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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
372
placebo, oral administration for 13 weeks (1 week titration and 12-week fixed dose).
Pregabalin 150mg/day (75mg BID), oral administration for 13 weeks (1-week titration and 12-week fixed dose).
Pregabalin 300mg/day (150mg/BID), oral administration for 13 weeks (1-week titration and 12-week fixed dose).
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Week 3
Mean Pain Scores at Week 4
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Pregabalin 600 mg/day (300 mg/BID), oral administration for 13 weeks (1-week titration and 12-week fixed dose).
Pfizer Investigational Site
Nagoya, Aichi-ken, 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-chūō, 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
...and 29 more locations
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
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Week 13
Endpoint Sensory Scores of the Short-Form McGill Pain Questionnaire
Sensory score range from 0-33. Higher scores indicate more severe pain.
Time frame: Week13/discontinuation
Endpoint Affective Scores of the Short-Form McGill Pain Questionnaire
Affective score range from 0-12. Higher scores indicate more severe pain.
Time frame: Week13/discontinuation
Endpoint Total Scores of the Short-Form McGill Pain Questionnaire
Total score range from 0-45. Higher scores indicate more severe pain.
Time frame: 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.
Time frame: 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.
Time frame: Week13/discontinuation
Mean Sleep Interference Scores at Endpoint
Scores range from 0-10. Higher scores indicate more severe interference with sleep.
Time frame: 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.
Time frame: Week13/discontinuation
Endpoint Medical Outcomes Study Sleep Scale Scores:Snoring
Score range for snoring is 0-100.Higher scores indicate more of the attribute.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Week13/discontinuation
Endpoint Medical Outcomes Study Sleep Scale Scores:Somnolence
Score range for Somnolence is 0-100. Higher scores indicate more of the attribute.
Time frame: 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.
Time frame: Week13/discontinuation
Endpoint Medical Outcomes Study Sleep Scale: Number of Participants With Optimal Sleep
Number of participants who reported Optimal Sleep
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Week13/discontinuation
Number of Patients Not Reporting Allodynia
Participants not reporting allodynia.
Time frame: Week13/discontinuation
Number of Patients Not Reporting Hyperalgesia
Participants not reporting hyperalgesia.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: week 13