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Completed

NCT Number: NCT00553475

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

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

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Key information

Conditions

Diabetic Neuropathy, Painful Diabetes Complications Diabetes Mellitus Diabetic Neuropathies Endocrine System Diseases Nervous System Diseases Neuromuscular Diseases Peripheral Nervous System Diseases

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

Loading trial locations.

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.
  • 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

Treatment and study plan

Placebo

Drug

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

Pregabalin

Drug

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

Primary outcomes

  1. Change From Baseline to Study Endpoint in Mean Weekly Pain Scores

    Time frame: 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.

  2. 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)

    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).

  3. Number of Responders

    Time frame: 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.

  4. Change From Baseline at Week 1 in Mean Weekly Pain Scores

    Time frame: 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

  5. Change From Baseline at Week 2 in Mean Weekly Pain Scores

    Time frame: 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

  6. Change From Baseline at Week 3 in Mean Weekly Pain Scores

    Time frame: 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

  7. Change From Baseline at Week 4 in Mean Weekly Pain Scores

    Time frame: 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

  8. Change From Baseline at Week 5 in Mean Weekly Pain Scores

    Time frame: 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

  9. Change From Baseline at Week 6 in Mean Weekly Pain Scores

    Time frame: 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

  10. Change From Baseline at Week 7 in Mean Weekly Pain Scores

    Time frame: 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

  11. Change From Baseline at Week 8 in Mean Weekly Pain Scores

    Time frame: 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

  12. Change From Baseline at Week 9 in Mean Weekly Pain Scores

    Time frame: 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

  13. Change From Baseline at Week 10 in Mean Weekly Pain Scores

    Time frame: 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

  14. Change From Baseline at Week 11 in Mean Weekly Pain Scores

    Time frame: 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

  15. Change From Baseline at Week 12 in Mean Weekly Pain Scores

    Time frame: 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

  16. Change From Baseline at Week 13 in Mean Weekly Pain Scores

    Time frame: 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 outcomes

  1. Change From Baseline in Short Form 36-Item (SF-36) Health Survey: Physical Functioning

    Time frame: 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.

  2. Change From Baseline in Short Form 36-Item (SF-36) Health Survey: Role Limitations-Physical

    Time frame: 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.

  3. Change From Baseline in Short Form 36-Item (SF-36) Health Survey: Bodily Pain

    Time frame: 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.

  4. Change From Baseline in Short Form 36-Item (SF-36) Health Survey: General Health Perception

    Time frame: 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.

  5. Change From Baseline in Short Form 36-Item (SF-36) Health Survey: Social Functioning

    Time frame: 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.

  6. Change From Baseline in Short Form 36-Item (SF-36) Health Survey: Role Limitations-Emotional

    Time frame: 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.

  7. Change From Baseline in Short Form 36-Item (SF-36) Health Survey: Vitality

    Time frame: 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.

  8. Change From Baseline in Short Form 36-Item (SF-36) Health Survey: Mental Health

    Time frame: 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.

  9. Change From Baseline in Mean Sleep Interference Scores

    Time frame: 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.

  10. Change From Baseline in Short-Form McGill Pain Questionnaire: Sensory Scores

    Time frame: 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.

  11. Change From Baseline in Short-Form McGill Pain Questionnaire: Affective Scores

    Time frame: 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.

  12. Change From Baseline in Short-Form McGill Pain Questionnaire: Total Scores

    Time frame: 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.

  13. Change From Baseline in Short-Form McGill Pain Questionnaire: Visual Analogue Scale Scores

    Time frame: 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.

  14. Change From Baseline in Short-Form McGill Pain Questionnaire: Present Pain Intensity Scores

    Time frame: 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.

  15. Change From Baseline in Medical Outcomes Study (MOS) - Sleep Scale: Sleep Disturbance

    Time frame: 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.

  16. Change From Baseline in Medical Outcomes Study (MOS) - Sleep Scale: Snoring

    Time frame: 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.

  17. Change From Baseline in Medical Outcomes Study (MOS) - Sleep Scale: Sleep Shortness of Breath or Headache

    Time frame: 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.

  18. Change From Baseline in Medical Outcomes Study (MOS) - Sleep Scale: Quantity of Sleep

    Time frame: 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.

  19. Change From Baseline in Medical Outcomes Study (MOS) - Sleep Scale: Sleep Adequacy

    Time frame: 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.

  20. Change From Baseline in Medical Outcomes Study (MOS) - Sleep Scale: Somnolence

    Time frame: 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.

  21. Change From Baseline in Medical Outcomes Study (MOS) - Sleep Scale: Overall Sleep Problems Index

    Time frame: 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.

  22. Clinical Global Impression of Change

    Time frame: 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).

  23. Patient Global Impression of Change

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

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

Industry

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Nov 5, 2007
Registry last updated
Jan 25, 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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