Trial Outcomes & Findings for Study of Celebrex (Celecoxib) in Patients With Recurrent Respiratory Papillomatosis (NCT NCT00571701)
NCT ID: NCT00571701
Last Updated: 2017-05-15
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
50 participants
Primary outcome timeframe
Baseline to 12 months
Results posted on
2017-05-15
Participant Flow
Patients were recruited from 7 participating sites throughout the U.S. (locations in NY, VA, SD, AL, CA, IA and TN) that had investigators experienced in the treatment of this disease.
Patients initially entered a 6 month pre-treatment observation period prior to randomization into the 2 treatment arms. 9 subjects did not start the treatment period and are therefore not included in demographics or the results sections.
Participant milestones
| Measure |
Celecoxib First (12 Months), Then Placebo (12 Months)
Patients randomized to start celecoxib 6 months after enrollment. Then cross over to placebo after 1 year. Celecoxib dosing will be given orally 400mg once a day for adults, 200 mg once a day for pediatric patients between 12-25kg, 100mg once a day for pediatric patients \< 12kg
celebrex (celecoxib): Adults: 400 mg daily Pediatrics: 100 mg daily for weight between 12-25 kg or 200 mg daily for weight \>25 kg
|
Placebo First (12 Months), Then Celecoxib (12 Months)
Patients randomized to start placebo 6 months after enrollment. One placebo capsule will be taken orally once a day. Placebo will match appearance of active celecoxib capsules. Cross over to 12 months of treatment with celecoxib after 1 year.
celebrex (celecoxib): Adults: 400 mg daily Pediatrics: 100 mg daily for weight between 12-25 kg or 200 mg daily for weight \>25 kg
|
|---|---|---|
|
First Intervention 12 Months
STARTED
|
19
|
22
|
|
First Intervention 12 Months
COMPLETED
|
16
|
21
|
|
First Intervention 12 Months
NOT COMPLETED
|
3
|
1
|
|
Second Intervention 12 Months
STARTED
|
16
|
21
|
|
Second Intervention 12 Months
COMPLETED
|
13
|
20
|
|
Second Intervention 12 Months
NOT COMPLETED
|
3
|
1
|
Reasons for withdrawal
| Measure |
Celecoxib First (12 Months), Then Placebo (12 Months)
Patients randomized to start celecoxib 6 months after enrollment. Then cross over to placebo after 1 year. Celecoxib dosing will be given orally 400mg once a day for adults, 200 mg once a day for pediatric patients between 12-25kg, 100mg once a day for pediatric patients \< 12kg
celebrex (celecoxib): Adults: 400 mg daily Pediatrics: 100 mg daily for weight between 12-25 kg or 200 mg daily for weight \>25 kg
|
Placebo First (12 Months), Then Celecoxib (12 Months)
Patients randomized to start placebo 6 months after enrollment. One placebo capsule will be taken orally once a day. Placebo will match appearance of active celecoxib capsules. Cross over to 12 months of treatment with celecoxib after 1 year.
celebrex (celecoxib): Adults: 400 mg daily Pediatrics: 100 mg daily for weight between 12-25 kg or 200 mg daily for weight \>25 kg
|
|---|---|---|
|
First Intervention 12 Months
Withdrawal by Subject
|
2
|
1
|
|
First Intervention 12 Months
Death
|
1
|
0
|
|
Second Intervention 12 Months
Adverse Event
|
0
|
1
|
|
Second Intervention 12 Months
Withdrawal by Subject
|
3
|
0
|
Baseline Characteristics
Study of Celebrex (Celecoxib) in Patients With Recurrent Respiratory Papillomatosis
Baseline characteristics by cohort
| Measure |
Celecoxib First, Then Placebo
n=19 Participants
Patients randomized to start celecoxib 6 months after enrollment. Then cross over to placebo after 1 year. Celecoxib dosing will be given orally 400mg once a day for adults, 200 mg once a day for pediatric patients between 12-25kg, 100mg once a day for pediatric patients \< 12kg
celebrex (celecoxib): Adults: 400 mg daily Pediatrics: 100 mg daily for weight between 12-25 kg or 200 mg daily for weight \>25 kg
|
Placebo First, Then Celecoxib
n=22 Participants
Patients randomized to start placebo 6 months after enrollment. One placebo capsule will be taken orally once a day. Placebo will match appearance of active celecoxib capsules. Cross over to 12 months of treatment with celecoxib after 1 year.
celebrex (celecoxib): Adults: 400 mg daily Pediatrics: 100 mg daily for weight between 12-25 kg or 200 mg daily for weight \>25 kg
|
Total
n=41 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Age < 20
|
9 participants
n=5 Participants
|
11 participants
n=7 Participants
|
20 participants
n=5 Participants
|
|
Age, Customized
Age 20 - < 40
|
3 participants
n=5 Participants
|
9 participants
n=7 Participants
|
12 participants
n=5 Participants
|
|
Age, Customized
Age 40 and above
|
7 participants
n=5 Participants
|
2 participants
n=7 Participants
|
9 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
16 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to 12 monthsPopulation: 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.
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.
Outcome measures
| Measure |
Celecoxib First, Then Placebo
n=16 Participants
Patients randomized to start celecoxib. Then cross over to placebo after 1 year. Celecoxib dosing will be given orally 400mg once a day for adults, 200 mg once a day for pediatric patients between 12-25kg, 100mg once a day for pediatric patients \< 12kg
celebrex (celecoxib): Adults: 400 mg daily Pediatrics: 100 mg daily for weight between 12-25 kg or 200 mg daily for weight \>25 kg
|
Placebo First, Then Celecoxib
n=21 Participants
Patients randomized to start placebo. One placebo capsule will be taken orally once a day. Placebo will match appearance of active celecoxib capsules. Cross over to 12 months of treatment with celecoxib after 1 year.
celebrex (celecoxib): Adults: 400 mg daily Pediatrics: 100 mg daily for weight between 12-25 kg or 200 mg daily for weight \>25 kg
|
Celecoxib First- Females
Females treated with celecoxib during the first treatment period
|
Placebo First- Females
Females treated with placebo during the first treatment period
|
|---|---|---|---|---|
|
Mean Percent Change in Papilloma Growth Rate at 12 Month Measurement Compared to Baseline
|
-5.4 percent change in mean growth rate
Standard Deviation 50.0
|
-15.2 percent change in mean growth rate
Standard Deviation 67.3
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsPopulation: 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 of patients with reduction in papilloma growth rate greater than 50% during the last 3 months of first treatment period compared to baseline
Outcome measures
| Measure |
Celecoxib First, Then Placebo
n=16 Participants
Patients randomized to start celecoxib. Then cross over to placebo after 1 year. Celecoxib dosing will be given orally 400mg once a day for adults, 200 mg once a day for pediatric patients between 12-25kg, 100mg once a day for pediatric patients \< 12kg
celebrex (celecoxib): Adults: 400 mg daily Pediatrics: 100 mg daily for weight between 12-25 kg or 200 mg daily for weight \>25 kg
|
Placebo First, Then Celecoxib
n=21 Participants
Patients randomized to start placebo. One placebo capsule will be taken orally once a day. Placebo will match appearance of active celecoxib capsules. Cross over to 12 months of treatment with celecoxib after 1 year.
celebrex (celecoxib): Adults: 400 mg daily Pediatrics: 100 mg daily for weight between 12-25 kg or 200 mg daily for weight \>25 kg
|
Celecoxib First- Females
Females treated with celecoxib during the first treatment period
|
Placebo First- Females
Females treated with placebo during the first treatment period
|
|---|---|---|---|---|
|
Percent of Patients With Positive Response to Treatment
|
12.5 percent responders
|
28.6 percent responders
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to12 monthsPopulation: 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 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
Outcome measures
| Measure |
Celecoxib First, Then Placebo
n=8 Participants
Patients randomized to start celecoxib. Then cross over to placebo after 1 year. Celecoxib dosing will be given orally 400mg once a day for adults, 200 mg once a day for pediatric patients between 12-25kg, 100mg once a day for pediatric patients \< 12kg
celebrex (celecoxib): Adults: 400 mg daily Pediatrics: 100 mg daily for weight between 12-25 kg or 200 mg daily for weight \>25 kg
|
Placebo First, Then Celecoxib
n=15 Participants
Patients randomized to start placebo. One placebo capsule will be taken orally once a day. Placebo will match appearance of active celecoxib capsules. Cross over to 12 months of treatment with celecoxib after 1 year.
celebrex (celecoxib): Adults: 400 mg daily Pediatrics: 100 mg daily for weight between 12-25 kg or 200 mg daily for weight \>25 kg
|
Celecoxib First- Females
n=8 Participants
Females treated with celecoxib during the first treatment period
|
Placebo First- Females
n=6 Participants
Females treated with placebo during the first treatment period
|
|---|---|---|---|---|
|
Effect of Gender on Percent of Patients With Reduction in Papilloma Growth Rate Greater Than 50%.
|
12.50 percent responders
|
40.00 percent responders
|
12.50 percent responders
|
0.00 percent responders
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsPopulation: 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.
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.
Outcome measures
| Measure |
Celecoxib First, Then Placebo
n=8 Participants
Patients randomized to start celecoxib. Then cross over to placebo after 1 year. Celecoxib dosing will be given orally 400mg once a day for adults, 200 mg once a day for pediatric patients between 12-25kg, 100mg once a day for pediatric patients \< 12kg
celebrex (celecoxib): Adults: 400 mg daily Pediatrics: 100 mg daily for weight between 12-25 kg or 200 mg daily for weight \>25 kg
|
Placebo First, Then Celecoxib
n=13 Participants
Patients randomized to start placebo. One placebo capsule will be taken orally once a day. Placebo will match appearance of active celecoxib capsules. Cross over to 12 months of treatment with celecoxib after 1 year.
celebrex (celecoxib): Adults: 400 mg daily Pediatrics: 100 mg daily for weight between 12-25 kg or 200 mg daily for weight \>25 kg
|
Celecoxib First- Females
n=8 Participants
Females treated with celecoxib during the first treatment period
|
Placebo First- Females
n=6 Participants
Females treated with placebo during the first treatment period
|
|---|---|---|---|---|
|
Effect of Juvenile Versus Adult Disease Onset on Percent of Patients With Reduction in Papilloma Growth Rate Greater Than 50%.
|
12.50 percentage of responders
|
7.69 percentage of responders
|
12.50 percentage of responders
|
33.33 percentage of responders
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsPopulation: 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 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.
Outcome measures
| Measure |
Celecoxib First, Then Placebo
n=11 Participants
Patients randomized to start celecoxib. Then cross over to placebo after 1 year. Celecoxib dosing will be given orally 400mg once a day for adults, 200 mg once a day for pediatric patients between 12-25kg, 100mg once a day for pediatric patients \< 12kg
celebrex (celecoxib): Adults: 400 mg daily Pediatrics: 100 mg daily for weight between 12-25 kg or 200 mg daily for weight \>25 kg
|
Placebo First, Then Celecoxib
n=14 Participants
Patients randomized to start placebo. One placebo capsule will be taken orally once a day. Placebo will match appearance of active celecoxib capsules. Cross over to 12 months of treatment with celecoxib after 1 year.
celebrex (celecoxib): Adults: 400 mg daily Pediatrics: 100 mg daily for weight between 12-25 kg or 200 mg daily for weight \>25 kg
|
Celecoxib First- Females
n=4 Participants
Females treated with celecoxib during the first treatment period
|
Placebo First- Females
n=5 Participants
Females treated with placebo during the first treatment period
|
|---|---|---|---|---|
|
Effect of HPV 6 Versus HPV 11 on Percent of Patients With Reduction in Papilloma Growth Rate Greater Than 50%
|
9.09 percent of responders
|
42.86 percent of responders
|
25.00 percent of responders
|
0.00 percent of responders
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsPopulation: 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.
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.
Outcome measures
| Measure |
Celecoxib First, Then Placebo
n=2 Participants
Patients randomized to start celecoxib. Then cross over to placebo after 1 year. Celecoxib dosing will be given orally 400mg once a day for adults, 200 mg once a day for pediatric patients between 12-25kg, 100mg once a day for pediatric patients \< 12kg
celebrex (celecoxib): Adults: 400 mg daily Pediatrics: 100 mg daily for weight between 12-25 kg or 200 mg daily for weight \>25 kg
|
Placebo First, Then Celecoxib
n=14 Participants
Patients randomized to start placebo. One placebo capsule will be taken orally once a day. Placebo will match appearance of active celecoxib capsules. Cross over to 12 months of treatment with celecoxib after 1 year.
celebrex (celecoxib): Adults: 400 mg daily Pediatrics: 100 mg daily for weight between 12-25 kg or 200 mg daily for weight \>25 kg
|
Celecoxib First- Females
Females treated with celecoxib during the first treatment period
|
Placebo First- Females
Females treated with placebo during the first treatment period
|
|---|---|---|---|---|
|
Correlation Between Mean Plasma Level of Celecoxib and Response.
|
151.3 pg. celecoxib/ml. plasma
Interval 126.6 to 176.0
|
543.41 pg. celecoxib/ml. plasma
Interval 10.0 to 2422.5
|
—
|
—
|
SECONDARY outcome
Timeframe: End of first treatment period (month 12) to end of second treatment period (month 24)Population: 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 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.
Outcome measures
| Measure |
Celecoxib First, Then Placebo
n=2 Participants
Patients randomized to start celecoxib. Then cross over to placebo after 1 year. Celecoxib dosing will be given orally 400mg once a day for adults, 200 mg once a day for pediatric patients between 12-25kg, 100mg once a day for pediatric patients \< 12kg
celebrex (celecoxib): Adults: 400 mg daily Pediatrics: 100 mg daily for weight between 12-25 kg or 200 mg daily for weight \>25 kg
|
Placebo First, Then Celecoxib
Patients randomized to start placebo. One placebo capsule will be taken orally once a day. Placebo will match appearance of active celecoxib capsules. Cross over to 12 months of treatment with celecoxib after 1 year.
celebrex (celecoxib): Adults: 400 mg daily Pediatrics: 100 mg daily for weight between 12-25 kg or 200 mg daily for weight \>25 kg
|
Celecoxib First- Females
Females treated with celecoxib during the first treatment period
|
Placebo First- Females
Females treated with placebo during the first treatment period
|
|---|---|---|---|---|
|
Maintenance of Response Following Discontinuation of Celecoxib
|
100 percent of patients
|
—
|
—
|
—
|
Adverse Events
Celecoxib
Serious events: 3 serious events
Other events: 16 other events
Deaths: 0 deaths
Placebo
Serious events: 2 serious events
Other events: 18 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Celecoxib
n=40 participants at risk
Patients who received celecoxib for 12 months during either time period
|
Placebo
n=39 participants at risk
Patients who received placebo for 12 months during either time period
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
death
|
2.5%
1/40 • Number of events 1 • AE reporting included all subjects who received at least three doses of study intervention. AE reporting was done throughout the entire 2 year period after randomization and also included up to approximately 30 days after the last dose of study drug was taken.
|
0.00%
0/39 • AE reporting included all subjects who received at least three doses of study intervention. AE reporting was done throughout the entire 2 year period after randomization and also included up to approximately 30 days after the last dose of study drug was taken.
|
|
Respiratory, thoracic and mediastinal disorders
pneumonia
|
5.0%
2/40 • AE reporting included all subjects who received at least three doses of study intervention. AE reporting was done throughout the entire 2 year period after randomization and also included up to approximately 30 days after the last dose of study drug was taken.
|
2.6%
1/39 • AE reporting included all subjects who received at least three doses of study intervention. AE reporting was done throughout the entire 2 year period after randomization and also included up to approximately 30 days after the last dose of study drug was taken.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
palpable lymph node
|
2.5%
1/40 • AE reporting included all subjects who received at least three doses of study intervention. AE reporting was done throughout the entire 2 year period after randomization and also included up to approximately 30 days after the last dose of study drug was taken.
|
0.00%
0/39 • AE reporting included all subjects who received at least three doses of study intervention. AE reporting was done throughout the entire 2 year period after randomization and also included up to approximately 30 days after the last dose of study drug was taken.
|
|
Respiratory, thoracic and mediastinal disorders
influenza
|
0.00%
0/40 • AE reporting included all subjects who received at least three doses of study intervention. AE reporting was done throughout the entire 2 year period after randomization and also included up to approximately 30 days after the last dose of study drug was taken.
|
2.6%
1/39 • AE reporting included all subjects who received at least three doses of study intervention. AE reporting was done throughout the entire 2 year period after randomization and also included up to approximately 30 days after the last dose of study drug was taken.
|
Other adverse events
| Measure |
Celecoxib
n=40 participants at risk
Patients who received celecoxib for 12 months during either time period
|
Placebo
n=39 participants at risk
Patients who received placebo for 12 months during either time period
|
|---|---|---|
|
Gastrointestinal disorders
abdominal pain
|
10.0%
4/40 • AE reporting included all subjects who received at least three doses of study intervention. AE reporting was done throughout the entire 2 year period after randomization and also included up to approximately 30 days after the last dose of study drug was taken.
|
12.8%
5/39 • AE reporting included all subjects who received at least three doses of study intervention. AE reporting was done throughout the entire 2 year period after randomization and also included up to approximately 30 days after the last dose of study drug was taken.
|
|
Gastrointestinal disorders
nausea or vomiting
|
5.0%
2/40 • AE reporting included all subjects who received at least three doses of study intervention. AE reporting was done throughout the entire 2 year period after randomization and also included up to approximately 30 days after the last dose of study drug was taken.
|
12.8%
5/39 • AE reporting included all subjects who received at least three doses of study intervention. AE reporting was done throughout the entire 2 year period after randomization and also included up to approximately 30 days after the last dose of study drug was taken.
|
|
Respiratory, thoracic and mediastinal disorders
non-cardiac chest discomfort
|
10.0%
4/40 • AE reporting included all subjects who received at least three doses of study intervention. AE reporting was done throughout the entire 2 year period after randomization and also included up to approximately 30 days after the last dose of study drug was taken.
|
10.3%
4/39 • AE reporting included all subjects who received at least three doses of study intervention. AE reporting was done throughout the entire 2 year period after randomization and also included up to approximately 30 days after the last dose of study drug was taken.
|
|
Respiratory, thoracic and mediastinal disorders
upper respiratory infection
|
17.5%
7/40 • AE reporting included all subjects who received at least three doses of study intervention. AE reporting was done throughout the entire 2 year period after randomization and also included up to approximately 30 days after the last dose of study drug was taken.
|
23.1%
9/39 • AE reporting included all subjects who received at least three doses of study intervention. AE reporting was done throughout the entire 2 year period after randomization and also included up to approximately 30 days after the last dose of study drug was taken.
|
|
General disorders
pyrexia
|
5.0%
2/40 • AE reporting included all subjects who received at least three doses of study intervention. AE reporting was done throughout the entire 2 year period after randomization and also included up to approximately 30 days after the last dose of study drug was taken.
|
12.8%
5/39 • AE reporting included all subjects who received at least three doses of study intervention. AE reporting was done throughout the entire 2 year period after randomization and also included up to approximately 30 days after the last dose of study drug was taken.
|
|
Gastrointestinal disorders
diarrhea
|
10.0%
4/40 • AE reporting included all subjects who received at least three doses of study intervention. AE reporting was done throughout the entire 2 year period after randomization and also included up to approximately 30 days after the last dose of study drug was taken.
|
7.7%
3/39 • AE reporting included all subjects who received at least three doses of study intervention. AE reporting was done throughout the entire 2 year period after randomization and also included up to approximately 30 days after the last dose of study drug was taken.
|
Additional Information
Dr. Bettie Steinberg
Northwell Health (previously known as NorthShore-LIJ Health System)
Phone: 516-562-1159
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place