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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00381719

Enrollment

330

Registered

2006-09-28

Start date

2006-10-31

Completion date

2007-11-30

Last updated

2008-01-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Neuropathy, Painful

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

Interventions

DRUGAGN 203818

3 mg Capsule twice daily for 4 weeks

DRUGplacebo capsule

Capsule twice daily for 4 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

* Any other uncontrolled disease * Pregnant or nursing females

Design outcomes

Primary

Measure	Time frame
Reduction in Daily Pain Score	1 Month

Secondary

Measure	Time frame
Changes in sleep interference score	Week 4
Beck depression inventory	Week 4
Quality of Life questionnaires	Week 4

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026