A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of Gabapentin Extended Release (G-ER) Tablets in the Treatment of Patients With Painful Diabetic Peripheral Neuropathy

Depomed0 sites147 target enrollmentApril 2006

ConditionsDiabetic Peripheral Neuropathy

InterventionsGabapentin Extended Release tablets Placebo

DrugsGabapentin Extended Release tablets Placebo

Overview

Phase: Phase 2
Intervention: Gabapentin Extended Release tablets
Conditions: Diabetic Peripheral Neuropathy
Sponsor: Depomed
Enrollment: 147
Primary Endpoint: The primary study objective is to assess the relative efficacy of G-ER versus placebo in reducing the mean daily pain score from the baseline week to end of efficacy treatment period (Treatment Week 4) in patients with DPN.
Status: Completed
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

The purpose of this study is to determine whether a new Gabapentin tablet, is safe and effective for the treatment of painful diabetic peripheral neuropathy.

Registry

clinicaltrials.gov

Start Date

April 2006

End Date

December 2006

Last Updated

14 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Depomed

Eligibility Criteria

Inclusion Criteria

•Men or women 18 years or older with diagnosis of type 1 or type 2 diabetes who have reported symmetrical painful symptoms in distal extremities for 1-5 years prior to the study and whose symptoms are attributable to sensorimotor diabetic peripheral neuropathy (DPN).
•Patients of childbearing potential must have a negative urine pregnancy test at screening/randomization, and must use medically acceptable methods of birth control.
•Patient has pain score of at least 4 on the 11-point Likert numerical rating scale at screening. Potential patients should not be informed of the pain intensity eligibility criterion prior to screening or randomization.
•Patient has a mean baseline week pain intensity of at least 4 on the 11-point Likert scale at the end of a one-week pre-treatment period and has completed at least 4 days of diary entries during the baseline week.
•Patient is on stable regimen of antidiabetes medication at screening that can be maintained during the study.
•Patient has hemoglobin A1c (HbA1c) ≤11% at screening.
•Patient has FPG ≤310 mg/dL at screening.
•Patient must have a minimum washout of greater than 5 times the half-life of the drug of any of several medications
•Patients currently treated with gabapentin or pregabalin at screening may be eligible for the study, but must have tapering period wherein the dose of gabapentin is reduced gradually over a period of at least 7 days plus a 2-day or 3-day washout of gabapentin or pregabalin, respectively, prior to start of the Baseline Week.
•Patient must have adequate eyesight to complete questions on the DiaryPro and SitePro. If a patient is unable to do so (for reasons other than severe eye disease) but a caregiver is available to complete these tasks following instruction from the patient, the caregiver may be trained to accomplish these tasks

Exclusion Criteria

•Patients who have previously not responded to treatment for DPN with gabapentin at doses of ≥1200 mg/day or pregabalin at doses ≥300 mg/day.
•Patients who previously experienced dose-limiting adverse effects that prevented titration of gabapentin to an effective dose.
•Patient has hypersensitivity to gabapentin.
•Patient is a nursing mother.
•Patient has used injected anesthetics or steroids within 30 days of baseline.
•Patient has certain conditions that could confound evaluation of painful DPN, in particular, amputations other than toes, non-diabetic neurologic disorders (e.g. phantom limb pain), and skin conditions affecting sensation in painful limbs.
•Patient has skin conditions in the area affected by the neuropathy that could alter sensation.
•Patient is in an immunocompromised state.
•Patient has an estimated creatinine clearance of \<60 ml/min calculated using the Cockroft Gault method (Appendix 3).
•Patient has had malignancy within past 2 years other than basal cell carcinoma.

Arms & Interventions

1

Intervention: Gabapentin Extended Release tablets

2

Intervention: Placebo

Outcomes

Primary Outcomes

The primary study objective is to assess the relative efficacy of G-ER versus placebo in reducing the mean daily pain score from the baseline week to end of efficacy treatment period (Treatment Week 4) in patients with DPN.

Time Frame: 4 weeks