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This research is to determine which medication, Zegerid (Omeprazole/Sodium Bicarbonate) or Pepcid AC (Famotidine), works best at reducing the chance that a patient will get an ulcer after gastric bypass surgery.
The purpose of this research is to evaluate information about the control of gastric acid in post gastric bypass surgery patients. Goal is to determine which medication best reduces the incidence of anastomotic ulcers post-operatively.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Omeprazole | Active Comparator | 40 mg Omeprazole daily |
|
| Famotidine | Active Comparator | 40 mg Famotidine daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Omeprazole | Drug | 40mg dose administered as a suspension or capsule as physician directs daily at bedtime for 14 weeks beginning day of hospital discharge following gastric bypass surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Complaints, Specifically About Pain, Vomiting, Dyspepsia, and/or Dysphagia. | during first 14 weeks after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Upper Endoscopy Indicated Due to Complaints | Endoscopic visualization of presence or absence of anastomotic ulcers if upper endoscopy indicated due to patient complaints - based upon severity of complaints | during first 14 weeks after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Roger de la Torre, MD | University of Missouri-Columbia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Missouri Health Care | Columbia | Missouri | 65212 | United States |
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While study participants were enrolled prior to their RYGB, they did not begin the study drug until after discharge from the hospital post-RYGB. During that time some patients were excluded, whether it was because the patient's surgery was cancelled or because the patient no longer met the inclusion/exclusion criteria.
Study participants were recruited from patients preparing for Roux-en-Y gastric bypass (RYGB) at Missouri Bariatric Services, the bariatric clinic associated with University of Missouri. Patients were recruited from November 2006 through November 2007.
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| ID | Title | Description |
|---|---|---|
| FG000 | Omeprazole | 40 mg daily at bedtime for 14 weeks |
| FG001 | Famotidine | 40 mg daily at bedtime for 14 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Omeprazole | 40 mg daily for 14 weeks |
| BG001 | Famotidine | 40 mg daily for 14 weeks |
| 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 | Number of Participants With Complaints, Specifically About Pain, Vomiting, Dyspepsia, and/or Dysphagia. | Patients lost to follow-up were not included in the data analysis. | Posted | Number | participants | during first 14 weeks after surgery |
|
|
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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 | Omeprazole | 40 mg daily for 14 weeks |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Archana Ramaswamy, MD | University of Missouri | 573-884-4003 | ramaswamya@health.missouri.edu |
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| ID | Term |
|---|---|
| D010437 | Peptic Ulcer |
| D011183 | Postoperative Complications |
| ID | Term |
|---|---|
| D004378 | Duodenal Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D009853 | Omeprazole |
| C494109 | omeprazole, sodium bicarbonate drug combination |
| D015738 | Famotidine |
| ID | Term |
|---|---|
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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|
| Famotidine | Drug | 40mg dose administered as a suspension or capsule as physician directs daily at bedtime for 14 weeks beginning day of hospital discharge following gastric bypass surgery. |
|
|
| BG002 |
| Total |
Total of all reporting groups |
| Participants |
|
| Sex/Gender, Customized | Gender information is missing for the Famotidine arm. | Number | participants |
|
| Region of Enrollment | Number | participants |
|
| Participants |
|
|
| Secondary | Number of Participants With Upper Endoscopy Indicated Due to Complaints | Endoscopic visualization of presence or absence of anastomotic ulcers if upper endoscopy indicated due to patient complaints - based upon severity of complaints | Patients lost to follow-up were not included in the study analysis. | Posted | Number | participants | during first 14 weeks after surgery |
|
|
|
| 0 |
| 17 |
| 0 |
| 17 |
| EG001 | Famotidine | 40 mg daily for 14 weeks | 0 | 13 | 0 | 13 |
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| D013272 | Stomach Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011725 |
| Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D013844 | Thiazoles |
| D001393 | Azoles |