Safety and Efficacy of AGN 203818 in Patients With Painful Diabetic Peripheral Neuropathy

Allergan330 enrolled

Overview

This study will explore the safety and effectiveness of different doses of AGN 203818 in treating pain in patients with painful diabetic peripheral neuropathy

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

330

Conditions

Diabetic Neuropathy, Painful

Interventions

AGN 203818DRUG

3 mg Capsule twice daily for 4 weeks

AGN 203818DRUG

20 mg Capsule twice daily for 4 weeks

AGN 203818DRUG

60 mg Capsule twice daily for 4 weeks

placebo capsule

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Diagnosis of diabetic peripheral neuropathy * Moderate to severe neuropathic pain Exclusion Criteria: * Any other uncontrolled disease * Pregnant or nursing females

Locations (1)

Unnamed facility

Tacoma, Washington, United States

Outcomes

Primary Outcomes

Reduction in Daily Pain Score

Time frame: 1 Month

Secondary Outcomes

Changes in sleep interference score

Time frame: Week 4

Beck depression inventory

Time frame: Week 4

Quality of Life questionnaires

Time frame: Week 4

Data from ClinicalTrials.gov

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