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| Name | Class |
|---|---|
| University of North Dakota | OTHER |
| Eli Lilly and Company | INDUSTRY |
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This study aims to determine the difference, if any, in the pharmacokinetics of duloxetine 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active drug | Experimental | All subjects received drug. Single arm. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Duloxetine | Drug | Single dose of 60 mg of duloxetine |
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| Measure | Description | Time Frame |
|---|---|---|
| Cmax | The difference, if any, in the pharmacokinetics parameters (Cmax) of duloxetine between patients who are nine to fifteen months post Roux-en-Y Bariatric Surgery and control subjects matched for BMI, age and gender. | 0, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2.25, 2.5, 3.5, 4.5, 6.5, 8.5, 10.5, 24, 48. 72 |
| Tmax | Time to maximum plasma concentration | 0, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2.25, 2.5, 3.5, 4.5, 6.5, 8.5, 10.5, 24, 48. 72 |
| AUCo-inf, | Area under the plasma concentration time curve | 0, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2.25, 2.5, 3.5, 4.5, 6.5, 8.5, 10.5, 24, 48. 72 |
| T1/2 | Half life | 0, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2.25, 2.5, 3.5, 4.5, 6.5, 8.5, 10.5, 24, 48. 72 |
| Measure | Description | Time Frame |
|---|---|---|
| Emesis | episodes of emesis. | 4 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| James L 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 | Control | Matched to bariatric subject via BMI, age and gender |
| FG001 | Bariatric | One year post surgery |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Available Bariatric surgery candidates and pilot study results.
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| ID | Title | Description |
|---|---|---|
| BG000 | Bariatric | Subjects 1 year post bariatric surgery 9 to 15 months post-RYGBP |
| BG001 | Control | Subjects matched to the bariatric subjects via BMI, age and gender |
| 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, 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 | Cmax | The difference, if any, in the pharmacokinetics parameters (Cmax) of duloxetine between patients who are nine to fifteen months post Roux-en-Y Bariatric Surgery and control subjects matched for BMI, age and gender. | Posted | Mean | Standard Deviation | ng/ml | 0, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2.25, 2.5, 3.5, 4.5, 6.5, 8.5, 10.5, 24, 48. 72 |
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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 | Bariatric | Subjects 1 year post bariatric surgery 9 to 15 months post-RYGBP |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Emesis | Gastrointestinal disorders | Emesis | Systematic Assessment | Emesis post drug ingestion |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. James Roerig | NRIFargo | 701 365 4919 | jroerig@nrifargo.com |
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| ID | Term |
|---|---|
| D000068736 | Duloxetine Hydrochloride |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D006573 | Heterocyclic Compounds, 1-Ring |
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| BG002 | Total | Total of all reporting groups |
| 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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| Units | Counts |
|---|---|
| Participants |
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| Secondary | Emesis | episodes of emesis. | Posted | Number | number of occurences | 4 days |
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| Primary | Tmax | Time to maximum plasma concentration | Posted | Mean | Standard Deviation | Hours | 0, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2.25, 2.5, 3.5, 4.5, 6.5, 8.5, 10.5, 24, 48. 72 |
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|
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| Primary | AUCo-inf, | Area under the plasma concentration time curve | Posted | Mean | Standard Deviation | ng h/mL | 0, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2.25, 2.5, 3.5, 4.5, 6.5, 8.5, 10.5, 24, 48. 72 |
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| Primary | T1/2 | Half life | Posted | Mean | Standard Deviation | hours | 0, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2.25, 2.5, 3.5, 4.5, 6.5, 8.5, 10.5, 24, 48. 72 |
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| 0 |
| 10 |
| 2 |
| 10 |
| EG001 | Control | Subjects matched to the bariatric subjects via BMI, age and gender | 0 | 10 | 3 | 10 |
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| D006571 |
| Heterocyclic Compounds |