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

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:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Impact of Timing on the Efficacy of Omeprazole/Sodium Bicarbonate Zegerid 40 mg in Healing Reflux Esophagitis

Resource links provided by NLM:

MedlinePlus related topics: Esophagus Disorders GERD

Drug Information available for: Omeprazole Omeprazole magnesium Esomeprazole Sodium Esomeprazole magnesium Sodium bicarbonate

U.S. FDA Resources

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 ]

Enrollment:	92
Study Start Date:	January 2008
Study Completion Date:	December 2010
Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.	Drug: Zegerid 40 mg am dose 40mg taken in the morning Other Name: Zegerid, omeprazole/sodium bicarbonate
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.	Drug: omeprazole/sodium bicarbonate (Zegerid 40 mg ) 40 mg taken at night time Other Name: Zegerid, Omeprazole.sodium bicarbonate

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

Locations

United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55901

Sponsors and Collaborators

Mayo Clinic

Santarus

Investigators

Principal Investigator:

Yvonne Romero, M.D.

Mayo Clinic

More Information

No publications provided

Responsible Party:	Yvonne Romero, M.D., Mayo Clinic
ClinicalTrials.gov Identifier:	NCT00693225 History of Changes
Other Study ID Numbers:	07-008503
Study First Received:	June 4, 2008
Last Updated:	June 8, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Mayo Clinic:

Errosive Esophagitis
Reflux Esophatitis
GERD

Additional relevant MeSH terms:

Esophagitis
Esophagitis, Peptic
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
Peptic Ulcer
Omeprazole

Omeprazole, sodium bicarbonate drug combination
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Proton Pump Inhibitors

ClinicalTrials.gov processed this record on February 09, 2012