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| Name | Class |
|---|---|
| Christiana Care Health Services | OTHER |
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The purpose of this study is to determine if the drug Celebrex changes the way the kidney gets rid of salt and maintains blood pressure.
There have been many studies done with analgesics such as acetaminophen and non-steroidal anti-inflammatory drugs; however it is not understood how blood pressure changes while using Celebrex. The study hypothesis is that Celebrex will increase salt sensitivity of blood pressure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Celebrex; Low sodium | Experimental | Subject completes a normal sodium diet (3 days), a low salt diet (7 days), followed by a high salt diet (7 days) while taking a celebrex pill (100 mg twice a day for 17 day trial), randomized for trial order (drug versus placebo) and sodium diet order (low versus high sodium). |
|
| Celebrex, High Sodium | Experimental | Subject completes a normal sodium diet (3 days), a high salt diet (7 days), followed by a low salt diet (7 days) while taking a celebrex pill (100 mg twice a day for 17 day trial), randomized for trial order (drug versus placebo) and sodium diet order (low versus high sodium). |
|
| Placebo, Low Sodium | Placebo Comparator | Subject completes a normal sodium diet (3 days), a low salt diet (7 days), followed by a high salt diet (7 days) while taking a placebo pill (twice a day for 17 day trial), randomized for trial order (drug versus placebo) and sodium diet order (low versus high sodium). |
|
| Placebo, High Sodium | Placebo Comparator | Subject completes a normal sodium diet (3 days), a high salt diet (7 days), followed by a low salt diet (7 days) while taking a placebo pill (twice a day for 17 day trial), randomized for trial order (drug versus placebo) and sodium diet order (low versus high sodium). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| celecoxib (Celebrex) | Drug | Celecoxib (Celebrex) was administered at 100 mg, twice per day for each day of sodium diet |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Arterial Pressure | Blood pressure was measured on the last day of each 7 day sodium diet for 24 hours using an ambulatory blood pressure monitor | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Urinary Sodium Excretion | Urine collected over 24 hour period on last day of each different sodium diet | 24 hour |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| William B Farquhar, PhD | University of Delaware | Principal Investigator |
| Michael Stillabower, MD | Christiana Care Health Services | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Delaware | Newark | Delaware | 19716 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Celebrex, High Sodium | Each subject completes a normal sodium diet (3 days), a high salt diet (7 days), and a low salt diet (7 days) while taking either a placebo or celebrex (each trial is 17 days long). Each subject completes 2 full 17 day trials (one month 'washout' between each trial); one time taking the placebo and one taking celebrex (randomized). |
| FG001 | Celebrex, Low Sodium | 100 mg Celebrex, twice per day for 7 days on low sodium diet |
| FG002 | Placebo, Low Sodium | Placebo pill taken twice per day over the course of the diet |
| FG003 | Placebo, High Sodium | Placebo pill taken twice per day over the course of the diet |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Celebrex, High Sodium | Each subject completes a normal sodium diet (3 days), a high salt diet (7 days), and a low salt diet (7 days) while taking either a placebo or celebrex (each trial is 17 days long). Each subject completes 2 full 17 day trials (one month 'washout' between each trial); one time taking the placebo and one taking celebrex (randomized). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Mean Arterial Pressure | Blood pressure was measured on the last day of each 7 day sodium diet for 24 hours using an ambulatory blood pressure monitor | Posted | Mean | Standard Error | mm Hg | 24 hours |
|
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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 | Celebrex, High Sodium | Each subject completes a normal sodium diet (3 days), a high salt diet (7 days), and a low salt diet (7 days) while taking either a placebo or celebrex (each trial is 17 days long). Each subject completes 2 full 17 day trials (one month 'washout' between each trial); one time taking the placebo and one taking celebrex (randomized). |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. William Farquhar | University of Delaware | 302-831-6178 | wbf@udel.edu |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000068579 | Celecoxib |
| ID | Term |
|---|---|
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
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|
| Placebo | Other | Placebo pill taken twice per day on each day of the diet |
|
| BG001 |
| Celebrex, Low Sodium |
100 mg Celebrex, twice per day for 7 days on low sodium diet |
| BG002 | Placebo, Low Sodium | Placebo pill taken twice per day over the course of the diet |
| BG003 | Placebo, High Sodium | Placebo pill taken twice per day over the course of the diet |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG003 | Placebo, High Sodium Diet | Blood pressure taken with an ambulatory blood pressure monitor, over 24 hours on the last day of the high sodium diet |
|
|
| Secondary | Urinary Sodium Excretion | Urine collected over 24 hour period on last day of each different sodium diet | Posted | Mean | Standard Error | mmol Na+/24 hr | 24 hour |
|
|
|
| 0 |
| 3 |
| 0 |
| 3 |
| EG001 | Celebrex, Low Sodium | 100 mg Celebrex, twice per day for 7 days on low sodium diet | 0 | 3 | 0 | 3 |
| EG002 | Placebo, Low Sodium | Placebo pill taken twice per day over the course of the diet | 0 | 3 | 0 | 3 |
| EG003 | Placebo, High Sodium | Placebo pill taken twice per day over the course of the diet | 0 | 3 | 0 | 3 |
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| 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 |