NCT00002996

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_2 pain

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 4, 1998

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
3.2 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2006

Completed
Last Updated

June 15, 2023

Status Verified

June 1, 2023

Enrollment Period

7.9 years

First QC Date

November 1, 1999

Last Update Submit

June 14, 2023

Conditions

Pain

Keywords

pain

Interventions

flecainide acetateDRUG

Eligibility Criteria

Age19 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (6)

CCOP - Cedar Rapids Oncology Project

Cedar Rapids, Iowa, 52403-1206, United States

Location

CCOP - Iowa Oncology Research Association

Des Moines, Iowa, 50309-1016, United States

Location

CCOP - Kalamazoo

Kalamazoo, Michigan, 49007-3731, United States

Location

Mayo Clinic Cancer Center

Rochester, Minnesota, 55905, United States

Location

CCOP - Sioux Community Cancer Consortium

Sioux Falls, South Dakota, 57104, United States

Location

University of Wisconsin Comprehensive Cancer Center

Madison, Wisconsin, 53792-0001, United States

Location

Related Publications (1)

  • 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. doi: 10.1177/0269216307083031.

    PMID: 18073252RESULT

MeSH Terms

Conditions

Pain

Interventions

Flecainide

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PiperidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Charles F. Von Gunten, MD, PhD

    Robert H. Lurie Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
SUPPORTIVE CARE
Sponsor Type
NETWORK

Study Record Dates

First Submitted

November 1, 1999

First Posted

January 27, 2003

Study Start

May 4, 1998

Primary Completion

April 1, 2006

Last Updated

June 15, 2023

Record last verified: 2023-06

Locations

US(6)