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Completed

NCT Number: NCT00424372

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

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

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Key information

Conditions

Neuralgia, Postherpetic Nervous System Diseases Neuralgia Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

National Hospital Organization Nagoya Medical Center, Nagoya, Aichi-ken, Japan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Pregabalin

Drug

Dosage: 150-600 mg/day (75-300 mg bid), oral administration, Treatment duration: 52 weeks

Primary outcomes

  1. Summary of Adverse Events

    Time frame: 52 weeks

    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 outcomes

  1. Short-Form McGill Pain Questionnaire the Efficacy of Change: Sensory Score

    Time frame: 52 weeks

    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.

  2. Short-Form McGill Pain Questionnaire the Efficacy of Change: Affective Score

    Time frame: 52 weeks

    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.

  3. Short-Form McGill Pain Questionnaire the Efficacy of Change: Total Score

    Time frame: 52 weeks

    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.

  4. Short-Form McGill Pain Questionnaire the Efficacy of Change: Present Pain Intensity

    Time frame: 52 weeks

    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.

  5. Short-Form McGill Pain Questionnaire the Efficacy of Change: Visual Analog Scale

    Time frame: 52 weeks

    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.

Sponsors and collaborators

Lead sponsor

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

Industry

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Jan 19, 2007
Registry last updated
Aug 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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