Trial Outcomes & Findings for Celecoxib Inhibition of Aromatase Expression and Inflammation in Adipose Tissue of Obese Postmenopausal Women (NCT NCT01901679)
NCT ID: NCT01901679
Last Updated: 2021-02-01
Results Overview
Study endpoint is a reduction in PGE-M in urine after treatment with celebrex
Recruitment status
COMPLETED
Study phase
EARLY_PHASE1
Target enrollment
10 participants
Primary outcome timeframe
10 days
Results posted on
2021-02-01
Participant Flow
Recruitment was conducted during 2 outpatient visits at Rockefeller University Hospital outpatient clinic. Recruitment of subjects began on 6/10/13 and was completed on 6/30/14.
All participants were screened for their usual dietary intake and instructed to continue to follow their usual diet during weeks prior to hospital admission and thoughout the entire study. . First group underwent 3 day run-in period inpatient, the second group underwent 14 day run-in period prior to starting Celecoxib 200mg po BID X 10 days.
Participant milestones
| Measure |
1st Group: 3 Day run-in Period
After 3 day run-in period, participants underwent baseline testing then started 10 days of Celecoxib 200mg po BID. Follow-up blood and stool collection was performed as outpatients 7-10 days after discharge.
|
2nd Group: 14 Day run-in Period
After 14 day run-in period, participants underwent baseline testing then started 10 days of Celecoxib 200mg po BID. Follow-up blood and stool collection was performed as outpatients 7-10 days after discharge.
|
|---|---|---|
|
Overall Study
STARTED
|
5
|
5
|
|
Overall Study
COMPLETED
|
5
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Celecoxib Inhibition of Aromatase Expression and Inflammation in Adipose Tissue of Obese Postmenopausal Women
Baseline characteristics by cohort
| Measure |
3 Day run-in Period
n=5 Participants
After 3 day run-in period, participants underwent baseline testing then started 10 days of Celecoxib 200mg po BID. Follow-up blood and stool collection was performed as outpatients 7-10 days after discharge.
|
14 Day run-in Period
n=5 Participants
After 14 day run-in period, participants underwent baseline testing then started 10 days of Celecoxib 200mg po BID. Follow-up blood and stool collection was performed as outpatients 7-10 days after discharge.
|
Total
n=10 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62 years
n=5 Participants
|
56 years
n=7 Participants
|
59 years
n=5 Participants
|
|
Sex/Gender, Customized
Female
|
5 participants
n=5 Participants
|
5 participants
n=7 Participants
|
10 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
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
|
Region of Enrollment
United States
|
5 participants
n=5 Participants
|
5 participants
n=7 Participants
|
10 participants
n=5 Participants
|
|
BMI
|
40.2 kg/m^2
n=5 Participants
|
39.7 kg/m^2
n=7 Participants
|
40.0 kg/m^2
n=5 Participants
|
PRIMARY outcome
Timeframe: 10 daysPopulation: These samples were collected but not analyzed due to technical reasons. Investigator has retired and access to results was not available for this outcome. Best efforts were made to obtain the data; however, they were unsuccessful.
Study endpoint is a reduction in PGE-M in urine after treatment with celebrex
Outcome measures
Outcome data not reported
Adverse Events
1st Group: 3 Day run-in Period
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
2nd Group: 14 Day run-in Period
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
1st Group: 3 Day run-in Period
n=5 participants at risk
After 3 day run-in period, participants underwent baseline testing then started 10 days of Celecoxib 200mg po BID. Follow-up blood and stool collection was performed as outpatients 7-10 days after discharge.
|
2nd Group: 14 Day run-in Period
n=5 participants at risk
After 14 day run-in period, participants underwent baseline testing then started 10 days of Celecoxib 200mg po BID. Follow-up blood and stool collection was performed as outpatients 7-10 days after discharge.
|
|---|---|---|
|
Injury, poisoning and procedural complications
hemorrhage
|
20.0%
1/5 • Number of events 1 • Collected during inpatient phase of study, an average of 14 days for 3 day run-in period or 24 days for 14 day run-in period
AE's were reported when discovered. Reports were from investigator assessment, nursing assessment and patient complaints. All AE's were documented and submitted to the IRBand PI as per protocol.
|
0.00%
0/5 • Collected during inpatient phase of study, an average of 14 days for 3 day run-in period or 24 days for 14 day run-in period
AE's were reported when discovered. Reports were from investigator assessment, nursing assessment and patient complaints. All AE's were documented and submitted to the IRBand PI as per protocol.
|
Other adverse events
| Measure |
1st Group: 3 Day run-in Period
n=5 participants at risk
After 3 day run-in period, participants underwent baseline testing then started 10 days of Celecoxib 200mg po BID. Follow-up blood and stool collection was performed as outpatients 7-10 days after discharge.
|
2nd Group: 14 Day run-in Period
n=5 participants at risk
After 14 day run-in period, participants underwent baseline testing then started 10 days of Celecoxib 200mg po BID. Follow-up blood and stool collection was performed as outpatients 7-10 days after discharge.
|
|---|---|---|
|
Injury, poisoning and procedural complications
bruise at biopsy site
|
40.0%
2/5 • Number of events 2 • Collected during inpatient phase of study, an average of 14 days for 3 day run-in period or 24 days for 14 day run-in period
AE's were reported when discovered. Reports were from investigator assessment, nursing assessment and patient complaints. All AE's were documented and submitted to the IRBand PI as per protocol.
|
80.0%
4/5 • Number of events 4 • Collected during inpatient phase of study, an average of 14 days for 3 day run-in period or 24 days for 14 day run-in period
AE's were reported when discovered. Reports were from investigator assessment, nursing assessment and patient complaints. All AE's were documented and submitted to the IRBand PI as per protocol.
|
|
Skin and subcutaneous tissue disorders
burn
|
20.0%
1/5 • Number of events 1 • Collected during inpatient phase of study, an average of 14 days for 3 day run-in period or 24 days for 14 day run-in period
AE's were reported when discovered. Reports were from investigator assessment, nursing assessment and patient complaints. All AE's were documented and submitted to the IRBand PI as per protocol.
|
0.00%
0/5 • Collected during inpatient phase of study, an average of 14 days for 3 day run-in period or 24 days for 14 day run-in period
AE's were reported when discovered. Reports were from investigator assessment, nursing assessment and patient complaints. All AE's were documented and submitted to the IRBand PI as per protocol.
|
|
Cardiac disorders
atypical chest pain
|
20.0%
1/5 • Number of events 1 • Collected during inpatient phase of study, an average of 14 days for 3 day run-in period or 24 days for 14 day run-in period
AE's were reported when discovered. Reports were from investigator assessment, nursing assessment and patient complaints. All AE's were documented and submitted to the IRBand PI as per protocol.
|
0.00%
0/5 • Collected during inpatient phase of study, an average of 14 days for 3 day run-in period or 24 days for 14 day run-in period
AE's were reported when discovered. Reports were from investigator assessment, nursing assessment and patient complaints. All AE's were documented and submitted to the IRBand PI as per protocol.
|
|
Investigations
elevated serum cholesterol
|
0.00%
0/5 • Collected during inpatient phase of study, an average of 14 days for 3 day run-in period or 24 days for 14 day run-in period
AE's were reported when discovered. Reports were from investigator assessment, nursing assessment and patient complaints. All AE's were documented and submitted to the IRBand PI as per protocol.
|
20.0%
1/5 • Number of events 1 • Collected during inpatient phase of study, an average of 14 days for 3 day run-in period or 24 days for 14 day run-in period
AE's were reported when discovered. Reports were from investigator assessment, nursing assessment and patient complaints. All AE's were documented and submitted to the IRBand PI as per protocol.
|
|
Investigations
elevated ALT
|
0.00%
0/5 • Collected during inpatient phase of study, an average of 14 days for 3 day run-in period or 24 days for 14 day run-in period
AE's were reported when discovered. Reports were from investigator assessment, nursing assessment and patient complaints. All AE's were documented and submitted to the IRBand PI as per protocol.
|
20.0%
1/5 • Number of events 1 • Collected during inpatient phase of study, an average of 14 days for 3 day run-in period or 24 days for 14 day run-in period
AE's were reported when discovered. Reports were from investigator assessment, nursing assessment and patient complaints. All AE's were documented and submitted to the IRBand PI as per protocol.
|
|
Gastrointestinal disorders
GI Bloating and constipation
|
0.00%
0/5 • Collected during inpatient phase of study, an average of 14 days for 3 day run-in period or 24 days for 14 day run-in period
AE's were reported when discovered. Reports were from investigator assessment, nursing assessment and patient complaints. All AE's were documented and submitted to the IRBand PI as per protocol.
|
20.0%
1/5 • Number of events 1 • Collected during inpatient phase of study, an average of 14 days for 3 day run-in period or 24 days for 14 day run-in period
AE's were reported when discovered. Reports were from investigator assessment, nursing assessment and patient complaints. All AE's were documented and submitted to the IRBand PI as per protocol.
|
|
Respiratory, thoracic and mediastinal disorders
sore throat and dry cough
|
0.00%
0/5 • Collected during inpatient phase of study, an average of 14 days for 3 day run-in period or 24 days for 14 day run-in period
AE's were reported when discovered. Reports were from investigator assessment, nursing assessment and patient complaints. All AE's were documented and submitted to the IRBand PI as per protocol.
|
20.0%
1/5 • Number of events 1 • Collected during inpatient phase of study, an average of 14 days for 3 day run-in period or 24 days for 14 day run-in period
AE's were reported when discovered. Reports were from investigator assessment, nursing assessment and patient complaints. All AE's were documented and submitted to the IRBand PI as per protocol.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place