Safety and Efficacy of Gabapentin in Diabetic Peripheral Neuropathy

NCT00712439 | Completed Phase 2

• 1 other identifier: 81-0046
• Study Type: interventional
• Target: 147
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Diabetic Peripheral Neuropathy

Keywords

DPN,; Diabetic; Peripheral; Neuropathy; Painful

Outcome Measures

Primary Outcomes (1)

• 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.

  4 weeks

Secondary Outcomes (1)

• Secondary efficacy measures will include changes from baseline in average daily sleep interference scores, SF-MPQ, BPI,NPS, PGIC, and CGIC.

  4 weeks

Study Arms (2)

1

EXPERIMENTAL

Drug: Gabapentin Extended Release tablets

2

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Gabapentin Extended Release tablets DRUG

1

Placebo DRUG

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Depomed: lead

Related Publications (2)

• Sandercock D, Cramer M, Biton V, Cowles VE. A gastroretentive gabapentin formulation for the treatment of painful diabetic peripheral neuropathy: efficacy and tolerability in a double-blind, randomized, controlled clinical trial. Diabetes Res Clin Pract. 2012 Sep;97(3):438-45. doi: 10.1016/j.diabres.2012.03.010. Epub 2012 Apr 11.

  PMID: 22497967 DERIVED

• Sandercock D, Cramer M, Wu J, Chiang YK, Biton V, Heritier M. Gabapentin extended release for the treatment of painful diabetic peripheral neuropathy: efficacy and tolerability in a double-blind, randomized, controlled clinical trial. Diabetes Care. 2009 Feb;32(2):e20. doi: 10.2337/dc08-1450. No abstract available.

  PMID: 19171730 DERIVED

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Rekha Sathyanarayana

  Depomed

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 8, 2008
• First Posted: July 10, 2008
• Study Start: April 1, 2006
• Primary Completion: November 1, 2006
• Study Completion: December 1, 2006
• Last Updated: June 8, 2011

Record last verified: 2011-06