Trial · NCT00571701
Study of Celebrex (Celecoxib) in Patients With Recurrent Respiratory Papillomatosis
NCT00571701, Phase 2, Completed, Northwell Health; results first posted 2017-02-23
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of Celebrex (Celecoxib) in Patients With Recurrent Respiratory Papillomatosis. Trials, record NCT00571701. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00571701
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Celebrex (Celecoxib) in Patients With Recurrent Respiratory Papillomatosis
- NCT number
- NCT00571701
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 50 participants, actual
- Lead sponsor
- Northwell Health
- Conditions
- Recurrent Respiratory Papillomatosis
- Interventions
- celebrex (celecoxib), placebo
- First posted
- 2007-12-12
- Last updated
- 2017-05-15
- Results first posted
- 2017-02-23
- Limitations and caveats
- Rare prevalence of moderate to severe recurrent respiratory papillomatosis (estimated at 1:1million) limited enrollment
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Percent Change in Papilloma Growth Rate at 12 Month Measurement Compared to Baseline | Baseline to 12 months | Change in mean growth rates during the last 3 months of the first treatment period compared to the mean values at baseline. Endoscopy and removal of all tumor was done every 3 months. Growth rate is calculated as the scored amount of papilloma recurrence in a 3 month period divided by the exact number of days since last endoscopy and removal of all tumor. |
| Secondary | Percent of Patients With Positive Response to Treatment | Baseline to 12 months | Percent of patients with reduction in papilloma growth rate greater than 50% during the last 3 months of first treatment period compared to baseline |
| Secondary | Effect of Gender on Percent of Patients With Reduction in Papilloma Growth Rate Greater Than 50%. | Baseline to12 months | Percent of patients of each gender with reduction in papilloma growth rate greater than 50% during the last 3 months of first treatment period compared to baseline |
| Secondary | Effect of Juvenile Versus Adult Disease Onset on Percent of Patients With Reduction in Papilloma Growth Rate Greater Than 50%. | Baseline to 12 months | Percent of juvenile versus adult onset patients with reduction in papilloma growth rate greater than 50% during the last 3 months of first treatment period compared to baseline. |
| Secondary | Effect of HPV 6 Versus HPV 11 on Percent of Patients With Reduction in Papilloma Growth Rate Greater Than 50% | Baseline to 12 months | Percent of patients with HPV 6 versus patients with HPV 11 with reduction in papilloma growth rate greater than 50% during the last 3 months of first treatment period compared to baseline. |
| Secondary | Correlation Between Mean Plasma Level of Celecoxib and Response. | Baseline to 12 months | Mean plasma levels of celecoxib over months 3-12 in first treatment period correlated with reduction in papilloma growth rate greater than 50% during the last 3 months of first treatment period compared to baseline. |
| Secondary | Maintenance of Response Following Discontinuation of Celecoxib | End of first treatment period (month 12) to end of second treatment period (month 24) | Percent of patients who responded to celecoxib with increase in papilloma growth rate of no greater than 0.01 at end of second treatment period compared to growth rate at end of first treatment period. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Mean Percent Change in Papilloma Growth Rate at 12 Month Measurement Compared to Baseline | Baseline to 12 months | All patients in each arm who completed the first 1 year treatment period. This is not a traditional cross-over study because we expected a sustained effect therefore no efficacy studies were done in segment C. | percent change in mean growth rate | MEAN |
| SECONDARY | Percent of Patients With Positive Response to Treatment | Baseline to 12 months | All patients that completed first treatment period. This is not a traditional cross-over study because we expected a sustained effect therefore no efficacy studies were done in segment C. | percent responders | NUMBER |
| SECONDARY | Effect of Gender on Percent of Patients With Reduction in Papilloma Growth Rate Greater Than 50%. | Baseline to12 months | All patients who completed first treatment period. This is not a traditional cross-over study because we expected a sustained effect therefore no efficacy studies were done in segment C. | percent responders | NUMBER |
| SECONDARY | Effect of Juvenile Versus Adult Disease Onset on Percent of Patients With Reduction in Papilloma Growth Rate Greater Than 50%. | Baseline to 12 months | Analysis conducted on all patients who completed first treatment period. Juvenile onset is defined as \<18 years of age at time of diagnosis. Age of disease onset for 2 patients was not available. This is not a traditional cross-over study because we expected a sustained effect therefore no efficacy studies were done in segment C. | percentage of responders | NUMBER |
| SECONDARY | Effect of HPV 6 Versus HPV 11 on Percent of Patients With Reduction in Papilloma Growth Rate Greater Than 50% | Baseline to 12 months | Analysis conducted on all patients with HPV 6 or 11 infection who completed first treatment period. One patient with both HPV 6 and 11 and one patient with neither 6 or 11 were excluded. This is not a traditional cross-over study because we expected a sustained effect therefore no efficacy studies were done in segment C. | percent of responders | NUMBER |
| SECONDARY | Correlation Between Mean Plasma Level of Celecoxib and Response. | Baseline to 12 months | All patients who were randomized to receive celecoxib first and completed the first treatment period. This is not a traditional cross-over study because we expected a sustained effect therefore no efficacy studies were done in segment C. | pg. celecoxib/ml. plasma | MEAN |
| SECONDARY | Maintenance of Response Following Discontinuation of Celecoxib | End of first treatment period (month 12) to end of second treatment period (month 24) | All patients with complete response to celecoxib in first treatment period who completed the second treatment period where they received placebo. Because the number of responders was so small, no statistical analysis was performed. | percent of patients | NUMBER |
Source ClinicalTrials.gov
Results by group19
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Mean Percent Change in Papilloma Growth Rate at 12 Month Measurement Compared to Baseline | Celecoxib First, Then Placebo | -5.4 | Standard Deviation 50.0 | percent change in mean growth rate | |
| Mean Percent Change in Papilloma Growth Rate at 12 Month Measurement Compared to Baseline | Placebo First, Then Celecoxib | -15.2 | Standard Deviation 67.3 | percent change in mean growth rate | |
| Percent of Patients With Positive Response to Treatment | Celecoxib First (12 Months), Then Placebo (12 Months) | 12.5 | percent responders | ||
| Percent of Patients With Positive Response to Treatment | Placebo First (12 Months), Then Celecoxib (12 Months) | 28.6 | percent responders | ||
| Effect of Gender on Percent of Patients With Reduction in Papilloma Growth Rate Greater Than 50%. | Celecoxib First - Males | 12.50 | percent responders | ||
| Effect of Gender on Percent of Patients With Reduction in Papilloma Growth Rate Greater Than 50%. | Placebo First- Males | 40.00 | percent responders | ||
| Effect of Gender on Percent of Patients With Reduction in Papilloma Growth Rate Greater Than 50%. | Celecoxib First- Females | 12.50 | percent responders | ||
| Effect of Gender on Percent of Patients With Reduction in Papilloma Growth Rate Greater Than 50%. | Placebo First- Females | 0.00 | percent responders | ||
| Effect of Juvenile Versus Adult Disease Onset on Percent of Patients With Reduction in Papilloma Growth Rate Greater Than 50%. | Celecoxib First- Juvenile Onset | 12.50 | percentage of responders | ||
| Effect of Juvenile Versus Adult Disease Onset on Percent of Patients With Reduction in Papilloma Growth Rate Greater Than 50%. | Placebo First- Juvenile-onsent | 7.69 | percentage of responders |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| First Intervention 12 Months | STARTED | Celecoxib First (12 Months), Then Placebo (12 Months) | 19 | |
| First Intervention 12 Months | STARTED | Placebo First (12 Months), Then Celecoxib (12 Months) | 22 | |
| First Intervention 12 Months | COMPLETED | Celecoxib First (12 Months), Then Placebo (12 Months) | 16 | |
| First Intervention 12 Months | COMPLETED | Placebo First (12 Months), Then Celecoxib (12 Months) | 21 | |
| First Intervention 12 Months | NOT COMPLETED | Celecoxib First (12 Months), Then Placebo (12 Months) | 3 | |
| First Intervention 12 Months | NOT COMPLETED | Placebo First (12 Months), Then Celecoxib (12 Months) | 1 | |
| Second Intervention 12 Months | STARTED | Celecoxib First (12 Months), Then Placebo (12 Months) | 16 | |
| Second Intervention 12 Months | STARTED | Placebo First (12 Months), Then Celecoxib (12 Months) | 21 | |
| Second Intervention 12 Months | COMPLETED | Celecoxib First (12 Months), Then Placebo (12 Months) | 13 | |
| Second Intervention 12 Months | COMPLETED | Placebo First (12 Months), Then Celecoxib (12 Months) | 20 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events20
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | abdominal pain | Gastrointestinal disorders | Celecoxib | 4 | 40 | |
| other | abdominal pain | Gastrointestinal disorders | Placebo | 5 | 39 | |
| other | nausea or vomiting | Gastrointestinal disorders | Celecoxib | 2 | 40 | |
| other | nausea or vomiting | Gastrointestinal disorders | Placebo | 5 | 39 | |
| other | non-cardiac chest discomfort | Respiratory, thoracic and mediastinal disorders | Celecoxib | 4 | 40 | |
| other | non-cardiac chest discomfort | Respiratory, thoracic and mediastinal disorders | Placebo | 4 | 39 | |
| other | upper respiratory infection | Respiratory, thoracic and mediastinal disorders | Celecoxib | 7 | 40 | |
| other | upper respiratory infection | Respiratory, thoracic and mediastinal disorders | Placebo | 9 | 39 | |
| other | pyrexia | General disorders | Celecoxib | 2 | 40 | |
| other | pyrexia | General disorders | Placebo | 5 | 39 |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Celecoxib | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Celecoxib | 16 | 40 |
| Total, other adverse events | Placebo | 18 | 39 |
| Total, serious adverse events | Celecoxib | 3 | 40 |
| Total, serious adverse events | Placebo | 2 | 39 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 16144915 | BACKGROUND |
Source PubMed
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| U01DC007946 | Celecoxib therapy for patients with recurrent respiratory papillomatosis | STEINBERG, BETTIE M. | FEINSTEIN INSTITUTE FOR MEDICAL RESEARCH | NATIONAL INSTITUTE ON DEAFNESS AND OTHER COMMUNICATION DISORDERS | 2007 to 2011 |
Source NIH RePORTER
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Celecoxib vs Placebo: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00571701
GET https://conductscience.org/api/trials/v1/NCT00571701/registered