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The study plans to find out whether Celebrex may be potentially useful to decrease inflammation in fat tissues and thereby lower the production of substances such as estrogens that may increase the risk of developing breast cancer and lead to a poor outcome of the disease.
This study seeks to examine how effective the celebrex may be in reducing inflammation, crown-like structures in fat tissue, the enzyme aromatase, PGE-M in the urine and estrogen in blood and urine. Volunteer subjects will be expected to stay in the hospital for about 2 weeks taking Celebrex for approximately 10 days while eating a diet similar to what they consumed before coming into the hospital for the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Celebrex | Experimental | 10 days treatment with Celebrex to evaluate reduction of PGE-M in urine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Celebrex | Drug | 200 mg PO BID |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| To Determine Whether Oral Administration of Celebrex to Obese Women Will Reduce the PGE-M in Urine | Study endpoint is a reduction in PGE-M in urine after treatment with celebrex | 10 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter Holt, MD | Rockefeller University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Rockefeller University | New York | New York | 10065 | United States |
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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 14 Day run-in Period |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | To Determine Whether Oral Administration of Celebrex to Obese Women Will Reduce the PGE-M in Urine | Study endpoint is a reduction in PGE-M in urine after treatment with celebrex | 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. | Posted | 10 days |
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| hemorrhage | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment | During abdominal fat biopsy procedure, there was moderate bleeding from the site. Procedure was stopped, and the bleeding ceased. Subject was stable and recovered promptly, but was monitored for an additional day for safety. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| bruise at biopsy site | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment | Due to the pinching of abdominal fat during the fat biopsy, a resultant bruise medial to the incision is common and expected. It resolved within 3-4 days and well tolerated. The risk is addressed in the informed consent. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Peter R Holt | The Rockefeller University | 212-327-7706 | holtp@rockefeller.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 12, 2017 | Sep 29, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000068579 | Celecoxib |
| ID | Term |
|---|---|
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
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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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex/Gender, Customized | Number | participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| BMI | Mean | Full Range | kg/m^2 |
|
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. |
|
| 0 |
| 5 |
| 1 |
| 5 |
| 2 |
| 5 |
| EG001 | 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. | 0 | 5 | 0 | 5 | 4 | 5 |
|
|
| burn | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment | Participant spilled hot tea on her chest wall resulting in 1st degree scald burn of her upper chest. |
|
| atypical chest pain | Cardiac disorders | CTCAE (4.0) | Systematic Assessment | Subject complained of chest pain after burning her skin with hot tea. |
|
| elevated serum cholesterol | Investigations | CTCAE (4.0) | Systematic Assessment | Subjet had history of hypercholesteremia. She stopped taking statin medication prescribed by PMD. Cholesterol level increased. PMD was informed and given test results. |
|
| elevated ALT | Investigations | CTCAE (4.0) | Systematic Assessment | After 10 days on celecoxib, subject had mild elevation in ALT |
|
| GI Bloating and constipation | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment | Subject complained of bloating and constipation. |
|
| sore throat and dry cough | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment | Subject complained of sore throat and dry cough after a group gathering. Afebrile. |
|
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001555 |
| Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011720 | Pyrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |