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

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.314 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

314

Conditions

Diabetic Neuropathy, Painful

Interventions

placeboDRUG

Dosage: placebo, oral administration, Treatment duration: 13 weeks (1-week titration and 12-week fixed dose)

pregabalinDRUG

Dosage: 300 mg/day (150 mg bid), oral administration, Treatment duration: 13 weeks (1-week titration and 12-week fixed dose)

pregabalinDRUG

Dosage: 600 mg/day (300 mg bid), oral administration, Treatment duration: 13 weeks (1-week titration and 12-week fixed dose)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (49)

Outcomes

Primary Outcomes

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.

Time frame: From baseline to Week 13 or up to study discontinuation (Study Endpoint)

Change From Baseline to Study Endpoint in Mean Weekly Pain Scores by Groups of Subjects With Expected Similar Plasma Concentrations

Time frame: From baseline to Week 13 or up to study discontinuation (Study Endpoint)

Number of Responders

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)

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

Time frame: From baseline to Week 1

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

Data from ClinicalTrials.gov

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Pfizer Investigational Site

Nagoya, Aichi-ken, Japan

Pfizer Investigational Site

Chikushino-shi, Fukuoka, Japan

Pfizer Investigational Site

Kasuga, Fukuoka, Japan

Pfizer Investigational Site

Date-shi, Fukushima, Japan

Pfizer Investigational Site

Nihommatsu, Fukushima, Japan

Pfizer Investigational Site

Shirakawa-shi, Fukushima, Japan

Pfizer Investigational Site

Sukagawa, Fukushima, Japan

Pfizer Investigational Site

Kure, Hiroshima, Japan

Pfizer Investigational Site

Chitose, Hokkaido, Japan

Pfizer Investigational Site

Ebetu, Hokkaido, Japan

...and 39 more locations

Time frame: From baseline to Week 2

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

Time frame: From baseline to Week 3

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

Time frame: From baseline to Week 4

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

Time frame: From baseline to Week 5

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

Time frame: From baseline to Week 6

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

Time frame: From baseline to Week 7

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

Time frame: From baseline to Week 8

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

Time frame: From baseline to Week 9

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

Time frame: From baseline to Week 10

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

Time frame: From baseline to Week 11

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

Time frame: From baseline to Week 12

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

Time frame: From baseline to Week 13

Secondary Outcomes

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.

Time frame: From baseline to Week 13 or up to study discontinuation (Study Endpoint)

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.

Time frame: From baseline to Week 13 or up to study discontinuation (Study Endpoint)

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.

Time frame: From baseline to Week 13 or up to study discontinuation (Study Endpoint)

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.

Time frame: From baseline to Week 13 or up to study discontinuation (Study Endpoint)

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.

Time frame: From baseline to Week 13 or up to study discontinuation (Study Endpoint)

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.

Time frame: From baseline to Week 13 or up to study discontinuation (Study Endpoint)

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.

Time frame: From baseline to Week 13 or up to study discontinuation (Study Endpoint)

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.

Time frame: From baseline to Week 13 or up to study discontinuation (Study Endpoint)

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.

Time frame: From baseline to Week 13 or up to study discontinuation (Study Endpoint)

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.

Time frame: From baseline to Week 13 or up to study discontinuation (Study Endpoint)

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.

Time frame: From baseline to Week 13 or up to study discontinuation (Study Endpoint)

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.

Time frame: From baseline to Week 13 or up to study discontinuation (Study Endpoint)

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.

Time frame: From baseline to Week 13 or up to study discontinuation (Study Endpoint)

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.

Time frame: From baseline to Week 13 or up to study discontinuation (Study Endpoint)

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.

Time frame: From baseline to Week 13 or up to study discontinuation (Study Endpoint)

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.

Time frame: From baseline to Week 13 or up to study discontinuation (Study Endpoint)

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.

Time frame: From baseline to Week 13 or up to study discontinuation (Study Endpoint)

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.

Time frame: From baseline to Week 13 or up to study discontinuation (Study Endpoint)

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.

Time frame: From baseline to Week 13 or up to study discontinuation (Study Endpoint)

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.

Time frame: From baseline to Week 13 or up to study discontinuation (Study Endpoint)

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.

Time frame: From baseline to Week 13 or up to study discontinuation (Study Endpoint)

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).

Time frame: Week 13 or up to discontinuation

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).

Time frame: Week 13 or up to discontinuation