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

NCT ID: NCT00381719

Last Updated: 2008-01-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

330 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-10-31

Study Completion Date

2007-11-30

Brief Summary

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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

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Conditions

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Diabetic Neuropathy, Painful

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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1

3 mg

Group Type EXPERIMENTAL

AGN 203818

Intervention Type DRUG

3 mg Capsule twice daily for 4 weeks

2

20 mg

Group Type EXPERIMENTAL

AGN 203818

Intervention Type DRUG

20 mg Capsule twice daily for 4 weeks

3

60 mg

Group Type EXPERIMENTAL

AGN 203818

Intervention Type DRUG

60 mg Capsule twice daily for 4 weeks

4

Placebo

Group Type PLACEBO_COMPARATOR

placebo capsule

Intervention Type DRUG

Capsule twice daily for 4 weeks

Interventions

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AGN 203818

3 mg Capsule twice daily for 4 weeks

Intervention Type DRUG

AGN 203818

20 mg Capsule twice daily for 4 weeks

Intervention Type DRUG

AGN 203818

60 mg Capsule twice daily for 4 weeks

Intervention Type DRUG

placebo capsule

Capsule twice daily for 4 weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Any other uncontrolled disease
* Pregnant or nursing females
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Allergan

INDUSTRY

Sponsor Role lead

Responsible Party

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Allergan, Inc.

Locations

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Tacoma, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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203818-004

Identifier Type: -

Identifier Source: org_study_id

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