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.

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

Diabetic Neuropathy, Painful

pregabalin (Lyrica)

Placebo

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

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.

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.

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 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.

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.

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.

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.

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.

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 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 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 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 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).

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.

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.

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).

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.

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.

Greystone Medical Research, LLC

Neurology Clinic, PC

Horizon Clinical Research Associates, PLLC

Dedicated Clinical Research, Inc.

Dedicated Clinical Research

Novara Clinical Research

Arizona Research Center

Radiant Research, Inc.

Genova Clinical Research, Inc.

Central Arkansas Research

Little Rock Diagnostic Clinic

Convergys Clinical Research, Inc.

Providence Clinical Research

Valley Research

Center for United Research, Inc.

Healthcare Partners Medical Group

University of Southern California, Keck School of Medicine, Department of Neurology

Richard S. Cherlin, MD

Northridge Neurological Research

Remek Research

Sierra Clinical Research

CNRI-San Diego, LLC

San Diego Clinical Trials

Center for Clinical Research, Inc.

Apex Research Institute

Neurological Research Institute

Diablo Clinical Research, Inc.

Foothills Pain Management

Aurora Family Medicine Center, PC

Alpine Clinical Research Center, Inc.

Mountain View Clinical Research

Chase Medical Research, LLC

Metabolic Research Institute, Inc.

Bradenton Research Center

Meridien Research

Innovative Research of West Florida, Inc.

Clinical Research of West Florida, Inc.

Deerfield Beach Cardiology Research

Gulfcoast Clinical Research Center

MD Clinical

Elite Research Institute

Suncoast Clinical Research, Inc.

Laszlo J. Mate, MD

Family Care Specialists, Inc.

Renstar Medical Research

Compass Research, LLC

Palm Beach Neurological Center, Advanced Research Consultants, Inc.

Suncoast Clinical Research

Neurology Clinical Research, Inc.

Clinical Research of Central Florida

NeuroTrials Research, Incorporated

CPM Research Institute

Columbus Research Foundation

Rockdale Medical Research Associates

Prism Research Group

Valley Health Care

East-West Medical Research Institute

Advanced Clinical Research

AMR Sakeena Research

Chicago Research Center, Inc.

American Medical Research, Inc.

MediSphere Medical Research Center, LLC

American Health Network

Rehabilitation Associates of Indiana

University of Kansas Medical Center

Heartland Research Associates, LLC

Kentucky Medical Research Center

Endocrinology Center of Southwest Louisiana

Heartland Research, LLC

Primary Physician Care, LLC

Arthritis and Diabetes Clinic, Inc

Miray Medical Center

Clinical Research Center of Cape Cod, Inc.

MedVadis Research Corporation

Clinical Pharmacology Study Group

Michigan Head Pain and Neurological Institute

Harris and Associates MD, PC

Borgess Diabetes Center

Borgess Research Institute

William Beaumont Hospital

KMED Research

Troy Internal Medicine, PC

MAPS Applied Research Center, Inc.

Medical Advanced Pain Specialists (MAPS)

Medical Advanced Pain Specialists

CRC of Jackson

Physician's Surgery Center

Randall T. Huling, Jr., MD, CPI

University of Missouri Healthcare/Cosmopolitan Diabetes and Endocrinology Center

Melinda A. Crockett-Maples

Clinvest

A & A Pain Institute of Saint Louis

Mercy Health Research

Lincoln Internal Medicine Associates

The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.

Participants who were inadequately controlled on their current DPN treatment were switched to SB pregabalin capsules at a starting dose of 150 mg/day and increased to 300 mg/day, administered three times daily up to Week 6. Participants who experienced \>=30% pain reduction from baseline to Week 6 were eligible for DB treatment phase.

Pregabalin SB

Participants who experienced \>=30% pain reduction in SB treatment phase, after Week 6 received pregabalin capsules 150 mg/day or 300 mg/day, administered three times daily up to Week 19 during DB treatment phase.

Pregabalin DB

Participants who experienced \>=30% pain reduction in SB treatment phase, after Week 6 received matching placebo capsules, administered three times daily up to Week 19 during DB treatment phase.

18 to 44 Years

45 to 64 Years

>=65 Years

Age, Customized

Sex: Female, Male

Pfizer ClinicalTrials.gov Call Center

P-value was calculated using analysis of covariance (ANCOVA), with terms for baseline mean pain score, center and treatment in the model.

Single-Blind Baseline

Change at Week 19 (DB Phase)

Full analysis set (FAS) included all participants randomized to double-blind treatment who received at least 1 dose of double-blind study treatment. Missing data were imputed using Last Observation Carried Forward (LOCF).

Change From Single-Blind Baseline in Mean Pain Score at Week 19 During Double-Blind Phase

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.

FAS included all participants randomized to double-blind treatment who received at least 1 dose of double-blind study treatment.

Time to Loss of Pain Response (Double-Blind Phase)

SB Baseline (n= 663)

Change at Week 6 (SB Phase) (n= 658)

Single-Blind Analysis Set (SBAS) included all participants who were enrolled in single-blind treatment phase and received at least 1 dose of study treatment. "N" (number of participants analyzed): participants who were evaluable for this measure and "n": participants who were evaluable for specified time-point. Missing data were imputed using LOCF.

Change From Single-Blind Baseline in Mean Pain Score at Week 6 During Single-Blind Phase

Week 1 (n= 657)

Week 2 (n= 636)

Week 3 (n= 613)

Week 4 (n= 585)

Week 5 (n= 565)

Week 6 (n= 548)

SBAS included all participants who were enrolled in single-blind treatment phase and received at least one dose of study treatment. Here "N" (number of participants analyzed) signifies participants who were evaluable for this measure and "n" signifies participants who were evaluable for specified time-point.

Weekly Mean Pain Scores (Single-Blind Phase)

DB Baseline (n= 147, 147)

Week 7 (n= 144, 145)

Week 8 (n= 143, 142)

Week 9 (n= 140, 133)

Week 10 (n= 138, 133)

Week 11 (n= 138, 128)

Week 12 (n= 135, 123)

Week 13 (n= 134, 122)

Week 14 (n= 133, 122)

Week 15 (n= 131, 118)

Week 16 (n= 132, 118)

Week 17 (n= 128, 115)

Week 18 (n= 128, 115)

Week 19 (n= 115, 104)

FAS included all participants randomized to double-blind treatment who received at least 1 dose of double-blind study treatment. Here "n" signifies participants who were evaluable for specified time-point for each arm group, respectively.

Weekly Mean Pain Scores (Double-Blind Phase)

>=30 % Reduction

>=50 % Reduction

SBAS included all participants who were enrolled into the single-blind treatment phase and received at least 1 dose of study treatment. Missing data were imputed using LOCF.

Percentage of Participants With At Least 30 Percent and 50 Percent Reduction in Mean Pain Score (Single-Blind Phase)

>=30% Reduction

>=50% Reduction

FAS included all participants randomized to double-blind treatment who received at least 1 dose of double-blind study treatment. Missing data were imputed using LOCF.

Percentage of Participants With At Least 30 Percent and 50 Percent Reduction in Mean Pain Score (Double-Blind Phase)

Very Much Improved

Much Improved

Minimally Improved

No Change

Minimally Worse

Much Worse

Very Much Worse

SBAS included all participants who were enrolled into the single-blind treatment phase and received at least one dose of study treatment. Here "N" (number of participants analyzed) signifies participants who were evaluable for this measure.

Patient Global Impression of Change (PGIC) (Single-Blind Phase)

FAS included all participants randomized to double-blind treatment who received at least 1 dose of double-blind study treatment. Here "N" (number of participants analyzed) signifies participants who were evaluable for this measure.

Patient Global Impression of Change (PGIC) (Double-Blind Phase)

SB Baseline: Sleep disturbance (n= 665)

SB Baseline: Snoring (n= 664)

SB Baseline: Awaken SOB or With Headache (n=665)

SB Baseline: Quantity of sleep (n=663)

SB Baseline: Sleep Adequacy (n=665)

SB Baseline: Somnolence (n=665)

SB Baseline: Sleep Problems Index (n=665)

Week 6: Sleep disturbance (n= 621)

Week 6: Snoring (n= 621)

Week 6: Awaken SOB or With Headache (n= 621)

Week 6: Quantity of sleep (n= 615)

Week 6: Sleep Adequacy (n= 621)

Week 6: Somnolence (n= 621)

Week 6: Sleep Problems Index (n= 621)

SBAS included all participants who were enrolled into the single-blind treatment phase and received at least one dose of study medication. Here "n" signifies participants who were evaluable for specified time-point.

Medical Outcomes Study -Sleep Scale (MOS-SS) (Single-Blind Phase)

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

About this trial

Study ID

Status

Type

Phase

Placebo

Accepting

Trial Timing

What is this trial about?

What are the participation requirements?