Impact of Timing on the Efficacy of Zegerid 40 mg in Healing Reflux Esophagitis: A Pilot Study
Condition: Erosive Esophagitis
MeSH terms: Esophagitis; Esophagitis, Peptic
Intervention: Omeprazole/sodium bicarbonate
Intervention description: Omeprazole/sodium bicarbonate powder for oral suspension 40 mg was supplied in individual packets that were emptied into a small cup containing 15-30 ml (1-2 tablespoons) of water, one per day, for 8 weeks.
Intervention MeSH terms: Omeprazole; Omeprazole, sodium bicarbonate drug combination
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 91.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Erosive Esophagitis; Reflux Esophagitis; Gastroesophageal reflux disease; GERD; proton pump inhibitor; omeprazole/sodium bicarbonate

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.
    

Eligibility 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.