Efficacy and Safety Study of Pregabalin in the Treatment of Pain on Walking in Patients With Diabetic Peripheral Neuropathy (DPN)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01474772
First received: November 15, 2011
Last updated: August 19, 2013
Last verified: August 2013
  Purpose

The intent of this study is to treat subjects with painful Diabetic Peripheral Neuropathy (DPN) who also have pain on walking and to determine whether or not pregabalin demonstrates improvement relative to placebo on the following: reducing DPN pain, reducing pain on walking, and providing other benefits associated with daily activities and quality of life.


Condition Intervention Phase
Diabetic Peripheral Neuropathy
Drug: Pregabalin
Other: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 3b Multicenter, Double-Blind, Randomized Cross-Over Efficacy and Safety Study of Pregabalin in the Treatment of Pain on Walking in Patients With Painful Diabetic Peripheral Neuropathy

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Reduction in Diabetic Peripheral Neuropathy (DPN) pain [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
  • Reduction in DPN pain on walking [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Responder rate, 30% and 50% improvement in mean pain response [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
  • Brief Pain Inventory-short form [ Time Frame: 14 weks ] [ Designated as safety issue: No ]
  • Daytime activity measured by actigraphy [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
  • Walk-12 [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
  • Norfolk Quality of Life for Diabetic Neuropathy [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
  • Patient Global Impression of Change [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Sleep Interference Rating Scale [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
  • Hospital Anxiety and Depression Scale [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
  • Euro Quality of Life-5 Dimensions [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]

Enrollment: 288
Study Start Date: December 2011
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pregabain Drug: Pregabalin
150-300 mg/day given in 3 divided doses as capsules
Other Name: Lyrica
Placebo Comparator: Placebo Other: placebo
matching placebo capsules given in 3 divided doses

  Eligibility

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

Inclusion Criteria:

  • Men or women who are at least 18 years old.
  • Diagnosis of painful diabetic peripheral neuropathy.
  • Pain on walking.

Exclusion Criteria:

  • Inability to walk 50 feet on a flat surface.
  • Pain on walking due to conditions other than diabetic peripheral neuropathy.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01474772

  Hide Study Locations
Locations
United States, Arizona
Dedicated Clinical Research
Goodyear, Arizona, United States, 85395
Arizona Research Center
Phoenix, Arizona, United States, 85023
United States, California
Neuro-Pain Medical Center
Fresno, California, United States, 93710
HealthCare Partners Medical Group
Los Angeles, California, United States, 90015
IDS Pharmacy
Los Angeles, California, United States, 90033
University of Southern California
Los Angeles, California, United States, 90033
United States, Florida
Pulmonary Associates of Brandon
Brandon, Florida, United States, 33511
PAB Clinical Research
Brandon, Florida, United States, 33511
Innovative Research of West Florida, Inc.
Clearwater, Florida, United States, 33756
The Office of Laszlo Jozef Mate, MD
North Palm Beach, Florida, United States, 33408
Meridien Research
Tampa, Florida, United States, 33606
Metabolic Research Institute, Inc.
West Palm Beach, Florida, United States, 33401
Clinical Research of Central Florida
Winter Haven, Florida, United States, 33880
United States, Georgia
Columbus Research Foundation
Columbus, Georgia, United States, 31904
United States, Indiana
MediSphere Medical Research Center, LLC
Evansville, Indiana, United States, 47714
United States, Kansas
Heartland Research Associates, LLC
Wichita, Kansas, United States, 67205
United States, Nebraska
Quality Clinical Research, Inc.
Omaha, Nebraska, United States, 68114
United States, Nevada
Desert Endocrinology Clinical Research Center
Henderson, Nevada, United States, 89052
Clinical Research Consortium
Las Vegas, Nevada, United States, 89119
The Office of Dr. Stephen H. Miller, MD
Las Vegas, Nevada, United States, 89144
United States, New York
The Medical Research Network, LLC
New York, New York, United States, 10128
United States, Ohio
Neurology and Neuroscience Center of Ohio
Toledo, Ohio, United States, 43623
United States, Oklahoma
Sooner Clinical Research
Oklahoma City, Oklahoma, United States, 73112
The Office of Veronique Sebastian, MD
Oklahoma City, Oklahoma, United States, 73120
United States, Oregon
Sunstone Medical Research, LLC
Medford, Oregon, United States, 97504
Oregon Health and Science University - Comprehensive Pain Center
Portland, Oregon, United States, 97239
Oregon Health and Science University - Department of Anesthesiology and Perioperative Medicine
Portland, Oregon, United States, 97239
United States, Pennsylvania
Blair Orthopedic Associates, Inc.
Altoona, Pennsylvania, United States, 16602
Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States, 16635
United States, Rhode Island
Memorial Hospital of Rhode Island
Pawtucket, Rhode Island, United States, 02860
United States, South Carolina
Neurology and Pain Clinic, LLC
Orangeburg, South Carolina, United States, 29118
United States, Texas
Centex Research, Inc.
Houston, Texas, United States, 77062
Houston Neurocare
Houston, Texas, United States, 77030
United States, Virginia
Eastern Virginia Medical School
Norfolk, Virginia, United States, 23507
Czech Republic
Privatni specializovana ambulance pro neurologii a detskou neurologii
Brno-Bystrc, Czech Republic, 635 00
Clintrial, s.r.o.
Praha 10, Czech Republic, 100 00
Fakultni nemocnice v Motole
Praha 5, Czech Republic, 150 06
South Africa
Dr DR Lakha's Practice
Johannesburg, Gauteng, South Africa, 1829
Dr Hemant Makan (Private Practice)
Lenasia, Gauteng, South Africa, 1820
Randles Road Medical Centre
Durban, Kwa-Zulu Natal, South Africa, 4000
Richards Bay Trial Centre
Richards Bay, South Africa, 3900
Sweden
Forskningsmottagningen Gamla Sjukhuset i Falkoping
Falkoping, Sweden, 521 43
Center for Lakemedelsstudier
Malmo, Sweden, 211 52
Citydiabetes
Stockholm, Sweden, 111 57
Bragee Medect AB
Stockholm, Sweden, 115 22
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01474772     History of Changes
Other Study ID Numbers: A0081269
Study First Received: November 15, 2011
Last Updated: August 19, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Diabetic Peripheral Neuropathy
Pain on Walking
Pregabalin

Additional relevant MeSH terms:
Peripheral Nervous System Diseases
Diabetic Neuropathies
Neuromuscular Diseases
Nervous System Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Pregabalin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on August 27, 2014