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

Neuralgia, Postherpetic Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00394901
• Other study ID #: A0081120
• Status: Completed
• Phase: Phase 3
• Start date: September 2006
• Est. completion date: November 2007

Study information

• Verified date: February 2010
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 372
• Est. completion date: November 2007
• Est. primary completion date: November 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Neuralgia
• Neuralgia, Postherpetic

Intervention

Drug:
• Placebo
placebo, oral administration for 13 weeks (1 week titration and 12-week fixed dose).
• Pregabalin
Pregabalin 150mg/day (75mg BID), oral administration for 13 weeks (1-week titration and 12-week fixed dose).
• Pregabalin
Pregabalin 300mg/day (150mg/BID), oral administration for 13 weeks (1-week titration and 12-week fixed dose).
• Pregabalin
Pregabalin 600 mg/day (300 mg/BID), oral administration for 13 weeks (1-week titration and 12-week fixed dose).

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Endpoint Sensory Scores of the Short-Form McGill Pain Questionnaire	Sensory score range from 0-33. Higher scores indicate more severe pain.	Week13/discontinuation
Secondary	Endpoint Affective Scores of the Short-Form McGill Pain Questionnaire	Affective score range from 0-12. Higher scores indicate more severe pain.	Week13/discontinuation
Secondary	Endpoint Total Scores of the Short-Form McGill Pain Questionnaire	Total score range from 0-45. Higher scores indicate more severe pain.	Week13/discontinuation
Secondary	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
Secondary	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
Secondary	Mean Sleep Interference Scores at Endpoint	Scores range from 0-10. Higher scores indicate more severe interference with sleep.	Week13/discontinuation
Secondary	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
Secondary	Endpoint Medical Outcomes Study Sleep Scale Scores:Snoring	Score range for snoring is 0-100.Higher scores indicate more of the attribute.	Week13/discontinuation
Secondary	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
Secondary	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
Secondary	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
Secondary	Endpoint Medical Outcomes Study Sleep Scale Scores:Somnolence	Score range for Somnolence is 0-100. Higher scores indicate more of the attribute.	Week13/discontinuation
Secondary	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
Secondary	Endpoint Medical Outcomes Study Sleep Scale: Number of Participants With Optimal Sleep	Number of participants who reported Optimal Sleep	Week13/discontinuation
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Number of Patients Not Reporting Allodynia	Participants not reporting allodynia.	Week13/discontinuation
Secondary	Number of Patients Not Reporting Hyperalgesia	Participants not reporting hyperalgesia.	Week13/discontinuation
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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

External Links

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