Last updated: 11/03/2018 11:05:24
A Clinical Study Of XP13512/GSK1838262 In Subjects With Neuropathic Pain From Post-Herpetic Neuralgia (PHN) Who Have Had An Inadequate Response To Gabapentin Treatment
Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: Study PXN110527: The investigation of the efficacy and pharmacokinetics of XP13512 in subjects with neuropathic pain associated with post-herpetic neuralgia (PHN) who have had an inadequate response to gabapentin treatment.
Trial description: The purpose of this study is evaluate the difference between two doses of gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, on pain associated with post-herpetic neuralgia.
Primary purpose:
Treatment
Trial design:
Crossover Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:
The mean daily average pain intensity score for the last week of each treatment period based on an 11-point PI-NRS (0 = “no pain” and 10 = “pain as bad as you can imagine”).
Timeframe: 4 Weeks
Secondary outcomes:
Sleep interference score recorded in the morning upon awakening
Timeframe: 4 Weeks
Current pain intensity score recorded in the morning upon awakening and in the evening before bedtime.
Timeframe: 4 Weeks
Day-time average pain intensity score recorded in the evening before bedtime. Day-time is defined as the time between rising in the morning and going to bed at night.
Timeframe: 4 Weeks
Night-time average pain intensity score recorded in the morning upon awakening. Night-time is defined as the time between going to bed at night and rising in the morning.
Timeframe: 4 Weeks
Percent of subjects achieving various levels of reduction in 24 hour average pain intensity score (derived from primary endpoint)
Timeframe: 4 Weeks
Rescue analgesic use recorded in the evening before bedtime
Timeframe: 4 Weeks
Plasma concentration of gabapentin from samples collected during Baseline and Treatment Period 1 and Treatment Period 2
Timeframe: 10 blood samples per subject during Baseline, Period 1 and Period 2 at various timepoints
Patient and clinician global impression of change (completed in physician's office)
Timeframe: 4 Weeks
Day-time worst pain intensity score recorded in the evening before bedtime. Day-time is defined as the time between rising in the morning and going to bed at night.
Timeframe: 4 Weeks
Physical functioning (completed in physician's office)
Timeframe: 4 Weeks
Night-time worst pain intensity score recorded in the morning upon awakening. Night-time is defined as the time between going to bed at night and rising in the morning.
Timeframe: 4 Weeks
Interventions:
Drug: GEn 1200mg/day
Drug: GEn 3600mg/day
Enrollment:
96
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Neuralgia, Postherpetic
Product
gabapentin enacarbil
Collaborators
Not applicable
Study date(s)
March 2008 to July 2009
Type
Interventional
Phase
1/2
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
none
- 18 years or older
- Documented medical diagnosis of PHN with pain present for at least 3 months from the healing of a herpes zoster rash
- 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
Inclusion and exclusion criteria
Inclusion criteria:
- 18 years or older
- Documented medical diagnosis of PHN with pain present for at least 3 months from the healing of a herpes zoster rash
- 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.
- Currently on a stable dose of 1800 mg/day of gabapentin for ≥2 weeks with inadequate response OR
- Not currently treated with gabapentin, but previously treated with ≥1800 mg/day of gabapentin for 4 weeks or more with inadequate response.
- 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)
- Current diagnosis of active epilepsy or any active seizure disorder requiring chronic therapy with antiepileptic drugs
- Medical condition or disorder that would interfere with the action, absorption, distribution, metabolism, or excretion of GEn, or, in the investigator's judgment
- Is considered to be clinically significant and may 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
- Current or chronic history of liver disease (including acute viral hepatitis), or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
- 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 meet entry criteria and must be stable for at least three months prior to enrollment
- History of clinically significant drug or alcohol abuse (DSM‑IV‑TR) or is unable to refrain from substance abuse throughout the study. 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 PHN, or
- Within preceding six months for studies related to PHN
- Treated previously with GEn
- History of allergic or medically significant adverse reaction to investigational products (including gabapentin) or their excipients, acetaminophen or related compounds
Trial location(s)
No location data available.
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2009-27-07
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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