A 13-Week, Randomized, Double-Blind, Multicenter, Placebo-Controlled Study Of Pregabalin For Postherpetic Neuralgia

NCT00394901 | Completed Phase 3 Results

• 1 other identifier: A0081120
• Study Type: interventional
• Target: 372
• Locations: 1 country
• Sites: 39

Brief Summary

The purpose of this study is to evaluate efficacy and safety of pregabalin in the treatment of postherpetic neuralgia in a dose-ranging manner.

Conditions

Neuralgia, Postherpetic

Outcome Measures

Primary Outcomes (16)

• Mean Pain Scores at Endpoint

  Endpoint mean pain score is defined as the mean of the last 7 daily pain diary rating while taking the study medication, up to and including day after last dose. Scores range from 0-10 (11 points ordinal) with higher scores indicating increased pain.

  Week13/discontinuation

• Mean Pain Score at Endpoint by Groups of Subjects With Expected Similar Plasma Concentrations

  Endpoint mean pain score is defined as the mean of the last 7 daily pain diary rating while taking the study medication, up to and including day after last dose. Scores range from 0-10 (11 points ordinal) with higher scores indicating increased pain.

  Week13/discontinuation

• Number of Responders

  A responder is defined as a subject with a 50% reduction in weekly mean pain score from baseline to endpoint.

  Week13/discontinuation

• Mean Pain Scores at Week 1

  Weekly mean pain score is defined as the mean of the last 7 daily diary pain ratings. Scores range from 0-10 (11 points ordinal)with higher scores indicating increased pain.

  Week 1

• Mean Pain Scores at Week 2

  Weekly mean pain score is defined as the mean of the last 7 daily diary pain ratings. Scores range from 0-10 (11 points ordinal)with higher scores indicating increased pain.

  Week 2

• Mean Pain Scores at Week 3

  Weekly mean pain score is defined as the mean of the last 7 daily diary pain ratings. Scores range from 0-10 (11 points ordinal)with higher scores indicating increased pain.

  Week 3

• Mean Pain Scores at Week 4

  Weekly mean pain score is defined as the mean of the last 7 daily diary pain ratings. Scores range from 0-10 (11 points ordinal)with higher scores indicating increased pain.

  Week4

• Mean Pain Scores at Week 5

  Weekly mean pain score is defined as the mean of the last 7 daily diary pain ratings. Scores range from 0-10 (11 points ordinal)with higher scores indicating increased pain.

  Week 5

• Mean Pain Scores at Week 6

  Weekly mean pain score is defined as the mean of the last 7 daily diary pain ratings. Scores range from 0-10 (11 points ordinal)with higher scores indicating increased pain.

  Week 6

• Mean Pain Scores at Week 7

  Weekly mean pain score is defined as the mean of the last 7 daily diary pain ratings. Scores range from 0-10 (11 points ordinal)with higher scores indicating increased pain.

  Week 7

• Mean Pain Scores at Week 8

  Weekly mean pain score is defined as the mean of the last 7 daily diary pain ratings. Scores range from 0-10 (11 points ordinal)with higher scores indicating increased pain.

  Week 8

• Mean Pain Scores at Week 9

  Weekly mean pain score is defined as the mean of the last 7 daily diary pain ratings. Scores range from 0-10 (11 points ordinal)with higher scores indicating increased pain.

  Week 9

• Mean Pain Scores at Week 10

  Weekly mean pain score is defined as the mean of the last 7 daily diary pain ratings. Scores range from 0-10 (11 points ordinal)with higher scores indicating increased pain.

  Week 10

• Mean Pain Scores at Week 11

  Weekly mean pain score is defined as the mean of the last 7 daily diary pain ratings. Scores range from 0-10 (11 points ordinal)with higher scores indicating increased pain.

  Week 11

• Mean Pain Scores at Week 12

  Weekly mean pain score is defined as the mean of the last 7 daily diary pain ratings. Scores range from 0-10 (11 points ordinal)with higher scores indicating increased pain.

  Week 12

• Mean Pain Scores at Week 13

  Weekly mean pain score is defined as the mean of the last 7 daily diary pain ratings. Scores range from 0-10 (11 points ordinal)with higher scores indicating increased pain.

  Week 13

Secondary Outcomes (39)

• Endpoint Sensory Scores of the Short-Form McGill Pain Questionnaire

  Week13/discontinuation

• Endpoint Affective Scores of the Short-Form McGill Pain Questionnaire

  Week13/discontinuation

• Endpoint Total Scores of the Short-Form McGill Pain Questionnaire

  Week13/discontinuation

• Endpoint Visual Analogue Scale Scores of the Short-Form McGill Pain Questionnaire

  Week13/discontinuation

• Endpoint Present Pain Intensity Scores of the Short-Form McGill Pain Questionnaire

  Week13/discontinuation

Study Arms (4)

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Pregabalin 150mg/day

EXPERIMENTAL

Drug: Pregabalin

Pregabalin 300mg/day

EXPERIMENTAL

Drug: Pregabalin

Pregabalin 600mg/day

EXPERIMENTAL

Drug: Pregabalin

Interventions

Placebo DRUG

placebo, oral administration for 13 weeks (1 week titration and 12-week fixed dose).

Placebo

Pregabalin DRUG

Pregabalin 150mg/day (75mg BID), oral administration for 13 weeks (1-week titration and 12-week fixed dose).

Pregabalin 150mg/day

Eligibility Criteria

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

You may qualify if:

• Visual Analogue Scale (VAS) of pain is higher than 40 mm.
• Pain is sustained for more than 3 months after healing of herpes zoster skin rash.

You may not qualify if:

• Malignancy within the past 2 years.
• Patients who have undergone neurolytic or neurosurgical therapy for postherpetic neuralgia.
• Creatinine clearance \</= 30 mL/min (estimated from serum creatinine, body weight, age, and sex using the Cockcroft and Gault equation, by omitting any decimal fractions).
• Patients having other severe pain which may impair the self assessment of the pain due to postherpetic neuralgia.
• Skin conditions in the affected dermatome that could alter sensation.

Sponsors & Collaborators

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

Study Sites (39)

Pfizer Investigational Site

Nagoya, Aichi-ken, Japan

Location

Pfizer Investigational Site

Ichikawa, Chiba, Japan

Location

Pfizer Investigational Site

Urayasu, Chiba, Japan

Location

Pfizer Investigational Site

Kasuga, Fukuoka, Japan

Location

Pfizer Investigational Site

Kasuya-gun, Fukuoka, Japan

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Pfizer Investigational Site

Maebaru-chūō, Fukuoka, Japan

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Pfizer Investigational Site

Maebashi, Gunma, Japan

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Pfizer Investigational Site

Takasaki, Gunma, Japan

Location

Pfizer Investigational Site

Asahikawa, Hokkaido, Japan

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Pfizer Investigational Site

Sapporo, Hokkaido, Japan

Location

Pfizer Investigational Site

Akashi, Hyōgo, Japan

Location

Pfizer Investigational Site

Amagasaki, Hyōgo, Japan

Location

Pfizer Investigational Site

Himeji, Hyōgo, Japan

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Pfizer Investigational Site

Kobe, Hyōgo, Japan

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Pfizer Investigational Site

Nishinomiya, Hyōgo, Japan

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Pfizer Investigational Site

Tsuchiura, Ibaraki, Japan

Location

Pfizer Investigational Site

Sagamihara, Kanagawa, Japan

Location

Pfizer Investigational Site

Yokohama, Kanagawa, Japan

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Pfizer Investigational Site

Sendai, Miyagi, Japan

Location

Pfizer Investigational Site

Beppu, Ohita, Japan

Location

Pfizer Investigational Site

Kishiwada, Osaka, Japan

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Pfizer Investigational Site

Takatsuki, Osaka, Japan

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Pfizer Investigational Site

Kawaguchi, Saitama, Japan

Location

Pfizer Investigational Site

Kitamoto, Saitama, Japan

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Pfizer Investigational Site

Tokorozawa, Saitama, Japan

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Pfizer Investigational Site

Adachi-ku, Tokyo, Japan

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Pfizer Investigational Site

Arakawa-ku, Tokyo, Japan

Location

Pfizer Investigational Site

Bunkyo-ku, Tokyo, Japan

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Pfizer Investigational Site

Edogawa-ku, Tokyo, Japan

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Pfizer Investigational Site

Mitaka, Tokyo, Japan

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Pfizer Investigational Site

Nakano-ku, Tokyo, Japan

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Pfizer Investigational Site

Shinagawa-ku, Tokyo, Japan

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Pfizer Investigational Site

Shinjuku-ku, Tokyo, Japan

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Pfizer Investigational Site

Suginami-ku, Tokyo, Japan

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Pfizer Investigational Site

Toshima-ku, Tokyo, Japan

Location

Pfizer Investigational Site

Fukuoka, Japan

Location

Pfizer Investigational Site

Fukushima, Japan

Location

Pfizer Investigational Site

Osaka, Japan

Location

Pfizer Investigational Site

Saitama, 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.govCallCenter@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: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2006
• First Posted: November 2, 2006
• Study Start: September 1, 2006
• Primary Completion: November 1, 2007
• Study Completion: November 1, 2007
• Last Updated: February 9, 2021
• Results First Posted: February 27, 2009

Record last verified: 2010-02

Locations

JP (39)