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

NCT ID: NCT00424372

Last Updated: 2021-08-27

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

126 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-12

Study Completion Date

2008-08-19

Brief Summary

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

Detailed Description

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Conditions

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Neuralgia, Postherpetic

Study Design

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Allocation Method

NON_RANDOMIZED

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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pregabalin

Group Type EXPERIMENTAL

pregabalin

Intervention Type DRUG

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

Interventions

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pregabalin

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

Intervention Type DRUG

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Gunma Pain Clinic Hospital

Maebashi, Gunma, Japan

Site Status

Takasaki Pain Clinic

Takasaki, Gunma, Japan

Site Status

Asahikawa Pain Clinic Hospital

Asahikawa, Hokkaido, Japan

Site Status

Kamui Pain Clinic

Asahikawa, Hokkaido, Japan

Site Status

Sapporo Asabu Clinic

Sapporo, Hokkaido, Japan

Site Status

Higashi Sapporo Hospital

Sapporo, Hokkaido, Japan

Site Status

Seimei Clinic

Akashi, Hyōgo, Japan

Site Status

Uchida Pain Relief Clinic

Amagasaki, Hyōgo, Japan

Site Status

National Hospital Organization Himeji Medical Center

Himeji, Hyōgo, Japan

Site Status

National Hospital Organization Nagoya Medical Center

Nagoya, Aichi-ken, Japan

Site Status

Kobayashi Clinic

Urayasu, Chiba, Japan

Site Status

Okabe Hospital

Kasuya-gun, Fukuoka, Japan

Site Status

National Hospital Organization Kobe Medical Center

Kobe, Hyōgo, Japan

Site Status

Nakamura Clinic

Kobe, Hyōgo, Japan

Site Status

National Hospital Organization Sagamihara National Hospital

Sagamihara, Kanagawa, Japan

Site Status

Suzuki Pain Clinic

Yokohama, Kanagawa, Japan

Site Status

Hajiri Pain Clinic

Yokohama, Kanagawa, Japan

Site Status

National Hospital Organization Yokohama Medical Center

Yokohama, Kanagawa, Japan

Site Status

Sendai Pain Clinic

Sendai, Miyagi, Japan

Site Status

Nakamura Hospital

Beppu, Ohita, Japan

Site Status

Kawaguchi Kogyo General Hospital

Kawaguchi, Saitama, Japan

Site Status

Kinoshita Clinic

Tokorozawa, Saitama, Japan

Site Status

Tokyo Women's Medical University Center East

Arakawa-ku, Tokyo, Japan

Site Status

Juntendo University Hospital

Bunkyo-ku, Tokyo, Japan

Site Status

Mitaka Pain Clinic

Mitaka, Tokyo, Japan

Site Status

Toriumi Pain Clinic

Nakano-ku, Tokyo, Japan

Site Status

Kanto Medical NTT East Corporation

Shinagawa-ku, Tokyo, Japan

Site Status

Naganuma Pain Clinic

Shinagawa-ku, Tokyo, Japan

Site Status

Tokyo Women's Medical University Hospital

Shinjuku-ku, Tokyo, Japan

Site Status

Mukai Clinic

Fukuoka, , Japan

Site Status

KM Pain Clinic

Fukuoka, , Japan

Site Status

Otsuki Sleep Clinic

Fukushima, , Japan

Site Status

Hasumi Pain Clinic

Saitama, , Japan

Site Status

Countries

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Japan

Related Links

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Other Identifiers

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A0081121

Identifier Type: -

Identifier Source: org_study_id

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