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Randomized, Double-Blind, Multicenter, Placebo-Controlled Study Of Pregabalin For Pain Associated With Diabetic Peripheral Neuropathy

Primary Purpose

Diabetic Neuropathy, Painful

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
placebo
pregabalin
pregabalin
Sponsored by
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Neuropathy, Painful

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Visual Analogue Scale (VAS) of pain is higher than 40 mm.
  • Diagnosis of type 1 or 2 diabetes mellitus for at least 1 year

Exclusion Criteria:

  • Malignancy within the past 2 years.
  • Neurologic disorders unrelated to diabetic neuropathy that may confuse the assessment of neuropathy pain

Sites / Locations

  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

Placebo

Pregabalin 300 mg/day

Pregabalin 600 mg/day

Arm Description

Outcomes

Primary Outcome Measures

Change From Baseline to Study Endpoint in Mean Weekly Pain Scores
Change from baseline: Score at study endpoint minus score at baseline. Study endpoint is defined as the mean of the last seven entries of the daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) while on study medication up to and including day after last dose.
Change From Baseline to Study Endpoint in Mean Weekly Pain Scores by Groups of Subjects With Expected Similar Plasma Concentrations
Change from baseline: Score at study endpoint minus score at baseline. Study endpoint is defined as the mean of the last seven entries of the daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) while on study medication up to and including day after last dose. Subjects are classified by exposure to pregabalin, which is estimated by creatinine clearance (CLcr).
Number of Responders
A responder is defined as a subject with a 50% reduction in weekly mean pain score from baseline to study endpoint.
Change From Baseline at Week 1 in Mean Weekly Pain Scores
The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 1. Change from baseline: Score at Week 1 minus score at baseline
Change From Baseline at Week 2 in Mean Weekly Pain Scores
The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 2. Change from baseline: Score at Week 2 minus score at baseline
Change From Baseline at Week 3 in Mean Weekly Pain Scores
The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 3. Change from baseline: Score at Week 3 minus score at baseline
Change From Baseline at Week 4 in Mean Weekly Pain Scores
The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 4. Change from baseline: Score at Week 4 minus score at baseline
Change From Baseline at Week 5 in Mean Weekly Pain Scores
The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 5. Change from baseline: Score at Week 5 minus score at baseline
Change From Baseline at Week 6 in Mean Weekly Pain Scores
The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 6. Change from baseline: Score at Week 6 minus score at baseline
Change From Baseline at Week 7 in Mean Weekly Pain Scores
The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 7. Change from baseline: Score at Week 7 minus score at baseline
Change From Baseline at Week 8 in Mean Weekly Pain Scores
The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 8. Change from baseline: Score at Week 8 minus score at baseline
Change From Baseline at Week 9 in Mean Weekly Pain Scores
The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 9. Change from baseline: Score at Week 9 minus score at baseline
Change From Baseline at Week 10 in Mean Weekly Pain Scores
The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 10. Change from baseline: Score at Week 10 minus score at baseline
Change From Baseline at Week 11 in Mean Weekly Pain Scores
The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 11. Change from baseline: Score at Week 11 minus score at baseline
Change From Baseline at Week 12 in Mean Weekly Pain Scores
The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 12. Change from baseline: Score at Week 12 minus score at baseline
Change From Baseline at Week 13 in Mean Weekly Pain Scores
The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 13. Change from baseline: Score at Week 13 minus score at baseline

Secondary Outcome Measures

Change From Baseline in Short Form 36-Item (SF-36) Health Survey: Physical Functioning
The mean change from baseline in Short-Form 36-Item Health Survey Scores at study endpoint. Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status.
Change From Baseline in Short Form 36-Item (SF-36) Health Survey: Role Limitations-Physical
The mean change from baseline in Short-Form 36-Item Health Survey Scores at study endpoint. Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status.
Change From Baseline in Short Form 36-Item (SF-36) Health Survey: Bodily Pain
The mean change from baseline in Short-Form 36-Item Health Survey Scores at study endpoint. Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status.
Change From Baseline in Short Form 36-Item (SF-36) Health Survey: General Health Perception
The mean change from baseline in Short-Form 36-Item Health Survey Scores at study endpoint. Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status.
Change From Baseline in Short Form 36-Item (SF-36) Health Survey: Social Functioning
The mean change from baseline in Short-Form 36-Item Health Survey Scores at study endpoint. Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status.
Change From Baseline in Short Form 36-Item (SF-36) Health Survey: Role Limitations-Emotional
The mean change from baseline in Short-Form 36-Item Health Survey Scores at study endpoint. Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status.
Change From Baseline in Short Form 36-Item (SF-36) Health Survey: Vitality
The mean change from baseline in Short-Form 36-Item Health Survey Scores at study endpoint. Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status.
Change From Baseline in Short Form 36-Item (SF-36) Health Survey: Mental Health
The mean change from baseline in Short-Form 36-Item Health Survey Scores at study endpoint. Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status.
Change From Baseline in Mean Sleep Interference Scores
The mean change from baseline in the weekly mean sleep interference score at study endpoint. Score range is from 0-10. Higher scores indicate more severe interference with sleep.
Change From Baseline in Short-Form McGill Pain Questionnaire: Sensory Scores
The mean change from baseline in Short-Form McGill Pain Questionnaire Scores at study endpoint. Sensory score ranges from 0-33. Higher scores indicate more severe pain.
Change From Baseline in Short-Form McGill Pain Questionnaire: Affective Scores
The mean change from baseline in Short-Form McGill Pain Questionnaire Scores at study endpoint. Affective score ranges from 0-12. Higher scores indicate more severe pain.
Change From Baseline in Short-Form McGill Pain Questionnaire: Total Scores
The mean change from baseline in Short-Form McGill Pain Questionnaire Scores at study endpoint. Total score ranges from 0-45. Higher scores indicate more severe pain.
Change From Baseline in Short-Form McGill Pain Questionnaire: Visual Analogue Scale Scores
The mean change from baseline in Short-Form McGill Pain Questionnaire Scores at study endpoint. Visual Analogue Scale Score ranges from 0-100 mm. Higher scores indicate more severe pain.
Change From Baseline in Short-Form McGill Pain Questionnaire: Present Pain Intensity Scores
The mean change from baseline in Short-Form McGill Pain Questionnaire Scores at study endpoint. Present pain intensity score ranges from 0-5. Higher scores indicate more severe pain.
Change From Baseline in Medical Outcomes Study (MOS) - Sleep Scale: Sleep Disturbance
The mean change from baseline in Medical Outcomes Study - Sleep Scale Scores at study endpoint. Score for sleep disturbance ranges from 0-100. Higher scores indicate more severe pain.
Change From Baseline in Medical Outcomes Study (MOS) - Sleep Scale: Snoring
The mean change from baseline in Medical Outcomes Study - Sleep Scale Scores at study endpoint. Score for snoring ranges from 0-100. Higher scores indicate more of the attribute.
Change From Baseline in Medical Outcomes Study (MOS) - Sleep Scale: Sleep Shortness of Breath or Headache
The mean change from baseline in Medical Outcomes Study - Sleep Scale Scores at study endpoint. Score for sleep shortness of breath or headache ranges from 0-100. Higher scores indicate more of the attribute.
Change From Baseline in Medical Outcomes Study (MOS) - Sleep Scale: Quantity of Sleep
The mean change from baseline in Medical Outcomes Study - Sleep Scale Scores at study endpoint. Score for quantity of sleep ranges from 0-24. Higher scores indicate more of the attribute named in the subscale.
Change From Baseline in Medical Outcomes Study (MOS) - Sleep Scale: Sleep Adequacy
The mean change from baseline in Medical Outcomes Study - Sleep Scale Scores at study endpoint. Score for sleep adequacy ranges from 0-100. Higher scores indicate more of the attribute.
Change From Baseline in Medical Outcomes Study (MOS) - Sleep Scale: Somnolence
The mean change from baseline in Medical Outcomes Study - Sleep Scale Scores at study endpoint. Score for somnolence ranges from 0-100. Higher scores indicate more of the attribute.
Change From Baseline in Medical Outcomes Study (MOS) - Sleep Scale: Overall Sleep Problems Index
The mean change from baseline in Medical Outcomes Study - Sleep Scale Scores at study endpoint. Score for overall sleep problems index ranges from 0-100. Higher scores indicate more of the attribute.
Clinical Global Impression of Change
Clinical Global Impression of Change is a clinician-rated instrument that measures change in patient's overall status on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse).
Patient Global Impression of Change
The Patient Global Impression of Change is a patient-rated instrument that measures change in patient's overall status on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse).

Full Information

First Posted
November 2, 2007
Last Updated
January 21, 2021
Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00553475
Brief Title
Randomized, Double-Blind, Multicenter, Placebo-Controlled Study Of Pregabalin For Pain Associated With Diabetic Peripheral Neuropathy
Official Title
Randomized, Double-Blind, Multicenter, Placebo-Controlled Study To Evaluate Efficacy And Safety Of Pregabalin (CI-1008) In The Treatment For Pain Associated With Diabetic Peripheral Neuropathy
Study Type
Interventional

2. Study Status

Record Verification Date
July 2010
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
March 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
To evaluate the efficacy and safety of pregabalin at 300 mg/day and 600 mg/day (BID) in patients with painful diabetic peripheral neuropathy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Neuropathy, Painful

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
314 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
Pregabalin 300 mg/day
Arm Type
Experimental
Arm Title
Pregabalin 600 mg/day
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
Dosage: placebo, oral administration, Treatment duration: 13 weeks (1-week titration and 12-week fixed dose)
Intervention Type
Drug
Intervention Name(s)
pregabalin
Intervention Description
Dosage: 300 mg/day (150 mg bid), oral administration, Treatment duration: 13 weeks (1-week titration and 12-week fixed dose)
Intervention Type
Drug
Intervention Name(s)
pregabalin
Intervention Description
Dosage: 600 mg/day (300 mg bid), oral administration, Treatment duration: 13 weeks (1-week titration and 12-week fixed dose)
Primary Outcome Measure Information:
Title
Change From Baseline to Study Endpoint in Mean Weekly Pain Scores
Description
Change from baseline: Score at study endpoint minus score at baseline. Study endpoint is defined as the mean of the last seven entries of the daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) while on study medication up to and including day after last dose.
Time Frame
From baseline to Week 13 or up to study discontinuation (Study Endpoint)
Title
Change From Baseline to Study Endpoint in Mean Weekly Pain Scores by Groups of Subjects With Expected Similar Plasma Concentrations
Description
Change from baseline: Score at study endpoint minus score at baseline. Study endpoint is defined as the mean of the last seven entries of the daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) while on study medication up to and including day after last dose. Subjects are classified by exposure to pregabalin, which is estimated by creatinine clearance (CLcr).
Time Frame
From baseline to Week 13 or up to study discontinuation (Study Endpoint)
Title
Number of Responders
Description
A responder is defined as a subject with a 50% reduction in weekly mean pain score from baseline to study endpoint.
Time Frame
From baseline to Week 13 or up to study discontinuation (Study Endpoint)
Title
Change From Baseline at Week 1 in Mean Weekly Pain Scores
Description
The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 1. Change from baseline: Score at Week 1 minus score at baseline
Time Frame
From baseline to Week 1
Title
Change From Baseline at Week 2 in Mean Weekly Pain Scores
Description
The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 2. Change from baseline: Score at Week 2 minus score at baseline
Time Frame
From baseline to Week 2
Title
Change From Baseline at Week 3 in Mean Weekly Pain Scores
Description
The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 3. Change from baseline: Score at Week 3 minus score at baseline
Time Frame
From baseline to Week 3
Title
Change From Baseline at Week 4 in Mean Weekly Pain Scores
Description
The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 4. Change from baseline: Score at Week 4 minus score at baseline
Time Frame
From baseline to Week 4
Title
Change From Baseline at Week 5 in Mean Weekly Pain Scores
Description
The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 5. Change from baseline: Score at Week 5 minus score at baseline
Time Frame
From baseline to Week 5
Title
Change From Baseline at Week 6 in Mean Weekly Pain Scores
Description
The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 6. Change from baseline: Score at Week 6 minus score at baseline
Time Frame
From baseline to Week 6
Title
Change From Baseline at Week 7 in Mean Weekly Pain Scores
Description
The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 7. Change from baseline: Score at Week 7 minus score at baseline
Time Frame
From baseline to Week 7
Title
Change From Baseline at Week 8 in Mean Weekly Pain Scores
Description
The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 8. Change from baseline: Score at Week 8 minus score at baseline
Time Frame
From baseline to Week 8
Title
Change From Baseline at Week 9 in Mean Weekly Pain Scores
Description
The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 9. Change from baseline: Score at Week 9 minus score at baseline
Time Frame
From baseline to Week 9
Title
Change From Baseline at Week 10 in Mean Weekly Pain Scores
Description
The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 10. Change from baseline: Score at Week 10 minus score at baseline
Time Frame
From baseline to Week 10
Title
Change From Baseline at Week 11 in Mean Weekly Pain Scores
Description
The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 11. Change from baseline: Score at Week 11 minus score at baseline
Time Frame
From baseline to Week 11
Title
Change From Baseline at Week 12 in Mean Weekly Pain Scores
Description
The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 12. Change from baseline: Score at Week 12 minus score at baseline
Time Frame
From baseline to Week 12
Title
Change From Baseline at Week 13 in Mean Weekly Pain Scores
Description
The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 13. Change from baseline: Score at Week 13 minus score at baseline
Time Frame
From baseline to Week 13
Secondary Outcome Measure Information:
Title
Change From Baseline in Short Form 36-Item (SF-36) Health Survey: Physical Functioning
Description
The mean change from baseline in Short-Form 36-Item Health Survey Scores at study endpoint. Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status.
Time Frame
From baseline to Week 13 or up to study discontinuation (Study Endpoint)
Title
Change From Baseline in Short Form 36-Item (SF-36) Health Survey: Role Limitations-Physical
Description
The mean change from baseline in Short-Form 36-Item Health Survey Scores at study endpoint. Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status.
Time Frame
From baseline to Week 13 or up to study discontinuation (Study Endpoint)
Title
Change From Baseline in Short Form 36-Item (SF-36) Health Survey: Bodily Pain
Description
The mean change from baseline in Short-Form 36-Item Health Survey Scores at study endpoint. Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status.
Time Frame
From baseline to Week 13 or up to study discontinuation (Study Endpoint)
Title
Change From Baseline in Short Form 36-Item (SF-36) Health Survey: General Health Perception
Description
The mean change from baseline in Short-Form 36-Item Health Survey Scores at study endpoint. Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status.
Time Frame
From baseline to Week 13 or up to study discontinuation (Study Endpoint)
Title
Change From Baseline in Short Form 36-Item (SF-36) Health Survey: Social Functioning
Description
The mean change from baseline in Short-Form 36-Item Health Survey Scores at study endpoint. Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status.
Time Frame
From baseline to Week 13 or up to study discontinuation (Study Endpoint)
Title
Change From Baseline in Short Form 36-Item (SF-36) Health Survey: Role Limitations-Emotional
Description
The mean change from baseline in Short-Form 36-Item Health Survey Scores at study endpoint. Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status.
Time Frame
From baseline to Week 13 or up to study discontinuation (Study Endpoint)
Title
Change From Baseline in Short Form 36-Item (SF-36) Health Survey: Vitality
Description
The mean change from baseline in Short-Form 36-Item Health Survey Scores at study endpoint. Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status.
Time Frame
From baseline to Week 13 or up to study discontinuation (Study Endpoint)
Title
Change From Baseline in Short Form 36-Item (SF-36) Health Survey: Mental Health
Description
The mean change from baseline in Short-Form 36-Item Health Survey Scores at study endpoint. Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status.
Time Frame
From baseline to Week 13 or up to study discontinuation (Study Endpoint)
Title
Change From Baseline in Mean Sleep Interference Scores
Description
The mean change from baseline in the weekly mean sleep interference score at study endpoint. Score range is from 0-10. Higher scores indicate more severe interference with sleep.
Time Frame
From baseline to Week 13 or up to study discontinuation (Study Endpoint)
Title
Change From Baseline in Short-Form McGill Pain Questionnaire: Sensory Scores
Description
The mean change from baseline in Short-Form McGill Pain Questionnaire Scores at study endpoint. Sensory score ranges from 0-33. Higher scores indicate more severe pain.
Time Frame
From baseline to Week 13 or up to study discontinuation (Study Endpoint)
Title
Change From Baseline in Short-Form McGill Pain Questionnaire: Affective Scores
Description
The mean change from baseline in Short-Form McGill Pain Questionnaire Scores at study endpoint. Affective score ranges from 0-12. Higher scores indicate more severe pain.
Time Frame
From baseline to Week 13 or up to study discontinuation (Study Endpoint)
Title
Change From Baseline in Short-Form McGill Pain Questionnaire: Total Scores
Description
The mean change from baseline in Short-Form McGill Pain Questionnaire Scores at study endpoint. Total score ranges from 0-45. Higher scores indicate more severe pain.
Time Frame
From baseline to Week 13 or up to study discontinuation (Study Endpoint)
Title
Change From Baseline in Short-Form McGill Pain Questionnaire: Visual Analogue Scale Scores
Description
The mean change from baseline in Short-Form McGill Pain Questionnaire Scores at study endpoint. Visual Analogue Scale Score ranges from 0-100 mm. Higher scores indicate more severe pain.
Time Frame
From baseline to Week 13 or up to study discontinuation (Study Endpoint)
Title
Change From Baseline in Short-Form McGill Pain Questionnaire: Present Pain Intensity Scores
Description
The mean change from baseline in Short-Form McGill Pain Questionnaire Scores at study endpoint. Present pain intensity score ranges from 0-5. Higher scores indicate more severe pain.
Time Frame
From baseline to Week 13 or up to study discontinuation (Study Endpoint)
Title
Change From Baseline in Medical Outcomes Study (MOS) - Sleep Scale: Sleep Disturbance
Description
The mean change from baseline in Medical Outcomes Study - Sleep Scale Scores at study endpoint. Score for sleep disturbance ranges from 0-100. Higher scores indicate more severe pain.
Time Frame
From baseline to Week 13 or up to study discontinuation (Study Endpoint)
Title
Change From Baseline in Medical Outcomes Study (MOS) - Sleep Scale: Snoring
Description
The mean change from baseline in Medical Outcomes Study - Sleep Scale Scores at study endpoint. Score for snoring ranges from 0-100. Higher scores indicate more of the attribute.
Time Frame
From baseline to Week 13 or up to study discontinuation (Study Endpoint)
Title
Change From Baseline in Medical Outcomes Study (MOS) - Sleep Scale: Sleep Shortness of Breath or Headache
Description
The mean change from baseline in Medical Outcomes Study - Sleep Scale Scores at study endpoint. Score for sleep shortness of breath or headache ranges from 0-100. Higher scores indicate more of the attribute.
Time Frame
From baseline to Week 13 or up to study discontinuation (Study Endpoint)
Title
Change From Baseline in Medical Outcomes Study (MOS) - Sleep Scale: Quantity of Sleep
Description
The mean change from baseline in Medical Outcomes Study - Sleep Scale Scores at study endpoint. Score for quantity of sleep ranges from 0-24. Higher scores indicate more of the attribute named in the subscale.
Time Frame
From baseline to Week 13 or up to study discontinuation (Study Endpoint)
Title
Change From Baseline in Medical Outcomes Study (MOS) - Sleep Scale: Sleep Adequacy
Description
The mean change from baseline in Medical Outcomes Study - Sleep Scale Scores at study endpoint. Score for sleep adequacy ranges from 0-100. Higher scores indicate more of the attribute.
Time Frame
From baseline to Week 13 or up to study discontinuation (Study Endpoint)
Title
Change From Baseline in Medical Outcomes Study (MOS) - Sleep Scale: Somnolence
Description
The mean change from baseline in Medical Outcomes Study - Sleep Scale Scores at study endpoint. Score for somnolence ranges from 0-100. Higher scores indicate more of the attribute.
Time Frame
From baseline to Week 13 or up to study discontinuation (Study Endpoint)
Title
Change From Baseline in Medical Outcomes Study (MOS) - Sleep Scale: Overall Sleep Problems Index
Description
The mean change from baseline in Medical Outcomes Study - Sleep Scale Scores at study endpoint. Score for overall sleep problems index ranges from 0-100. Higher scores indicate more of the attribute.
Time Frame
From baseline to Week 13 or up to study discontinuation (Study Endpoint)
Title
Clinical Global Impression of Change
Description
Clinical Global Impression of Change is a clinician-rated instrument that measures change in patient's overall status on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse).
Time Frame
Week 13 or up to discontinuation
Title
Patient Global Impression of Change
Description
The Patient Global Impression of Change is a patient-rated instrument that measures change in patient's overall status on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse).
Time Frame
Week 13 or up to discontinuation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Visual Analogue Scale (VAS) of pain is higher than 40 mm. Diagnosis of type 1 or 2 diabetes mellitus for at least 1 year Exclusion Criteria: Malignancy within the past 2 years. Neurologic disorders unrelated to diabetic neuropathy that may confuse the assessment of neuropathy pain
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Nagoya
State/Province
Aichi
Country
Japan
Facility Name
Pfizer Investigational Site
City
Chikushino
State/Province
Fukuoka
Country
Japan
Facility Name
Pfizer Investigational Site
City
Kasuga
State/Province
Fukuoka
Country
Japan
Facility Name
Pfizer Investigational Site
City
Date-shi
State/Province
Fukushima
Country
Japan
Facility Name
Pfizer Investigational Site
City
Nihonmatsu
State/Province
Fukushima
Country
Japan
Facility Name
Pfizer Investigational Site
City
Shirakawa-shi
State/Province
Fukushima
Country
Japan
Facility Name
Pfizer Investigational Site
City
Sukagawa
State/Province
Fukushima
Country
Japan
Facility Name
Pfizer Investigational Site
City
Kure
State/Province
Hiroshima
Country
Japan
Facility Name
Pfizer Investigational Site
City
Chitose
State/Province
Hokkaido
Country
Japan
Facility Name
Pfizer Investigational Site
City
Ebetu
State/Province
Hokkaido
Country
Japan
Facility Name
Pfizer Investigational Site
City
Sapporo
State/Province
Hokkaido
Country
Japan
Facility Name
Pfizer Investigational Site
City
Sapporo
State/Province
Hokkaiido
Country
Japan
Facility Name
Pfizer Investigational Site
City
Kobe
State/Province
Hyogo
Country
Japan
Facility Name
Pfizer Investigational Site
City
Inashiki
State/Province
Ibaraki
Country
Japan
Facility Name
Pfizer Investigational Site
City
Kamakura
State/Province
Kanagawa
Country
Japan
Facility Name
Pfizer Investigational Site
City
Yokohama
State/Province
Kanagawa
Country
Japan
Facility Name
Pfizer Investigational Site
City
Yatsushiro
State/Province
Kumamoto
Country
Japan
Facility Name
Pfizer Investigational Site
City
Sendai
State/Province
Miyagi
Country
Japan
Facility Name
Pfizer Investigational Site
City
Matsumoto
State/Province
Nagano
Country
Japan
Facility Name
Pfizer Investigational Site
City
Ueda
State/Province
Nagano
Country
Japan
Facility Name
Pfizer Investigational Site
City
Beppu
State/Province
Oita
Country
Japan
Facility Name
Pfizer Investigational Site
City
Yamada
State/Province
Okayama
Country
Japan
Facility Name
Pfizer Investigational Site
City
Naha
State/Province
Okinawa
Country
Japan
Facility Name
Pfizer Investigational Site
City
Tomishiro
State/Province
Okinawa
Country
Japan
Facility Name
Pfizer Investigational Site
City
Urazoe
State/Province
Okinawa
Country
Japan
Facility Name
Pfizer Investigational Site
City
Higashiosaka
State/Province
Osaka
Country
Japan
Facility Name
Pfizer Investigational Site
City
Hirano-ku
State/Province
Osaka
Country
Japan
Facility Name
Pfizer Investigational Site
City
Kishiwada
State/Province
Osaka
Country
Japan
Facility Name
Pfizer Investigational Site
City
Suminoe-ku
State/Province
Osaka
Country
Japan
Facility Name
Pfizer Investigational Site
City
Sunto-gun
State/Province
Shizuoka
Country
Japan
Facility Name
Pfizer Investigational Site
City
Oyama-shi
State/Province
Tochigi
Country
Japan
Facility Name
Pfizer Investigational Site
City
Utsunomiya
State/Province
Tochigi
Country
Japan
Facility Name
Pfizer Investigational Site
City
Arakawa
State/Province
Tokyo
Country
Japan
Facility Name
Pfizer Investigational Site
City
Bunkyo-ku
State/Province
Tokyo
Country
Japan
Facility Name
Pfizer Investigational Site
City
Chiyoda-ku
State/Province
Tokyo
Country
Japan
Facility Name
Pfizer Investigational Site
City
Chuo-ku
State/Province
Tokyo
Country
Japan
Facility Name
Pfizer Investigational Site
City
Minato-ku
State/Province
Tokyo
Country
Japan
Facility Name
Pfizer Investigational Site
City
Nishitokyo
State/Province
Tokyo
Country
Japan
Facility Name
Pfizer Investigational Site
City
Ohta-ku
State/Province
Tokyo
Country
Japan
Facility Name
Pfizer Investigational Site
City
Shibuya-ku
State/Province
Tokyo
Country
Japan
Facility Name
Pfizer Investigational Site
City
Fukuoka
Country
Japan
Facility Name
Pfizer Investigational Site
City
Kumamoto
Country
Japan
Facility Name
Pfizer Investigational Site
City
Nagasaki
Country
Japan
Facility Name
Pfizer Investigational Site
City
Niigata
Country
Japan
Facility Name
Pfizer Investigational Site
City
Oita
Country
Japan
Facility Name
Pfizer Investigational Site
City
Okayama
Country
Japan
Facility Name
Pfizer Investigational Site
City
Saga
Country
Japan
Facility Name
Pfizer Investigational Site
City
Saitama
Country
Japan
Facility Name
Pfizer Investigational Site
City
Tokushima
Country
Japan

12. IPD Sharing Statement

Citations:
PubMed Identifier
31802967
Citation
Alexander J Jr, Edwards RA, Manca L, Grugni R, Bonfanti G, Emir B, Whalen E, Watt S, Brodsky M, Parsons B. Integrating Machine Learning With Microsimulation to Classify Hypothetical, Novel Patients for Predicting Pregabalin Treatment Response Based on Observational and Randomized Data in Patients With Painful Diabetic Peripheral Neuropathy. Pragmat Obs Res. 2019 Oct 31;10:67-76. doi: 10.2147/POR.S214412. eCollection 2019.
Results Reference
derived
PubMed Identifier
30521533
Citation
Alexander J Jr, Edwards RA, Brodsky M, Manca L, Grugni R, Savoldelli A, Bonfanti G, Emir B, Whalen E, Watt S, Parsons B. Using time series analysis approaches for improved prediction of pain outcomes in subgroups of patients with painful diabetic peripheral neuropathy. PLoS One. 2018 Dec 6;13(12):e0207120. doi: 10.1371/journal.pone.0207120. eCollection 2018. Erratum In: PLoS One. 2019 Feb 26;14(2):e0212959.
Results Reference
derived
PubMed Identifier
30206821
Citation
Edwards RA, Bonfanti G, Grugni R, Manca L, Parsons B, Alexander J. Predicting Responses to Pregabalin for Painful Diabetic Peripheral Neuropathy Based on Trajectory-Focused Patient Profiles Derived from the First 4 Weeks of Treatment. Adv Ther. 2018 Oct;35(10):1585-1597. doi: 10.1007/s12325-018-0780-3. Epub 2018 Sep 11.
Results Reference
derived
PubMed Identifier
30084288
Citation
Parsons B, Li C, Emir B, Vinik AI. The efficacy of pregabalin for treating pain associated with diabetic peripheral neuropathy in subjects with type 1 or type 2 diabetes mellitus. Curr Med Res Opin. 2018 Nov;34(11):2015-2022. doi: 10.1080/03007995.2018.1509304. Epub 2018 Sep 20.
Results Reference
derived
PubMed Identifier
27611736
Citation
Markman JD, Jensen TS, Semel D, Li C, Parsons B, Behar R, Sadosky AB. Effects of Pregabalin in Patients with Neuropathic Pain Previously Treated with Gabapentin: A Pooled Analysis of Parallel-Group, Randomized, Placebo-controlled Clinical Trials. Pain Pract. 2017 Jul;17(6):718-728. doi: 10.1111/papr.12516. Epub 2016 Dec 1.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A0081163&StudyName=Randomized%2C%20Double-Blind%2C%20Multicenter%2C%20Placebo-Controlled%20Study%20Of%20Pregabalin%20For%20Pain%20Associated%20With%20Diabetic%20Peripheral%20Neuropathy
Description
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Learn more about this trial

Randomized, Double-Blind, Multicenter, Placebo-Controlled Study Of Pregabalin For Pain Associated With Diabetic Peripheral Neuropathy

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