- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00002996
Flecainide in Treating Patients With Chronic Neuropathic Pain
Flecainide for the Treatment of Chronic Neuropathic Pain: A Phase II Trial
RATIONALE: Flecainide therapy may help patients with neuropathic pain live more comfortably.
PURPOSE: Phase II trial to study the effectiveness of flecainide in treating patients with chronic neuropathic pain from cancer or AIDS.
Study Overview
Detailed Description
OBJECTIVES:
- Investigate the effectiveness of flecainide in the management of neuropathic pain.
OUTLINE: Patients are given a brief pain inventory (BPI) form to assess their pain upon enrollment in the study. Following a 7 day stabilization period, flecainide is administered. One capsule of flecainide is given twice a day on days 8-10, two capsules are given twice a day on days 11-14 and three capsules are given twice a day on days 15-21. BPI forms are completed on days 8, 15 and 22 to assess neuropathic pain.
PROJECTED ACCRUAL: A total of 7-20 patients will be accrued for this study.
Study Type
Enrollment (Estimated)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Iowa
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Cedar Rapids, Iowa, United States, 52403-1206
- CCOP - Cedar Rapids Oncology Project
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Des Moines, Iowa, United States, 50309-1016
- CCOP - Iowa Oncology Research Association
-
-
Michigan
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Kalamazoo, Michigan, United States, 49007-3731
- CCOP - Kalamazoo
-
-
Minnesota
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Rochester, Minnesota, United States, 55905
- Mayo Clinic Cancer Center
-
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South Dakota
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Sioux Falls, South Dakota, United States, 57104
- CCOP - Sioux Community Cancer Consortium
-
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Wisconsin
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Madison, Wisconsin, United States, 53792-0001
- University of Wisconsin Comprehensive Cancer Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
DISEASE CHARACTERISTICS:
- Chronic neuropathic pain with diagnosis of cancer or AIDS
PATIENT CHARACTERISTICS:
Age:
- Over 18
Performance status:
- Not specified
Life expectancy:
- Not specified
Hematopoietic:
- Not specified
Hepatic:
- SGOT no greater than 2 times upper limit of normal (ULN)
Renal:
- Creatinine no greater than 2 times ULN
Cardiovascular:
- No clinical history of infarction or angina
- No advanced heart failure
- No sick sinus syndrome, intraventricular conduction disease, second or third degree AV block or arrhythmias requiring treatment (exception may be granted by cardiac consult)
- No focal wall motion abnormalities
- Ejection fraction at least 40%
- Systolic blood pressure at least 90 mm Hg
Other:
- Must be able to take oral medication
- No known allergy or adverse reaction to flecainide, mexilitene or any other type I antiarrhythmic drug
- Not pregnant or nursing
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- At least 2 weeks since prior chemotherapy that may cause neuropathy
Endocrine therapy:
- At least 2 weeks since prior corticosteroids
Radiotherapy:
- Not specified
Surgery:
- Not specified
Other:
- No tricyclic antidepressant treatment within past 2 weeks
- No concurrent use of flecainide, mexiletene or any other type I antiarrhythmic drug
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
Collaborators and Investigators
Collaborators
Investigators
- Study Chair: Charles F. Von Gunten, MD, PhD, Robert H. Lurie Cancer Center
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CDR0000065544
- E1Z95
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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