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

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ClinicalTrials.gov Identifier: NCT00553475
Recruitment Status : Completed
First Posted : November 5, 2007
Results First Posted : June 22, 2010
Last Update Posted : July 20, 2010
Sponsor:
Information provided by:
Pfizer

Tracking Information
First Submitted Date  ICMJE November 2, 2007
First Posted Date  ICMJE November 5, 2007
Results First Submitted Date  ICMJE March 10, 2010
Results First Posted Date  ICMJE June 22, 2010
Last Update Posted Date July 20, 2010
Study Start Date  ICMJE October 2007
Actual Primary Completion Date March 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 16, 2010)
  • 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.
  • 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).
  • 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.
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
Original Primary Outcome Measures  ICMJE
 (submitted: November 2, 2007)
Numerical rating scale for pain [ Time Frame: 1-13 weeks ]
Change History Complete list of historical versions of study NCT00553475 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 16, 2010)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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).
  • 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).
Original Secondary Outcome Measures  ICMJE
 (submitted: November 2, 2007)
  • Short-form McGill Pain Questionnaire [ Time Frame: 1-13 weeks ]
  • MOS-Sleep Scale for sleep [ Time Frame: 1-13 weeks ]
  • Patient Global Impression of Change [ Time Frame: 1-13 weeks ]
  • Clinical Global Impression of Change [ Time Frame: 1-13 weeks ]
  • SF-36 Health Survey [ Time Frame: 1-13 weeks ]
  • Daily Sleep Intereference Diary [ Time Frame: 1-13 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Randomized, Double-Blind, Multicenter, Placebo-Controlled Study Of Pregabalin For Pain Associated With Diabetic Peripheral Neuropathy
Official Title  ICMJE 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
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Diabetic Neuropathy, Painful
Intervention  ICMJE
  • Drug: placebo
    Dosage: placebo, oral administration, Treatment duration: 13 weeks (1-week titration and 12-week fixed dose)
  • Drug: pregabalin
    Dosage: 300 mg/day (150 mg bid), oral administration, Treatment duration: 13 weeks (1-week titration and 12-week fixed dose)
  • Drug: pregabalin
    Dosage: 600 mg/day (300 mg bid), oral administration, Treatment duration: 13 weeks (1-week titration and 12-week fixed dose)
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Intervention: Drug: placebo
  • Experimental: Pregabalin 300 mg/day
    Intervention: Drug: pregabalin
  • Experimental: Pregabalin 600 mg/day
    Intervention: Drug: pregabalin
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 17, 2009)
314
Original Estimated Enrollment  ICMJE
 (submitted: November 2, 2007)
308
Actual Study Completion Date  ICMJE March 2009
Actual Primary Completion Date March 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00553475
Other Study ID Numbers  ICMJE A0081163
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trials Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date July 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP