A Long-Term Study To Evaluate Safety And Efficacy Of Pregabalin For Postherpetic Neuralgia
- Registration Number
- NCT00424372
- Lead Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Brief Summary
To evaluate the safety of the long-term use of pregabalin.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 126
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description pregabalin pregabalin -
- Primary Outcome Measures
Name Time Method Summary of Adverse Events 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 Outcome Measures
Name Time Method Short-Form McGill Pain Questionnaire the Efficacy of Change: Total Score 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.
Short-Form McGill Pain Questionnaire the Efficacy of Change: Visual Analog Scale 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.
Short-Form McGill Pain Questionnaire the Efficacy of Change: Affective Score 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.
Short-Form McGill Pain Questionnaire the Efficacy of Change: Sensory Score 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.
Short-Form McGill Pain Questionnaire the Efficacy of Change: Present Pain Intensity 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.
Trial Locations
- Locations (33)
Tokyo Women's Medical University Hospital
🇯🇵Shinjuku-ku, Tokyo, Japan
Sapporo Asabu Clinic
🇯🇵Sapporo, Hokkaido, Japan
Kobayashi Clinic
🇯🇵Urayasu, Chiba, Japan
Higashi Sapporo Hospital
🇯🇵Sapporo, Hokkaido, Japan
National Hospital Organization Nagoya Medical Center
🇯🇵Nagoya, Aichi, Japan
Okabe Hospital
🇯🇵Kasuya-gun, Fukuoka, Japan
National Hospital Organization Yokohama Medical Center
🇯🇵Yokohama, Kanagawa, Japan
Gunma Pain Clinic Hospital
🇯🇵Maebashi, Gunma, Japan
Takasaki Pain Clinic
🇯🇵Takasaki, Gunma, Japan
Kamui Pain Clinic
🇯🇵Asahikawa, Hokkaido, Japan
Seimei Clinic
🇯🇵Akashi, Hyogo, Japan
Uchida Pain Relief Clinic
🇯🇵Amagasaki, Hyogo, Japan
National Hospital Organization Sagamihara National Hospital
🇯🇵Sagamihara, Kanagawa, Japan
National Hospital Organization Himeji Medical Center
🇯🇵Himeji, Hyogo, Japan
Nakamura Clinic
🇯🇵Kobe, Hyogo, Japan
Hajiri Pain Clinic
🇯🇵Yokohama, Kanagawa, Japan
Nakamura Hospital
🇯🇵Beppu, Ohita, Japan
Suzuki Pain Clinic
🇯🇵Yokohama, Kanagawa, Japan
Kawaguchi Kogyo General Hospital
🇯🇵Kawaguchi, Saitama, Japan
Tokyo Women's Medical University Center East
🇯🇵Arakawa-ku, Tokyo, Japan
Kinoshita Clinic
🇯🇵Tokorozawa, Saitama, Japan
Juntendo University Hospital
🇯🇵Bunkyo-ku, Tokyo, Japan
Mitaka Pain Clinic
🇯🇵Mitaka, Tokyo, Japan
Naganuma Pain Clinic
🇯🇵Shinagawa-ku, Tokyo, Japan
Kanto Medical NTT East Corporation
🇯🇵Shinagawa-ku, Tokyo, Japan
Toriumi Pain Clinic
🇯🇵Nakano-ku, Tokyo, Japan
Mukai Clinic
🇯🇵Fukuoka, Japan
KM Pain Clinic
🇯🇵Fukuoka, Japan
Hasumi Pain Clinic
🇯🇵Saitama, Japan
Otsuki Sleep Clinic
🇯🇵Fukushima, Japan
Asahikawa Pain Clinic Hospital
🇯🇵Asahikawa, Hokkaido, Japan
National Hospital Organization Kobe Medical Center
🇯🇵Kobe, Hyogo, Japan
Sendai Pain Clinic
🇯🇵Sendai, Miyagi, Japan