Phase 4
Completed N=40
Ulcer Prevention Study in Post Gastric Bypass Patients
Marginal Ulcers
Source: ClinicalTrials.gov NCT00557349 ↗
Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Jan 2017
Primary outcomePrimary: Number of Participants With Complaints, Specifically About Pain, Vomiting, Dyspepsia, and/or Dysphagia. — 17; 13 participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Complaints, Specifically About Pain, Vomiting, Dyspepsia, and/or Dysphagia. |
17; 13 | — |
| SECONDARY Number of Participants With Upper Endoscopy Indicated Due to Complaints |
1; 13 | — |
Eligibility Criteria
Inclusion Criteria
- Subject is age ≥ 18 years
- Patient meets the criteria for laparoscopic gastric bypass surgery
- Females only: Patient is willing to take a urine pregnancy test
Exclusion Criteria
- Subject allergic to omeprazole or famotidine
- Patient receiving antifungal (i.e. ketoconazole or itraconazole)
- Hepatic insufficiency
- History of Crohns disease
- History of Zollinger-Ellison disease
- Patient received an investigational drug within 30 days of enrollment
- Patient currently enrolled in another research project
- Females Only: Pregnancy or plan on becoming pregnant during the next 14 weeks
Data sourced from ClinicalTrials.gov (NCT00557349). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.