Back to resultsSafety and Efficacy of AGN 203818 in Patients With Painful Diabetic Peripheral Neuropathy
Primary Purpose
Diabetic Neuropathy, Painful
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
AGN 203818
AGN 203818
AGN 203818
placebo capsule
Sponsored by
About this trial
This is an interventional treatment trial for Diabetic Neuropathy, Painful
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of diabetic peripheral neuropathy
- Moderate to severe neuropathic pain
Exclusion Criteria:
- Any other uncontrolled disease
- Pregnant or nursing females
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
1
2
3
4
Arm Description
3 mg
20 mg
60 mg
Placebo
Outcomes
Primary Outcome Measures
Reduction in Daily Pain Score
Secondary Outcome Measures
Changes in sleep interference score
Beck depression inventory
Quality of Life questionnaires
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00381719
Brief Title
Safety and Efficacy of AGN 203818 in Patients With Painful Diabetic Peripheral Neuropathy
Study Type
Interventional
2. Study Status
Record Verification Date
December 2007
Overall Recruitment Status
Completed
Study Start Date
October 2006 (undefined)
Primary Completion Date
November 2007 (Actual)
Study Completion Date
November 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Allergan
4. Oversight
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Neuropathy, Painful
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
330 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
3 mg
Arm Title
2
Arm Type
Experimental
Arm Description
20 mg
Arm Title
3
Arm Type
Experimental
Arm Description
60 mg
Arm Title
4
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
AGN 203818
Intervention Description
3 mg Capsule twice daily for 4 weeks
Intervention Type
Drug
Intervention Name(s)
AGN 203818
Intervention Description
20 mg Capsule twice daily for 4 weeks
Intervention Type
Drug
Intervention Name(s)
AGN 203818
Intervention Description
60 mg Capsule twice daily for 4 weeks
Intervention Type
Drug
Intervention Name(s)
placebo capsule
Intervention Description
Capsule twice daily for 4 weeks
Primary Outcome Measure Information:
Title
Reduction in Daily Pain Score
Time Frame
1 Month
Secondary Outcome Measure Information:
Title
Changes in sleep interference score
Time Frame
Week 4
Title
Beck depression inventory
Time Frame
Week 4
Title
Quality of Life questionnaires
Time Frame
Week 4
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of diabetic peripheral neuropathy
Moderate to severe neuropathic pain
Exclusion Criteria:
Any other uncontrolled disease
Pregnant or nursing females
Facility Information:
City
Tacoma
State/Province
Washington
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Safety and Efficacy of AGN 203818 in Patients With Painful Diabetic Peripheral Neuropathy
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