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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00553475
First received: November 2, 2007
Last updated: July 16, 2010
Last verified: July 2010
  Purpose

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


Condition Intervention Phase
Diabetic Neuropathy, Painful
Drug: placebo
Drug: pregabalin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
    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 [ Time Frame: From baseline to Week 13 or up to study discontinuation (Study Endpoint) ] [ Designated as safety issue: No ]
    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 [ Time Frame: From baseline to Week 13 or up to study discontinuation (Study Endpoint) ] [ Designated as safety issue: No ]
    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 [ Time Frame: From baseline to Week 1 ] [ Designated as safety issue: No ]

    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 [ Time Frame: From baseline to Week 2 ] [ Designated as safety issue: No ]

    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 [ Time Frame: From baseline to Week 3 ] [ Designated as safety issue: No ]

    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 [ Time Frame: From baseline to Week 4 ] [ Designated as safety issue: No ]

    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 [ Time Frame: From baseline to Week 5 ] [ Designated as safety issue: No ]

    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 [ Time Frame: From baseline to Week 6 ] [ Designated as safety issue: No ]

    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 [ Time Frame: From baseline to Week 7 ] [ Designated as safety issue: No ]

    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 [ Time Frame: From baseline to Week 8 ] [ Designated as safety issue: No ]

    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 [ Time Frame: From baseline to Week 9 ] [ Designated as safety issue: No ]

    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 [ Time Frame: From baseline to Week 10 ] [ Designated as safety issue: No ]

    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 [ Time Frame: From baseline to Week 11 ] [ Designated as safety issue: No ]

    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 [ Time Frame: From baseline to Week 12 ] [ Designated as safety issue: No ]

    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 [ Time Frame: From baseline to Week 13 ] [ Designated as safety issue: No ]

    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 [ Time Frame: From baseline to Week 13 or up to study discontinuation (Study Endpoint) ] [ Designated as safety issue: No ]
    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 [ Time Frame: From baseline to Week 13 or up to study discontinuation (Study Endpoint) ] [ Designated as safety issue: No ]
    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 [ Time Frame: From baseline to Week 13 or up to study discontinuation (Study Endpoint) ] [ Designated as safety issue: No ]
    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 [ Time Frame: From baseline to Week 13 or up to study discontinuation (Study Endpoint) ] [ Designated as safety issue: No ]
    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 [ Time Frame: From baseline to Week 13 or up to study discontinuation (Study Endpoint) ] [ Designated as safety issue: No ]
    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 [ Time Frame: From baseline to Week 13 or up to study discontinuation (Study Endpoint) ] [ Designated as safety issue: No ]
    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 [ Time Frame: From baseline to Week 13 or up to study discontinuation (Study Endpoint) ] [ Designated as safety issue: No ]
    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 [ Time Frame: From baseline to Week 13 or up to study discontinuation (Study Endpoint) ] [ Designated as safety issue: No ]
    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 [ Time Frame: From baseline to Week 13 or up to study discontinuation (Study Endpoint) ] [ Designated as safety issue: No ]
    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 [ Time Frame: From baseline to Week 13 or up to study discontinuation (Study Endpoint) ] [ Designated as safety issue: No ]
    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 [ Time Frame: From baseline to Week 13 or up to study discontinuation (Study Endpoint) ] [ Designated as safety issue: No ]
    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 [ Time Frame: From baseline to Week 13 or up to study discontinuation (Study Endpoint) ] [ Designated as safety issue: No ]
    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 [ Time Frame: From baseline to Week 13 or up to study discontinuation (Study Endpoint) ] [ Designated as safety issue: No ]
    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 [ Time Frame: From baseline to Week 13 or up to study discontinuation (Study Endpoint) ] [ Designated as safety issue: No ]
    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 [ Time Frame: From baseline to Week 13 or up to study discontinuation (Study Endpoint) ] [ Designated as safety issue: No ]
    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 [ Time Frame: From baseline to Week 13 or up to study discontinuation (Study Endpoint) ] [ Designated as safety issue: No ]
    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 [ Time Frame: From baseline to Week 13 or up to study discontinuation (Study Endpoint) ] [ Designated as safety issue: No ]
    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 [ Time Frame: From baseline to Week 13 or up to study discontinuation (Study Endpoint) ] [ Designated as safety issue: No ]
    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 [ Time Frame: From baseline to Week 13 or up to study discontinuation (Study Endpoint) ] [ Designated as safety issue: No ]
    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 [ Time Frame: From baseline to Week 13 or up to study discontinuation (Study Endpoint) ] [ Designated as safety issue: No ]
    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 [ Time Frame: From baseline to Week 13 or up to study discontinuation (Study Endpoint) ] [ Designated as safety issue: No ]
    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 [ Time Frame: Week 13 or up to discontinuation ] [ Designated as safety issue: No ]
    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 [ Time Frame: Week 13 or up to discontinuation ] [ Designated as safety issue: No ]
    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).


Enrollment: 314
Study Start Date: October 2007
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Drug: placebo
Dosage: placebo, oral administration, Treatment duration: 13 weeks (1-week titration and 12-week fixed dose)
Experimental: Pregabalin 300 mg/day Drug: pregabalin
Dosage: 300 mg/day (150 mg bid), oral administration, Treatment duration: 13 weeks (1-week titration and 12-week fixed dose)
Experimental: Pregabalin 600 mg/day Drug: pregabalin
Dosage: 600 mg/day (300 mg bid), oral administration, Treatment duration: 13 weeks (1-week titration and 12-week fixed dose)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00553475

  Show 49 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trials Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00553475     History of Changes
Other Study ID Numbers: A0081163
Study First Received: November 2, 2007
Results First Received: March 10, 2010
Last Updated: July 16, 2010
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Diabetic Neuropathies
Peripheral Nervous System Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Nervous System Diseases
Neuromuscular Diseases
Gamma-Aminobutyric Acid
Pregabalin
Analgesics
Anticonvulsants
Calcium Channel Blockers
Cardiovascular Agents
Central Nervous System Agents
GABA Agents
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014