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

NCT00424372 | Completed Phase 3 Results

• 1 other identifier: A0081121
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 33

Brief Summary

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

Conditions

Neuralgia, Postherpetic

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

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

  52 weeks

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

  52 weeks

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

  52 weeks

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

  52 weeks

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

  52 weeks

Study Arms (1)

pregabalin

EXPERIMENTAL

Drug: pregabalin

Interventions

pregabalin DRUG

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

pregabalin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

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

Study Sites (33)

National Hospital Organization Nagoya Medical Center

Nagoya, Aichi-ken, 460-0001, Japan

Location

Kobayashi Clinic

Urayasu, Chiba, 279-0012, Japan

Location

Okabe Hospital

Kasuya-gun, Fukuoka, 811-2122, Japan

Location

Gunma Pain Clinic Hospital

Maebashi, Gunma, 379-2147, Japan

Location

Takasaki Pain Clinic

Takasaki, Gunma, 370-0035, Japan

Location

Asahikawa Pain Clinic Hospital

Asahikawa, Hokkaido, 070-0034, Japan

Location

Kamui Pain Clinic

Asahikawa, Hokkaido, 070-8013, Japan

Location

Sapporo Asabu Clinic

Sapporo, Hokkaido, 001-0045, Japan

Location

Higashi Sapporo Hospital

Sapporo, Hokkaido, 003-8585, Japan

Location

Seimei Clinic

Akashi, Hyōgo, 673-0016, Japan

Location

Uchida Pain Relief Clinic

Amagasaki, Hyōgo, 661-0012, Japan

Location

National Hospital Organization Himeji Medical Center

Himeji, Hyōgo, 670-8520, Japan

Location

National Hospital Organization Kobe Medical Center

Kobe, Hyōgo, 654-0155, Japan

Location

Nakamura Clinic

Kobe, Hyōgo, 655-0854, Japan

Location

National Hospital Organization Sagamihara National Hospital

Sagamihara, Kanagawa, 228-8522, Japan

Location

Suzuki Pain Clinic

Yokohama, Kanagawa, 227-0043, Japan

Location

Hajiri Pain Clinic

Yokohama, Kanagawa, 236-0037, Japan

Location

National Hospital Organization Yokohama Medical Center

Yokohama, Kanagawa, 245-8575, Japan

Location

Sendai Pain Clinic

Sendai, Miyagi, 983-0036, Japan

Location

Nakamura Hospital

Beppu, Ohita, 874-0937, Japan

Location

Kawaguchi Kogyo General Hospital

Kawaguchi, Saitama, 332-0031, Japan

Location

Kinoshita Clinic

Tokorozawa, Saitama, 359-0038, Japan

Location

Tokyo Women's Medical University Center East

Arakawa-ku, Tokyo, 116-8567, Japan

Location

Juntendo University Hospital

Bunkyo-ku, Tokyo, 113-8431, Japan

Location

Mitaka Pain Clinic

Mitaka, Tokyo, 181-0013, Japan

Location

Toriumi Pain Clinic

Nakano-ku, Tokyo, 165-0027, Japan

Location

Kanto Medical NTT East Corporation

Shinagawa-ku, Tokyo, 141-0022, Japan

Location

Naganuma Pain Clinic

Shinagawa-ku, Tokyo, 141-0022, Japan

Location

Tokyo Women's Medical University Hospital

Shinjuku-ku, Tokyo, 162-8666, Japan

Location

Mukai Clinic

Fukuoka, 812-0011, Japan

Location

KM Pain Clinic

Fukuoka, 814-0001, Japan

Location

Otsuki Sleep Clinic

Fukushima, 960-8044, Japan

Location

Hasumi Pain Clinic

Saitama, 330-0805, Japan

Location

Related Links

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

MeSH Terms

Conditions

Neuralgia, Postherpetic

Interventions

Pregabalin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2007
• First Posted: January 19, 2007
• Study Start: January 12, 2007
• Primary Completion: August 19, 2008
• Study Completion: August 19, 2008
• Last Updated: August 27, 2021
• Results First Posted: September 28, 2009

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will share

Locations

JP (33)