A Study In Patients With Neuropathic Pain From Diabetic Peripheral Neuropathy (DPN) (NCT00643760) | Clinical Trial Compass
CompletedPhase 2
A Study In Patients With Neuropathic Pain From Diabetic Peripheral Neuropathy (DPN)
United States421 participantsStarted 2008-03
Plain-language 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)
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
What they're measuring
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
Timeframe: Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit)