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

A LONG-TERM STUDY TO EVALUATE SAFETY AND EFFICACY STUDY OF PREGABALIN IN THE TREATMENT OF POSTHERPETIC NEURALGIA.

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

Study Overview

• Status: Completed
• Conditions: Neuralgia, Postherpetic
• Intervention / Treatment: Drug: pregabalin

• Study Type: Interventional
• Enrollment (Actual): 126
• Phase: Phase 3

Contacts and Locations

Study Locations

• Japan
  • Fukuoka, Japan, 812-0011
    • Mukai Clinic
  • Fukuoka, Japan, 814-0001
    • KM Pain Clinic
  • Fukushima, Japan, 960-8044
    • Otsuki Sleep Clinic
  • Saitama, Japan, 330-0805
    • Hasumi Pain Clinic
  • Aichi
    • Nagoya, Aichi, Japan, 460-0001
      • National Hospital Organization Nagoya Medical Center
  • Chiba
    • Urayasu, Chiba, Japan, 279-0012
      • Kobayashi Clinic
  • Fukuoka
    • Kasuya-gun, Fukuoka, Japan, 811-2122
      • Okabe Hospital
  • Gunma
    • Maebashi, Gunma, Japan, 379-2147
      • Gunma Pain Clinic Hospital
    • Takasaki, Gunma, Japan, 370-0035
      • Takasaki Pain Clinic
  • Hokkaido
    • Asahikawa, Hokkaido, Japan, 070-0034
      • Asahikawa Pain Clinic Hospital
    • Asahikawa, Hokkaido, Japan, 070-8013
      • Kamui Pain Clinic
    • Sapporo, Hokkaido, Japan, 001-0045
      • Sapporo Asabu Clinic
    • Sapporo, Hokkaido, Japan, 003-8585
      • Higashi Sapporo Hospital
  • Hyogo
    • Akashi, Hyogo, Japan, 673-0016
      • Seimei Clinic
    • Amagasaki, Hyogo, Japan, 661-0012
      • Uchida Pain Relief Clinic
    • Himeji, Hyogo, Japan, 670-8520
      • National Hospital Organization Himeji Medical Center
    • Kobe, Hyogo, Japan, 654-0155
      • National Hospital Organization Kobe Medical Center
    • Kobe, Hyogo, Japan, 655-0854
      • Nakamura Clinic
  • Kanagawa
    • Sagamihara, Kanagawa, Japan, 228-8522
      • National Hospital Organization Sagamihara National Hospital
    • Yokohama, Kanagawa, Japan, 245-8575
      • National Hospital Organization Yokohama Medical Center
    • Yokohama, Kanagawa, Japan, 227-0043
      • Suzuki Pain Clinic
    • Yokohama, Kanagawa, Japan, 236-0037
      • Hajiri Pain Clinic
  • Miyagi
    • Sendai, Miyagi, Japan, 983-0036
      • Sendai Pain Clinic
  • Ohita
    • Beppu, Ohita, Japan, 874-0937
      • Nakamura Hospital
  • Saitama
    • Kawaguchi, Saitama, Japan, 332-0031
      • Kawaguchi Kogyo General Hospital
    • Tokorozawa, Saitama, Japan, 359-0038
      • Kinoshita Clinic
  • Tokyo
    • Arakawa-ku, Tokyo, Japan, 116-8567
      • Tokyo Women's Medical University Center East
    • Bunkyo-ku, Tokyo, Japan, 113-8431
      • Juntendo University Hospital
    • Mitaka, Tokyo, Japan, 181-0013
      • Mitaka Pain Clinic
    • Nakano-ku, Tokyo, Japan, 165-0027
      • Toriumi Pain Clinic
    • Shinagawa-ku, Tokyo, Japan, 141-0022
      • Kanto Medical NTT East Corporation
    • Shinagawa-ku, Tokyo, Japan, 141-0022
      • Naganuma Pain Clinic
    • Shinjuku-ku, Tokyo, Japan, 162-8666
      • Tokyo Women's Medical University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: pregabalin	Drug: pregabalin; Dosage: 150-600 mg/day (75-300 mg bid), oral administration, Treatment duration: 52 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	52 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	52 weeks
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.	52 weeks
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.	52 weeks
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.	52 weeks
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.	52 weeks

Collaborators and Investigators

• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): January 12, 2007
• Primary Completion (Actual): August 19, 2008
• Study Completion (Actual): August 19, 2008

Study Registration Dates

• First Submitted: January 18, 2007
• First Submitted That Met QC Criteria: January 18, 2007
• First Posted (Estimate): January 19, 2007

Study Record Updates

• Last Update Posted (Actual): August 27, 2021
• Last Update Submitted That Met QC Criteria: July 30, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Neuromuscular Diseases; Peripheral Nervous System Diseases; Neuralgia; Neuralgia, Postherpetic; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Tranquilizing Agents; Psychotropic Drugs; Membrane Transport Modulators; Anti-Anxiety Agents; Anticonvulsants; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Pregabalin
• Other Study ID Numbers: A0081121

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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.