Clinical trial NCT01455415: Effect Of Pregabalin Treatment In Patients With Diabetic Nerve Pain Who Currently Use A Non-Steroid Anti-Inflammatory Drug (NSAID) For Another Pain
Official title: A Study Of Pregabalin In The Treatment Of Subjects With Painful Diabetic Peripheral Neuropathy With Background Treatment Of Nsaid For Other Pain Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Painful Diabetic Peripheral Neuropathy
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2011-10-20
Enrollment: 306
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: This study is to test the effectiveness of pregabalin in treating nerve pain caused by diabetes. The suitable subjects will be patients who also use an non-steroid anti-inflammatory drug for another pain which is not related to the diabetic nerve pain.


Eligibility criteria: Inclusion Criteria:

* Type 1 or 2 diabetes with painful neuropathy
* Currently treated with one NSAID (including COX 2 inhibitors) for a co morbid pain condition with a regular dose
* Meet pre-defined level of pain severity at entrance

Exclusion Criteria:

* History of failed pregabalin treatment due to lack of efficacy at therapeutic dose
* Participated in a previous or ongoing pregabalin clinical trial
* Neurologic disorders unrelated to diabetic neuropathy that may confound the assessment of distal neuropathic pain

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 5 and 9)
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 5 and 9)
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 5 and 9)
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 5 and 9)
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 5 and 9)
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 5 and 9)
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 5 and 9)
measure: HADS-D Total Score at the End of Each Treatment Period (Week 6 of Each Treatment Period)
timeFrame: End of Period (includes both Visits 5 and 9)
measure: Norfolk Quality of Life-Diabetic Neuropathy (Norfolk QOL-DN) Total Quality of Life (TQOL) Score at the End of Each Treatment Period (Week 6 of Each Treatment Period)
timeFrame: End of Period (includes both Visits 5 and 9)
measure: Norfolk QOL-DN Symptoms Domain Score at the End of Each Treatment Period (Week 6 of Each Treatment Period)
timeFrame: End of Period (includes both Visits 5 and 9)
measure: Norfolk QOL-DN Activities of Daily Living Domain Score at the End of Each Treatment Period (Week 6 of Each Treatment Period)
timeFrame: End of Period (includes both Visits 5 and 9)
measure: Norfolk QOL-DN Physical Functioning / Large Fiber Domain Score at the End of Each Treatment Period (Week 6 of Each Treatment Period)
timeFrame: End of Period (includes both Visits 5 and 9)
measure: Norfolk QOL-DN Small Fiber Domain Score at the End of Each Treatment Period (Week 6 of Each Treatment Period)
timeFrame: End of Period (includes both Visits 5 and 9)
measure: Norfolk QOL-DN Autonomic Domain Score at the End of Each Treatment Period (Week 6 of Each Treatment Period)
timeFrame: End of Period (includes both Visits 5 and 9)
measure: Euro QoL-5 Dimensions (EQ-5D) Mobility Domain Score at the End of Each Treatment Period (Week 6 of Each Treatment Period)
timeFrame: End of Period (includes both Visits 5 and 9)
measure: EQ-5D Self-Care Domain Score at the End of Each Treatment Period (Week 6 of Each Treatment Period)
timeFrame: End of Period (includes both Visits 5 and 9)
measure: EQ-5D Usual Activities Domain Score at the End of Each Treatment Period (Week 6 of Each Treatment Period)
timeFrame: End of Period (includes both Visits 5 and 9)
measure: EQ-5D Pain / Discomfort Domain Score at the End of Each Treatment Period (Week 6 of Each Treatment Period)
timeFrame: End of Period (includes both Visits 5 and 9)
measure: EQ-5D Anxiety / Depression Domain Score at the End of Each Treatment Period (Week 6 of Each Treatment Period)
timeFrame: End of Period (includes both Visits 5 and 9)
measure: EQ-5D Dolan 1997 Index Summary Score at the End of Each Treatment Period (Week 6 of Each Treatment Period)
timeFrame: End of Period (includes both Visits 5 and 9)
measure: EQ-5D Dolan 2002 Index Summary Score at the End of Each Treatment Period (Week 6 of Each Treatment Period)
timeFrame: End of Period (includes both Visits 5 and 9)
measure: Patient Global Impression of Change (PGIC) Score at the End of Period 1 (Week 6) - Original Scores
timeFrame: End of Period 1 (V5)
measure: PGIC Score at the End of Period 1 (Week 6) - Categorized Scores
timeFrame: End of Period 1 (V5)
Other outcomes:
Locations:
city: Goodyear
country: United States
facility: Dedicated Clinical Research
state: Arizona
city: Phoenix
country: United States
facility: Clinical Research Consortium
state: Arizona
city: Phoenix
country: United States
facility: Arizona Research Center
state: Arizona
city: Phoenix
country: United States
facility: Advanced Podiatry
state: Arizona
city: Phoenix
country: United States
facility: Precision Trials
state: Arizona
city: Phoenix
country: United States
facility: The Office of Joshua D. Holland, M.D.
state: Arizona
city: Tucson
country: United States
facility: Genova Clinical Research
state: Arizona
city: Fresno
country: United States
facility: Neuro-Pain Medical Center
state: California
city: Lakewood
country: United States
facility: Center for United Research, Inc.
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: Los Angeles
country: United States
facility: National Research Institute
state: California
city: Walnut Creek
country: United States
facility: Diablo Clinical Research, Inc.
state: California
city: New London
country: United States
facility: Coastal Connecticut Research, LLC
state: Connecticut
city: New London
country: United States
facility: Neurological Group, PC
state: Connecticut
city: Waterbury
country: United States
facility: Chase Medical Research, LLC
state: Connecticut
city: Bradenton
country: United States
facility: Meridien Research
state: Florida
city: Brooksville
country: United States
facility: Meridien Research
state: Florida
city: Fort Myers
country: United States
facility: Gulfcoast Clinical Research Center
state: Florida
city: Hallandale Beach
country: United States
facility: MD Clinical
state: Florida
city: Hialeah
country: United States
facility: AGA Clinical Trials
state: Florida
city: Palm Beach Gardens
country: United States
facility: Palm Beach Neurological Center,
state: Florida
city: Saint Petersburg
country: United States
facility: Meridien Research
state: Florida
city: Tampa
country: United States
facility: Meridien Research
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: Chicago
country: United States
facility: Suburban Clinical Research
state: Illinois
city: Naperville
country: United States
facility: Suburban Clinical Research
state: Illinois
city: Lexington
country: United States
facility: Central Kentucky Research Associates, Inc.
state: Kentucky
city: Monroe
country: United States
facility: Arthritis and Diabetes Clinic, Inc.
state: Louisiana
city: Brockton
country: United States
facility: Beacon Clinical Research, LLC
state: Massachusetts
city: Brockton
country: United States
facility: Miray Medical Center
state: Massachusetts
city: Fall River
country: United States
facility: Genesis Clinical Research, LLC
state: Massachusetts
city: Kalamazoo
country: United States
facility: Borgess Diabetes Center
state: Michigan
city: Kalamazoo
country: United States
facility: Borgess Research Institute
state: Michigan
city: Saint Louis
country: United States
facility: Mercy Health Research
state: Missouri
city: Omaha
country: United States
facility: Quality Clinical Research, Inc.
state: Nebraska
city: Las Vegas
country: United States
facility: Clinical Research Consortium
state: Nevada
city: Las Vegas
country: United States
facility: Mirkil Medical Group
state: Nevada
city: Las Vegas
country: United States
facility: V.Jerome Mirkil, MD
state: Nevada
city: New York
country: United States
facility: The Medical Research Network, LLC
state: New York
city: Lexington
country: United States
facility: Davidson Medical Ministries
state: North Carolina
city: Cincinnati
country: United States
facility: Radiant Research (admin office)
state: Ohio
city: Columbus
country: United States
facility: Radiant Research
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: 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: Orangeburg
country: United States
facility: Neurology and Pain Clinic, LLC
state: South Carolina
city: Knoxville
country: United States
facility: New Phase Research and Development
state: Tennessee
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center at Dallas
state: Texas
city: Houston
country: United States
facility: Houston Neurocare
state: Texas
city: Houston
country: United States
facility: Centex Research, Inc.
state: Texas
city: Pelhrimov
country: Czechia
facility: UNARS, s.r.o.
city: Praha 10
country: Czechia
facility: Clintrial, s.r.o.
city: Praha 5
country: Czechia
facility: Fakultni nemocnice v Motole
city: Roma
country: Italy
facility: Fondazione PTV Policlinico Tor Vergata di Roma
city: Malmo
country: Sweden
facility: Center for Lakemedelsstudier
city: Stockholm
country: Sweden
facility: Citydiabetes
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Raskin P, Huffman C, Yurkewicz L, Pauer L, Scavone JM, Yang R, Parsons B. Pregabalin in Patients With Painful Diabetic Peripheral Neuropathy Using an NSAID for Other Pain Conditions: A Double-Blind Crossover Study. Clin J Pain. 2016 Mar;32(3):203-10. doi: 10.1097/AJP.0000000000000254.