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Study Of Pregabalin (Lyrica) In Patients With Painful Diabetic Peripheral Neuropathy

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ClinicalTrials.gov Identifier: NCT01057693
Recruitment Status : Completed
First Posted : January 27, 2010
Results First Posted : February 22, 2013
Last Update Posted : February 20, 2019
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE January 26, 2010
First Posted Date  ICMJE January 27, 2010
Results First Submitted Date  ICMJE January 18, 2013
Results First Posted Date  ICMJE February 22, 2013
Last Update Posted Date February 20, 2019
Actual Study Start Date  ICMJE March 31, 2010
Actual Primary Completion Date January 30, 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 18, 2013)
Change From Single-Blind Baseline in Mean Pain Score at Week 19 During Double-Blind Phase [ Time Frame: SB Baseline, Week 19 (DB Phase) ]
Mean pain score was defined as the mean of the last 7 daily diary pain ratings. Participants rated their DPN pain over the past 24 hours on an 11-point numeric rating scale ranging from 0 = no pain to 10 = worst possible pain. A rating of 1-3 was considered as mild pain; 4-6 = moderate pain; and 7-10 = severe pain. SB baseline refers to the last 7 pain diary entries up to and including Day 1.
Original Primary Outcome Measures  ICMJE
 (submitted: January 26, 2010)
Mean pain score from the daily pain diary [ Time Frame: 19 weeks ]
Change History Complete list of historical versions of study NCT01057693 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 18, 2013)
  • Time to Loss of Pain Response (Double-Blind Phase) [ Time Frame: SB Baseline up to Week 19 ]
    Time to loss of pain response (based on the daily pain diary data) during the DB treatment phase was analyzed using survival analysis technique. Loss of pain response was defined as less than (<) 15% pain response relative to the SB baseline. SB baseline refers to the last 7 pain diary entries up to and including Day 1.
  • Change From Single-Blind Baseline in Mean Pain Score at Week 6 During Single-Blind Phase [ Time Frame: SB Baseline, Week 6 (SB Phase) ]
    Mean pain score was defined as the mean of the last 7 daily diary pain ratings. Participants rated their DPN pain over the past 24 hours on an 11-point numeric rating scale ranging from 0 = no pain to 10 = worst possible pain. A rating of 1-3 was considered as mild pain; 4-6 = moderate pain; and 7-10 = severe pain. SB baseline refers to the last 7 pain diary entries up to and including Day 1.
  • Weekly Mean Pain Scores (Single-Blind Phase) [ Time Frame: Week 1, 2, 3, 4, 5, 6 ]
    Weekly mean pain score was defined as the mean of the daily diary pain ratings split into 7 day intervals. Participants rated their DPN pain over the past 24 hours on an 11-point numeric rating scale ranging from 0 = no pain to 10 = worst possible pain. A rating of 1-3 was considered as mild pain; 4-6 = moderate pain; and 7-10 = severe pain.
  • Weekly Mean Pain Scores (Double-Blind Phase) [ Time Frame: DB Baseline, Week 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19 ]
    Weekly mean pain score was defined as the mean of the daily diary pain ratings split into 7 day intervals. Participants rated their DPN pain over the past 24 hours on an 11-point numeric rating scale ranging from 0 = no pain to 10 = worst possible pain. A rating of 1-3 was considered as mild pain; 4-6 = moderate pain; and 7-10 = severe pain. SB baseline refers to the last 7 pain diary entries up to and including Day 1. DB baseline refers to the last 7 pain diary entries up to and including DB Day 1.
  • Percentage of Participants With At Least 30 Percent and 50 Percent Reduction in Mean Pain Score (Single-Blind Phase) [ Time Frame: Week 6 ]
    Mean pain score was defined as the mean of the last 7 daily diary pain ratings. Participants rated their DPN pain over the past 24 hours on an 11-point numeric rating scale ranging from 0 = no pain to 10 = worst possible pain. A rating of 1-3 was considered as mild pain; 4-6 = moderate pain; and 7-10 = severe pain. Percentage of participants who had at least 30% and 50% pain reduction from SB baseline to Week 6 is reported. SB baseline refers to the last 7 pain diary entries up to and including Day 1.
  • Percentage of Participants With At Least 30 Percent and 50 Percent Reduction in Mean Pain Score (Double-Blind Phase) [ Time Frame: Week 19 ]
    Mean pain score was defined as the mean of the last 7 daily diary pain ratings. Participants rated their DPN pain over the past 24 hours on an 11-point numeric rating scale ranging from 0 = no pain to 10 = worst possible pain. A rating of 1-3 was considered as mild pain; 4-6 = moderate pain; and 7-10 = severe pain. Percentage of participants who had at least 30% and 50% pain reduction from SB baseline to Week 19 is reported.
  • Patient Global Impression of Change (PGIC) (Single-Blind Phase) [ Time Frame: Week 6 ]
    PGIC: participant rated instrument to measure participant's change in overall status on a 7-point scale; range from 1 (very much improved) to 7 (very much worse). Number of participants in each category are reported.
  • Patient Global Impression of Change (PGIC) (Double-Blind Phase) [ Time Frame: Week 19 ]
    PGIC: participant rated instrument to measure participant's change in overall status on a 7-point scale; range from 1 (very much improved) to 7 (very much worse). Number of participants in each category are reported.
  • Medical Outcomes Study -Sleep Scale (MOS-SS) (Single-Blind Phase) [ Time Frame: SB Baseline, Week 6 ]
    Participant-rated 12-item questionnaire to assess constructs of sleep over past week; 7 subscales: sleep disturbance (range 0-100), snoring (range 0-100), awaken short of breath (SOB) or with headache (range 0-100), sleep adequacy (range 0-100), somnolence (range: 0-100); sleep quantity (range: 0-24), optimal sleep (yes/no), and 9 item index measures of sleep disturbance provide composite scores: sleep problems index (range 0-100). Except adequacy, optimal sleep and quantity, higher scores=more impairment.
  • Medical Outcomes Study -Sleep Scale (MOS-SS) (Double-Blind Phase) [ Time Frame: Week 19 ]
    Participant-rated 12-item questionnaire to assess constructs of sleep over past week; 7 subscales: sleep disturbance (range 0-100), snoring (range 0-100), awaken short of breath (SOB) or with headache (range 0-100), sleep adequacy (range 0-100), somnolence (range: 0-100); sleep quantity (range: 0-24), optimal sleep (yes/no), and 9 item index measures of sleep disturbance provide composite scores: sleep problems index (range 0-100). Except adequacy, optimal sleep and quantity, higher scores=more impairment.
  • Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study-Sleep Scale (MOS-SS) (Single-Blind Phase) [ Time Frame: SB Baseline, Week 6 ]
    MOS-SS: participant-rated 12 item questionnaire to assess constructs of sleep over past week. It included 7 subscales: sleep disturbance, snoring, awaken short of breath or with headache, sleep adequacy, somnolence, sleep quantity, optimal sleep, and 9 item index measures of sleep disturbance provide composite scores: sleep problems index. Participants responded whether their sleep was optimal or not optimal by choosing yes or no.
  • Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study-Sleep Scale (MOS-SS) (Double-Blind Phase) [ Time Frame: Week 19 ]
    MOS-SS: participant-rated 12 item questionnaire to assess constructs of sleep over past week. It included 7 subscales: sleep disturbance, snoring, awaken short of breath or with headache, sleep adequacy, somnolence, sleep quantity, optimal sleep, and 9 item index measures of sleep disturbance provide composite scores: sleep problems index. Participants responded whether their sleep was optimal or not optimal by choosing yes or no.
  • Weekly Mean Sleep Interference Score (Single-Blind Phase) [ Time Frame: SB Baseline, Week 1, 2, 3, 4, 5, 6 ]
    Weekly mean sleep interference score was defined as the mean of the daily sleep interference diary ratings split into 7 day intervals. Participants rated how painful DPN has interfered with their sleep during the past 24 hours on an 11-point numeric rating scale ranging from 0 = does not interfere with sleep to 10 = completely interferes (unable to sleep due to pain). SB baseline refers to the last 7 pain diary entries up to and including Day 1.
  • Weekly Mean Sleep Interference Score (Double-Blind Phase) [ Time Frame: DB Baseline, Week 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19 ]
    Weekly mean sleep interference score was defined as the mean of the daily sleep interference diary ratings split into 7 day intervals. Participants rated how painful DPN has interfered with their sleep during the past 24 hours on an 11-point numeric rating scale ranging from 0 = does not interfere with sleep to 10 = completely interferes (unable to sleep due to pain).
  • Endpoint Mean Sleep Interference Score (Single-Blind Phase) [ Time Frame: Week 6 ]
    Endpoint mean sleep interference score was defined as the mean of the last 7 sleep interference diaries while receiving SB treatment. Participants rated how painful DPN has interfered with their sleep during the past 24 hours on an 11-point numeric rating scale ranging from 0 = does not interfere to 10 = completely interferes (unable to sleep due to pain).
  • Endpoint Mean Sleep Interference Score (Double-Blind Phase) [ Time Frame: Week 19 ]
    Endpoint mean sleep interference score was defined as the mean of the last 7 sleep interference diaries while receiving DB treatment. Participants rated how painful DPN has interfered with their sleep during the past 24 hours on an 11-point numeric rating scale ranging from 0 = does not interfere to 10 = completely interferes (unable to sleep due to pain).
  • Quality of Life Questionnaire- Diabetic Neuropathy (QOL-DN) (Single-Blind Phase) [ Time Frame: SB Baseline, Week 6 ]
    QOL-DN: 35-item participant-rated questionnaire used to assess impact of diabetic neuropathy on the quality of life of participants with diabetic neuropathy. Consists of 5 domains: Physical functioning(Ph Fn)/large fiber (sum of item 8, 11, 13-15, 24, 27-35; range -4 to 56); Activities of daily living (sum of item 12, 22, 23, 25, 26; range 0 to 20); Symptoms (sum of item 1-7, 9; range 0 to 32); Small fiber (sum of item 10, 16, 17, 18; range 0 to 16); Autonomic (sum of item 19, 20, 21; range 0 to 12) and total QOL score (sum of items 1-35) range: -4 to 136. Higher score implied worse QOL.
  • Quality of Life Questionnaire- Diabetic Neuropathy (QOL-DN) (Double-Blind Phase) [ Time Frame: Week 19 ]
    QOL-DN: 35-item participant-rated questionnaire used to assess impact of diabetic neuropathy on the quality of life of participants with diabetic neuropathy. Consists of 5 domains: Physical functioning(Ph Fn)/large fiber (sum of item 8, 11, 13-15, 24, 27-35; range -4 to 56); Activities of daily living (sum of item 12, 22, 23, 25, 26; range 0 to 20); Symptoms (sum of item 1-7, 9; range 0 to 32); Small fiber (sum of item 10, 16, 17, 18; range 0 to 16); Autonomic (sum of item 19, 20, 21; range 0 to 12) and total QOL score (sum of items 1-35) range: -4 to 136. Higher score implied worse QOL.
  • Pain Visual Analog Scale (VAS) (Single-Blind Phase) [ Time Frame: SB Baseline, Week 6 ]
    Participants rated their pain on a 100 millimeter (mm) Visual Analog Scale (VAS) ranging from 0 mm = no pain to 100 mm = worst possible pain.
  • Pain Visual Analog Scale (VAS) (Double-Blind Phase) [ Time Frame: Week 19 ]
    Participants rated their pain on a 100 millimeter (mm) Visual Analog Scale (VAS) ranging from 0 mm = no pain to 100 mm = worst possible pain.
  • Brief Pain Inventory-Short Form (BPI-sf) (Single-Blind Phase) [ Time Frame: SB Baseline, Week 6 ]
    BPI-sf: self-administered questionnaire developed to assess severity, impact of pain on daily functions, consisted of 5 questions. Questions 1-4 measured the severity of pain based on pain experienced over the past 24-hours on an 11-point scale ranged from 0 (no pain) to10 (worst possible pain). Question 5: 7 item subsets that measured level of interference of pain on daily functions on an 11-point scale ranged from 0 (does not interfere) to 10 (completely interferes).
  • Brief Pain Inventory-Short Form (BPI-sf) (Double-Blind Phase) [ Time Frame: Week 19 ]
    BPI-sf: self-administered questionnaire developed to assess severity, impact of pain on daily functions, consisted of 5 questions. Questions 1-4 measured the severity of pain based on pain experienced over the past 24-hours on an 11-point scale ranged from 0 (no pain) to10 (worst possible pain). Question 5: 7 item subsets that measured level of interference of pain on daily functions on an 11-point scale ranged from 0 (does not interfere) to 10 (completely interferes).
  • Hospital Anxiety and Depression Scale (HADS) (Single-Blind Phase) [ Time Frame: SB Baseline, Week 6 ]
    HADS: self-administered questionnaire, consists of 2 sub-scales; measuring anxiety (HADS-A), and depression (HADS-D). Each sub-scale consists of 7 items on which participants responded as to how each item applies to them on a 4-point scale ranging from 0 (no anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score range for each sub-scale = 0 to 21, where higher score indicates more severe anxiety or depression.
  • Hospital Anxiety and Depression Scale (HADS) (Double-Blind Phase) [ Time Frame: Week 19 ]
    HADS: self-administered questionnaire, consists of 2 sub-scales; measuring anxiety (HADS-A), and depression (HADS-D). Each sub-scale consists of 7 items on which participants responded as to how each item applies to them on a 4-point scale ranging from 0 (no anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score range for each sub-scale = 0 to 21, where higher score indicates more severe anxiety or depression.
  • Patient Global Evaluation of Study Medication (GESM) (Single-Blind Phase) [ Time Frame: Week 6 ]
    GESM: single-item, self-administered treatment satisfaction questionnaire. Participants answered "how would you rate the study medication you received for pain?" on a 7-point scale ranging from 1 (very satisfied) to 7 (very dissatisfied). Number of participants in each category are reported.
  • Patient Global Evaluation of Study Medication (GESM) (Double-Blind Phase) [ Time Frame: Week 19 ]
    GESM: single-item, self-administered treatment satisfaction questionnaire. Participants answered "how would you rate the study medication you received for pain?" on a 7-point scale ranging from 1 (very satisfied) to 7 (very dissatisfied). Number of participants in each category are reported.
Original Secondary Outcome Measures  ICMJE
 (submitted: January 26, 2010)
  • Time to loss of pain response [ Time Frame: 19 weeks ]
  • Proportion of pain responders [ Time Frame: 6 weeks, 19 weeks ]
  • Patient Global Impression of Change [ Time Frame: 6 weeks, 19 weeks ]
  • Medical Outcomes Study - Sleep Scale [ Time Frame: At study start, 6 weeks, and 19 weeks ]
  • Sleep score from the daily sleep diary [ Time Frame: 19 weeks ]
  • Quality of Life Questionnaire - Diabetic Neuropathy [ Time Frame: At study start, 6 weeks, and 19 weeks ]
  • Pain visual analogue scale [ Time Frame: Twice at study start, 6 weeks, and 19 weeks ]
  • Modified Brief Pain Inventory [ Time Frame: At study start, 6 weeks, and 19 weeks ]
  • Global Evaluation of Study Medication [ Time Frame: 6 weeks and 19 weeks ]
  • Hospital Anxiety and Depression Scale [ Time Frame: At study start, 6 weeks, and 19 weeks ]
  • Adverse events [ Time Frame: 20 weeks ]
  • Clinical laboratory tests [ Time Frame: At study start, 6 weeks, and 19 weeks ]
  • Physical & neurological exam, including vital signs and edema assessment [ Time Frame: At study start, 6 weeks, and 19 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study Of Pregabalin (Lyrica) In Patients With Painful Diabetic Peripheral Neuropathy
Official Title  ICMJE A PHASE 3B MULTICENTER, DOUBLE-BLIND, RANDOMIZED WITHDRAWAL EFFICACY AND SAFETY STUDY OF PREGABALIN IN THE TREATMENT OF PATIENTS WITH INADEQUATELY TREATED PAINFUL DIABETIC PERIPHERAL NEUROPATHY
Brief Summary Patients will be switched from their current medication for painful diabetic peripheral neuropathy to evaluate the safety and efficacy of pregabalin as compared to placebo. All patients will receive pregabalin, and half of patients will receive placebo at some point during the study.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Diabetic Neuropathy, Painful
Intervention  ICMJE
  • Drug: pregabalin (Lyrica)
    Lyrica 150-300 mg/day. Medication is supplied as capsules and given 3 times daily.
  • Drug: Placebo
    Placebo is supplied as capsules and given 3 times daily.
Study Arms  ICMJE
  • Experimental: pregabalin (Lyrica)
    Intervention: Drug: pregabalin (Lyrica)
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Publications * Raskin P, Huffman C, Toth C, Asmus MJ, Messig M, Sanchez RJ, Pauer L. Pregabalin in patients with inadequately treated painful diabetic peripheral neuropathy: a randomized withdrawal trial. Clin J Pain. 2014 May;30(5):379-90. doi: 10.1097/AJP.0b013e31829ea1a1.

*   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: February 1, 2019)
633
Original Estimated Enrollment  ICMJE
 (submitted: January 26, 2010)
564
Actual Study Completion Date  ICMJE January 30, 2012
Actual Primary Completion Date January 30, 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients must have painful diabetic peripheral neuropathy and be receiving treatment for this condition.

Exclusion Criteria:

  • Patients with other pain conditions cannot participate.
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 Canada,   Puerto Rico,   South Africa,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01057693
Other Study ID Numbers  ICMJE A0081242
2009-017389-21 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
URL: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date February 2019

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