A Study In Patients With Neuropathic Pain From Diabetic Peripheral Neuropathy (DPN)
Study PXN110448: A Dose-response Study of XP13512, Compared With Concurrent Placebo Control and LYRICA(Pregabalin), in Subjects With Neuropathic Pain Associated Withdiabetic Peripheral Neuropathy (DPN)
1 other identifier
interventional
421
1 country
90
Brief Summary
The purpose of this study is to determine whether gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn is effective in the treatment of neuropathic pain associated with diabetic peripheral neuropathy(DPN)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Mar 2008
Shorter than P25 for phase_2
90 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 19, 2008
CompletedStudy Start
First participant enrolled
March 1, 2008
CompletedFirst Posted
Study publicly available on registry
March 26, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2009
CompletedResults Posted
Study results publicly available
May 11, 2011
CompletedJuly 22, 2013
January 1, 2013
11 months
February 19, 2008
April 21, 2011
July 15, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Baseline in the Mean 24-hour Average Pain Intensity (API) Score at End of Maintenance Treatment (EOMT) Using Last Observation Carried Forward (LOCF) Data
Baseline and EOMT values are the calculated means of the daily 24-hour API scores for each participant during the last 7 days prior to randomization (Baseline) and the earliest date of Week 13 visit/Withdrawal visit/last dose of study drug (EOMT). Participants used a hand-held diary to rate their API over the preceding 24 hours, using an 11-point Pain Intensity Numerical Rating Scale (PI-NRS) (0=no pain, 10=pain as bad as you can imagine). LOCF was used if less than 4 days of diary data were provided. Change from baseline was calculated as the EOMT score minus the Baseline score.
Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit)
Secondary Outcomes (18)
Change From Baseline in the Mean Day-time Average Pain Intensity (API) Score at EOMT Using LOCF Data
Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit)
Change From Baseline in the Mean Night-time Average Pain Intensity (API) Score at EOMT Using LOCF Data
Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit)
Change From Baseline in the Mean Current (Morning) Pain Intensity Score at EOMT Using LOCF Data
Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit)
Change From Baseline in the Mean Current (Evening) Pain Intensity Score at EOMT Using LOCF Data
Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit)
Change From Baseline in the Mean Day-time Worst Pain Intensity Score at EOMT Using LOCF Data
Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit)
- +13 more secondary outcomes
Study Arms (5)
Placebo
PLACEBO COMPARATORPlacebo
Pregabalin
OTHERPregabalin 300mg/day (positive control), maintenance treatment 14 weeks
GEn 1200mg/day
EXPERIMENTALgabapentin enacarbil 1200mg/day, maintenance treatment 14 weeks
GEn 2400mg/day
EXPERIMENTALgabapentin enacarbil 2400mg/day, maintenance treatment 14 weeks
GEn 3600mg/day
EXPERIMENTALgabapentin enacarbil 3600mg/day, maintanance treatment 14 weeks
Interventions
gabapentin enacarbil 1200mg/day
gabapentin enacarbil 2400mg/day
gabapentin enacarbil 3600mg/day
Eligibility Criteria
You may qualify if:
- years or older
- Female subjects are eligible to enter if of non-childbearing potential or not lactating, has a negative pregnancy test and agrees to use a specified highly effective method for avoiding pregnancy
- Documented medical diagnosis of Type 1 or 2 diabetes including:
- Stable glycemic control for 3 months defined as \<25% change of routine insulin, \<50% change of routine oral anti-diabetic agent dose and HbA1c \< 8%. (HbA1c of 8 to 11% eligible if attempts to improve diabetic control failed)
- DPN defined by:
- Bilateral reduced or absent reflexes at the ankles, or
- Bilateral impaired vibration, pinprick, fine touch or temperature perception in the distal lower extremities And
- Persistent distal burning or dull pain in the feet, or
- Persistent proximal aching pain in the legs, or
- Paroxysmal electric, shooting, stabbing pain, or
- Dysasthesias, or
- Evoked pain And
- history of pain for at least six months and no greater than five years attributed to DPN (refers to duration of pain)
- Baseline 24-hour average daily pain intensity score \>4.0 as measured on an 11 point pain intensity numerical rating scale
- Provides written informed consent in accordance with all applicable regulatory requirements
You may not qualify if:
- Other chronic pain conditions not associated with DPN. However, the subject will not be excluded if:
- The pain condition is located at a different region of the body, and
- The pain intensity of this condition is not greater than the pain intensity of the DPN, and
- The subject can assess their DPN independently of other pain condition.
- Other causes of neuropathy or lower extremity pain
- Is unable to discontinue prohibited medications or non-drug therapies or procedures throughout the duration of the study
- Hepatic impairment defined as ALT or AST \> 2x upper limit of normal (ULN) or alkaline phosphatase or bilirubin \> 1.5x ULN
- Chronic hepatitis B or C
- Impaired renal function defined as either creatinine clearance \< 60 mL/min or requiring hemodialysis
- Corrected QT (QTc) interval \>450 msec or QTc interval \>480 msec for patients with Bundle Branch Block
- Uncontrolled hypertension at screen (sitting systolic \>160 mmHg and/or sitting diastolic \>90 mmHg
- Current diagnosis of active epilepsy or any active seizure disorder requiring chronic therapy with antiepileptic drug(s)
- Medical condition or disorder that would interfere with the action, absorption, distribution, metabolism, or excretion of GEn or pregabalin, or, in the investigator's judgment:
- Is considered to be clinically significant and could pose a safety concern or,
- Could interfere with the accurate assessment of safety or efficacy, or,
- +11 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- XenoPort, Inc.lead
Study Sites (90)
GSK Investigational Site
Alabaster, Alabama, 35007, United States
GSK Investigational Site
Birmingham, Alabama, 35205, United States
GSK Investigational Site
Dothan, Alabama, 36303, United States
GSK Investigational Site
Hoover, Alabama, 35216, United States
GSK Investigational Site
Jasper, Alabama, 35501, United States
GSK Investigational Site
Muscle Shoals, Alabama, 35662, United States
GSK Investigational Site
Northport, Alabama, 35476, United States
GSK Investigational Site
Tuscaloosa, Alabama, 35406, United States
GSK Investigational Site
Mesa, Arizona, 85210, United States
GSK Investigational Site
Peoria, Arizona, 85381 - 4828, United States
GSK Investigational Site
Tempe, Arizona, 85282, United States
GSK Investigational Site
Hot Springs, Arkansas, 71901, United States
GSK Investigational Site
Little Rock, Arkansas, 72205, United States
GSK Investigational Site
Anaheim, California, 92801, United States
GSK Investigational Site
Concord, California, 94520, United States
GSK Investigational Site
Escondido, California, 92026, United States
GSK Investigational Site
Fresno, California, 93720, United States
GSK Investigational Site
Huntington Park, California, 90255, United States
GSK Investigational Site
La Jolla, California, 92037, United States
GSK Investigational Site
Los Gatos, California, 95032, United States
GSK Investigational Site
Mission Viejo, California, 92691, United States
GSK Investigational Site
Newport Beach, California, 92660, United States
GSK Investigational Site
Northridge, California, 91325, United States
GSK Investigational Site
Oxnard, California, 93030, United States
GSK Investigational Site
Riverside, California, 92506, United States
GSK Investigational Site
San Diego, California, 92117, United States
GSK Investigational Site
Santa Ana, California, 92705, United States
GSK Investigational Site
Santa Monica, California, 90404, United States
GSK Investigational Site
Temecula, California, 92591, United States
GSK Investigational Site
Walnut Creek, California, 94598, United States
GSK Investigational Site
Westlake Village, California, 91361, United States
GSK Investigational Site
Brandon, Florida, 33511, United States
GSK Investigational Site
Clearwater, Florida, 33765, United States
GSK Investigational Site
Fort Lauderdale, Florida, 33308, United States
GSK Investigational Site
Fort Myers, Florida, 33916, United States
GSK Investigational Site
Hallandale, Florida, 33009, United States
GSK Investigational Site
Hollywood, Florida, 33021, United States
GSK Investigational Site
New Port Richey, Florida, 34652, United States
GSK Investigational Site
Ocala, Florida, 34471, United States
GSK Investigational Site
Ormond Beach, Florida, 32174, United States
GSK Investigational Site
Pembroke Pines, Florida, 33024, United States
GSK Investigational Site
St. Petersburg, Florida, 33702, United States
GSK Investigational Site
Tallahassee, Florida, 32308, United States
GSK Investigational Site
Atlanta, Georgia, 30308, United States
GSK Investigational Site
Decatur, Georgia, 30033, United States
GSK Investigational Site
Marietta, Georgia, 30060, United States
GSK Investigational Site
Roswell, Georgia, 30076, United States
GSK Investigational Site
Chicago, Illinois, 60637, United States
GSK Investigational Site
Libertyville, Illinois, 60048, United States
GSK Investigational Site
Evansville, Indiana, 47713, United States
GSK Investigational Site
Evansville, Indiana, 47714, United States
GSK Investigational Site
Wichita, Kansas, 67207, United States
GSK Investigational Site
Rockville, Maryland, 20852, United States
GSK Investigational Site
Wellesley Hills, Massachusetts, 02481, United States
GSK Investigational Site
Kalamazoo, Michigan, 49048, United States
GSK Investigational Site
Olive Branch, Mississippi, 38654, United States
GSK Investigational Site
Kansas City, Missouri, 64111, United States
GSK Investigational Site
St Louis, Missouri, 63110, United States
GSK Investigational Site
St Louis, Missouri, 63117, United States
GSK Investigational Site
Las Vegas, Nevada, 89016, United States
GSK Investigational Site
Las Vegas, Nevada, 89119, United States
GSK Investigational Site
Albuquerque, New Mexico, 87106, United States
GSK Investigational Site
Albuquerque, New Mexico, 87108, United States
GSK Investigational Site
Flushing, New York, 11365, United States
GSK Investigational Site
New York, New York, 10128, United States
GSK Investigational Site
North Massapequa, New York, 11758, United States
GSK Investigational Site
Rochester, New York, 14609, United States
GSK Investigational Site
Staten Island, New York, 10301, United States
GSK Investigational Site
Greensboro, North Carolina, 27408, United States
GSK Investigational Site
Raleigh, North Carolina, 27607, United States
GSK Investigational Site
Salisbury, North Carolina, 28144, United States
GSK Investigational Site
Toledo, Ohio, 43623, United States
GSK Investigational Site
Norman, Oklahoma, 73071, United States
GSK Investigational Site
Eugene, Oregon, 97404, United States
GSK Investigational Site
Medford, Oregon, 97501, United States
GSK Investigational Site
Levittown, Pennsylvania, 19056, United States
GSK Investigational Site
Pittsburgh, Pennsylvania, 15243, United States
GSK Investigational Site
Greer, South Carolina, 29651, United States
GSK Investigational Site
Mt. Pleasant, South Carolina, 29464, United States
GSK Investigational Site
Kingsport, Tennessee, 37660, United States
GSK Investigational Site
Houston, Texas, 77030, United States
GSK Investigational Site
San Antonio, Texas, 78229, United States
GSK Investigational Site
San Antonio, Texas, 78238, United States
GSK Investigational Site
Alexandria, Virginia, 22311, United States
GSK Investigational Site
Richmond, Virginia, 23249, United States
GSK Investigational Site
Weber City, Virginia, 24290, United States
GSK Investigational Site
Spokane, Washington, 99202, United States
GSK Investigational Site
Spokane, Washington, 99208, United States
GSK Investigational Site
Tacoma, Washington, 98405, United States
GSK Investigational Site
Vancouver, Washington, 98664, United States
Related Publications (1)
Rauck R, Makumi CW, Schwartz S, Graff O, Meno-Tetang G, Bell CF, Kavanagh ST, McClung CL. A randomized, controlled trial of gabapentin enacarbil in subjects with neuropathic pain associated with diabetic peripheral neuropathy. Pain Pract. 2013 Jul;13(6):485-96. doi: 10.1111/papr.12014. Epub 2012 Nov 27.
PMID: 23186035DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- XenoPort Call Center
- Organization
- XenoPort, Inc.
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 19, 2008
First Posted
March 26, 2008
Study Start
March 1, 2008
Primary Completion
February 1, 2009
Study Completion
February 1, 2009
Last Updated
July 22, 2013
Results First Posted
May 11, 2011
Record last verified: 2013-01