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Completed

NCT Number: NCT00394901

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

The purpose of this study is to evaluate efficacy and safety of pregabalin in the treatment of postherpetic neuralgia in a dose-ranging manner.

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Key information

Conditions

Neuralgia, Postherpetic Nervous System Diseases Neuralgia Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Pfizer Investigational Site, Nagoya, Aichi-ken, Japan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Placebo

Drug

placebo, oral administration for 13 weeks (1 week titration and 12-week fixed dose).

Pregabalin

Drug

Pregabalin 150mg/day (75mg BID), oral administration for 13 weeks (1-week titration and 12-week fixed dose).

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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.

  16. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. Mean Sleep Interference Scores at Endpoint

    Time frame: Week13/discontinuation

    Scores range from 0-10. Higher scores indicate more severe interference with sleep.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. Endpoint Medical Outcomes Study Sleep Scale: Number of Participants With Optimal Sleep

    Time frame: Week13/discontinuation

    Number of participants who reported Optimal Sleep

  15. 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.

  16. 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.

  17. 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.

  18. 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.

  19. 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.

  20. 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.

  21. 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.

  22. 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.

  23. 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.

  24. 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.

  25. Number of Patients Not Reporting Allodynia

    Time frame: Week13/discontinuation

    Participants not reporting allodynia.

  26. Number of Patients Not Reporting Hyperalgesia

    Time frame: Week13/discontinuation

    Participants not reporting hyperalgesia.

  27. 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.

  28. 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.

  29. 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.

  30. 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.

  31. 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.

  32. 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.

  33. 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.

  34. 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.

  35. 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.

  36. 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.

  37. 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.

  38. 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.

  39. 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.

Sponsors and collaborators

Lead sponsor

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

Industry

Registry information

Official study title

A 13-Week, Randomized, Double-Blind, Multicenter, Placebo-Controlled Study To Evaluate Efficacy And Safety Of Pregabalin In The Treatment Of Postherpetic Neuralgia

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Nov 2, 2006
Registry last updated
Feb 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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