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 range2 Years

SexALL

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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

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