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| Name | Class |
|---|---|
| University of North Dakota | OTHER |
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The purpose of this study is to determine the difference, if any, in the area under the sertraline plasma level time curve (AUC) between patients who are nine to fifteen months post Roux-en-Y Bariatric Surgery and control subjects matched for body mass index (BMI), age and gender.
Secondary objectives include the determination of changes in mean CPmax, Time to CPmax and Volume of Distribution between the two groups. Also, assessment of subject tolerance of sertraline utilizing the UKU side effect rating scale.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Post bariatric surgery | Experimental | Roux en Y bariatric surgery |
|
| Control | Other | No surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bariatric surgery | Procedure | Roux en Y bariatric surgery |
| |
| Measure | Description | Time Frame |
|---|---|---|
| AUC Post Surgery (n =5) Compared to AUC Control (n=5) | AUC of surgery group compared to the AUC of control group | 0, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 3.5, 4.5, 6.5, 8.5, 10.5 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| James Roerig, PharmD, BCPP | Neuropsychiatric Research Institute and University of North Dakota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Neuropsychiatric Research Institute | Fargo | North Dakota | 58103 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Experimental | Post surgery group Sertraline : Single dose of 100mg sertraline |
| FG001 | Control Group | active drug No surgery matched subjects |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Active Drug | Single arm study, all receive active drug Sertraline : Single dose of 100mg sertraline |
| Units | Counts |
|---|---|
| Participants |
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| 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 | AUC Post Surgery (n =5) Compared to AUC Control (n=5) | AUC of surgery group compared to the AUC of control group | Per protocol | Posted | Mean | Standard Deviation | ng-hr/mL | 0, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 3.5, 4.5, 6.5, 8.5, 10.5 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 | Active Drug | Two arm study, all receive active drug Sertraline : Single dose of 100mg sertraline |
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small sample size absence of men in either group. short data collection period, characterization of the linear elimination phase of the AUC was not possible.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| James L. Roerig PharmD, BCPP | University of North Dakota - Neuropsychiatric Research Institute | 701 365 4919 | jroerig@nrifargo.com |
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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 |
|---|---|
| D050110 | Bariatric Surgery |
| ID | Term |
|---|---|
| D049088 | Bariatrics |
| D000073319 | Obesity Management |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
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| control |
| Other |
No surgery |
|
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 0 |
| 10 |
| 0 |
| 10 |
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |