Safety and Efficacy of Gabapentin in Diabetic Peripheral Neuropathy

This study has been completed.
Sponsor:
Information provided by:
Depomed
ClinicalTrials.gov Identifier:
NCT00712439
First received: July 8, 2008
Last updated: June 6, 2011
Last verified: June 2011
  Purpose

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.


Condition Intervention Phase
Diabetic Peripheral Neuropathy
Drug: Gabapentin Extended Release tablets
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Depomed:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Secondary efficacy measures will include changes from baseline in average daily sleep interference scores, SF-MPQ, BPI,NPS, PGIC, and CGIC. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Enrollment: 147
Study Start Date: April 2006
Study Completion Date: December 2006
Primary Completion Date: November 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Gabapentin Extended Release tablets
Placebo Comparator: 2 Drug: Placebo

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  • Patient has had gastric reduction surgery.
  • Patient has severe chronic diarrhea, chronic constipation [unless attributed to drugs that will be washed out], uncontrolled irritable bowel syndrome (IBS) or unexplained weight loss.
  • Patient has any abnormal chemistry or hematology results that are deemed by the investigator to be clinically significant.
  • Patient has a history of substance abuse within the past year.
  • Patient has had 1 or more visits to an emergency room or hospital within the previous 30 days due to hypoglycemia.
  • Patient has a history of seizure (except for infantile febrile seizure) or is at risk of seizure due to head trauma.
  • Patient has a history of pernicious anemia, untreated hypothyroidism, chronic hepatitis B or C, hepatitis within the past 3 months, or HIV infection.
  • Patient has any other serious medical condition that, in the opinion of the Investigator would jeopardize the safety of the patient or affect the validity of the study results.
  • Continuing use of any concomitant medication excluded by Inclusion Criterion 8.
  • Patient has participated in a clinical trial of an investigational drug or device within 30 days of the screening visit
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00712439

Sponsors and Collaborators
Depomed
Investigators
Study Director: Rekha Sathyanarayana Depomed
  More Information

No publications provided by Depomed

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Lynne Rowe, Depomed
ClinicalTrials.gov Identifier: NCT00712439     History of Changes
Other Study ID Numbers: 81-0046
Study First Received: July 8, 2008
Last Updated: June 6, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Depomed:
DPN,
Diabetic
Peripheral
Neuropathy
Painful

Additional relevant MeSH terms:
Peripheral Nervous System Diseases
Demyelinating Diseases
Polyneuropathies
Nerve Compression Syndromes
Neurologic Manifestations
Neurotoxicity Syndromes
Diabetic Neuropathies
Neuromuscular Diseases
Nervous System Diseases
Signs and Symptoms
Poisoning
Substance-Related Disorders
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Gabapentin
Gamma-Aminobutyric Acid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anticonvulsants
Antiparkinson Agents
Anti-Dyskinesia Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 17, 2014