Phase 4
Completed N=91
Impact of Timing on the Efficacy of Zegerid 40 mg in Healing Reflux Esophagitis: A Pilot Study
Erosive Esophagitis
Source: ClinicalTrials.gov NCT00693225 ↗
Enrolled (actual)
91
Serious AEs
0.0%
Results posted
Sep 2012
Primary outcomePrimary: Percent of Subjects Overall Who Healed, Improved, or Stayed the Same or Worsened After 8 Weeks of Treatment — 83; 81; 15; 14 percentage of patients — p=1.0
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent of Subjects Overall Who Healed, Improved, or Stayed the Same or Worsened After 8 Weeks of Treatment |
83; 81; 15; 14; 2; 5 | 1.0 |
| SECONDARY Percent of Subjects With Moderate Esophagitis (LA Grade C) Who Healed, Improved, or Stayed the Same or Worsened After 8 Weeks of Treatment |
88; 79; 12; 14; 0; 7 | — |
| SECONDARY Percent of Subjects With Severe Esophagitis (LA Grade D) Who Healed, Improved, or Stayed the Same After 8 Weeks of Treatment |
75; 86; 19; 14; 6; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Subjects who have either moderate to severe erosive esophagitis (Los Angeles grade C or D)
- 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.
- Subjects able to return to Mayo Clinic Rochester for follow up endoscopy 8 weeks after start of study.
- Female subjects are eligible if they are not pregnant or lactating and one of the following criteria is met:
- Surgically sterile (by means of hysterectomy or bilateral tubal ligation).
- At least one year postmenopausal (no menses for greater than or equal to 12 months).
- 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
- Subjects already on or failed omeprazole in past, or intolerant of PPI therapy
- Subjects who are using clopidogrel (Plavix)
- Subjects with one or more of the following diagnoses:
- Neoplasm of the esophagus or stomach
- Previous upper gastrointestinal surgery (esophagectomy, Heller myotomy, hiatal hernial repair)
- Diabetic gastroparesis
- Esophageal motility disorder: Achalasia or scleroderma
- Zollinger-Ellison syndrome
- Infection with human immunodeficiency virus (HIV)
- Bleeding diathesis
- History of gastric or small bowel obstruction
- Inability to read due to blindness, cognitive dysfunction, English language illiteracy
- Disorders which predispose to unreliable responses such as Schizophrenia, Alzheimer's disease or significant memory loss
- Pregnant and lactating females will be excluded as PPIs are not thought safe for the fetus (Pregnancy Category C).
- 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.
- Residence outside of the US (due to difficulties with overseas postal service) or in prison.
Data sourced from ClinicalTrials.gov (NCT00693225). 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.