Last updated: 11/07/2018 02:58:06
A Study In Patients With Neuropathic Pain From Diabetic Peripheral Neuropathy (DPN)
Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
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)
Trial description: 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)
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:
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
Timeframe: Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit)
Secondary outcomes:
Change from baseline in the mean day-time average pain intensity (API) score at EOMT using LOCF data
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit)
Change from baseline in the mean daily dose of rescue medication at EOMT using LOCF data
Timeframe: 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
Timeframe: 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
Timeframe: Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit)
Change from baseline in pain score after taking a 50-foot walk at EOMT
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: Any time post-baseline until date of last dose of study medication (up to Week 13)
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
Timeframe: Baseline and EOMT
Change from baseline in quality of life as assessed by the 36-Item Short Form Health Survey (SF-36) at EOMT using LOCF data
Timeframe: Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit)
Change from baseline in emotional functioning as assessed by the Profile of Mood States-Brief Form (POMS-B) at EOMT using LOCF data
Timeframe: Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit)
Interventions:
Drug: GEn 2400mg/day
Drug: GEn 1200mg/day
Drug: Placebo
Drug: Pregabalin
Drug: GEn 3600mg/day
Enrollment:
421
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
R Rauck, S Schwartz, S Kavanaugh, C Makumi, O Graff, C McClung , G Meno-Tetang, C Bell. A Randomized, Controlled Trial of Gabapentin Enacarbil in Subjects with Neuropathic Pain Associated with Diabetic Peripheral Neuropathy. Pain Practice. 2013;13(6):485-496.
Medical condition
Neuropathy, Diabetic
Product
gabapentin enacarbil
Collaborators
Not applicable
Study date(s)
March 2008 to February 2009
Type
Interventional
Phase
2/3
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
none
- 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
- 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
Inclusion and exclusion 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
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
2009-17-02
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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