Clinical trial NCT00394901: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Neuralgia, Postherpetic
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2006-11-02
Enrollment: 372
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Mean Pain Scores at Endpoint
timeFrame: Week13/discontinuation
measure: Mean Pain Score at Endpoint by Groups of Subjects With Expected Similar Plasma Concentrations
timeFrame: Week13/discontinuation
measure: Number of Responders
timeFrame: Week13/discontinuation
measure: Mean Pain Scores at Week 1
timeFrame: Week 1
measure: Mean Pain Scores at Week 2
timeFrame: Week 2
measure: Mean Pain Scores at Week 3
timeFrame: Week 3
measure: Mean Pain Scores at Week 4
timeFrame: Week4
measure: Mean Pain Scores at Week 5
timeFrame: Week 5
measure: Mean Pain Scores at Week 6
timeFrame: Week 6
measure: Mean Pain Scores at Week 7
timeFrame: Week 7
measure: Mean Pain Scores at Week 8
timeFrame: Week 8
measure: Mean Pain Scores at Week 9
timeFrame: Week 9
measure: Mean Pain Scores at Week 10
timeFrame: Week 10
measure: Mean Pain Scores at Week 11
timeFrame: Week 11
measure: Mean Pain Scores at Week 12
timeFrame: Week 12
measure: Mean Pain Scores at Week 13
timeFrame: Week 13
Secondary outcomes:
measure: Endpoint Sensory Scores of the Short-Form McGill Pain Questionnaire
timeFrame: Week13/discontinuation
measure: Endpoint Affective Scores of the Short-Form McGill Pain Questionnaire
timeFrame: Week13/discontinuation
measure: Endpoint Total Scores of the Short-Form McGill Pain Questionnaire
timeFrame: Week13/discontinuation
measure: Endpoint Visual Analogue Scale Scores of the Short-Form McGill Pain Questionnaire
timeFrame: Week13/discontinuation
measure: Endpoint Present Pain Intensity Scores of the Short-Form McGill Pain Questionnaire
timeFrame: Week13/discontinuation
measure: Mean Sleep Interference Scores at Endpoint
timeFrame: Week13/discontinuation
measure: Endpoint Medical Outcomes Study Sleep Scale Scores:Sleep Disturbance
timeFrame: Week13/discontinuation
measure: Endpoint Medical Outcomes Study Sleep Scale Scores:Snoring
timeFrame: Week13/discontinuation
measure: Endpoint Medical Outcomes Study Sleep Scale Scores:Awaken Short of Breath or With Headache
timeFrame: Week13/discontinuation
measure: Endpoint Medical Outcomes Study Sleep Scale Scores:Quantity of Sleep
timeFrame: Week13/discontinuation
measure: Endpoint Medical Outcomes Study Sleep Scale Scores:Sleep Adequacy
timeFrame: Week13/discontinuation
measure: Endpoint Medical Outcomes Study Sleep Scale Scores:Somnolence
timeFrame: Week13/discontinuation
measure: Endpoint Medical Outcomes Study Sleep Scale Scores:Overall Sleep Problem Index
timeFrame: Week13/discontinuation
measure: Endpoint Medical Outcomes Study Sleep Scale: Number of Participants With Optimal Sleep
timeFrame: Week13/discontinuation
measure: Endpoint Patient Global Impression Change
timeFrame: Week13/discontinuation
measure: Endpoint Clinical Global Impression Change
timeFrame: Week13/discontinuation
measure: Endpoint Short-Form 36-Item Health Survey Scores: Physical Functioning
timeFrame: Week13/discontinuation
measure: Endpoint Short-Form 36-Item Health Survey Scores: Role Limitations-Physical
timeFrame: Week13/discontinuation
measure: Endpoint Short-Form 36-Item Health Survey Scores: Bodily Pain
timeFrame: Week13/discontinuation
measure: Endpoint Short-Form 36-Item Health Survey Scores: General Health Perception
timeFrame: Week13/discontinuation
measure: Endpoint Short-Form 36-Item Health Survey Scores: Social Functioning
timeFrame: Week13/discontinuation
measure: Endpoint Short-Form 36-Item Health Survey Scores: Role Limitations-Emotional
timeFrame: Week13/discontinuation
measure: Endpoint Short-Form 36-Item Health Survey Scores: Vitality
timeFrame: Week13/discontinuation
measure: Endpoint Short-Form 36-Item Health Survey Scores: Mental Health
timeFrame: Week13/discontinuation
measure: Number of Patients Not Reporting Allodynia
timeFrame: Week13/discontinuation
measure: Number of Patients Not Reporting Hyperalgesia
timeFrame: Week13/discontinuation
measure: Mean Sleep Interference Scores at Week 1
timeFrame: week 1
measure: Mean Sleep Interference Scores at Week 2
timeFrame: week 2
measure: Mean Sleep Interference Scores at Week 3
timeFrame: week 3
measure: Mean Sleep Interference Scores at Week 4
timeFrame: week 4
measure: Mean Sleep Interference Scores at Week 5
timeFrame: week 5
measure: Mean Sleep Interference Scores at Week 6
timeFrame: week 6
measure: Mean Sleep Interference Scores at Week 7
timeFrame: week 7
measure: Mean Sleep Interference Scores at Week 8
timeFrame: week 8
measure: Mean Sleep Interference Scores at Week 9
timeFrame: week 9
measure: Mean Sleep Interference Scores at Week 10
timeFrame: week 10
measure: Mean Sleep Interference Scores at Week 11
timeFrame: week 11
measure: Mean Sleep Interference Scores at Week 12
timeFrame: week 12
measure: Mean Sleep Interference Scores at Week 13
timeFrame: week 13
Other outcomes:
Locations:
city: Nagoya
country: Japan
facility: Pfizer Investigational Site
state: Aichi
city: Ichikawa
country: Japan
facility: Pfizer Investigational Site
state: Chiba
city: Urayasu
country: Japan
facility: Pfizer Investigational Site
state: Chiba
city: Kasuga
country: Japan
facility: Pfizer Investigational Site
state: Fukuoka
city: Kasuya-gun
country: Japan
facility: Pfizer Investigational Site
state: Fukuoka
city: Maebaru
country: Japan
facility: Pfizer Investigational Site
state: Fukuoka
city: Maebashi
country: Japan
facility: Pfizer Investigational Site
state: Gunma
city: Takasaki
country: Japan
facility: Pfizer Investigational Site
state: Gunma
city: Asahikawa
country: Japan
facility: Pfizer Investigational Site
state: Hokkaido
city: Sapporo
country: Japan
facility: Pfizer Investigational Site
state: Hokkaido
city: Akashi
country: Japan
facility: Pfizer Investigational Site
state: Hyogo
city: Amagasaki
country: Japan
facility: Pfizer Investigational Site
state: Hyogo
city: Himeji
country: Japan
facility: Pfizer Investigational Site
state: Hyogo
city: Kobe
country: Japan
facility: Pfizer Investigational Site
state: Hyogo
city: Nishinomiya
country: Japan
facility: Pfizer Investigational Site
state: Hyogo
city: Tsuchiura
country: Japan
facility: Pfizer Investigational Site
state: Ibaraki
city: Sagamihara
country: Japan
facility: Pfizer Investigational Site
state: Kanagawa
city: Yokohama
country: Japan
facility: Pfizer Investigational Site
state: Kanagawa
city: Sendai
country: Japan
facility: Pfizer Investigational Site
state: Miyagi
city: Beppu
country: Japan
facility: Pfizer Investigational Site
state: Ohita
city: Kishiwada
country: Japan
facility: Pfizer Investigational Site
state: Osaka
city: Takatsuki
country: Japan
facility: Pfizer Investigational Site
state: Osaka
city: Kawaguchi
country: Japan
facility: Pfizer Investigational Site
state: Saitama
city: Kitamoto
country: Japan
facility: Pfizer Investigational Site
state: Saitama
city: Tokorozawa
country: Japan
facility: Pfizer Investigational Site
state: Saitama
city: Adachi-ku
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Arakawa-ku
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Bunkyo-ku
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Edogawa-ku
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Mitaka
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Nakano-ku
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Shinagawa-ku
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Suginami-ku
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Toshima-ku
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Fukuoka
country: Japan
facility: Pfizer Investigational Site
city: Fukushima
country: Japan
facility: Pfizer Investigational Site
city: Osaka
country: Japan
facility: Pfizer Investigational Site
city: Saitama
country: Japan
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: