Impact of Timing on the Efficacy of Zegerid 40 mg in Healing Reflux Esophagitis: A Pilot Study
Information source: Mayo Clinic
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Errosive Esophagitis
Intervention: Zegerid 40 mg am dose (Drug); omeprazole/sodium bicarbonate (Zegerid 40 mg ) (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: Mayo Clinic Official(s) and/or principal investigator(s):
Yvonne Romero, M.D., Principal Investigator, Affiliation: Mayo Clinic
Overall contact:
Debra Geno, CCRP, Phone: 507-538-0367, Email: debra.geno@mayo.edu
Summary
Compare the percent of subjects with moderate/severe esophagitis who achieve complete
endoscopic resolution after 8 weeks of treatment morning vs. bedtime.
Clinical Details
Official title: Impact of Timing on the Efficacy of Omeprazole/Sodium Bicarbonate Zegerid 40 mg in Healing Reflux Esophagitis
Study design: Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study
Primary outcome: 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.
Secondary outcome: 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
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).
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Debra Geno, CCRP, Phone: 507-538-0367, Email: debra.geno@mayo.edu
Mayo Clinic, Rochester, Minnesota 55901, United States; Recruiting
Yvonne Romero, M.D., Phone: 507-284-2467, Email: romero.yvonne@mayo.edu
Deb Geno, Phone: 507-538-0367, Email: debra.geno@mayo.edu
Yvonne Romero, M.D., Principal Investigator
Additional Information
Starting date: January 2008
Ending date: March 2009
Last updated: August 4, 2009
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