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Impact of Timing on the Efficacy of Zegerid 40 mg in Healing Reflux Esophagitis: A Pilot Study
This study is currently recruiting participants.
Verified by Mayo Clinic, August 2009
First Received: June 4, 2008   Last Updated: August 4, 2009   History of Changes
Sponsor: Mayo Clinic
Collaborator: Santarus
Information provided by: Mayo Clinic
ClinicalTrials.gov Identifier: NCT00693225
  Purpose

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


Condition Intervention
Errosive Esophagitis
Drug: Zegerid 40 mg am dose
Drug: omeprazole/sodium bicarbonate (Zegerid 40 mg )

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study
Official Title: Impact of Timing on the Efficacy of Omeprazole/Sodium Bicarbonate Zegerid 40 mg in Healing Reflux Esophagitis

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome 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 ] [ Designated as safety issue: No ]

Secondary Outcome 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: January 2008
Estimated Study Completion Date: March 2009
Estimated Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Active Comparator
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.
Drug: Zegerid 40 mg am dose
40mg taken in the morning
2: Active Comparator
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.
Drug: omeprazole/sodium bicarbonate (Zegerid 40 mg )
40 mg taken at night time

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00693225

Contacts
Contact: Debra Geno, CCRP 507-538-0367 debra.geno@mayo.edu
Contact: Mary Fredericksen, L.P.N. 507-538-1887 fredericksen.mary@mayo.edu

Locations
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55901
Contact: Yvonne Romero, M.D.     507-284-2467     romero.yvonne@mayo.edu    
Contact: Deb Geno     507-538-0367     debra.geno@mayo.edu    
Principal Investigator: Yvonne Romero, M.D.            
Sponsors and Collaborators
Mayo Clinic
Santarus
Investigators
Principal Investigator: Yvonne Romero, M.D. Mayo Clinic
  More Information

No publications provided

Responsible Party: Mayo Clinic ( Yvonne Romero, M.D. )
Study ID Numbers: 07-008503
Study First Received: June 4, 2008
Last Updated: August 4, 2009
ClinicalTrials.gov Identifier: NCT00693225     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by Mayo Clinic:
Errosive Esophagitis
Reflux Esophatitis
GERD

Additional relevant MeSH terms:
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Diseases
Gastrointestinal Agents
Omeprazole
Enzyme Inhibitors
Pharmacologic Actions
Esophagitis
Esophagitis, Peptic
Digestive System Diseases
Therapeutic Uses
Anti-Ulcer Agents
Esophageal Diseases
Gastroenteritis
Peptic Ulcer

ClinicalTrials.gov processed this record on February 08, 2010