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Trial record 1 of 1 for:    NCT00394901
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A 13-Week, Randomized, Double-Blind, Multicenter, Placebo-Controlled Study Of Pregabalin For Postherpetic Neuralgia

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ClinicalTrials.gov Identifier: NCT00394901
Recruitment Status : Completed
First Posted : November 2, 2006
Results First Posted : February 27, 2009
Last Update Posted : February 9, 2021
Sponsor:
Information provided by (Responsible Party):
Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. )

Tracking Information
First Submitted Date  ICMJE October 31, 2006
First Posted Date  ICMJE November 2, 2006
Results First Submitted Date  ICMJE November 7, 2008
Results First Posted Date  ICMJE February 27, 2009
Last Update Posted Date February 9, 2021
Study Start Date  ICMJE September 2006
Actual Primary Completion Date November 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 26, 2009)
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: October 31, 2006)
Numerical rating scale for pain caused by postherpetic neuralgia after 13-week treatment of pregabalin/placebo
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 14, 2009)
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: October 31, 2006)
Daily Sleep Interference Diary, Short-form McGill Pain Questionnaire, MOS-Sleep Scale for sleep, Patient Global Impression of Change, Clinical Global Impression of Change, SF-36 Health Survey
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A 13-Week, Randomized, Double-Blind, Multicenter, Placebo-Controlled Study Of Pregabalin For Postherpetic Neuralgia
Official Title  ICMJE A 13-Week, Randomized, Double-Blind, Multicenter, Placebo-Controlled Study To Evaluate Efficacy And Safety Of Pregabalin In The Treatment Of Postherpetic Neuralgia
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Condition  ICMJE Neuralgia, Postherpetic
Intervention  ICMJE
  • Drug: Placebo
    placebo, oral administration for 13 weeks (1 week titration and 12-week fixed dose).
  • Drug: Pregabalin
    Pregabalin 150mg/day (75mg BID), oral administration for 13 weeks (1-week titration and 12-week fixed dose).
  • Drug: Pregabalin
    Pregabalin 300mg/day (150mg/BID), oral administration for 13 weeks (1-week titration and 12-week fixed dose).
  • Drug: Pregabalin
    Pregabalin 600 mg/day (300 mg/BID), oral administration for 13 weeks (1-week titration and 12-week fixed dose).
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
  • Experimental: Pregabalin 150mg/day
    Intervention: Drug: Pregabalin
  • Experimental: Pregabalin 300mg/day
    Intervention: Drug: Pregabalin
  • Experimental: Pregabalin 600mg/day
    Intervention: Drug: Pregabalin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 24, 2008)
372
Original Enrollment  ICMJE
 (submitted: October 31, 2006)
360
Actual Study Completion Date  ICMJE November 2007
Actual Primary Completion Date November 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00394901
Other Study ID Numbers  ICMJE A0081120
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. )
Study Sponsor  ICMJE Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date February 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP