Back to resultsA 13-Week, Randomized, Double-Blind, Multicenter, Placebo-Controlled Study Of Pregabalin For Postherpetic Neuralgia
Primary Purpose
Neuralgia, Postherpetic
Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Placebo
Pregabalin
Pregabalin
Pregabalin
Sponsored by
About this trial
This is an interventional treatment trial for Neuralgia, Postherpetic
Eligibility 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.
Sites / Locations
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Placebo Comparator
Experimental
Experimental
Experimental
Arm Label
Placebo
Pregabalin 150mg/day
Pregabalin 300mg/day
Pregabalin 600mg/day
Arm Description
Outcomes
Primary Outcome Measures
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.
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.
Number of Responders
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Sensory score range from 0-33. Higher scores indicate more severe pain.
Endpoint Affective Scores of the Short-Form McGill Pain Questionnaire
Affective score range from 0-12. Higher scores indicate more severe pain.
Endpoint Total Scores of the Short-Form McGill Pain Questionnaire
Total score range from 0-45. Higher scores indicate more severe pain.
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.
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.
Mean Sleep Interference Scores at Endpoint
Scores range from 0-10. Higher scores indicate more severe interference with sleep.
Endpoint Medical Outcomes Study Sleep Scale Scores:Sleep Disturbance
Score range for sleep disturbance is 0-100.Higher scores indicate more of the attribute.
Endpoint Medical Outcomes Study Sleep Scale Scores:Snoring
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
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
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
Score range for sleep adequacy is 0-100. Higher scores indicate more of the attribute.
Endpoint Medical Outcomes Study Sleep Scale Scores:Somnolence
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
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
Number of participants who reported Optimal Sleep
Endpoint Patient Global Impression Change
Patient Global Impression Change is scaled from 1 to 7. 1=very much improved, 7=very much worse.
Endpoint Clinical Global Impression Change
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
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
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
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
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
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
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
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
Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status.
Number of Patients Not Reporting Allodynia
Participants not reporting allodynia.
Number of Patients Not Reporting Hyperalgesia
Participants not reporting hyperalgesia.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT00394901
First Posted
October 31, 2006
Last Updated
January 21, 2021
Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00394901
Brief Title
A 13-Week, Randomized, Double-Blind, Multicenter, Placebo-Controlled Study Of Pregabalin For Postherpetic Neuralgia
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2010
Overall Recruitment Status
Completed
Study Start Date
September 2006 (undefined)
Primary Completion Date
November 2007 (Actual)
Study Completion Date
November 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuralgia, Postherpetic
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
372 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
Pregabalin 150mg/day
Arm Type
Experimental
Arm Title
Pregabalin 300mg/day
Arm Type
Experimental
Arm Title
Pregabalin 600mg/day
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
placebo, oral administration for 13 weeks (1 week titration and 12-week fixed dose).
Intervention Type
Drug
Intervention Name(s)
Pregabalin
Intervention Description
Pregabalin 150mg/day (75mg BID), oral administration for 13 weeks (1-week titration and 12-week fixed dose).
Intervention Type
Drug
Intervention Name(s)
Pregabalin
Intervention Description
Pregabalin 300mg/day (150mg/BID), oral administration for 13 weeks (1-week titration and 12-week fixed dose).
Intervention Type
Drug
Intervention Name(s)
Pregabalin
Intervention Description
Pregabalin 600 mg/day (300 mg/BID), oral administration for 13 weeks (1-week titration and 12-week fixed dose).
Primary Outcome Measure Information:
Title
Mean Pain Scores at Endpoint
Description
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.
Time Frame
Week13/discontinuation
Title
Mean Pain Score at Endpoint by Groups of Subjects With Expected Similar Plasma Concentrations
Description
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.
Time Frame
Week13/discontinuation
Title
Number of Responders
Description
A responder is defined as a subject with a 50% reduction in weekly mean pain score from baseline to endpoint.
Time Frame
Week13/discontinuation
Title
Mean Pain Scores at Week 1
Description
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.
Time Frame
Week 1
Title
Mean Pain Scores at Week 2
Description
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.
Time Frame
Week 2
Title
Mean Pain Scores at Week 3
Description
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.
Time Frame
Week 3
Title
Mean Pain Scores at Week 4
Description
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.
Time Frame
Week4
Title
Mean Pain Scores at Week 5
Description
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.
Time Frame
Week 5
Title
Mean Pain Scores at Week 6
Description
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.
Time Frame
Week 6
Title
Mean Pain Scores at Week 7
Description
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.
Time Frame
Week 7
Title
Mean Pain Scores at Week 8
Description
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.
Time Frame
Week 8
Title
Mean Pain Scores at Week 9
Description
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.
Time Frame
Week 9
Title
Mean Pain Scores at Week 10
Description
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.
Time Frame
Week 10
Title
Mean Pain Scores at Week 11
Description
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.
Time Frame
Week 11
Title
Mean Pain Scores at Week 12
Description
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.
Time Frame
Week 12
Title
Mean Pain Scores at Week 13
Description
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.
Time Frame
Week 13
Secondary Outcome Measure Information:
Title
Endpoint Sensory Scores of the Short-Form McGill Pain Questionnaire
Description
Sensory score range from 0-33. Higher scores indicate more severe pain.
Time Frame
Week13/discontinuation
Title
Endpoint Affective Scores of the Short-Form McGill Pain Questionnaire
Description
Affective score range from 0-12. Higher scores indicate more severe pain.
Time Frame
Week13/discontinuation
Title
Endpoint Total Scores of the Short-Form McGill Pain Questionnaire
Description
Total score range from 0-45. Higher scores indicate more severe pain.
Time Frame
Week13/discontinuation
Title
Endpoint Visual Analogue Scale Scores of the Short-Form McGill Pain Questionnaire
Description
Visual Analogue Scale Score range from 0-100mm. Higher scores indicate more severe pain.
Time Frame
Week13/discontinuation
Title
Endpoint Present Pain Intensity Scores of the Short-Form McGill Pain Questionnaire
Description
Present pain intensity score range from 0-5. Higher scores indicate more severe pain.
Time Frame
Week13/discontinuation
Title
Mean Sleep Interference Scores at Endpoint
Description
Scores range from 0-10. Higher scores indicate more severe interference with sleep.
Time Frame
Week13/discontinuation
Title
Endpoint Medical Outcomes Study Sleep Scale Scores:Sleep Disturbance
Description
Score range for sleep disturbance is 0-100.Higher scores indicate more of the attribute.
Time Frame
Week13/discontinuation
Title
Endpoint Medical Outcomes Study Sleep Scale Scores:Snoring
Description
Score range for snoring is 0-100.Higher scores indicate more of the attribute.
Time Frame
Week13/discontinuation
Title
Endpoint Medical Outcomes Study Sleep Scale Scores:Awaken Short of Breath or With Headache
Description
Score range for awaken short of breath or with headache is 0-100. Higher scores indicate more of the attribute.
Time Frame
Week13/discontinuation
Title
Endpoint Medical Outcomes Study Sleep Scale Scores:Quantity of Sleep
Description
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.
Time Frame
Week13/discontinuation
Title
Endpoint Medical Outcomes Study Sleep Scale Scores:Sleep Adequacy
Description
Score range for sleep adequacy is 0-100. Higher scores indicate more of the attribute.
Time Frame
Week13/discontinuation
Title
Endpoint Medical Outcomes Study Sleep Scale Scores:Somnolence
Description
Score range for Somnolence is 0-100. Higher scores indicate more of the attribute.
Time Frame
Week13/discontinuation
Title
Endpoint Medical Outcomes Study Sleep Scale Scores:Overall Sleep Problem Index
Description
Score range for overall sleep problem index is 0-100. Higher scores indicate more of the attribute.
Time Frame
Week13/discontinuation
Title
Endpoint Medical Outcomes Study Sleep Scale: Number of Participants With Optimal Sleep
Description
Number of participants who reported Optimal Sleep
Time Frame
Week13/discontinuation
Title
Endpoint Patient Global Impression Change
Description
Patient Global Impression Change is scaled from 1 to 7. 1=very much improved, 7=very much worse.
Time Frame
Week13/discontinuation
Title
Endpoint Clinical Global Impression Change
Description
Clinical Global Impression Change is scaled from 1 to 7. 1=very much improved, 7=very much worse.
Time Frame
Week13/discontinuation
Title
Endpoint Short-Form 36-Item Health Survey Scores: Physical Functioning
Description
Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status.
Time Frame
Week13/discontinuation
Title
Endpoint Short-Form 36-Item Health Survey Scores: Role Limitations-Physical
Description
Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status.
Time Frame
Week13/discontinuation
Title
Endpoint Short-Form 36-Item Health Survey Scores: Bodily Pain
Description
Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status.
Time Frame
Week13/discontinuation
Title
Endpoint Short-Form 36-Item Health Survey Scores: General Health Perception
Description
Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status.
Time Frame
Week13/discontinuation
Title
Endpoint Short-Form 36-Item Health Survey Scores: Social Functioning
Description
Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status.
Time Frame
Week13/discontinuation
Title
Endpoint Short-Form 36-Item Health Survey Scores: Role Limitations-Emotional
Description
Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status.
Time Frame
Week13/discontinuation
Title
Endpoint Short-Form 36-Item Health Survey Scores: Vitality
Description
Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status.
Time Frame
Week13/discontinuation
Title
Endpoint Short-Form 36-Item Health Survey Scores: Mental Health
Description
Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status.
Time Frame
Week13/discontinuation
Title
Number of Patients Not Reporting Allodynia
Description
Participants not reporting allodynia.
Time Frame
Week13/discontinuation
Title
Number of Patients Not Reporting Hyperalgesia
Description
Participants not reporting hyperalgesia.
Time Frame
Week13/discontinuation
Title
Mean Sleep Interference Scores at Week 1
Description
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.
Time Frame
week 1
Title
Mean Sleep Interference Scores at Week 2
Description
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.
Time Frame
week 2
Title
Mean Sleep Interference Scores at Week 3
Description
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.
Time Frame
week 3
Title
Mean Sleep Interference Scores at Week 4
Description
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.
Time Frame
week 4
Title
Mean Sleep Interference Scores at Week 5
Description
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.
Time Frame
week 5
Title
Mean Sleep Interference Scores at Week 6
Description
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.
Time Frame
week 6
Title
Mean Sleep Interference Scores at Week 7
Description
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.
Time Frame
week 7
Title
Mean Sleep Interference Scores at Week 8
Description
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.
Time Frame
week 8
Title
Mean Sleep Interference Scores at Week 9
Description
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.
Time Frame
week 9
Title
Mean Sleep Interference Scores at Week 10
Description
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.
Time Frame
week 10
Title
Mean Sleep Interference Scores at Week 11
Description
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.
Time Frame
week 11
Title
Mean Sleep Interference Scores at Week 12
Description
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.
Time Frame
week 12
Title
Mean Sleep Interference Scores at Week 13
Description
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.
Time Frame
week 13
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Nagoya
State/Province
Aichi
Country
Japan
Facility Name
Pfizer Investigational Site
City
Ichikawa
State/Province
Chiba
Country
Japan
Facility Name
Pfizer Investigational Site
City
Urayasu
State/Province
Chiba
Country
Japan
Facility Name
Pfizer Investigational Site
City
Kasuga
State/Province
Fukuoka
Country
Japan
Facility Name
Pfizer Investigational Site
City
Kasuya-gun
State/Province
Fukuoka
Country
Japan
Facility Name
Pfizer Investigational Site
City
Maebaru
State/Province
Fukuoka
Country
Japan
Facility Name
Pfizer Investigational Site
City
Maebashi
State/Province
Gunma
Country
Japan
Facility Name
Pfizer Investigational Site
City
Takasaki
State/Province
Gunma
Country
Japan
Facility Name
Pfizer Investigational Site
City
Asahikawa
State/Province
Hokkaido
Country
Japan
Facility Name
Pfizer Investigational Site
City
Sapporo
State/Province
Hokkaido
Country
Japan
Facility Name
Pfizer Investigational Site
City
Akashi
State/Province
Hyogo
Country
Japan
Facility Name
Pfizer Investigational Site
City
Amagasaki
State/Province
Hyogo
Country
Japan
Facility Name
Pfizer Investigational Site
City
Himeji
State/Province
Hyogo
Country
Japan
Facility Name
Pfizer Investigational Site
City
Kobe
State/Province
Hyogo
Country
Japan
Facility Name
Pfizer Investigational Site
City
Nishinomiya
State/Province
Hyogo
Country
Japan
Facility Name
Pfizer Investigational Site
City
Tsuchiura
State/Province
Ibaraki
Country
Japan
Facility Name
Pfizer Investigational Site
City
Sagamihara
State/Province
Kanagawa
Country
Japan
Facility Name
Pfizer Investigational Site
City
Yokohama
State/Province
Kanagawa
Country
Japan
Facility Name
Pfizer Investigational Site
City
Sendai
State/Province
Miyagi
Country
Japan
Facility Name
Pfizer Investigational Site
City
Beppu
State/Province
Ohita
Country
Japan
Facility Name
Pfizer Investigational Site
City
Kishiwada
State/Province
Osaka
Country
Japan
Facility Name
Pfizer Investigational Site
City
Takatsuki
State/Province
Osaka
Country
Japan
Facility Name
Pfizer Investigational Site
City
Kawaguchi
State/Province
Saitama
Country
Japan
Facility Name
Pfizer Investigational Site
City
Kitamoto
State/Province
Saitama
Country
Japan
Facility Name
Pfizer Investigational Site
City
Tokorozawa
State/Province
Saitama
Country
Japan
Facility Name
Pfizer Investigational Site
City
Adachi-ku
State/Province
Tokyo
Country
Japan
Facility Name
Pfizer Investigational Site
City
Arakawa-ku
State/Province
Tokyo
Country
Japan
Facility Name
Pfizer Investigational Site
City
Bunkyo-ku
State/Province
Tokyo
Country
Japan
Facility Name
Pfizer Investigational Site
City
Edogawa-ku
State/Province
Tokyo
Country
Japan
Facility Name
Pfizer Investigational Site
City
Mitaka
State/Province
Tokyo
Country
Japan
Facility Name
Pfizer Investigational Site
City
Nakano-ku
State/Province
Tokyo
Country
Japan
Facility Name
Pfizer Investigational Site
City
Shinagawa-ku
State/Province
Tokyo
Country
Japan
Facility Name
Pfizer Investigational Site
City
Shinjuku-ku
State/Province
Tokyo
Country
Japan
Facility Name
Pfizer Investigational Site
City
Suginami-ku
State/Province
Tokyo
Country
Japan
Facility Name
Pfizer Investigational Site
City
Toshima-ku
State/Province
Tokyo
Country
Japan
Facility Name
Pfizer Investigational Site
City
Fukuoka
Country
Japan
Facility Name
Pfizer Investigational Site
City
Fukushima
Country
Japan
Facility Name
Pfizer Investigational Site
City
Osaka
Country
Japan
Facility Name
Pfizer Investigational Site
City
Saitama
Country
Japan
12. IPD Sharing Statement
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A0081120&StudyName=A%2013-Week%2C%20Randomized%2C%20Double-Blind%2C%20Multicenter%2C%20Placebo-Controlled%20Study%20Of%20Pregabalin%20For%20Postherpetic%20Neuralgia
Description
To obtain contact information for a study center near you, click here.
Learn more about this trial
A 13-Week, Randomized, Double-Blind, Multicenter, Placebo-Controlled Study Of Pregabalin For Postherpetic Neuralgia
We'll reach out to this number within 24 hrs