NCT00381719
Completed
Phase 2
Safety and Efficacy of AGN 203818 in Patients With Painful Diabetic Peripheral Neuropathy
ConditionsDiabetic Neuropathy, Painful
Overview
- Phase
- Phase 2
- Intervention
- AGN 203818
- Conditions
- Diabetic Neuropathy, Painful
- Sponsor
- Allergan
- Enrollment
- 330
- Primary Endpoint
- Reduction in Daily Pain Score
- Status
- Completed
- Last Updated
- 18 years ago
Overview
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
Investigators
Eligibility Criteria
Inclusion Criteria
- •Diagnosis of diabetic peripheral neuropathy
- •Moderate to severe neuropathic pain
Exclusion Criteria
- •Any other uncontrolled disease
- •Pregnant or nursing females
Arms & Interventions
1
3 mg
Intervention: AGN 203818
2
20 mg
Intervention: AGN 203818
3
60 mg
Intervention: AGN 203818
4
Placebo
Intervention: placebo capsule
Outcomes
Primary Outcomes
Reduction in Daily Pain Score
Time Frame: 1 Month
Secondary Outcomes
- Changes in sleep interference score(Week 4)
- Beck depression inventory(Week 4)
- Quality of Life questionnaires(Week 4)
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