Official Title: “Impact of Timing on the Efficacy of Omeprazole/Sodium Bicarbonate Zegerid 40 mg in Healing Reflux Esophagitis”

Compare the percent of subjects with moderate/severe esophagitis who achieve complete endoscopic resolution after 8 weeks of treatment morning vs. bedtime.

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study

Study Primary Completion Date: January 2009

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(s) in this Clinical Trial

• Drug: Zegerid 40 mg am dose
  • 40mg taken in the morning
• Drug: omeprazole/sodium bicarbonate (Zegerid 40 mg )
  • 40 mg taken at night time

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
  • Compare the percent of subjects with moderate Los Angeles (LA) grade C or severe LA grade D reflux esophagitis who heal/lack mucosal breaks of their esophageal lining following 8 weeks of therapy with omeprazole/sodium bicarbonate oral suspension 40 mg, once per day, taken in the morning vs. taken at bedtime.
• Active Comparator: 2
  • Compare the percent of subjects with moderate Los Angeles (LA) grade C or severe LA grade D reflux esophagitis who heal/lack mucosal breaks of their esophageal lining following 8 weeks of therapy with omeprazole/sodium bicarbonate oral suspension 40 mg, once per day, taken in the morning vs. taken at bedtime.

Primary Measures

• We anticipate this study will generate preliminary estimates for the percent of subjects who heal moderate to severe esophagitis with morning vs. bedtime omeprazole/sodium bicarbonate.
  • Time Frame: 8 weeks
    Safety Issue?: No

Secondary Measures

• Of those subjects with persistent esophageal erosions following 8 weeks of acid suppression therapy, assess the percent with abnormal acid reflux as detected by 24 hour pH monitoring
  • Time Frame: 2
    Safety Issue?: No

Inclusion Criteria:

• Age 18 or older
• Have either moderate to serve erosive esophatitis
• Returning to Mayo Clinic Rochester for follow up endoscopy 8 weeks after start of study.

Exclusion Criteria:

• already on or failed omeprazole in past
• intolerant to PPI therapy
• will not be returning to Rochester Mayo Clinic in 8 weeks for clinical endoscopy.
• Can not read to blindness, cognitive dysfunction

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Mayo Clinic

Overall Clinical Trial Officials and Contacts

Yvonne Romero, M.D. Principal Investigator Mayo Clinic  

Overall Contact: Debra Geno, Study Coorinator 507-538-0367 debra.geno@mayo.edu

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00693225

Study ID Number: 07-008503

ClinicalTrials.gov Identifier: NCT00693225

Health Authority: United States: Food and Drug Administration