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OpenTrials
Completed

NCT Number: NCT00381719

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

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

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Key information

Conditions

Diabetic Neuropathy, Painful Diabetes Complications Diabetes Mellitus Diabetic Neuropathies Endocrine System Diseases Nervous System Diseases Neuromuscular Diseases Peripheral Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Tacoma, Washington, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Any other uncontrolled disease
  • Pregnant or nursing females

Treatment and study plan

AGN 203818

Drug

3 mg Capsule twice daily for 4 weeks

Placebo capsule

Drug

Capsule twice daily for 4 weeks

Primary outcomes

  1. Reduction in Daily Pain Score

    Time frame: 1 Month

Secondary outcomes

  1. Changes in sleep interference score

    Time frame: Week 4

  2. Beck depression inventory

    Time frame: Week 4

  3. Quality of Life questionnaires

    Time frame: Week 4

Sponsors and collaborators

Lead sponsor

Allergan

Industry

Registry information

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Sep 28, 2006
Registry last updated
Jan 7, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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