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

• 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: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
• Information provided by (Responsible Party): Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. )

Tracking Information

• First Submitted Date: October 31, 2006
• First Posted Date: November 2, 2006
• Results First Submitted Date: November 7, 2008
• Results First Posted Date: February 27, 2009
• Last Update Posted Date: February 9, 2021
• Study Start Date: September 2006
• Actual Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (submitted: October 31, 2006): Numerical rating scale for pain caused by postherpetic neuralgia after 13-week treatment of pregabalin/placebo

Current Secondary Outcome Measures (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 (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: 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
• 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: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Care Provider); Primary Purpose: Treatment
• Condition: Neuralgia, Postherpetic

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: September 24, 2008): 372
• Original Enrollment (submitted: October 31, 2006): 360
• Actual Study Completion Date: November 2007
• Actual Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Japan

Administrative Information

• NCT Number: NCT00394901
• Other Study ID Numbers: A0081120
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. )
• Study Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
• Collaborators: Not Provided

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

• PRS Account: Pfizer
• Verification Date: February 2010