Impact of Timing on the Efficacy of Zegerid 40 mg in Healing Reflux Esophagitis: A Pilot Study
Information source: Mayo Clinic
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Erosive Esophagitis
Intervention: Omeprazole/sodium bicarbonate (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Yvonne Romero Official(s) and/or principal investigator(s): Yvonne Romero, M.D., Principal Investigator, Affiliation: Mayo Clinic
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.
Clinical Details
Official title: Impact of Timing on the Efficacy of Omeprazole/Sodium Bicarbonate Zegerid 40 mg in Healing Reflux Esophagitis
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Percent of Subjects Overall Who Healed, Improved, or Stayed the Same or Worsened After 8 Weeks of Treatment
Secondary outcome: Percent of Subjects With Moderate Esophagitis (LA Grade C) Who Healed, Improved, or Stayed the Same or Worsened After 8 Weeks of TreatmentPercent of Subjects With Severe Esophagitis (LA Grade D) Who Healed, Improved, or Stayed the Same After 8 Weeks of Treatment
Detailed description:
Hypothesis: The timing of administration of omeprazole/sodium bicarbonate (Zegerid) will
impact nocturnal esophageal acid exposure and healing of esophagitis. Specifically, we
hypothesize that omeprazole/sodium bicarbonate, taken at bedtime, will be superior in
healing esophagitis compared to omeprazole/sodium bicarbonate taken in the morning.
Specific Aim: Compare the percent of subjects with moderate/severe esophagitis who achieve
complete endoscopic resolution after 8 weeks of treatment (morning vs. bedtime).
Intervention: All subjects received a one-on-one educational session describing the normal
physiology of the upper gastrointestinal tract, the pathophysiology of hiatal hernia and
reflux esophagitis, and food stuffs that contribute to reflux, prior to their invitation to
participate in the trial. Outpatients who underwent a clinically indicated
esophagogastroduodenoscopy (EGD) as advised by their primary health care provider in an
open-access endoscopy unit who were diagnosed with Los Angeles grade C or D erosive reflux
esophagitis were invited to participate.
Omeprazole/sodium bicarbonate powder for oral suspension 40 mg was supplied in individual
packets that are emptied into a small cup containing 15-30 ml (1-2 tablespoons) of water,
one per day, for 8 weeks. They were asked to stir well and drink immediately then refill the
cup with water and drink. Subjects assigned to morning dosing were instructed to take the
medication on an empty stomach, immediately upon rising, 20 to 60 minutes prior to chewing a
solid. Subjects assigned to bedtime dosing were instructed to keep the medication by their
bedside; taking the medication in a standing or seated upright position immediately before
turning off the lights with the intention to sleep. The subject was instructed to not use
other liquids or foods for 20 minutes after taking their study medication for those
allocated to morning dosing, and until the next morning for those allocated to bedtime
dosing.
Gelusilâ„¢ was distributed for use as an "on demand" rescue antacid; the frequency of use was
recorded with the plan to use Gelusilâ„¢ consumption as a potential confounder of
omeprazole/sodium bicarbonate efficacy. Other antacids, including sodium bicarbonate,
magnesium hydroxide, calcium carbonate, and sucralfate were prohibited. Subjects taking
non-omeprazole proton pump inhibitors (PPIs) and/or Histamine Receptor Antagonist (HRAs)
were advised to discontinue these medications while they participated in this study. No
other medication was altered for this study.
After 8 weeks, a follow-up EGD was performed to assess mucosal integrity by an endoscopist
blinded to the study and subject allocation.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Mayo Clinic, Rochester, Minnesota 55901, United States
Additional Information
Starting date: January 2008
Last updated: August 21, 2012
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