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NCT00381719 Clinical Trial

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

Diabetic Neuropathy, Painful Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00381719
Other study ID # 203818-004
Secondary ID
Status Completed
Phase Phase 2
First received September 26, 2006
Last updated January 3, 2008
Start date October 2006
Est. completion date November 2007

Study information
Verified date December 2007
Source Allergan
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Completed
Enrollment 330
Est. completion date November 2007
Est. primary completion date November 2007
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Diagnosis of diabetic peripheral neuropathy

- Moderate to severe neuropathic pain

Exclusion Criteria:

- Any other uncontrolled disease

- Pregnant or nursing females

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• AGN 203818
3 mg Capsule twice daily for 4 weeks
• AGN 203818
20 mg Capsule twice daily for 4 weeks
• AGN 203818
60 mg Capsule twice daily for 4 weeks
• placebo capsule
Capsule twice daily for 4 weeks

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Allergan

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Reduction in Daily Pain Score 1 Month No
Secondary Changes in sleep interference score Week 4 No
Secondary Beck depression inventory Week 4 No
Secondary Quality of Life questionnaires Week 4 No
See also
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Completed NCT00159679 - Pregabalin in the Treatment of Pain Due to Diabetic Peripheral Neuropathy Phase 4
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Active, not recruiting NCT04469270 - Study to Assess Safety and Efficacy of Engensis in Painful Diabetic Peripheral Neuropathy Phase 3
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Completed NCT01628627 - Frequency Modulated Neural Stimulation (FREMS) in Symptomatic Diabetic Neuropathy Phase 4
Completed NCT03315598 - Evaluation of an Effectiveness and Safety of the Electroacupuncture in the Management of Intractable Neuropathic Pain N/A
Completed NCT01057693 - Study Of Pregabalin (Lyrica) In Patients With Painful Diabetic Peripheral Neuropathy Phase 3
Completed NCT01564459 - Study to Evaluate MK-6096 in the Treatment of Painful Diabetic Neuropathy (PDN) in Adults (MK-6096-021) Phase 2
Recruiting NCT01214590 - Preliminary Assessment of the Efficacy of the VascuActive™ Device on Diabetic Peripheral Neuropathy N/A
Completed NCT01089556 - A Study in Painful Diabetic Neuropathy Phase 3
Completed NCT00501202 - Study for Safety and Effectiveness of RWJ-333369 (Carsibamate) for the Treatment of Diabetic Peripheral Neuropathy (DPN). Phase 2