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Madison, Wisconsin 53792

  • Pain

Purpose:

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 summary:

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.


Criteria:

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 is Available At:


Original ID:

CDR0000065544


NCT ID:

NCT00002996


Secondary ID:

E1Z95


Study Acronym:


Brief Title:

Flecainide in Treating Patients With Chronic Neuropathic Pain


Official Title:

Flecainide for the Treatment of Chronic Neuropathic Pain: A Phase II Trial


Overall Status:

Completed


Study Phase:

Phase 2


Genders:

Both


Minimum Age:

19 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Eastern Cooperative Oncology Group


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Primary Purpose: Supportive Care


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

20


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Charles F. Von Gunten, MD, PhD
Study Chair
Robert H. Lurie Cancer Center

Study Dates

Start Date:February 1998
Primary Completion Date:April 2006
Primary Completion Type:Actual
Verification Date:January 2010
Last Changed Date:January 26, 2010
First Received Date:November 1, 1999

Study Outcomes

There are no available Study Outcomes

Study Interventions

Intervention Type:Drug
Name:flecainide acetate

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Eastern Cooperative Oncology Group
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Cancer Institute (NCI)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Results Reference
Citation:von Gunten CF, Eappen S, Cleary JF, Taylor SG 4th, Moots P, Regevik N, Cleeland C, Cella D. Flecainide for the treatment of chronic neuropathic pain: a Phase II trial. Palliat Med. 2007 Dec;21(8):667-72.
PMID:18073252

Data Source: ClinicalTrials.gov

Date Processed: April 03, 2020

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