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

NCT01474772 | Completed Phase 3 Results

• 2 other identifiers: A00812692011-003266-32
• Study Type: interventional
• Target: 217
• Locations: 4 countries
• Sites: 45

Brief Summary

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.

Conditions

Diabetic Peripheral Neuropathy

Keywords

Diabetic Peripheral Neuropathy; Pain on Walking; Pregabalin

Outcome Measures

Primary Outcomes (2)

• Average Diabetic Peripheral Neuropathy (DPN) Pain Based on a Numeric Rating Scale (NRS) Over the Last 7 Days of Each Treatment Period (Week 6 of Each Treatment Period)

  The daily pain diary consisted of an 11-point numeric scale ranging from 0 ("no pain") to 10 ("worst possible pain"). Participants described their pain during the past 24 hours by having chosen the appropriate number between 0 and 10. Self-assessment was performed daily each evening before bedtime (6.00 pm to midnight) on the telephone via Interactive Voice Recognition System (IVRS). The endpoint mean pain score was defined as the mean of the last 7 daily diary pain ratings while taking study medication in each treatment period - Period 1 and Period 2, respectively. A rating of 1 - 3 was considered as mild pain; 4 - 6 as moderate pain; and 7 - 10 as severe pain.

  End of Period (includes both Visits 6 and 11)

• DPN Pain on Walking Based on a 11-point NRS of Each Treatment Period (Week 6 of Each Treatment Period)

  The post-test DPN pain on walking NRS consisted of an 11-point numeric scale ranging from 0 ("no pain") to 10 ("worst possible pain"). Participants described their DPN pain in their legs and/or feet while walking during the 50-foot walk test by choosing the appropriate number between 0 and 10. The post-test DPN pain on walking NRS was completed by the participant using paper-pen administration immediately after completing the 50-foot walk test at the end of each treatment period - Period 1 and Period 2, respectively. A rating of 1 - 3 was considered as mild pain; 4 - 6 as moderate pain; and 7 - 10 as severe pain.

  End of Period (includes both Visits 6 and 11)

Secondary Outcomes (19)

• Percentage of Participants Achieving 30% Reduction in Mean DPN Pain Score From Baseline at the End of Each Treatment Period (Week 6 of Each Treatment Period)

  End of Period (includes both Visits 6 and 11)

• Percentage of Participants Achieving 50% Reduction in Mean DPN Pain Score From Baseline at the End of Each Treatment Period (Week 6 of Each Treatment Period)

  End of Period (includes both Visits 6 and 11)

• Brief Pain Inventory-Short Form (BPI-sf) Score for Pain-Severity Domain at the End of Each Treatment Period (Week 6 of Each Treatment Period)

  End of Period (includes both Visits 6 and 11)

• BPI-sf Score for Pain-Interference Domain at the End of Each Treatment Period (Week 6 of Each Treatment Period)

  End of Period (includes both Visits 6 and 11)

• BPI-sf Score for Pain-Interference With Walking Ability at the End of Each Treatment Period (Week 6 of Each Treatment Period)

  End of Period (includes both Visits 6 and 11)

Study Arms (2)

Pregabain

EXPERIMENTAL

Drug: Pregabalin

Placebo

PLACEBO COMPARATOR

Other: placebo

Interventions

Pregabalin DRUG

150-300 mg/day given in 3 divided doses as capsules

Also known as: Lyrica

Pregabain

placebo OTHER

matching placebo capsules given in 3 divided doses

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Inability to walk 50 feet on a flat surface.
• Pain on walking due to conditions other than diabetic peripheral neuropathy.

Sponsors & Collaborators

• Pfizer's Upjohn has merged with Mylan to form Viatris Inc.: lead

Study Sites (45)

Dedicated Clinical Research

Goodyear, Arizona, 85395, United States

Location

Arizona Research Center

Phoenix, Arizona, 85023, United States

Location

Neuro-Pain Medical Center

Fresno, California, 93710, United States

Location

HealthCare Partners Medical Group

Los Angeles, California, 90015, United States

Location

IDS Pharmacy

Los Angeles, California, 90033, United States

Location

University of Southern California

Los Angeles, California, 90033, United States

Location

PAB Clinical Research

Brandon, Florida, 33511, United States

Location

Pulmonary Associates of Brandon

Brandon, Florida, 33511, United States

Location

Innovative Research of West Florida, Inc.

Clearwater, Florida, 33756, United States

Location

The Office of Laszlo Jozef Mate, MD

North Palm Beach, Florida, 33408, United States

Location

Meridien Research

Tampa, Florida, 33606, United States

Location

Metabolic Research Institute, Inc.

West Palm Beach, Florida, 33401, United States

Location

Clinical Research of Central Florida

Winter Haven, Florida, 33880, United States

Location

Columbus Research Foundation

Columbus, Georgia, 31904, United States

Location

MediSphere Medical Research Center, LLC

Evansville, Indiana, 47714, United States

Location

Heartland Research Associates, LLC

Wichita, Kansas, 67205, United States

Location

Quality Clinical Research, Inc.

Omaha, Nebraska, 68114, United States

Location

Desert Endocrinology Clinical Research Center

Henderson, Nevada, 89052, United States

Location

Clinical Research Consortium

Las Vegas, Nevada, 89119, United States

Location

The Office of Dr. Stephen H. Miller, MD

Las Vegas, Nevada, 89144, United States

Location

The Medical Research Network, LLC

New York, New York, 10128, United States

Location

Neurology and Neuroscience Center of Ohio

Toledo, Ohio, 43623, United States

Location

Sooner Clinical Research

Oklahoma City, Oklahoma, 73112, United States

Location

The Office of Veronique Sebastian, MD

Oklahoma City, Oklahoma, 73120, United States

Location

Sunstone Medical Research, LLC

Medford, Oregon, 97504, United States

Location

Oregon Health and Science University - Comprehensive Pain Center

Portland, Oregon, 97239, United States

Location

Oregon Health and Science University - Department of Anesthesiology and Perioperative Medicine

Portland, Oregon, 97239, United States

Location

Blair Orthopedic Associates, Inc.

Altoona, Pennsylvania, 16602, United States

Location

Altoona Center for Clinical Research

Duncansville, Pennsylvania, 16635, United States

Location

Memorial Hospital of Rhode Island

Pawtucket, Rhode Island, 02860, United States

Location

Neurology and Pain Clinic, LLC

Orangeburg, South Carolina, 29118, United States

Location

Houston Neurocare

Houston, Texas, 77030, United States

Location

Centex Research, Inc.

Houston, Texas, 77062, United States

Location

Eastern Virginia Medical School

Norfolk, Virginia, 23507, United States

Location

Privatni specializovana ambulance pro neurologii a detskou neurologii

Brno-Bystrc, 635 00, Czechia

Location

Clintrial, s.r.o.

Prague, 100 00, Czechia

Location

Fakultni nemocnice v Motole

Prague, 150 06, Czechia

Location

Dr DR Lakha's Practice

Johannesburg, Gauteng, 1829, South Africa

Location

Dr Hemant Makan (Private Practice)

Lenasia, Gauteng, 1820, South Africa

Location

Randles Road Medical Centre

Durban, KwaZulu-Natal, 4000, South Africa

Location

Richards Bay Trial Centre

Richards Bay, 3900, South Africa

Location

Forskningsmottagningen Gamla Sjukhuset i Falkoping

Falköping, 521 43, Sweden

Location

Center for Lakemedelsstudier

Malmo, 211 52, Sweden

Location

Citydiabetes

Stockholm, 111 57, Sweden

Location

Bragee Medect AB

Stockholm, 115 22, Sweden

Location

Related Publications (1)

• Huffman C, Stacey BR, Tuchman M, Burbridge C, Li C, Parsons B, Pauer L, Scavone JM, Behar R, Yurkewicz L. Efficacy and Safety of Pregabalin in the Treatment of Patients With Painful Diabetic Peripheral Neuropathy and Pain on Walking. Clin J Pain. 2015 Nov;31(11):946-58. doi: 10.1097/AJP.0000000000000198.

  PMID: 25565583 DERIVED

Related Links

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

MeSH Terms

Interventions

Pregabalin

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2011
• First Posted: November 18, 2011
• Study Start: October 1, 2011
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: January 28, 2021
• Results First Posted: November 18, 2014

Record last verified: 2014-11

Locations

SE (4); US (34); CZ (3); ZA (4)