Phase 2
N=41
Study of Celebrex (Celecoxib) in Patients With Recurrent Respiratory Papillomatosis
Recurrent Respiratory Papillomatosis
Bottom Line
View on ClinicalTrials.gov: NCT00571701 ↗Enrolled (actual)
41
Serious AEs
6.3%
Results posted
Feb 2017
Primary outcome: Primary: Mean Percent Change in Papilloma Growth Rate at 12 Month Measurement Compared to Baseline — -5.4; -15.2 percent change in mean growth rate — p=0.57
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- celebrex (celecoxib) (Drug); placebo (Drug)
- Age
- Pediatric, Adult, Older Adult · 2+ yrs
- Sex
- All
- Sponsor
- Northwell Health
- Primary completion
- Jan 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Percent Change in Papilloma Growth Rate at 12 Month Measurement Compared to Baseline |
-5.4; -15.2 | 0.57 |
| SECONDARY Percent of Patients With Positive Response to Treatment |
12.5; 28.6 | 0.43 |
| SECONDARY Effect of Gender on Percent of Patients With Reduction in Papilloma Growth Rate Greater Than 50%. |
12.50; 40.00; 12.50; 0.00 | >0.3 |
| SECONDARY Effect of Juvenile Versus Adult Disease Onset on Percent of Patients With Reduction in Papilloma Growth Rate Greater Than 50%. |
12.50; 7.69; 12.50; 33.33 | 1.00 |
| SECONDARY Effect of HPV 6 Versus HPV 11 on Percent of Patients With Reduction in Papilloma Growth Rate Greater Than 50% |
9.09; 42.86; 25.00; 0.00 | > 0.5 |
| SECONDARY Correlation Between Mean Plasma Level of Celecoxib and Response. |
151.3; 543.41 | >0.56 |
| SECONDARY Maintenance of Response Following Discontinuation of Celecoxib |
100 | — |
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.
Eligibility Criteria
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 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
Data sourced from ClinicalTrials.gov (NCT00571701). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.