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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01057693
First received: January 26, 2010
Last updated: January 18, 2013
Last verified: January 2013

January 26, 2010
January 18, 2013
March 2010
January 2012   (final data collection date for primary outcome measure)
Change From Single-Blind Baseline in Mean Pain Score at Week 19 During Double-Blind Phase [ Time Frame: SB Baseline, Week 19 (DB Phase) ] [ Designated as safety issue: No ]
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.
Mean pain score from the daily pain diary [ Time Frame: 19 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01057693 on ClinicalTrials.gov Archive Site
  • Time to Loss of Pain Response (Double-Blind Phase) [ Time Frame: SB Baseline up to Week 19 ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.
  • Time to loss of pain response [ Time Frame: 19 weeks ] [ Designated as safety issue: No ]
  • Proportion of pain responders [ Time Frame: 6 weeks, 19 weeks ] [ Designated as safety issue: No ]
  • Patient Global Impression of Change [ Time Frame: 6 weeks, 19 weeks ] [ Designated as safety issue: No ]
  • Medical Outcomes Study - Sleep Scale [ Time Frame: At study start, 6 weeks, and 19 weeks ] [ Designated as safety issue: No ]
  • Sleep score from the daily sleep diary [ Time Frame: 19 weeks ] [ Designated as safety issue: No ]
  • Quality of Life Questionnaire - Diabetic Neuropathy [ Time Frame: At study start, 6 weeks, and 19 weeks ] [ Designated as safety issue: No ]
  • Pain visual analogue scale [ Time Frame: Twice at study start, 6 weeks, and 19 weeks ] [ Designated as safety issue: No ]
  • Modified Brief Pain Inventory [ Time Frame: At study start, 6 weeks, and 19 weeks ] [ Designated as safety issue: No ]
  • Global Evaluation of Study Medication [ Time Frame: 6 weeks and 19 weeks ] [ Designated as safety issue: No ]
  • Hospital Anxiety and Depression Scale [ Time Frame: At study start, 6 weeks, and 19 weeks ] [ Designated as safety issue: No ]
  • Adverse events [ Time Frame: 20 weeks ] [ Designated as safety issue: Yes ]
  • Clinical laboratory tests [ Time Frame: At study start, 6 weeks, and 19 weeks ] [ Designated as safety issue: Yes ]
  • Physical & neurological exam, including vital signs and edema assessment [ Time Frame: At study start, 6 weeks, and 19 weeks ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Study Of Pregabalin (Lyrica) In Patients With Painful Diabetic Peripheral Neuropathy
A Phase 3b Multicenter, Double-Blind, Efficacy And Safety Study Of Pregabalin In The Treatment Of Patients With Inadequately Treated Painful Diabetic Peripheral Neuropathy

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Diabetic Neuropathy, Painful
  • Drug: pregabalin (Lyrica)
    Lyrica 150-300 mg/day. Medication is supplied as capsules and given 3 times daily.
    Other Name: pregabalin (Lyrica)
  • Drug: Placebo
    Placebo is supplied as capsules and given 3 times daily.
  • Experimental: pregabalin (Lyrica)
    Intervention: Drug: pregabalin (Lyrica)
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
665
January 2012
January 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
South Africa,   United States,   Canada,   Puerto Rico
 
NCT01057693
A0081242
No
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
January 2013

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