A Study In Patients With Neuropathic Pain From Diabetic Peripheral Neuropathy (DPN)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
XenoPort, Inc.
ClinicalTrials.gov Identifier:
NCT00643760
First received: February 19, 2008
Last updated: July 15, 2013
Last verified: January 2013
  Purpose

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)


Condition Intervention Phase
Neuropathy, Diabetic
Drug: Placebo
Drug: GEn 1200mg/day
Drug: GEn 2400mg/day
Drug: GEn 3600mg/day
Drug: Pregabalin
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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)

Resource links provided by NLM:


Further study details as provided by XenoPort, Inc.:

Primary Outcome Measures:
  • 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 [ Time Frame: Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit) ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Change From Baseline in the Mean Day-time Average Pain Intensity (API) Score at EOMT Using LOCF Data [ Time Frame: Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit) ] [ Designated as safety issue: No ]
    Day-time is defined as the time between rising in the morning and going to bed at night. Participants recorded day-time API on a daily basis in the evening before bedtime using an 11-point PI-NRS (0=no pain, 10=pain as bad as you can imagine). Baseline and EOMT are as defined for the primary endpoint. Change from baseline was calculated as the EOMT score minus the baseline score. An ANCOVA model with baseline value, BMI, grouped center as covariates was used.

  • Change From Baseline in the Mean Night-time Average Pain Intensity (API) Score at EOMT Using LOCF Data [ Time Frame: Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit) ] [ Designated as safety issue: No ]
    Night-time is defined as the time between going to bed at night and rising in the morning. Participants recorded night-time API on a daily basis in the morning upon awakening using an 11-point PI-NRS (0=no pain, 10=pain as bad as you can imagine). Baseline and EOMT are as defined for the primary endpoint. Change from baseline was calculated as the EOMT score minus the baseline score. An ANCOVA model with baseline value, BMI, grouped center as covariates was used.

  • Change From Baseline in the Mean Current (Morning) Pain Intensity Score at EOMT Using LOCF Data [ Time Frame: Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit) ] [ Designated as safety issue: No ]
    Current pain is defined as the participant's assessment of pain intensity "right now." Participants recorded their current morning pain intensity in the morning upon wakening using an 11-point PI-NRS (0=no pain, 10=pain as bad as you can imagine). Baseline and EOMT are as defined for the primary endpoint. Change from baseline was calculated as the EOMT score minus the baseline score. An ANCOVA model with baseline value, BMI, grouped center as covariates was used.

  • Change From Baseline in the Mean Current (Evening) Pain Intensity Score at EOMT Using LOCF Data [ Time Frame: Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit) ] [ Designated as safety issue: No ]
    Current pain is defined as the participant's assessment of pain intensity "right now." Participants recorded their current evening pain intensity in the evening before bedtime using an 11-point PI-NRS (0=no pain, 10=pain as bad as you can imagine). Baseline and EOMT are as defined for the primary endpoint. Change from baseline was calculated as the EOMT score minus the baseline score. An ANCOVA model with baseline value, BMI, grouped center as covariates was used.

  • Change From Baseline in the Mean Day-time Worst Pain Intensity Score at EOMT Using LOCF Data [ Time Frame: Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit) ] [ Designated as safety issue: No ]
    Day-time worst pain is defined as the partipant's assessment of their worst pain between rising in the morning and going to bed at night. Participants recorded day-time worst pain in the evening before bedtime using an 11-point PI-NRS (0=no pain, 10=pain as bad as you can imagine). Baseline and EOMT are as defined for the primary endpoint. Change from baseline was calculated as the EOMT score minus the baseline score. An ANCOVA model with baseline value, BMI, grouped center as covariates was used.

  • Change From Baseline in the Mean Night-time Worst Pain Intensity Score at EOMT Using LOCF Data [ Time Frame: Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit) ] [ Designated as safety issue: No ]
    Night-time worst pain is defined as the partipant's assessment of their worst pain between going to bed at night and rising in the morning. Participants recorded night-time worst pain in the morning upon awakening using an 11-point PI-NRS (0=no pain, 10=pain as bad as you can imagine). Baseline and EOMT are as defined for the primary endpoint. Change from baseline was calculated as the EOMT score minus the baseline score. An ANCOVA model with baseline value, BMI, grouped center as covariates was used.

  • Change From Baseline in the Mean Sleep Interference Score at EOMT Using LOCF Data [ Time Frame: Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit) ] [ Designated as safety issue: No ]
    Participants assessed sleep interference due to pain on a daily basis in the morning upon awakening using an 11-point NRS (0=pain does not interfere with sleep, 10=pain completely interferes with sleep). Baseline and EOMT are as defined for the primary endpoint. Change from baseline was calculated as the EOMT score minus the baseline score. An ANCOVA model with baseline value, BMI, grouped center as covariates was used.

  • Change From Baseline in the Mean Daily Dose of Rescue Medication at EOMT Using LOCF Data [ Time Frame: Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit) ] [ Designated as safety issue: No ]
    Mean daily use of rescue medication (milligrams of acetaminophen) was calculated by determining the average number of tablets taken per day of rescue medication (Commerical Tylenol) during treatment and multiplying that by 500 mg. Baseline and EOMT are as defined for the primary endpoint. Change from baseline was calculated as the EOMT score minus the baseline score. An ANCOVA model with baseline value, BMI, grouped center as covariates was used.

  • Change From Baseline in Pain Quality as Assessed by the Neuropathic Pain Scale (NPS) Summary Scores at EOMT Using LOCF Data [ Time Frame: Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit) ] [ Designated as safety issue: No ]
    The NPS assesses pain qualities and consists of 11-items, 10 assessed on an 11-point NRS (0=no impact to 10=greatest impact); and 1 open-ended question not used in score calculation. 4 summary scores are calculated: NPS 10 (items 1-7, 9-11), NPS 8 (8 pain descriptor items), NPS Non-Allodynic (NA) (8 NA items), and NPS 4 (4 pain quality items); and range from 0 to 100 (0=no impact and 100=greatest impact). The analysis is based on the change from baseline (BL) (EOMT score minus the BL score) using an ANCOVA model with BL value, BMI, grouped center as covariates.

  • Change From Baseline in Pain Characteristics and Intensity as Assessed by the Short Form-McGill Pain Questionnaire (SF-MPQ) at EOMT Using LOCF Data [ Time Frame: Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit) ] [ Designated as safety issue: No ]
    The SF-MPQ, a general pain instrument, assesses the characteristics and intensity of pain and consists of 15-items assessed on a 4-point scale (0=none, 1=mild, 2=moderate, and 3=severe). 3 summary scores are calculated: sensory score (sum of items 1-11, range 0-33), affective score (sum of items 12-15, range 0-12), total score (sum of items 1-15, range 0-45), where lower scores = lower pain/impact. Analysis is based on the change from baseline (BL) (EOMT score minus the BL score) using an ANCOVA model with BL value, BMI, grouped center as covariates.

  • Change From Baseline in Pain Score After Taking a 50-foot Walk at EOMT [ Time Frame: Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit) ] [ Designated as safety issue: No ]
    Baseline and EOMT scores are the pain scores each participant reported after taking a 50-foot walk at the randomization and Week 13/Withdrawal visits, respectively, using an 11-point PI-NRS (0=no pain, 10=pain as bad as you can imagine). Change from baseline was calculated as the EOMT score minus the baseline score. An ANCOVA model with BMI, baseline pain intensity after 50-foot walk, pain intensity prior to 50-foot walk at the visit being assessed, and grouped center as covariates was used.

  • Number of Participants Who Are Responders on the Patient Global Impression of Change (PGIC) Questionnaire at EOMT Using LOCF Data [ Time Frame: EOMT (representing the earliest date of Week 13 visit/withdrawal visit) ] [ Designated as safety issue: No ]
    The PGIC is a single-item questionnaire designed to provide an overall assessment of treatment from the participant's perspective since the start of the study. It is measured on a 7-point scale, where 1=very much improved and 7=very much worse. A participant is considered a responder if they have a response of "very much improved" or "much improved." EOMT response is defined as the score recorded at the Week 13/Withdrawal visit.

  • Number of Participants Who Are Responders on the Clinician Global Impression of Change (CGIC) Questionnaire at EOMT Using LOCF Data [ Time Frame: EOMT (representing the earliest date of Week 13 visit/withdrawal visit) ] [ Designated as safety issue: No ]
    The CGIC is a single-item questionnaire designed to provide an overall assessment of treatment from the clinician's perspective since the start of the study. It is measured on a 7-point scale, where 1=very much improved and 7=very much worse. A participant is considered a responder if they have a response of "very much improved" or "much improved." EOMT response is defined as the score recorded at the Week 13/Withdrawal visit.

  • Number of Participants Achieving Various Levels of Percent Reduction From Baseline in the Mean 24-hour Average Pain Intensity Score at EOMT Using LOCF Data [ Time Frame: Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit) ] [ Designated as safety issue: No ]
    Baseline and EOMT scores are the calculated means of the 24-hour average pain scores for each participant during the last 7 days prior to randomization and EOMT, respectively. Percent reduction from baseline was calculated as the [(EOMT score minus the baseline score)divided by the baseline score], multiplied by 100. The PI-NRS is an 11-point scale (0=no pain, 10=pain as bad as you can imagine) by which a participant assesses their 24-hour average pain intensity.

  • Time to Onset of Sustained Improvement in the 24-hour Average Pain Intensity Score [ Time Frame: Any time post-baseline until date of last dose of study medication (up to Week 13) ] [ Designated as safety issue: No ]
    Sustained improvement in the 24-hour average pain intensity score is defined as at least 2 consecutive days on which the 24-hour average pain intensity score is >=2 points less than the mean 24-hour average pain intensity score at baseline. Time to onset is measured from baseline and was calculated as first day of event minus last day of baseline and is expressed in days. Baseline score is the calculated mean of the 24-hour average pain score for each participant during the last 7 days prior to randomization.

  • Change From Baseline in Severity of Pain and the Impact of Pain as Assessed by the Brief Pain Inventory (BPI) at EOMT Using LOCF Data [ Time Frame: Baseline and EOMT ] [ Designated as safety issue: No ]
    The BPI, a general pain instrument, assesses the severity and interference of pain; and consists of 6 items assessed on an 11-point NRS (0=no impact and 10=greatest impact). 2 summary scores are calculated: BPI Severity Score (average of first 4 items) and BPI Interference Score (average of 7 responses to item 6); where each summary score ranges from 0 to 10 (0=no impact and 10=greatest impact). Analysis of this endpoint is based on the change from baseline (BL) (EOMT score minus the BL score) using an ANCOVA model with BL value, BMI, grouped center as covariates.

  • Change From Baseline in Quality of Life as Assessed by the 36-Item Short Form Health Survey (SF-36) at EOMT Using LOCF Data [ Time Frame: Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit) ] [ Designated as safety issue: No ]
    The SF-36 is a general health-related quality of life instrument consisting of 36 items with various response options (Yes/No, 5- to 6-point Likert scale). Summary scores are calculated for 8 domains and 2 components (physical and mental); where scores range from 0 to 100 (higher scores = better quality of life). Analysis of this endpoint is based on the change from baseline (BL) (EOMT score minus the BL score) using an ANCOVA model with BL value, BMI, grouped center as covariates.

  • Change From Baseline in Emotional Functioning as Assessed by the Profile of Mood States-Brief Form (POMS-B) at EOMT Using LOCF Data [ Time Frame: Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit) ] [ Designated as safety issue: No ]
    The POMS-B, an emotional functioning instrument, assesses mood, tension, and other psychological symptoms and consists of 30-items assessed on a 5-point scale (0=not at all to 4=extremely). 6 summary scores are calculated: Tension/Anxiety, Depression/Rejection, Anger/Hostility, Vigor/Activity, Fatigue/Inertia, and Confusion/Bewilderment; and range from 0-20 (higher scores = more negative mood state). Analysis of this endpoint is based on the change from baseline (BL) (EOMT score minus the BL score) using an ANCOVA model with BL value, BMI, grouped center as covariates.


Enrollment: 421
Study Start Date: March 2008
Study Completion Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Placebo
Drug: Placebo
placebo
Pregabalin
Pregabalin 300mg/day (positive control), maintenance treatment 14 weeks
Drug: Pregabalin
pregabalin 300mg/day
Other Name: pregabalin
Experimental: GEn 1200mg/day
gabapentin enacarbil 1200mg/day, maintenance treatment 14 weeks
Drug: GEn 1200mg/day
gabapentin enacarbil 1200mg/day
Other Names:
  • XP13512
  • GSK1838262
  • gabapentin enacarbil
Experimental: GEn 2400mg/day
gabapentin enacarbil 2400mg/day, maintenance treatment 14 weeks
Drug: GEn 2400mg/day
gabapentin enacarbil 2400mg/day
Other Names:
  • gabapentin enacarbil
  • GSK1838262
  • XP13512
Experimental: GEn 3600mg/day
gabapentin enacarbil 3600mg/day, maintanance treatment 14 weeks
Drug: GEn 3600mg/day
gabapentin enacarbil 3600mg/day
Other Names:
  • XP13512
  • GSK1838262
  • gabapentin enacarbil

Detailed Description:

This is a dose-response study of XP13512 compared with concurrent placebo control and LYRICA (pregabalin), in subjects with neuropathic pain associated with DPN. Three doses of XP13512 (1200 mg/day, 2400 mg/day and 3600 mg/day) are being evaluated for the management of neuropathic pain associated with DPN. Approximately 392 subjects from 70 to 80 participating sites in the US will be randomized to receive either XP13512 at the above mentioned doses, placebo or pregabalin (300mg/day).

  Eligibility

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

Inclusion criteria:

  • 18 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

Exclusion criteria:

  • 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,
  • Could potentially affect a subject's safety or study outcome
  • Meets criteria defined by the DSM‑IV‑TR for a major depressive episode or for active significant psychiatric disorders within last year
  • Depression in remission, with or without antidepressant treatment, may participate, unless stable antidepressant regimen is a prohibited medication
  • Antidepressant medication may not be changed or discontinued to met entry criteria and must be stable for at least 3 months prior to enrollment
  • History of clinically significant drug or alcohol abuse (DSM‑IV‑TR). Benzodiazepines or atypical benzodiazepines as hypnotic sleep agents permitted
  • Currently participating in another clinical study in which the subject is, or will be exposed to an investigational or non-investigational drug or device
  • Has participated in a clinical study and was exposed to investigational or non-investigational drug or device:
  • Within preceding month for studies unrelated to DPN, or
  • Within six months for studies related to DPN
  • Treated previously with GEn
  • History of allergic or medically significant adverse reaction to investigational products (including gabapentin or pregabalin) or their excipients, acetaminophen or related compounds
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00643760

  Hide Study Locations
Locations
United States, Alabama
GSK Investigational Site
Alabaster, Alabama, United States, 35007
GSK Investigational Site
Birmingham, Alabama, United States, 35205
GSK Investigational Site
Dothan, Alabama, United States, 36303
GSK Investigational Site
Hoover, Alabama, United States, 35216
GSK Investigational Site
Jasper, Alabama, United States, 35501
GSK Investigational Site
Muscle Shoals, Alabama, United States, 35662
GSK Investigational Site
Northport, Alabama, United States, 35476
GSK Investigational Site
Tuscaloosa, Alabama, United States, 35406
United States, Arizona
GSK Investigational Site
Mesa, Arizona, United States, 85210
GSK Investigational Site
Peoria, Arizona, United States, 85381 - 4828
GSK Investigational Site
Tempe, Arizona, United States, 85282
United States, Arkansas
GSK Investigational Site
Hot Springs, Arkansas, United States, 71901
GSK Investigational Site
Little Rock, Arkansas, United States, 72205
United States, California
GSK Investigational Site
Anaheim, California, United States, 92801
GSK Investigational Site
Concord, California, United States, 94520
GSK Investigational Site
Escondido, California, United States, 92026
GSK Investigational Site
Fresno, California, United States, 93720
GSK Investigational Site
Huntington Park, California, United States, 90255
GSK Investigational Site
La Jolla, California, United States, 92037
GSK Investigational Site
Los Gatos, California, United States, 95032
GSK Investigational Site
Mission Viejo, California, United States, 92691
GSK Investigational Site
Newport Beach, California, United States, 92660
GSK Investigational Site
Northridge, California, United States, 91325
GSK Investigational Site
Oxnard, California, United States, 93030
GSK Investigational Site
Riverside, California, United States, 92506
GSK Investigational Site
San Diego, California, United States, 92117
GSK Investigational Site
Santa Ana, California, United States, 92705
GSK Investigational Site
Santa Monica, California, United States, 90404
GSK Investigational Site
Temecula, California, United States, 92591
GSK Investigational Site
Walnut Creek, California, United States, 94598
GSK Investigational Site
Westlake Village, California, United States, 91361
United States, Florida
GSK Investigational Site
Brandon, Florida, United States, 33511
GSK Investigational Site
Clearwater, Florida, United States, 33765
GSK Investigational Site
Fort Lauderdale, Florida, United States, 33308
GSK Investigational Site
Fort Myers, Florida, United States, 33916
GSK Investigational Site
Hallandale Beach, Florida, United States, 33009
GSK Investigational Site
Hollywood, Florida, United States, 33021
GSK Investigational Site
New Port Richey, Florida, United States, 34652
GSK Investigational Site
Ocala, Florida, United States, 34471
GSK Investigational Site
Ormond Beach, Florida, United States, 32174
GSK Investigational Site
Pembroke Pines, Florida, United States, 33024
GSK Investigational Site
St. Petersburg, Florida, United States, 33702
GSK Investigational Site
Tallahassee, Florida, United States, 32308
United States, Georgia
GSK Investigational Site
Atlanta, Georgia, United States, 30308
GSK Investigational Site
Decatur, Georgia, United States, 30033
GSK Investigational Site
Marietta, Georgia, United States, 30060
GSK Investigational Site
Roswell, Georgia, United States, 30076
United States, Illinois
GSK Investigational Site
Chicago, Illinois, United States, 60637
GSK Investigational Site
Libertyville, Illinois, United States, 60048
United States, Indiana
GSK Investigational Site
Evansville, Indiana, United States, 47714
GSK Investigational Site
Evansville, Indiana, United States, 47713
United States, Kansas
GSK Investigational Site
Wichita, Kansas, United States, 67207
United States, Maryland
GSK Investigational Site
Rockville, Maryland, United States, 20852
United States, Massachusetts
GSK Investigational Site
Wellesley Hills, Massachusetts, United States, 02481
United States, Michigan
GSK Investigational Site
Kalamazoo, Michigan, United States, 49048
United States, Mississippi
GSK Investigational Site
Olive Branch, Mississippi, United States, 38654
United States, Missouri
GSK Investigational Site
Kansas City, Missouri, United States, 64111
GSK Investigational Site
St. Louis, Missouri, United States, 63117
GSK Investigational Site
St. Louis, Missouri, United States, 63110
United States, Nevada
GSK Investigational Site
Las Vegas, Nevada, United States, 89016
GSK Investigational Site
Las Vegas, Nevada, United States, 89119
United States, New Mexico
GSK Investigational Site
Albuquerque, New Mexico, United States, 87106
GSK Investigational Site
Albuquerque, New Mexico, United States, 87108
United States, New York
GSK Investigational Site
Flushing, New York, United States, 11365
GSK Investigational Site
New York, New York, United States, 10128
GSK Investigational Site
North Massapequa, New York, United States, 11758
GSK Investigational Site
Rochester, New York, United States, 14609
GSK Investigational Site
Staten Island, New York, United States, 10301
United States, North Carolina
GSK Investigational Site
Greensboro, North Carolina, United States, 27408
GSK Investigational Site
Raleigh, North Carolina, United States, 27607
GSK Investigational Site
Salisbury, North Carolina, United States, 28144
United States, Ohio
GSK Investigational Site
Toledo, Ohio, United States, 43623
United States, Oklahoma
GSK Investigational Site
Norman, Oklahoma, United States, 73071
United States, Oregon
GSK Investigational Site
Eugene, Oregon, United States, 97404
GSK Investigational Site
Medford, Oregon, United States, 97501
United States, Pennsylvania
GSK Investigational Site
Levittown, Pennsylvania, United States, 19056
GSK Investigational Site
Pittsburgh, Pennsylvania, United States, 15243
United States, South Carolina
GSK Investigational Site
Greer, South Carolina, United States, 29651
GSK Investigational Site
Mount Pleasant, South Carolina, United States, 29464
United States, Tennessee
GSK Investigational Site
Kingsport, Tennessee, United States, 37660
United States, Texas
GSK Investigational Site
Houston, Texas, United States, 77030
GSK Investigational Site
San Antonio, Texas, United States, 78229
GSK Investigational Site
San Antonio, Texas, United States, 78238
United States, Virginia
GSK Investigational Site
Alexandria, Virginia, United States, 22311
GSK Investigational Site
Richmond, Virginia, United States, 23249
GSK Investigational Site
Weber City, Virginia, United States, 24290
United States, Washington
GSK Investigational Site
Spokane, Washington, United States, 99208
GSK Investigational Site
Spokane, Washington, United States, 99202
GSK Investigational Site
Tacoma, Washington, United States, 98405
GSK Investigational Site
Vancouver, Washington, United States, 98664
Sponsors and Collaborators
XenoPort, Inc.
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: XenoPort, Inc.
ClinicalTrials.gov Identifier: NCT00643760     History of Changes
Other Study ID Numbers: 110448
Study First Received: February 19, 2008
Results First Received: April 21, 2011
Last Updated: July 15, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by XenoPort, Inc.:
Peripheral Diabetic Neuropathy (PDN)
Neuropathic Pain

Additional relevant MeSH terms:
Diabetic Neuropathies
Neuralgia
Peripheral Nervous System Diseases
Demyelinating Diseases
Polyneuropathies
Nerve Compression Syndromes
Neurologic Manifestations
Neurotoxicity Syndromes
Neuromuscular Diseases
Nervous System Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Pain
Signs and Symptoms
Poisoning
Substance-Related Disorders
Gabapentin
Pregabalin
Gamma-Aminobutyric Acid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anticonvulsants
Antiparkinson Agents
Anti-Dyskinesia Agents

ClinicalTrials.gov processed this record on April 17, 2014