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Sponsored by: |
National Institute on Deafness and Other Communication Disorders (NIDCD) |
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Information provided by: | National Institute on Deafness and Other Communication Disorders (NIDCD) |
ClinicalTrials.gov Identifier: | NCT00571701 |
This is a randomized double blind controlled study to determine if celebrex (celecoxib), a selective COX-2 inhibitor, can decrease the rate of recurrence in adult and pediatric patients with recurrent respiratory papillomatosis. All patients will be evaluated for disease 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 no 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.
Condition | Intervention | Phase |
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Recurrent Respiratory Papillomatosis |
Drug: celebrex (celecoxib) Drug: placebo capsules |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Safety/Efficacy Study |
Official Title: | A Multicentered Randomized Study of Celebrex (Celecoxib) in Patients With Recurrent Respiratory Papillomatosis |
Estimated Enrollment: | 62 |
Study Start Date: | February 2008 |
Estimated Study Completion Date: | July 2012 |
Estimated Primary Completion Date: | July 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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early treatment: Active Comparator
Patients randomized to start celecoxib 6 months after enrollment. Then cross over to placebo after 1 year.
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Drug: celebrex (celecoxib)
Adults: 400 mg daily Pediatrics: 100 mg daily for weight between 12-25 kg or 200 mg daily for weight >25 kg
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delayed treatment: Placebo Comparator
Patients randomized to start placebo 6 months after enrollment. Cross over to 12 months of treatment with celecoxib after 1 year.
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Drug: placebo capsules
Not relevant
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This is a randomized double blind placebo-controlled study,with plans to include 5 additional U.S. centers in the near future. The primary goal of this study is to determine whether celecoxib has efficacy in elimination or reduction of recurrent disease in patients with RRP. Our secondary goals are to determine whether continued celecoxib is required to maintain response, to correlate response with select patient demographics and persistence of latent HPV DNA, and to determine whether celecoxib is acting through inhibition of COX-2, in order to begin to determine mechanism of effects in vivo on RRP. The study design encompasses a 30-month period, which can be divided into three segments:
Segment A: This is a 6 month run-in period in which all patients are assessed by direct laryngoscopy/bronchoscopy for disease severity, to permit growth rate stabilization and confirm accuracy of training of participating physicians. Patients will be treated by conventional surgery at three months and six months after enrollment.
Segment B: Patients begin 12 months of 400mg(adults), 100 mg (pediatric weight between 12 and 25 kg)or 200 mg (pediatric weight > 25kg) celecoxib daily or placebo treatment in addition to surgical removal of all papillomas at each 3 month interval. This segment directly tests the hypothesis that celecoxib is an efficacious treatment for moderate to severe RRP and forms the basis for the primary statistical analyses.
Segment C: The primary purpose of this segment is to determine whether gains made during celecoxib therapy are maintained after it is discontinued, or whether celecoxib will need to be taken indefinitely. This will be determined by a 12 month period on placebo after cessation of celecoxib for the early treatment group.
Ages Eligible for Study: | 2 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients who have rapid regrowth of papillomas, requiring endoscopic removal at least 3 times within the past 12 months AND A papilloma growth rate from 0.03 to 0.06 (moderate) or >0.06 (severe) at time of initial direct endoscopy OR Having tracheal and/or bronchial or pulmonary papillomatosis (severe)
Exclusion Criteria:
Contact: Ginny Mullooly, RN | 718-470-7011 | gmullool@lij.edu |
United States, New York | |
Long Island Jewish Medical Center | Recruiting |
New Hyde Park, New York, United States, 11040 |
Principal Investigator: | Bettie M Steinberg, PhD | Long Island Jewish Medical Center |
Responsible Party: | Feinstein Institute for Medical Research ( Bettie M. Steinberg, Ph.D./Chief Scientific Officer ) |
Study ID Numbers: | 1 U01 DC007946-01A2, NIH grant U01DC007946-01A2 |
Study First Received: | December 10, 2007 |
Last Updated: | August 5, 2008 |
ClinicalTrials.gov Identifier: | NCT00571701 |
Health Authority: | United States: Federal Government |
HPV RRP |
Celecoxib Neoplasms, Squamous Cell Papilloma |
Recurrent respiratory papillomatosis Recurrence Neoplasms, Glandular and Epithelial |
Anti-Inflammatory Agents Disease Attributes Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Cyclooxygenase Inhibitors Enzyme Inhibitors Pharmacologic Actions Neoplasms |
Pathologic Processes Analgesics, Non-Narcotic Sensory System Agents Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Analgesics Peripheral Nervous System Agents Antirheumatic Agents Central Nervous System Agents |