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

Allergan

Status and phase: Completed; Phase 2

Conditions: Diabetic Neuropathy, Painful

Treatments: Drug: placebo capsule; Drug: AGN 203818

Study type: Interventional

Funder types: Industry

Identifiers

NCT00381719

203818-004

Details and patient eligibility

About

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

Enrollment: 330 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Any other uncontrolled disease
• Pregnant or nursing females

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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330 participants in 4 patient groups, including a placebo group

1

Experimental group

Description:

3 mg

Treatment:

Drug: AGN 203818

Drug: AGN 203818

Drug: AGN 203818

2

Experimental group

Description:

20 mg

Treatment:

Drug: AGN 203818

Drug: AGN 203818

Drug: AGN 203818

3

Experimental group

Description:

60 mg

Treatment:

Drug: AGN 203818

Drug: AGN 203818

Drug: AGN 203818

4

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: placebo capsule