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

Phase 3

Completed

Conditions: Diabetic Neuropathy, Painful

Interventions: Drug: pregabalin
Drug: placebo

Registration Number: NCT00553475

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

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 314

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pregabalin 300 mg/day	pregabalin	-
Placebo	placebo	-
Pregabalin 600 mg/day	pregabalin	-

Primary Outcome Measures

Name	Time	Method
Change From Baseline to Study Endpoint in Mean Weekly Pain Scores	From baseline to Week 13 or up to study discontinuation (Study Endpoint)	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.
Number of Responders	From baseline to Week 13 or up to study discontinuation (Study Endpoint)	A responder is defined as a subject with a 50% reduction in weekly mean pain score from baseline to study endpoint.
Change From Baseline to Study Endpoint in Mean Weekly Pain Scores by Groups of Subjects With Expected Similar Plasma Concentrations	From baseline to Week 13 or up to study discontinuation (Study Endpoint)	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).
Change From Baseline at Week 1 in Mean Weekly Pain Scores	From baseline to Week 1	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	From baseline to Week 2	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	From baseline to Week 3	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	From baseline to Week 4	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	From baseline to Week 5	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	From baseline to Week 6	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	From baseline to Week 7	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	From baseline to Week 8	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	From baseline to Week 9	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	From baseline to Week 10	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	From baseline to Week 11	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	From baseline to Week 12	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	From baseline to Week 13	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

Name	Time	Method
Change From Baseline in Short Form 36-Item (SF-36) Health Survey: Physical Functioning	From baseline to Week 13 or up to study discontinuation (Study Endpoint)	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	From baseline to Week 13 or up to study discontinuation (Study Endpoint)	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	From baseline to Week 13 or up to study discontinuation (Study Endpoint)	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	From baseline to Week 13 or up to study discontinuation (Study Endpoint)	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	From baseline to Week 13 or up to study discontinuation (Study Endpoint)	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	From baseline to Week 13 or up to study discontinuation (Study Endpoint)	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	From baseline to Week 13 or up to study discontinuation (Study Endpoint)	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	From baseline to Week 13 or up to study discontinuation (Study Endpoint)	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	From baseline to Week 13 or up to study discontinuation (Study Endpoint)	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: Affective Scores	From baseline to Week 13 or up to study discontinuation (Study Endpoint)	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 Medical Outcomes Study (MOS) - Sleep Scale: Quantity of Sleep	From baseline to Week 13 or up to study discontinuation (Study Endpoint)	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	From baseline to Week 13 or up to study discontinuation (Study Endpoint)	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	From baseline to Week 13 or up to study discontinuation (Study Endpoint)	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	From baseline to Week 13 or up to study discontinuation (Study Endpoint)	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.
Change From Baseline in Short-Form McGill Pain Questionnaire: Sensory Scores	From baseline to Week 13 or up to study discontinuation (Study Endpoint)	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: Total Scores	From baseline to Week 13 or up to study discontinuation (Study Endpoint)	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	From baseline to Week 13 or up to study discontinuation (Study Endpoint)	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	From baseline to Week 13 or up to study discontinuation (Study Endpoint)	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	From baseline to Week 13 or up to study discontinuation (Study Endpoint)	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	From baseline to Week 13 or up to study discontinuation (Study Endpoint)	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	From baseline to Week 13 or up to study discontinuation (Study Endpoint)	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.
Clinical Global Impression of Change	Week 13 or up to discontinuation	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	Week 13 or up to discontinuation	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).