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

Phase 2

Completed

• Conditions: Diabetic Neuropathy, Painful
• Interventions: Drug: AGN 203818; Drug: placebo capsule

• Registration Number: NCT00381719
• Lead Sponsor: Allergan

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-09-26
• Study First Submitted QC: 2006-09-26
• Study First Posted: 2006-09-28
• Study Start: 2006-10
• Primary Completion: 2007-11
• Study Completion: 2007-11
• Status Verified: 2007-12
• Last Update Submitted: 2008-01-03
• Last Update Posted: 2008-01-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 330

Inclusion Criteria

• Diagnosis of diabetic peripheral neuropathy
• Moderate to severe neuropathic pain

Exclusion Criteria

• Any other uncontrolled disease
• Pregnant or nursing females

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	AGN 203818	3 mg
3	AGN 203818	60 mg
4	placebo capsule	Placebo
2	AGN 203818	20 mg

Primary Outcome Measures

Name	Time	Method
Reduction in Daily Pain Score	1 Month

Secondary Outcome Measures

Name	Time	Method
Changes in sleep interference score	Week 4
Beck depression inventory	Week 4
Quality of Life questionnaires	Week 4