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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00394901
First received: October 31, 2006
Last updated: February 26, 2010
Last verified: February 2010
  Purpose
The purpose of this study is to evaluate efficacy and safety of pregabalin in the treatment of postherpetic neuralgia in a dose-ranging manner.

Condition Intervention Phase
Neuralgia, Postherpetic Drug: Placebo Drug: Pregabalin Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: A 13-Week, Randomized, Double-Blind, Multicenter, Placebo-Controlled Study To Evaluate Efficacy And Safety Of Pregabalin In The Treatment Of Postherpetic Neuralgia

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Mean Pain Scores at Endpoint [ Time Frame: Week13/discontinuation ]
    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.

  • Mean Pain Score at Endpoint by Groups of Subjects With Expected Similar Plasma Concentrations [ Time Frame: Week13/discontinuation ]
    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.

  • Number of Responders [ Time Frame: Week13/discontinuation ]
    A responder is defined as a subject with a 50% reduction in weekly mean pain score from baseline to endpoint.

  • Mean Pain Scores at Week 1 [ Time Frame: 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.

  • Mean Pain Scores at Week 2 [ Time Frame: 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.

  • Mean Pain Scores at Week 3 [ Time Frame: 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.

  • Mean Pain Scores at Week 4 [ Time Frame: Week4 ]
    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.

  • Mean Pain Scores at Week 5 [ Time Frame: 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.

  • Mean Pain Scores at Week 6 [ Time Frame: 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.

  • Mean Pain Scores at Week 7 [ Time Frame: 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.

  • Mean Pain Scores at Week 8 [ Time Frame: 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.

  • Mean Pain Scores at Week 9 [ Time Frame: 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.

  • Mean Pain Scores at Week 10 [ Time Frame: 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.

  • Mean Pain Scores at Week 11 [ Time Frame: 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.

  • Mean Pain Scores at Week 12 [ Time Frame: 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.

  • Mean Pain Scores at Week 13 [ Time Frame: 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.


Secondary Outcome Measures:
  • Endpoint Sensory Scores of the Short-Form McGill Pain Questionnaire [ Time Frame: Week13/discontinuation ]
    Sensory score range from 0-33. Higher scores indicate more severe pain.

  • Endpoint Affective Scores of the Short-Form McGill Pain Questionnaire [ Time Frame: Week13/discontinuation ]
    Affective score range from 0-12. Higher scores indicate more severe pain.

  • Endpoint Total Scores of the Short-Form McGill Pain Questionnaire [ Time Frame: Week13/discontinuation ]
    Total score range from 0-45. Higher scores indicate more severe pain.

  • Endpoint Visual Analogue Scale Scores of the Short-Form McGill Pain Questionnaire [ Time Frame: Week13/discontinuation ]
    Visual Analogue Scale Score range from 0-100mm. Higher scores indicate more severe pain.

  • Endpoint Present Pain Intensity Scores of the Short-Form McGill Pain Questionnaire [ Time Frame: Week13/discontinuation ]
    Present pain intensity score range from 0-5. Higher scores indicate more severe pain.

  • Mean Sleep Interference Scores at Endpoint [ Time Frame: Week13/discontinuation ]
    Scores range from 0-10. Higher scores indicate more severe interference with sleep.

  • Endpoint Medical Outcomes Study Sleep Scale Scores:Sleep Disturbance [ Time Frame: Week13/discontinuation ]
    Score range for sleep disturbance is 0-100.Higher scores indicate more of the attribute.

  • Endpoint Medical Outcomes Study Sleep Scale Scores:Snoring [ Time Frame: Week13/discontinuation ]
    Score range for snoring is 0-100.Higher scores indicate more of the attribute.

  • Endpoint Medical Outcomes Study Sleep Scale Scores:Awaken Short of Breath or With Headache [ Time Frame: Week13/discontinuation ]
    Score range for awaken short of breath or with headache is 0-100. Higher scores indicate more of the attribute.

  • Endpoint Medical Outcomes Study Sleep Scale Scores:Quantity of Sleep [ Time Frame: Week13/discontinuation ]
    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.

  • Endpoint Medical Outcomes Study Sleep Scale Scores:Sleep Adequacy [ Time Frame: Week13/discontinuation ]
    Score range for sleep adequacy is 0-100. Higher scores indicate more of the attribute.

  • Endpoint Medical Outcomes Study Sleep Scale Scores:Somnolence [ Time Frame: Week13/discontinuation ]
    Score range for Somnolence is 0-100. Higher scores indicate more of the attribute.

  • Endpoint Medical Outcomes Study Sleep Scale Scores:Overall Sleep Problem Index [ Time Frame: Week13/discontinuation ]
    Score range for overall sleep problem index is 0-100. Higher scores indicate more of the attribute.

  • Endpoint Medical Outcomes Study Sleep Scale: Number of Participants With Optimal Sleep [ Time Frame: Week13/discontinuation ]
    Number of participants who reported Optimal Sleep

  • Endpoint Patient Global Impression Change [ Time Frame: Week13/discontinuation ]
    Patient Global Impression Change is scaled from 1 to 7. 1=very much improved, 7=very much worse.

  • Endpoint Clinical Global Impression Change [ Time Frame: Week13/discontinuation ]
    Clinical Global Impression Change is scaled from 1 to 7. 1=very much improved, 7=very much worse.

  • Endpoint Short-Form 36-Item Health Survey Scores: Physical Functioning [ Time Frame: Week13/discontinuation ]
    Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status.

  • Endpoint Short-Form 36-Item Health Survey Scores: Role Limitations-Physical [ Time Frame: Week13/discontinuation ]
    Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status.

  • Endpoint Short-Form 36-Item Health Survey Scores: Bodily Pain [ Time Frame: Week13/discontinuation ]
    Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status.

  • Endpoint Short-Form 36-Item Health Survey Scores: General Health Perception [ Time Frame: Week13/discontinuation ]
    Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status.

  • Endpoint Short-Form 36-Item Health Survey Scores: Social Functioning [ Time Frame: Week13/discontinuation ]
    Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status.

  • Endpoint Short-Form 36-Item Health Survey Scores: Role Limitations-Emotional [ Time Frame: Week13/discontinuation ]
    Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status.

  • Endpoint Short-Form 36-Item Health Survey Scores: Vitality [ Time Frame: Week13/discontinuation ]
    Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status.

  • Endpoint Short-Form 36-Item Health Survey Scores: Mental Health [ Time Frame: Week13/discontinuation ]
    Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status.

  • Number of Patients Not Reporting Allodynia [ Time Frame: Week13/discontinuation ]
    Participants not reporting allodynia.

  • Number of Patients Not Reporting Hyperalgesia [ Time Frame: Week13/discontinuation ]
    Participants not reporting hyperalgesia.

  • Mean Sleep Interference Scores at Week 1 [ Time Frame: 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.

  • Mean Sleep Interference Scores at Week 2 [ Time Frame: 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.

  • Mean Sleep Interference Scores at Week 3 [ Time Frame: 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.

  • Mean Sleep Interference Scores at Week 4 [ Time Frame: 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.

  • Mean Sleep Interference Scores at Week 5 [ Time Frame: 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.

  • Mean Sleep Interference Scores at Week 6 [ Time Frame: 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.

  • Mean Sleep Interference Scores at Week 7 [ Time Frame: 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.

  • Mean Sleep Interference Scores at Week 8 [ Time Frame: 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.

  • Mean Sleep Interference Scores at Week 9 [ Time Frame: 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.

  • Mean Sleep Interference Scores at Week 10 [ Time Frame: 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.

  • Mean Sleep Interference Scores at Week 11 [ Time Frame: 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.

  • Mean Sleep Interference Scores at Week 12 [ Time Frame: 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.

  • Mean Sleep Interference Scores at Week 13 [ Time Frame: 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.


Enrollment: 372
Study Start Date: September 2006
Study Completion Date: November 2007
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).
Experimental: Pregabalin 300mg/day Drug: Pregabalin
Pregabalin 300mg/day (150mg/BID), oral administration for 13 weeks (1-week titration and 12-week fixed dose).
Experimental: Pregabalin 600mg/day Drug: Pregabalin
Pregabalin 600 mg/day (300 mg/BID), oral administration for 13 weeks (1-week titration and 12-week fixed dose).

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00394901

Locations
Japan
Pfizer Investigational Site
Nagoya, Aichi, Japan
Pfizer Investigational Site
Ichikawa, Chiba, Japan
Pfizer Investigational Site
Urayasu, Chiba, Japan
Pfizer Investigational Site
Kasuga, Fukuoka, Japan
Pfizer Investigational Site
Kasuya-gun, Fukuoka, Japan
Pfizer Investigational Site
Maebaru, Fukuoka, Japan
Pfizer Investigational Site
Maebashi, Gunma, Japan
Pfizer Investigational Site
Takasaki, Gunma, Japan
Pfizer Investigational Site
Asahikawa, Hokkaido, Japan
Pfizer Investigational Site
Sapporo, Hokkaido, Japan
Pfizer Investigational Site
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
Tsuchiura, Ibaraki, Japan
Pfizer Investigational Site
Sagamihara, Kanagawa, Japan
Pfizer Investigational Site
Yokohama, Kanagawa, Japan
Pfizer Investigational Site
Sendai, Miyagi, Japan
Pfizer Investigational Site
Beppu, Ohita, Japan
Pfizer Investigational Site
Kishiwada, Osaka, Japan
Pfizer Investigational Site
Takatsuki, Osaka, Japan
Pfizer Investigational Site
Kawaguchi, Saitama, Japan
Pfizer Investigational Site
Kitamoto, Saitama, Japan
Pfizer Investigational Site
Tokorozawa, Saitama, Japan
Pfizer Investigational Site
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
Fukuoka, Japan
Pfizer Investigational Site
Fukushima, Japan
Pfizer Investigational Site
Osaka, Japan
Pfizer Investigational Site
Saitama, Japan
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00394901     History of Changes
Other Study ID Numbers: A0081120
Study First Received: October 31, 2006
Results First Received: November 7, 2008
Last Updated: February 26, 2010

Additional relevant MeSH terms:
Neuralgia
Neuralgia, Postherpetic
Pain
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Pregabalin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs

ClinicalTrials.gov processed this record on June 26, 2017