Clinical Trials/NCT00619476

NCT00619476

Completed

Phase 2

Study PXN110748: An Efficacy and Safety Study of XP13512 Compared With a Concurrent Placebo Control in Subjects With Neuropathic Pain Associated With Post-herpetic Neuralgia (PHN)

XenoPort, Inc.1 site in 1 country376 target enrollmentFebruary 2008

ConditionsNeuralgia, Postherpetic

InterventionsPlacebo GEn 1200mg/day GEn 2400mg/day GEn 3600mg/day

DrugsGEn 1200mg/day GEn 2400mg/day GEn 3600mg/day Placebo

Overview

Phase: Phase 2
Intervention: Placebo
Conditions: Neuralgia, Postherpetic
Sponsor: XenoPort, Inc.
Enrollment: 376
Locations: 1
Primary Endpoint: Change From Baseline in the Mean 24-hour Average Pain Intensity (API) Score at the End of Maintenance Treatment (EOMT) Using Last Observation Carried Forward (LOCF) Data
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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 post-herpetic neuralgia (PHN).

Detailed Description

The primary purpose of study PXN110748 was to evaluate efficacy and safety of 3 fixed doses of GEn in the treatment of PHN.

Registry

clinicaltrials.gov

Start Date

February 2008

End Date

July 2009

Last Updated

12 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

XenoPort, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•18 years or older
•Female subjects are eligible if of non-childbearing potential or not lactating, has a negative pregnancy, and agrees to use one a specified highly effective method for avoiding pregnancy
•Documented medical diagnosis of PHN of with pain present for at least three months from the healing of a herpes zoster rash
•Baseline 24-hour average pain intensity score ≥ 4.0 based on an 11-point PI-NRS
•Provides written informed consent in accordance with all applicable regulatory requirements

Exclusion Criteria

•Other chronic pain conditions not associated with PHN. However, the subject will not be excluded if:
•The pain is located at a different region of the body; and
•The pain intensity is not greater than the pain intensity of the PHN; and
•The subject can assess PHN pain independently of other 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 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)

Arms & Interventions

Placebo

placebo

Intervention: Placebo

GEn 1200mg/day

gabapentin enacarbil 1200mg/day, maintenance treatment 14 weeks

Intervention: GEn 1200mg/day

GEn 2400mg/day

gabapentin enacarbil 2400mg/day, maintenance treatment 14 weeks

Intervention: GEn 2400mg/day

GEn 3600mg/day

gabapentin enacarbil 3600mg/day, maintenance treatment 14 weeks

Intervention: GEn 3600mg/day

Outcomes

Primary Outcomes

Change From Baseline in the Mean 24-hour Average Pain Intensity (API) Score at the 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)

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 average pain intensity over the preceding 24 hours, using an 11-point PI-Numerical Rating Scale (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 EOMT score minus Baseline score.

Secondary Outcomes

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 Night-time Worst 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 Sleep Interference 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 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 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))
Change From Baseline in Pain Quality as Assessed by the Neuropathic Pain Scale (NPS) Summary Scores at EOMT Using LOCF Data(Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit))
Change From Baseline in Pain Characteristics and Intensity as Assessed by the Short Form-McGill Pain Questionnaire (SF-MPQ) at EOMT Using LOCF Data(Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit))
Change From Baseline in Dynamic Allodynia at EOMT Using LOCF Data(Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit))
Number of Participants Who Are Responders on the Patient Global Impression of Change (PGIC) Questionnaire at EOMT Using LOCF Data(EOMT (representing the earliest date of Week 13 visit/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(Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit))
Time to Onset of Sustained Improvement in the 24-hour Average Pain Intensity Score(Anytime post-baseline until date of last dose of study medication (up to Week 13))
Change From Baseline in the Mean Daily Dose in Milligrams of Rescue Medication at EOMT Using LOCF Data(Baseline and EOMT (Week 13 or early withdrawal))
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(Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit))
Change From Baseline in Quality of Life as Assessed by the SF-36 at EOMT Using LOCF Data(Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit))
Change From Baseline in Emotional Functioning as Assessed by the POMS-B at EOMT Using LOCF Data(Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit))
Number of Participants Who Are Responders on the Clinician Global Impression of Change (CGIC) Questionnaire at EOMT Using LOCF Data(EOMT (representing the earliest date of Week 13 visit/withdrawal visit))