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

Phase 3CompletedNCT00424372

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.126 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

126

Conditions

Neuralgia, Postherpetic

Interventions

pregabalinDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (33)

Outcomes

Primary Outcomes

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.

Time frame: 52 weeks

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

National Hospital Organization Nagoya Medical Center

Nagoya, Aichi-ken, Japan

Kobayashi Clinic

Urayasu, Chiba, Japan

Okabe Hospital

Kasuya-gun, Fukuoka, Japan

Gunma Pain Clinic Hospital

Maebashi, Gunma, Japan

Takasaki Pain Clinic

Takasaki, Gunma, Japan

Asahikawa Pain Clinic Hospital

Asahikawa, Hokkaido, Japan

Kamui Pain Clinic

Asahikawa, Hokkaido, Japan

Sapporo Asabu Clinic

Sapporo, Hokkaido, Japan

Higashi Sapporo Hospital

Sapporo, Hokkaido, Japan

Seimei Clinic

Akashi, Hyōgo, Japan

...and 23 more locations