Flecainide in Treating Patients With Chronic Neuropathic Pain - Tabular View

Tracking Information

First Received Date ^ICMJE

November 1, 1999

Last Updated Date

July 23, 2008

Start Date ^ICMJE

February 1998

Primary Completion Date

December 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00002996 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Flecainide in Treating Patients With Chronic Neuropathic Pain

Official Title ^ICMJE

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

Brief Summary

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.

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 Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Supportive Care

Condition ^ICMJE

Pain

Intervention ^ICMJE

Drug: flecainide acetate

Study Arms / Comparison Groups

Publications *

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.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

Completion Date

Primary Completion Date

December 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

19 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00002996

Responsible Party

Study ID Numbers ^ICMJE

CDR0000065544, ECOG-1Z95

Study Sponsor ^ICMJE

Eastern Cooperative Oncology Group

Collaborators ^ICMJE

National Cancer Institute (NCI)

Investigators ^ICMJE

Study Chair:

Charles F. Von Gunten, MD, PhD

Robert H. Lurie Cancer Center

Information Provided By

National Cancer Institute (NCI)

Verification Date

August 2001

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP