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

  Purpose

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.

Condition	Intervention	Phase
Diabetic Neuropathy, Painful	Drug: pregabalin (Lyrica) Drug: Placebo	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A Phase 3b Multicenter, Double-Blind, Efficacy And Safety Study Of Pregabalin In The Treatment Of Patients With Inadequately Treated Painful Diabetic Peripheral Neuropathy

Resource links provided by NLM:

Genetics Home Reference related topics: Charcot-Marie-Tooth disease hereditary neuropathy with liability to pressure palsies

MedlinePlus related topics: Anxiety Diabetic Nerve Problems Peripheral Nerve Disorders

Drug Information available for: Pregabalin

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

• 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.
  
  

Secondary Outcome Measures:

• 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.
  
  

Enrollment:	665
Study Start Date:	March 2010
Study Completion Date:	January 2012
Primary Completion Date:	January 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: pregabalin (Lyrica)	Drug: pregabalin (Lyrica) Lyrica 150-300 mg/day. Medication is supplied as capsules and given 3 times daily. Other Name: pregabalin (Lyrica)
Placebo Comparator: Placebo	Drug: Placebo Placebo is supplied as capsules and given 3 times daily.

  Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01057693

  Show 173 Study Locations

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

  More Information

Additional Information:

To obtain contact information for a study center near you, click here. 

No publications provided

Responsible Party:	Pfizer
ClinicalTrials.gov Identifier:	NCT01057693     History of Changes
Other Study ID Numbers:	A0081242
Study First Received:	January 26, 2010
Results First Received:	January 18, 2013
Last Updated:	January 18, 2013
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

Diabetic peripheral neuropathy Lyrica pregabalin pain

Additional relevant MeSH terms:

Diabetic Neuropathies Pain Peripheral Nervous System Diseases Demyelinating Diseases Polyneuropathies Nerve Compression Syndromes Neurologic Manifestations Neurotoxicity Syndromes Neuromuscular Diseases Nervous System Diseases Diabetes Complications Diabetes Mellitus Endocrine System Diseases

Signs and Symptoms Poisoning Substance-Related Disorders Pregabalin Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Anticonvulsants

ClinicalTrials.gov processed this record on May 22, 2013

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