A Phase 4 interventional study of Omeprazole and Famotidine in Marginal Ulcers, sponsored by University of Missouri-Columbia. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-01-19.
Sponsored by University of Missouri-Columbia · Phase 4, Interventional, and Prevention
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.
193 studies on the registry are indexed under Peptic Ulcer; 31 are open to participants now.
This study's enrollment of 40 is below the median of 150 across 142 interventional studies indexed under Peptic Ulcer.
Browse Peptic Ulcer studies →University of Missouri-Columbia is the lead sponsor of 357 studies on the registry; 70 are open to participants now.
Of its 42 completed or terminated interventional studies of FDA-regulated products, 28 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
40 mg Omeprazole daily
Drug: Omeprazole
40 mg Famotidine daily
Drug: Famotidine
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.
Also known as: Zegerid
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.
Also known as: Pepcid
Number of Participants With Complaints, Specifically About Pain, Vomiting, Dyspepsia, and/or Dysphagia.
Time frame: during first 14 weeks after surgery
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
Time frame: during first 14 weeks after surgery
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.
| Milestone | Omeprazole | Famotidine |
|---|---|---|
| Started | 22 | 18 |
| Completed | 17 | 13 |
| Not completed | 5 | 5 |
| participants | Omeprazole | Famotidine |
|---|---|---|
| Number of Participants With Complaints, Specifically About Pain, Vomiting, Dyspepsia, and/or Dysphagia. | 17 | 13 |
Endoscopic visualization of presence or absence of anastomotic ulcers if upper endoscopy indicated due to patient complaints - based upon severity of complaints
| participants | Omeprazole | Famotidine |
|---|---|---|
| Number of Participants With Upper Endoscopy Indicated Due to Complaints | 1 | 13 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Omeprazole | — | 0/17 (0%) | 0/17 (0%) |
| Famotidine | — | 0/13 (0%) | 0/13 (0%) |
| Age, Categorical(Participants) | Omeprazole | Famotidine | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 22 | 18 | 40 |
| >=65 years | 0 | 0 | 0 |
| Sex/Gender, Customized(participants) | Omeprazole | Famotidine | Total |
|---|---|---|---|
| Unknown | 0 | 18 | 18 |
| Male | 8 | 0 | 8 |
| Female | 14 | 0 | 14 |
| Region of Enrollment(participants) | Omeprazole | Famotidine | Total |
|---|---|---|---|
| United States | 22 | 18 | 40 |
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.
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University of Missouri-Columbia