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

NCT00693225 | Completed Phase 4 Results

• 1 other identifier: 07-008503
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Erosive Esophagitis

Keywords

Erosive Esophagitis; Reflux Esophagitis; Gastroesophageal reflux disease; GERD; proton pump inhibitor; omeprazole/sodium bicarbonate

Outcome Measures

Primary Outcomes (1)

• Percent of Subjects Overall Who Healed, Improved, or Stayed the Same or Worsened After 8 Weeks of Treatment

  After 8 weeks of treatment a follow-up esophagogastroduodenoscopy (EGD) was performed by an endoscopist blinded to the study and subject allocation. The evaluation results were grouped as follows: LA C esophagitis at baseline: healed = no erosions in the esophagus; improved= LA grades A or B; Same or worse = C or D at follow-up LA D esophagitis at baseline: healed = no erosions in the esophagus; improved=LA grades A, B, or C; Same=LA grade D at follow-up.

  8 weeks

Secondary Outcomes (2)

• Percent of Subjects With Moderate Esophagitis (LA Grade C) Who Healed, Improved, or Stayed the Same or Worsened After 8 Weeks of Treatment

  8 weeks

• Percent of Subjects With Severe Esophagitis (LA Grade D) Who Healed, Improved, or Stayed the Same After 8 Weeks of Treatment

  8 weeks

Study Arms (2)

Omeprazole/sodium bicarbonate AM dose

ACTIVE COMPARATOR

8 weeks of therapy with omeprazole/sodium bicarbonate oral suspension 40 mg, once per day, taken in the morning

Drug: Omeprazole/sodium bicarbonate

Omeprazole/sodium bicarbonate PM dose

EXPERIMENTAL

8 weeks of therapy with omeprazole/sodium bicarbonate oral suspension 40 mg, once per day, taken at bedtime

Drug: Omeprazole/sodium bicarbonate

Interventions

Omeprazole/sodium bicarbonate DRUG

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.

Also known as: Zegerid

Omeprazole/sodium bicarbonate AM dose; Omeprazole/sodium bicarbonate PM dose

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yvonne Romero: lead
• Bausch Health Americas, Inc.: collaborator

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55901, United States

Location

MeSH Terms

Conditions

Esophagitis, Peptic; Gastroesophageal Reflux

Interventions

omeprazole, sodium bicarbonate drug combination

Condition Hierarchy (Ancestors)

Esophagitis; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Gastroenteritis; Peptic Ulcer; Duodenal Diseases; Intestinal Diseases; Stomach Diseases; Esophageal Motility Disorders; Deglutition Disorders

Limitations and Caveats

Our methods relied upon pill counting as a proxy for adherence to medical therapy. Now that PPIs are available over the counter, few patients present de novo with LA C and LA D esophagitis. We didn't control for other factors that can affect GERD.

Results Point of Contact

• Title: Dr. Yvonne Romero
• Organization: Mayo Clinic

romero.yvonne@mayo.edu

507-266-9156

Study Officials

• Yvonne Romero, M.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Yvonne Romero, MD

Study Record Dates

• First Submitted: June 4, 2008
• First Posted: June 6, 2008
• Study Start: January 1, 2008
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: September 20, 2012
• Results First Posted: September 20, 2012

Record last verified: 2012-08

Locations

US (1)