japan
Facility Name
Tokyo Women's Medical University Center East
City
Arakawa-ku
State/Province
Tokyo
ZIP/Postal Code
116-8567
Country
Japan
Facility Name
Juntendo University Hospital
City
Bunkyo-ku
State/Province
Tokyo
ZIP/Postal Code
113-8431
Country
Japan
Facility Name
Mitaka Pain Clinic
City
Mitaka
State/Province
Tokyo
ZIP/Postal Code
181-0013
Country
Japan
Facility Name
Toriumi Pain Clinic
City
Nakano-ku
State/Province
Tokyo
ZIP/Postal Code
165-0027
Country
Japan
Facility Name
Kanto Medical NTT East Corporation
City
Shinagawa-ku
State/Province
Tokyo
ZIP/Postal Code
141-0022
Country
Japan
Facility Name
Naganuma Pain Clinic
City
Shinagawa-ku
State/Province
Tokyo
ZIP/Postal Code
141-0022
Country
Japan
Facility Name
Tokyo Women's Medical University Hospital
City
Shinjuku-ku
State/Province
Tokyo
ZIP/Postal Code
162-8666
Country
Japan
Facility Name
Mukai Clinic
City
Fukuoka
ZIP/Postal Code
812-0011
Country
Japan
Facility Name
KM Pain Clinic
City
Fukuoka
ZIP/Postal Code
814-0001
Country
Japan
Facility Name
Otsuki Sleep Clinic
City
Fukushima
ZIP/Postal Code
960-8044
Country
Japan
Facility Name
Hasumi Pain Clinic
City
Saitama
ZIP/Postal Code
330-0805
Country
Japan

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
IPD Sharing URL
https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A0081121&StudyName=A%20Long-Term%20Study%20To%20Evaluate%20Safety%20And%20Efficacy%20Of%20Pregabalin%20For%20Postherpetic%20Neuralgia
Description
To obtain contact information for a study center near you, click here.

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A Long-Term Study To Evaluate Safety And Efficacy Of Pregabalin For Postherpetic Neuralgia

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