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

Neuralgia, Postherpetic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00424372
• Other study ID #: A0081121
• Status: Completed
• Phase: Phase 3
• Start date: January 12, 2007
• Est. completion date: August 19, 2008

Study information

• Verified date: July 2021
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 126
• Est. completion date: August 19, 2008
• Est. primary completion date: August 19, 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Neuralgia
• Neuralgia, Postherpetic

Intervention

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

Locations

Country	Name	City	State
Japan	Seimei Clinic	Akashi	Hyogo
Japan	Uchida Pain Relief Clinic	Amagasaki	Hyogo
Japan	Tokyo Women's Medical University Center East	Arakawa-ku	Tokyo
Japan	Asahikawa Pain Clinic Hospital	Asahikawa	Hokkaido
Japan	Kamui Pain Clinic	Asahikawa	Hokkaido
Japan	Nakamura Hospital	Beppu	Ohita
Japan	Juntendo University Hospital	Bunkyo-ku	Tokyo
Japan	KM Pain Clinic	Fukuoka
Japan	Mukai Clinic	Fukuoka
Japan	Otsuki Sleep Clinic	Fukushima
Japan	National Hospital Organization Himeji Medical Center	Himeji	Hyogo
Japan	Okabe Hospital	Kasuya-gun	Fukuoka
Japan	Kawaguchi Kogyo General Hospital	Kawaguchi	Saitama
Japan	Nakamura Clinic	Kobe	Hyogo
Japan	National Hospital Organization Kobe Medical Center	Kobe	Hyogo
Japan	Gunma Pain Clinic Hospital	Maebashi	Gunma
Japan	Mitaka Pain Clinic	Mitaka	Tokyo
Japan	National Hospital Organization Nagoya Medical Center	Nagoya	Aichi
Japan	Toriumi Pain Clinic	Nakano-ku	Tokyo
Japan	National Hospital Organization Sagamihara National Hospital	Sagamihara	Kanagawa
Japan	Hasumi Pain Clinic	Saitama
Japan	Higashi Sapporo Hospital	Sapporo	Hokkaido
Japan	Sapporo Asabu Clinic	Sapporo	Hokkaido
Japan	Sendai Pain Clinic	Sendai	Miyagi
Japan	Kanto Medical NTT East Corporation	Shinagawa-ku	Tokyo
Japan	Naganuma Pain Clinic	Shinagawa-ku	Tokyo
Japan	Tokyo Women's Medical University Hospital	Shinjuku-ku	Tokyo
Japan	Takasaki Pain Clinic	Takasaki	Gunma
Japan	Kinoshita Clinic	Tokorozawa	Saitama
Japan	Kobayashi Clinic	Urayasu	Chiba
Japan	Hajiri Pain Clinic	Yokohama	Kanagawa
Japan	National Hospital Organization Yokohama Medical Center	Yokohama	Kanagawa
Japan	Suzuki Pain Clinic	Yokohama	Kanagawa

Sponsors (1)

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

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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

External Links

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