Study of Celebrex (Celecoxib) in Patients With Recurrent Respiratory Papillomatosis
Information source: North Shore Long Island Jewish Health System
Information obtained from ClinicalTrials.gov on October 22, 2007
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Recurrent Respiratory Papillomatosis
Intervention: celebrex (celecoxib) (Drug)
Phase: Phase 2/Phase 3
Status: Recruiting
Sponsored by: North Shore Long Island Jewish Health System Official(s) and/or principal investigator(s):
Allan Abramson, MD, Principal Investigator, Affiliation: Long Island Jewish Medical Center
Overall contact:
Ginny Mullooly, RN, Phone: 718-470-7011, Email: gmullool@lij.edu
Summary
This is a randomized double blind controlled study to determine if celbrex (celecoxib), a selective COX-2 inhibitor, can decrease the rate of recurrence in adult patients with recurrent respiratory papillomatosis. All patients will be evaluated for diesease severity at enrollment and at 3 month intervals for 30 months. After randomization, patients in the early treatment arm will begin celecoxib 6 months after enrollment. The delayed treatment arm will begin celecoxib 18 months after enrollment. All patients will receive celecoxib for 1 year. During the time that patients do not receive celecoxib, they will receive a placebo capsule with the same appearance. Follow-up visits will occur at three month intervals for the duration of the study.
Clinical Details
Official title:
Randomized Study of Celebrex (Celecoxib) in Patients With Recurrent Respiratory Papillomatosis
Study design: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: What is the efficacy of celebrex response relative to conventional endoscopy and surgical removal.Do any clinical characteristics predict response.
Secondary outcome: Do tissue levels of prostaglandin E2 or activated EGFR in patients treated with celebrex predict response.Does celebrex reduce persistence of HPV DNA or alter HPV expression. Do immunological characteristics predict response.
Eligibility
Minimum age: 18 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Three or more surgical procedures in year prior to enrollment or tracheal disease.
- Age > 18 years.
Exclusion Criteria:
- fewer than 3 surgical procedures in previous year, without tracheal disease.
- Age < 18 years
- Pregnancy or breastfeeding
- serum creatinine > 1. 5 mg/dl
- History of documented peptic ulcer disease or gastritis
- Abnormal liver function tests, as total bilirubin >1. 5 X normal and SGOT >2 X normal
- Allergy to NSAIDS or Sulfa containing drugs
- Patients with connective tissus diseases such as SLE, Raynaud's or Systemic Sclerosis
- Patients on warfarin
- Patients on loop or thiazide diuretics without medical clearance to start drug
- Patients with congestive heart failure
- Patients on >= 81 mg of ASA without medical clearance to start drug
Locations and Contacts
Ginny Mullooly, RN, Phone: 718-470-7011, Email: gmullool@lij.edu
Long Island Jewish Medical Center, New Hyde Park, New York 11530, United States; Recruiting
Ginny Mullooly, RN, Phone: 718-470-7011, Email: gmullool@lij.edu
Allan Abramson, MD, Principal Investigator
Additional Information
Starting date:
February 2004
Last updated: March 1, 2006
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