CompletedPhase 2

Study of Celebrex (Celecoxib) in Patients With Recurrent Respiratory Papillomatosis

United States50 participantsStarted 2008-02

Plain-language summary

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 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.

Who can participate

Age range

2 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Moderate to severe disease, defined as: 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) * Age \> 2 years * Gender- no restriction * Race- no restriction Exclusion Criteria: * Fewer than 3 surgical procedures in previous year, without tracheal disease * Age \< 2 years * Pregnancy, trying to become pregnant, breastfeeding or not willing to comply with birth control methods if sexually active female * Serum creatinine \> 1.5 X normal * History of documented peptic ulcer disease or gastritis persisting despite treatment * Abnormal liver function tests, as total bilirubin \>1.5 X normal and SGOT \> 3 X normal * Allergy to NSAIDs, sulfa containing drugs or symptoms of Stevens-Johnson Syndrome * Patients with connective tissue diseases such as SLE, Raynaud's or Systemic Sclerosis * Patients with known diabetes * Patients on warfarin, or on loop or thiazide diuretics * Patients with a history of cardiovascular disease, myocardial infarct or stroke * Patients with congestive heart failure * Patients regularly taking \> 81 mg of aspirin/day * Patients with uncontrolled hypertension * Patients with RRP associated malignancy currently receiving chemotherapy and/or radiation

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Mean Percent Change in Papilloma Growth Rate at 12 Month Measurement Compared to Baseline

Timeframe: Baseline to 12 months

Trial details

NCT IDNCT00571701

SponsorNorthwell Health

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2015-01

Results submitted2016-08-09

View on ClinicalTrials.gov More Recurrent Respiratory Papillomatosis trials