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

A 13-Week, Randomized, Double-Blind, Multicenter, Placebo-Controlled Study To Evaluate Efficacy And Safety Of Pregabalin In The Treatment Of Postherpetic Neuralgia

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

Study Overview

• Status: Completed
• Conditions: Neuralgia, Postherpetic
• Intervention / Treatment: Drug: Placebo; Drug: Pregabalin; Drug: Pregabalin; Drug: Pregabalin

• Study Type: Interventional
• Enrollment (Actual): 372
• Phase: Phase 3

Contacts and Locations

Study Locations

• Japan
  • Fukuoka, Japan
    • Pfizer Investigational Site
  • Fukushima, Japan
    • Pfizer Investigational Site
  • Osaka, Japan
    • Pfizer Investigational Site
  • Saitama, Japan
    • Pfizer Investigational Site
  • Aichi
    • Nagoya, Aichi, Japan
      • Pfizer Investigational Site
  • Chiba
    • Ichikawa, Chiba, Japan
      • Pfizer Investigational Site
    • Urayasu, Chiba, Japan
      • Pfizer Investigational Site
  • Fukuoka
    • Kasuga, Fukuoka, Japan
      • Pfizer Investigational Site
    • Kasuya-gun, Fukuoka, Japan
      • Pfizer Investigational Site
    • Maebaru, Fukuoka, Japan
      • Pfizer Investigational Site
  • Gunma
    • Maebashi, Gunma, Japan
      • Pfizer Investigational Site
    • Takasaki, Gunma, Japan
      • Pfizer Investigational Site
  • Hokkaido
    • Asahikawa, Hokkaido, Japan
      • Pfizer Investigational Site
    • Sapporo, Hokkaido, Japan
      • Pfizer Investigational Site
  • Hyogo
    • Akashi, Hyogo, Japan
      • Pfizer Investigational Site
    • Amagasaki, Hyogo, Japan
      • Pfizer Investigational Site
    • Himeji, Hyogo, Japan
      • Pfizer Investigational Site
    • Kobe, Hyogo, Japan
      • Pfizer Investigational Site
    • Nishinomiya, Hyogo, Japan
      • Pfizer Investigational Site
  • Ibaraki
    • Tsuchiura, Ibaraki, Japan
      • Pfizer Investigational Site
  • Kanagawa
    • Sagamihara, Kanagawa, Japan
      • Pfizer Investigational Site
    • Yokohama, Kanagawa, Japan
      • Pfizer Investigational Site
  • Miyagi
    • Sendai, Miyagi, Japan
      • Pfizer Investigational Site
  • Ohita
    • Beppu, Ohita, Japan
      • Pfizer Investigational Site
  • Osaka
    • Kishiwada, Osaka, Japan
      • Pfizer Investigational Site
    • Takatsuki, Osaka, Japan
      • Pfizer Investigational Site
  • Saitama
    • Kawaguchi, Saitama, Japan
      • Pfizer Investigational Site
    • Kitamoto, Saitama, Japan
      • Pfizer Investigational Site
    • Tokorozawa, Saitama, Japan
      • Pfizer Investigational Site
  • Tokyo
    • Adachi-ku, Tokyo, Japan
      • Pfizer Investigational Site
    • Arakawa-ku, Tokyo, Japan
      • Pfizer Investigational Site
    • Bunkyo-ku, Tokyo, Japan
      • Pfizer Investigational Site
    • Edogawa-ku, Tokyo, Japan
      • Pfizer Investigational Site
    • Mitaka, Tokyo, Japan
      • Pfizer Investigational Site
    • Nakano-ku, Tokyo, Japan
      • Pfizer Investigational Site
    • Shinagawa-ku, Tokyo, Japan
      • Pfizer Investigational Site
    • Shinjuku-ku, Tokyo, Japan
      • Pfizer Investigational Site
    • Suginami-ku, Tokyo, Japan
      • Pfizer Investigational Site
    • Toshima-ku, Tokyo, Japan
      • Pfizer Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; placebo, oral administration for 13 weeks (1 week titration and 12-week fixed dose).
Experimental: Pregabalin 150mg/day	Drug: Pregabalin; Pregabalin 150mg/day (75mg BID), oral administration for 13 weeks (1-week titration and 12-week fixed dose).; Drug: Pregabalin; Pregabalin 300mg/day (150mg/BID), oral administration for 13 weeks (1-week titration and 12-week fixed dose).; Drug: Pregabalin; Pregabalin 600 mg/day (300 mg/BID), oral administration for 13 weeks (1-week titration and 12-week fixed dose).
Experimental: Pregabalin 300mg/day	Drug: Pregabalin; Pregabalin 150mg/day (75mg BID), oral administration for 13 weeks (1-week titration and 12-week fixed dose).; Drug: Pregabalin; Pregabalin 300mg/day (150mg/BID), oral administration for 13 weeks (1-week titration and 12-week fixed dose).; Drug: Pregabalin; Pregabalin 600 mg/day (300 mg/BID), oral administration for 13 weeks (1-week titration and 12-week fixed dose).
Experimental: Pregabalin 600mg/day	Drug: Pregabalin; Pregabalin 150mg/day (75mg BID), oral administration for 13 weeks (1-week titration and 12-week fixed dose).; Drug: Pregabalin; Pregabalin 300mg/day (150mg/BID), oral administration for 13 weeks (1-week titration and 12-week fixed dose).; Drug: Pregabalin; Pregabalin 600 mg/day (300 mg/BID), oral administration for 13 weeks (1-week titration and 12-week fixed dose).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Endpoint Sensory Scores of the Short-Form McGill Pain Questionnaire	Sensory score range from 0-33. Higher scores indicate more severe pain.	Week13/discontinuation
Endpoint Affective Scores of the Short-Form McGill Pain Questionnaire	Affective score range from 0-12. Higher scores indicate more severe pain.	Week13/discontinuation
Endpoint Total Scores of the Short-Form McGill Pain Questionnaire	Total score range from 0-45. Higher scores indicate more severe pain.	Week13/discontinuation
Endpoint Visual Analogue Scale Scores of the Short-Form McGill Pain Questionnaire	Visual Analogue Scale Score range from 0-100mm. Higher scores indicate more severe pain.	Week13/discontinuation
Endpoint Present Pain Intensity Scores of the Short-Form McGill Pain Questionnaire	Present pain intensity score range from 0-5. Higher scores indicate more severe pain.	Week13/discontinuation
Mean Sleep Interference Scores at Endpoint	Scores range from 0-10. Higher scores indicate more severe interference with sleep.	Week13/discontinuation
Endpoint Medical Outcomes Study Sleep Scale Scores:Sleep Disturbance	Score range for sleep disturbance is 0-100.Higher scores indicate more of the attribute.	Week13/discontinuation
Endpoint Medical Outcomes Study Sleep Scale Scores:Snoring	Score range for snoring is 0-100.Higher scores indicate more of the attribute.	Week13/discontinuation
Endpoint Medical Outcomes Study Sleep Scale Scores:Awaken Short of Breath or With Headache	Score range for awaken short of breath or with headache is 0-100. Higher scores indicate more of the attribute.	Week13/discontinuation
Endpoint Medical Outcomes Study Sleep Scale Scores:Quantity of Sleep	Sleep Quantity subscale is scored from 0-24 indicating the number of hours of sleep. Higher scores indicate more of the attribute named in the subscale.	Week13/discontinuation
Endpoint Medical Outcomes Study Sleep Scale Scores:Sleep Adequacy	Score range for sleep adequacy is 0-100. Higher scores indicate more of the attribute.	Week13/discontinuation
Endpoint Medical Outcomes Study Sleep Scale Scores:Somnolence	Score range for Somnolence is 0-100. Higher scores indicate more of the attribute.	Week13/discontinuation
Endpoint Medical Outcomes Study Sleep Scale Scores:Overall Sleep Problem Index	Score range for overall sleep problem index is 0-100. Higher scores indicate more of the attribute.	Week13/discontinuation
Endpoint Medical Outcomes Study Sleep Scale: Number of Participants With Optimal Sleep	Number of participants who reported Optimal Sleep	Week13/discontinuation
Endpoint Patient Global Impression Change	Patient Global Impression Change is scaled from 1 to 7. 1=very much improved, 7=very much worse.	Week13/discontinuation
Endpoint Clinical Global Impression Change	Clinical Global Impression Change is scaled from 1 to 7. 1=very much improved, 7=very much worse.	Week13/discontinuation
Endpoint Short-Form 36-Item Health Survey Scores: Physical Functioning	Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status.	Week13/discontinuation
Endpoint Short-Form 36-Item Health Survey Scores: Role Limitations-Physical	Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status.	Week13/discontinuation
Endpoint Short-Form 36-Item Health Survey Scores: Bodily Pain	Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status.	Week13/discontinuation
Endpoint Short-Form 36-Item Health Survey Scores: General Health Perception	Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status.	Week13/discontinuation
Endpoint Short-Form 36-Item Health Survey Scores: Social Functioning	Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status.	Week13/discontinuation
Endpoint Short-Form 36-Item Health Survey Scores: Role Limitations-Emotional	Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status.	Week13/discontinuation
Endpoint Short-Form 36-Item Health Survey Scores: Vitality	Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status.	Week13/discontinuation
Endpoint Short-Form 36-Item Health Survey Scores: Mental Health	Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status.	Week13/discontinuation
Number of Patients Not Reporting Allodynia	Participants not reporting allodynia.	Week13/discontinuation
Number of Patients Not Reporting Hyperalgesia	Participants not reporting hyperalgesia.	Week13/discontinuation
Mean Sleep Interference Scores at Week 1	Weekly mean sleep interference scores is defined as the mean of the last 7 daily diary interference with sleep ratings. Scores range from 0-10 (11 points ordinal) with higher scores indicating more severe interference with sleep.	week 1
Mean Sleep Interference Scores at Week 2	Weekly mean sleep interference scores is defined as the mean of the last 7 daily diary interference with sleep ratings. Scores range from 0-10 (11 points ordinal) with higher scores indicating more severe interference with sleep.	week 2
Mean Sleep Interference Scores at Week 3	Weekly mean sleep interference scores is defined as the mean of the last 7 daily diary interference with sleep ratings. Scores range from 0-10 (11 points ordinal) with higher scores indicating more severe interference with sleep.	week 3
Mean Sleep Interference Scores at Week 4	Weekly mean sleep interference scores is defined as the mean of the last 7 daily diary interference with sleep ratings. Scores range from 0-10 (11 points ordinal) with higher scores indicating more severe interference with sleep.	week 4
Mean Sleep Interference Scores at Week 5	Weekly mean sleep interference scores is defined as the mean of the last 7 daily diary interference with sleep ratings. Scores range from 0-10 (11 points ordinal) with higher scores indicating more severe interference with sleep.	week 5
Mean Sleep Interference Scores at Week 6	Weekly mean sleep interference scores is defined as the mean of the last 7 daily diary interference with sleep ratings. Scores range from 0-10 (11 points ordinal) with higher scores indicating more severe interference with sleep.	week 6
Mean Sleep Interference Scores at Week 7	Weekly mean sleep interference scores is defined as the mean of the last 7 daily diary interference with sleep ratings. Scores range from 0-10 (11 points ordinal) with higher scores indicating more severe interference with sleep.	week 7
Mean Sleep Interference Scores at Week 8	Weekly mean sleep interference scores is defined as the mean of the last 7 daily diary interference with sleep ratings. Scores range from 0-10 (11 points ordinal) with higher scores indicating more severe interference with sleep.	week 8
Mean Sleep Interference Scores at Week 9	Weekly mean sleep interference scores is defined as the mean of the last 7 daily diary interference with sleep ratings. Scores range from 0-10 (11 points ordinal) with higher scores indicating more severe interference with sleep.	week 9
Mean Sleep Interference Scores at Week 10	Weekly mean sleep interference scores is defined as the mean of the last 7 daily diary interference with sleep ratings. Scores range from 0-10 (11 points ordinal) with higher scores indicating more severe interference with sleep.	week 10
Mean Sleep Interference Scores at Week 11	Weekly mean sleep interference scores is defined as the mean of the last 7 daily diary interference with sleep ratings. Scores range from 0-10 (11 points ordinal) with higher scores indicating more severe interference with sleep.	week 11
Mean Sleep Interference Scores at Week 12	Weekly mean sleep interference scores is defined as the mean of the last 7 daily diary interference with sleep ratings. Scores range from 0-10 (11 points ordinal) with higher scores indicating more severe interference with sleep.	week 12
Mean Sleep Interference Scores at Week 13	Weekly mean sleep interference scores is defined as the mean of the last 7 daily diary interference with sleep ratings. Scores range from 0-10 (11 points ordinal) with higher scores indicating more severe interference with sleep.	week 13

Collaborators and Investigators

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

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start: September 1, 2006
• Primary Completion (Actual): November 1, 2007
• Study Completion (Actual): November 1, 2007

Study Registration Dates

• First Submitted: October 31, 2006
• First Submitted That Met QC Criteria: October 31, 2006
• First Posted (Estimate): November 2, 2006

Study Record Updates

• Last Update Posted (Actual): February 9, 2021
• Last Update Submitted That Met QC Criteria: January 21, 2021
• Last Verified: February 1, 2010

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Neuromuscular Diseases; Peripheral Nervous System Diseases; Neuralgia; Neuralgia, Postherpetic; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Tranquilizing Agents; Psychotropic Drugs; Membrane Transport Modulators; Anti-Anxiety Agents; Anticonvulsants; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Pregabalin
• Other Study ID Numbers: A0081120