Impact of Timing on the Efficacy of Zegerid 40 mg in Healing Reflux Esophagitis: A Pilot Study

• Status: Completed
• Trial end date: 2010-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study was to determine the effect of morning versus bedtime administration of omeprazole/sodium bicarbonate (Zegerid) on endoscopic healing for patients with moderate or severe reflux esophagitis. Our hypothesis was that bedtime administration of Zegerid would be superior in healing esophagitis compared to morning administration prior to a meal.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yvonne Romero
• Collaborators: Bausch Health Americas, Inc.; Valeant Pharmaceuticals International, Inc.
• Treatments: Omeprazole; Omeprazole, sodium bicarbonate drug combination

Criteria

Inclusion Criteria:

1. Subjects who have either moderate to severe erosive esophagitis (Los Angeles grade C or D)

2. Subjects with esophagitis despite use of a non-omeprazole Proton Pump Inhibitor (PPI)(s) or histamine receptor antagonist (HRA) were invited to participate without a wash-out period.

3. Subjects able to return to Mayo Clinic Rochester for follow up endoscopy 8 weeks after start of study.

4. Female subjects are eligible if they are not pregnant or lactating and one of the following criteria is met:

1. Surgically sterile (by means of hysterectomy or bilateral tubal ligation).

2. At least one year postmenopausal (no menses for greater than or equal to 12 months).

3. Subject is using a highly effective method of contraception, if of childbearing potential and has a negative urine human chorionic gonadotropin beta subunit (B-HCG) pregnancy test during screening, and prior to trial drug administration.

Exclusion Criteria:

1. Subjects already on or failed omeprazole in past, or intolerant of PPI therapy

2. Subjects who are using clopidogrel (Plavix)

3. Subjects with one or more of the following diagnoses:

1. Neoplasm of the esophagus or stomach

2. Previous upper gastrointestinal surgery (esophagectomy, Heller myotomy, hiatal hernial repair)

3. Diabetic gastroparesis

4. Esophageal motility disorder: Achalasia or scleroderma

5. Zollinger-Ellison syndrome

6. Infection with human immunodeficiency virus (HIV)

7. Bleeding diathesis

8. History of gastric or small bowel obstruction

9. Inability to read due to blindness, cognitive dysfunction, English language illiteracy

10. Disorders which predispose to unreliable responses such as Schizophrenia, Alzheimer's disease or significant memory loss

11. Pregnant and lactating females will be excluded as PPIs are not thought safe for the fetus (Pregnancy Category C).

4. Children younger than 18 years of age will be excluded as their compliance might be dictated by others, such as their parents, and their results would not be generalizable to the adult population. Other vulnerable populations, such as those with diminished mental acuity, will be excluded for the same reason.

5. Residence outside of the US (due to difficulties with overseas postal service) or in prison.