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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Diabetic Neuropathies
Neuromuscular Diseases
Nervous System Diseases
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
Cardiovascular Agents
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents

ClinicalTrials.gov processed this record on September 18, 2014