Study of Celebrex (Celecoxib) in Patients With Recurrent Respiratory Papillomatosis
Completed · Phase 2 · Has a placebo group
Conditions studied: Recurrent Respiratory Papillomatosis
In brief
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.
Key facts
- Study ID
- NCT00571701
- Run by
- Northwell Health
- People needed
- 50
- Starts
- 2008-02-01
- Expected to finish
- 2015-01-01
- Last updated by the study team
- 2017-05-15
Who can join
Age: 2 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- University of Alabama Birmingham — Birmingham, Alabama, United States
- UCSF Medical Center — San Francisco, California, United States
- University of Iowa — Iowa City, Iowa, United States
- Long Island Jewish Medical Center — New Hyde Park, New York, United States
- Sanford Health /USD — Sioux Falls, South Dakota, United States
- Vanderbilt University — Nashville, Tennessee, United States
- Eastern Virginia Medical School — Norfolk, Virginia, United States
Full record on ClinicalTrials.gov
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