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Trial record 1 of 1 for:    NCT00141219
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Pregabalin Peripheral Neuropathic Pain Study

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ClinicalTrials.gov Identifier: NCT00141219
Recruitment Status : Completed
First Posted : September 1, 2005
Results First Posted : March 13, 2009
Last Update Posted : February 9, 2021
Sponsor:
Information provided by (Responsible Party):
Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. )

Tracking Information
First Submitted Date  ICMJE August 30, 2005
First Posted Date  ICMJE September 1, 2005
Results First Submitted Date  ICMJE December 19, 2008
Results First Posted Date  ICMJE March 13, 2009
Last Update Posted Date February 9, 2021
Study Start Date  ICMJE December 2005
Actual Primary Completion Date December 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 23, 2009)
Daily Pain Rating Scale (DPRS)- Mean Pain Score (ITT Population) [ Time Frame: Endpoint- Week 8 or Early Discontinuation ]
DPRS is 11-point rating scale from 0 (no pain) to 10 (worst possible pain). Subjects instructed to describe their pain (daily upon awakening) during preceding 24 hrs by choosing the appropriate number between 0-10. Mean endpoint pain score was obtained from the last 7 available DPRS scores of the daily pain diary while subject on study medication.
Original Primary Outcome Measures  ICMJE
 (submitted: August 30, 2005)
Endpoint Mean Pain Scores from DPRS
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 10, 2009)
  • Daily Pain Rating Scale (DPRS)- Number of 30% Responders (With Respect to Pain Scores) [ Time Frame: Endpoint- Week 8 or Early Discontinuation ]
    DPRS consists of an 11-point rating scale ranging from 0 (no pain) to 10 (worst possible pain). A 30% responder at endpoint is a subject who has a 30% or more reduction in mean pain score at endpoint compared to baseline
  • Daily Pain Rating Scale (DPRS)- Number of 50% Responders (With Respect to Pain Scores) [ Time Frame: Endpoint- Week 8 or Early Discontination ]
    DPRS consists of an 11-point rating scale ranging from 0 (no pain) to 10 (worst possible pain). A 50% responder at endpoint is a subject who has a 50% or more reduction in mean pain score at endpoint compared to baseline.
  • Daily Pain Rating Scale (DPRS)- Weekly Mean Pain Score [ Time Frame: Weeks 1 to 8 ]
    DPRS is 11-point rating scale (0=no pain to 10=worst possible pain). Subjects instructed to describe pain (upon awakening) during preceding 24 hrs by choosing appropriate number between 0-10. Mean endpoint pain score obtained from last 7 available DPRS scores of daily pain diary while subject on study medication. Overall Comparison=8-week average.
  • Duration Adjusted Average Change (DAAC) of (Adjusted) Mean Pain Score [ Time Frame: Weeks 1 to 8 ]
    DAAC is a score used to assess treatment effects averaged over the entire length of the study. DAAC from baseline to weekly mean pain score was derived by calculating the mean of all post-baseline scores minus baseline mean pain score, and then weighing this according to the proportion of the planned study duration the subject actually completed.
  • Mean Sleep Interference Score Based on Daily Sleep Interference Scale (DSIS). [ Time Frame: Endpoint- Week 8 or Early Discontinuation ]
    DSIS consists of an 11-point rating scale (0 = pain did not interfere with sleep to 10 = completely interfered with sleep). Higher score indicating greater level of sleep disturbance.
  • Mean Sleep Score as Computed by DSIS. [ Time Frame: Weeks 1 to 8 ]
    DSIS consists of an 11-point rating scale ranging from 0 = pain did not interfere with sleep to 10 = pain completely interfered with sleep. Overall Comparison= 8-week average.
  • Medical Outcome Study (MOS) Sleep Disturbance [ Time Frame: Week 8 ]
    MOS Sleep Scale is a subject-rated questionnaire consisting of 12 items that assess the key constructs of sleep; assesses sleep for the 4 weeks prior to evaluation. The MOS Sleep Disturbance sub-scale scores range from 0 to 100, lower scores indicate less disturbance.
  • Medical Outcome Study (MOS) Snoring Score [ Time Frame: Week 8 ]
    MOS Sleep Scale is a subject-rated questionnaire consisting of 12 items that assess the key constructs of sleep; assesses sleep for the 4 weeks prior to evaluation. The MOS Snoring sub-scale scores range from 0 to 100, lower scores indicate less snoring.
  • Medical Outcome Study (MOS) Awaken Short of Breath or Headache [ Time Frame: Week 8 ]
    MOS Sleep Scale is a subject-rated questionnaire consisting of 12 items that assess the key constructs of sleep; assesses sleep for the 4 weeks prior to evaluation. The MOS Awaken Short of Breath or with a Headache sub-scale scores range from 0 to 100, lower scores indicate less difficulty.
  • Medical Outcome Study (MOS) Sleep Quantity [ Time Frame: Week 8 ]
    MOS Sleep Scale is a subject-rated questionnaire consisting of 12 items that assess the key constructs of sleep; assesses sleep for the 4 weeks prior to evaluation. The MOS Sleep Quantity sub-scale scores range from 0 to 24 (number of hours slept).
  • Medical Outcome Study (MOS) Optimal Sleep: Number of Participants With Optimal Sleep [ Time Frame: Week 8 ]
    MOS Sleep Scale is a subject-rated questionnaire consisting of 12 items that assess the key constructs of sleep; assesses sleep for the 4 weeks prior to evaluation. The MOS Optimal Sleep sub-scale score is a binary outcome derived from Sleep Quantity (SQ): the response is YES (or 1) if SQ = 7 or 8 hours per night.
  • Medical Outcome Study (MOS) Sleep Adequacy [ Time Frame: Week 8 ]
    MOS Sleep Scale is a subject-rated questionnaire consisting of 12 items that assess the key constructs of sleep; assesses sleep for the 4 weeks prior to evaluation. The MOS Sleep Adequacy sub-scale scores range from 0 to 100, higher scores indicate greater sleep adequacy.
  • Medical Outcome Study (MOS) Somnolence [ Time Frame: Week 8 ]
    MOS Sleep Scale is a subject-rated questionnaire consisting of 12 items that assess the key constructs of sleep; assesses sleep for the 4 weeks prior to evaluation. The MOS Somnolence sub-scale scores range from 0 to 100, lower scores indicate less somnolence.
  • Medical Outcome Study (MOS) Overall Sleep Problems Index [ Time Frame: Week 8 ]
    MOS Sleep Scale is a subject-rated questionnaire consisting of 12 items that assess the key constructs of sleep; assesses sleep for the 4 weeks prior to evaluation. The MOS Overall Sleep Problems Index is a 9-item sub-scale; scores range from 0 to 100, lower scores indicate fewer sleep problems.
  • Euro Quality of Life (QOL) (EQ-5D) Utility Score [ Time Frame: Week 8 ]
    EQ-5D, a subject-completed questionnaire, assesses health-related QOL. QOL Health State Profile (HSP) is designed to record subject's level of current health across 5 domains (mobility, self-care, usual activities, pain/discomfort & anxiety/depression); scores are used to calculate EQ-5D Utility Score; range: -0.594 to 1.000 (from worst to best).
  • Euro Quality of Life (EQ-5D) Visual Analog Scale (VAS) [ Time Frame: Week 8 ]
    EQ-5D is a subject-completed questionnaire to assess health-related QOL (Health State Profile (HSP) & Visual Analog Scale (VAS)). The VAS is designed to rate the subject's current health state on a scale from 0 to 100 where 0 represents the worst imaginable health state and 100 represents the best imaginable health state.
  • Hospital Anxiety and Depression Scale- Anxiety (HADS-A) Score [ Time Frame: Week 8 ]
    HADS-A consists of 7 items that are assessed by a score of 0 = no anxiety to 3 = severe feeling of anxiety. The anxiety subscale determines a state of generalized anxiety (including anxious mood, restlessness, anxious thoughts, panic attacks). Score range = 0 to 21; higher scores indicate a greater intensity of anxiety
  • Hospital Anxiety and Depression Scale- Depression (HADS-D) Score [ Time Frame: Week 8 ]
    HADS-D consists of 7 items that are assessed by a score of 0 = no depression to 3 = severe feeling of depression. The depression subscale focuses on the state of lost interest and diminished pleasure response ("lowering of hedonic tone"). Score range = 0 to 21; higher scores indicate a greater intensity of depression
  • Patient Global Impression of Change (PGIC) [ Time Frame: Week 8 ]
    PGIC is a subject-rated instrument that measured change in subject's overall status on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improved = minimally improved, much improved, and very much improved; Worse = minimally worse, much worse, and very much worse.
  • Clinical Global Impression of Change (CGIC) [ Time Frame: Week 8 ]
    CGIC is a clinician-rated instrument that assesses the subject's overall global improvement on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improved = minimally improved, much improved, and very much improved; Worse = minimally worse, much worse, and very much worse.
  • Duration Adjusted Average Change (DAAC) of (Unadjusted) Mean Pain Score [ Time Frame: Weeks 1 to 8 ]
    DAAC is a score used to assess treatment effects averaged over the entire length of the study. DAAC from baseline to weekly mean pain score was derived by calculating the mean of all post-baseline scores minus baseline mean pain score, and then weighing this according to the proportion of the planned study duration the subject actually completed.
Original Secondary Outcome Measures  ICMJE
 (submitted: August 30, 2005)
  • •Proportion of 30% Responders (With Respect to Pain Scores) at Endpoint.
  • •Proportion of 50% Responders (With Respect to Pain Scores) at Endpoint.
  • •Weekly Mean Pain Score from DPRS.
  • •Weekly Mean Sleep Interference Score from Daily Sleep Interference Scale
Current Other Pre-specified Outcome Measures
 (submitted: September 23, 2009)
Daily Pain Rating Scale (DPRS)- Mean Pain Scores (Evaluable Population) [ Time Frame: Endpoint- Week 8 or Early Discontinuation ]
DPRS is 11-point rating scale from 0 (no pain) to 10 (worst possible pain). Subjects instructed to describe their pain (daily upon awakening) during preceding 24 hrs by choosing the appropriate number between 0-10. Mean endpoint pain score was obtained from the last 7 available DPRS scores of the daily pain diary while subject on study medication.
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pregabalin Peripheral Neuropathic Pain Study
Official Title  ICMJE A 10-Week, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Pregabalin (150 mg - 600 mg/Day) Using a Flexible, Optimized Dose Schedule in Subjects With Peripheral Neuropathic Pain
Brief Summary To evaluate the efficacy of pregabalin, using a flexible, optimized dose schedule with dose adjustment based on Daily Pain Rating Scale (DPRS), compared to placebo in subjects with peripheral neuropathic pain.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Diabetic Neuropathies
  • Neuralgia
Intervention  ICMJE
  • Drug: pregabalin
    150-600mg/day, BID
  • Drug: Placebo
    Placebo
Study Arms  ICMJE
  • Experimental: 1
    Intervention: Drug: pregabalin
  • Placebo Comparator: 2
    Intervention: Drug: Placebo
Publications * Not Provided

*   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: January 9, 2008)
241
Original Enrollment  ICMJE
 (submitted: August 30, 2005)
234
Actual Study Completion Date  ICMJE December 2007
Actual Primary Completion Date December 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Diagnosis of peripheral neuropathic pain syndrome, including diabetic peripheral neuropathy (DPN), postherpetic neuralgia (PHN), or post-traumatic neuropathic pain (including post-surgical), confirmed by a qualified pain specialist.
  • Subjects must have completed at least 4 daily pain diaries during the 7 days prior to Visit 2 and have an average pain score of ≥4 over the 7 days prior to Visit 2 (randomization).

Exclusion Criteria:

  • Neurologic disorders unrelated to DPN, PHN, or post-traumatic neuropathic pain (including post-surgical), that may confuse or confound the assessment of neuropathic pain.
  • Presence of any severe pain associated with conditions other than DPN, PHN, or post-traumatic neuropathic pain (including post-surgical) that may confound the assessment or self evaluation of the pain due to DPN, PHN, or post-traumatic neuropathic pain (including post-surgical).
  • Creatinine clearance < 30 mL/min (estimated from serum creatinine, body weight, age, and sex using the Cockcroft and Gault equation in Appendix E). Maximum dose for subjects with creatinine clearance of 30 to 60 mL/min is 300 mg/day
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 Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00141219
Other Study ID Numbers  ICMJE A0081037
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. )
Study Sponsor  ICMJE Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date September 2009

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