Clinical trial NCT01474772: Efficacy and Safety Study of Pregabalin in the Treatment of Pain on Walking in Patients With Diabetic Peripheral Neuropathy (DPN)
Official title: A Phase 3b Multicenter, Double-blind, Randomized, Placebo-controlled Cross-over Efficacy And Safety Study Of Pregabalin In The Treatment Of Patients With Painful Diabetic Peripheral Neuropathy And Pain On Walking
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetic Peripheral Neuropathy
Keywords: Diabetic Peripheral Neuropathy
Pain on Walking
Pregabalin
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2011-11-18
Enrollment: 217
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: 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)
timeFrame: End of Period (includes both Visits 6 and 11)
measure: DPN Pain on Walking Based on a 11-point NRS of Each Treatment Period (Week 6 of Each Treatment Period)
timeFrame: End of Period (includes both Visits 6 and 11)
Secondary outcomes:
measure: 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)
timeFrame: End of Period (includes both Visits 6 and 11)
measure: 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)
timeFrame: End of Period (includes both Visits 6 and 11)
measure: 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)
timeFrame: End of Period (includes both Visits 6 and 11)
measure: BPI-sf Score for Pain-Interference Domain at the End of Each Treatment Period (Week 6 of Each Treatment Period)
timeFrame: End of Period (includes both Visits 6 and 11)
measure: BPI-sf Score for Pain-Interference With Walking Ability at the End of Each Treatment Period (Week 6 of Each Treatment Period)
timeFrame: End of Period (includes both Visits 6 and 11)
measure: Daytime Total Activity Counts Per Day Measured by Actigraphy Over the Last 7 Days of Each Treatment Period (Week 6 of Each Treatment Period)
timeFrame: End of Period (includes both Visits 6 and 11)
measure: Steps Per Day Measured by Actigraphy Over the Last 7 Days of Each Treatment Period (Week 6 of Each Treatment Period)
timeFrame: End of Period (includes both Visits 6 and 11)
measure: Walk 12 Questionnaire Over the Last 2 Weeks of Each Treatment Period (Week 6 of Each Treatment Period)
timeFrame: End of Period (includes both Visits 6 and 11)
measure: Norfolk Quality of Life-Diabetic Neuropathy (Norfolk QOL-DN) Total Quality of Life (TQOL) Score Measured Over the Last 2 Weeks of Each Treatment Period (Week 6 of Each Treatment Period)
timeFrame: End of Period (includes both Visits 6 and 11)
measure: Norfolk QOL-DN Symptoms Domain Score Measured Over the Last 2 Weeks of Each Treatment Period (Week 6 of Each Treatment Period)
timeFrame: End of Period (includes both Visits 6 and 11)
measure: Norfolk QOL-DN Activities of Daily Living Domain Score Measured Over the Last 2 Weeks of Each Treatment Period (Week 6 of Each Treatment Period)
timeFrame: End of Period (includes both Visits 6 and 11)
measure: Norfolk QOL-DN Physical Functioning / Large Fiber Domain Score Measured Over the Last 2 Weeks of Each Treatment Period (Week 6 of Each Treatment Period)
timeFrame: End of Period (includes both Visits 6 and 11)
measure: Norfolk QOL-DN Small Fiber Domain Score Measured Over the Last 2 Weeks of Each Treatment Period (Week 6 of Each Treatment Period)
timeFrame: End of Period (includes both Visits 6 and 11)
measure: Norfolk QOL-DN Autonomic Domain Score Measured Over the Last 2 Weeks of Each Treatment Period (Week 6 of Each Treatment Period)
timeFrame: End of Period (includes both Visits 6 and 11)
measure: Percentage of Participants With Patient Global Impression of Change (PGIC) Score From Baseline at the End of Period 1 (Week 6)
timeFrame: End of Period 1 (V6)
measure: Mean Sleep Interference Rating Score at the End of Each Treatment Period (Week 6 of Each Treatment Period)
timeFrame: End of Period (includes both Visits 6 and 11)
measure: Hospital Anxiety and Depression Scale - Anxiety (HADS-A) Total Score at the End of Each Treatment Period (Week 6 of Each Treatment Period)
timeFrame: End of Period (includes both Visits 6 and 11)
measure: Hospital Anxiety and Depression Scale - Depression (HADS-D) Total Score at the End of Each Treatment Period (Week 6 of Each Treatment Period)
timeFrame: End of Period (includes both Visits 6 and 11)
measure: Euro QoL-5 Dimensions (EQ-5D) - Health State Profile Utility Scores at the End of Each Treatment Period (Week 6 of Each Treatment Period)
timeFrame: End of Period (includes both Visits 6 and 11)
Other outcomes:
Locations:
city: Goodyear
country: United States
facility: Dedicated Clinical Research
state: Arizona
city: Phoenix
country: United States
facility: Arizona Research Center
state: Arizona
city: Fresno
country: United States
facility: Neuro-Pain Medical Center
state: California
city: Los Angeles
country: United States
facility: HealthCare Partners Medical Group
state: California
city: Los Angeles
country: United States
facility: IDS Pharmacy
state: California
city: Los Angeles
country: United States
facility: University of Southern California
state: California
city: Brandon
country: United States
facility: PAB Clinical Research
state: Florida
city: Brandon
country: United States
facility: Pulmonary Associates of Brandon
state: Florida
city: Clearwater
country: United States
facility: Innovative Research of West Florida, Inc.
state: Florida
city: North Palm Beach
country: United States
facility: The Office of Laszlo Jozef Mate, MD
state: Florida
city: Tampa
country: United States
facility: Meridien Research
state: Florida
city: West Palm Beach
country: United States
facility: Metabolic Research Institute, Inc.
state: Florida
city: Winter Haven
country: United States
facility: Clinical Research of Central Florida
state: Florida
city: Columbus
country: United States
facility: Columbus Research Foundation
state: Georgia
city: Evansville
country: United States
facility: MediSphere Medical Research Center, LLC
state: Indiana
city: Wichita
country: United States
facility: Heartland Research Associates, LLC
state: Kansas
city: Omaha
country: United States
facility: Quality Clinical Research, Inc.
state: Nebraska
city: Henderson
country: United States
facility: Desert Endocrinology Clinical Research Center
state: Nevada
city: Las Vegas
country: United States
facility: Clinical Research Consortium
state: Nevada
city: Las Vegas
country: United States
facility: The Office of Dr. Stephen H. Miller, MD
state: Nevada
city: New York
country: United States
facility: The Medical Research Network, LLC
state: New York
city: Toledo
country: United States
facility: Neurology and Neuroscience Center of Ohio
state: Ohio
city: Oklahoma City
country: United States
facility: Sooner Clinical Research
state: Oklahoma
city: Oklahoma City
country: United States
facility: The Office of Veronique Sebastian, MD
state: Oklahoma
city: Medford
country: United States
facility: Sunstone Medical Research, LLC
state: Oregon
city: Portland
country: United States
facility: Oregon Health and Science University - Comprehensive Pain Center
state: Oregon
city: Portland
country: United States
facility: Oregon Health and Science University - Department of Anesthesiology and Perioperative Medicine
state: Oregon
city: Altoona
country: United States
facility: Blair Orthopedic Associates, Inc.
state: Pennsylvania
city: Duncansville
country: United States
facility: Altoona Center for Clinical Research
state: Pennsylvania
city: Pawtucket
country: United States
facility: Memorial Hospital of Rhode Island
state: Rhode Island
city: Orangeburg
country: United States
facility: Neurology and Pain Clinic, LLC
state: South Carolina
city: Houston
country: United States
facility: Houston Neurocare
state: Texas
city: Houston
country: United States
facility: Centex Research, Inc.
state: Texas
city: Norfolk
country: United States
facility: Eastern Virginia Medical School
state: Virginia
city: Brno-Bystrc
country: Czechia
facility: Privatni specializovana ambulance pro neurologii a detskou neurologii
city: Praha 10
country: Czechia
facility: Clintrial, s.r.o.
city: Praha 5
country: Czechia
facility: Fakultni nemocnice v Motole
city: Johannesburg
country: South Africa
facility: Dr DR Lakha's Practice
state: Gauteng
city: Lenasia
country: South Africa
facility: Dr Hemant Makan (Private Practice)
state: Gauteng
city: Durban
country: South Africa
facility: Randles Road Medical Centre
state: Kwa-Zulu Natal
city: Richards Bay
country: South Africa
facility: Richards Bay Trial Centre
city: Falkoping
country: Sweden
facility: Forskningsmottagningen Gamla Sjukhuset i Falkoping
city: Malmo
country: Sweden
facility: Center for Lakemedelsstudier
city: Stockholm
country: Sweden
facility: Citydiabetes
city: Stockholm
country: Sweden
facility: Bragee Medect AB
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: 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.