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Rabeprazole in Subjects With Gastroesophageal Reflux Disease (GERD)

Kansas Board of Regents logo

Kansas Board of Regents

Status and phase

Completed
Phase 2

Conditions

Esophageal Reflux

Treatments

Drug: Rabeprazole

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT00222170
RE Study

Details and patient eligibility

About

The purpose of this study is to determine the production of mucin in GERD/RE subjects before and after 8 weeks of treatment with rabeprazole.

Full description

Enrolled patients will undergo collection of salivary and esophageal secretions. Subsequently, all patients will receive rabeprazole (20mg QD) for 8 weeks and will be re-endoscoped to confirm complete healing of reflux esophagitis. In patients with completely healed reflux esophagitis the second collection of salivary and esophageal secretion will be implemented. In both secretions, adequately coded for the laboratory Research Fellow (blinded in terms of which sample is collected before and which after treatment with rabeprazole) the content of mucin will be measured using commercially available assay and its secretion expressed in units per minute of collection time.

Enrollment

24 patients

Sex

All

Ages

19 to 79 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria: 24 patients with endoscopically confirmed reflux esophagitis (Grades A-D according to LA classification) in patients with chronic symptoms of GERD (heartburn with or without regurgitation) between the age of 19 and 79, 12M & 12F, will be included.

Exclusion criteria: History of GI surgery, primary esophageal motor disorders, any systemic disease, history of drug or alcohol abuse, pregnancy or nursing, allergy to the same drug class as rabeprazole, the need for any concurrent therapy that affects salivary secretion (causing so-called "dry mouth syndrome").

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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