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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00204750
Other study ID # 8953
Secondary ID
Status Completed
Phase Phase 2/Phase 3
First received September 12, 2005
Last updated December 23, 2007
Start date August 2001
Est. completion date December 2006

Study information

Verified date December 2007
Source University of Utah
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

The primary objective of this study is to compare the efficacy of bougie dilation to electrosurgical incision of symptomatic schatzki's rings at one year follow-up in the presence of rabeprazole treatment. All patients will be followed for one year for recurrence and/or severity of dysphagia and will be placed on rabeprazole for that time period.


Description:

Fifty consecutive patients referred for endoscopic evaluation at endoscopy labs at the University of Utah Health Sciences Center and the Salt Lake City VA Medical Center for dysphagia will be enrolled in the study prior to endoscopy. If a Schatzki's Ring is found at endoscopy, the patient will be randomized to electrosurgical incision or standard bougie dilation. Patients will be placed on rabeprazole for one year. Follow-up on recurrence and/or severity of dysphagia will be analyzed at interim time periods (1,3,6, 9 12 months).


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date December 2006
Est. primary completion date December 2006
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- Between the ages of 18-80 with symptomatic Schatzki's ring

- No history of bleeding diathesis or other contraindication to bougie dilation or electrosurgical incision

Exclusion Criteria:

- Contraindication to proton pump inhibitors

- Pregnancy

- Inability to provide informed consent

- History of previous esophagogastric surgery

- Presence of esophageal peptic stricture, esophageal motility disorder or esophageal cancer that could otherwise account for dysphagia

- Nasopharyngeal lesion or nasal intubation intolerance causing inability to undergo esophageal motility testing and ambulatory pH monitoring

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Procedure:
Bougie Dilation
Bougie dilation will be performed as standard
Needle-knife incision
Needle-knife incision will be performed

Locations

Country Name City State
United States University of Utah HSC Salt Lake City Utah

Sponsors (2)

Lead Sponsor Collaborator
University of Utah PriCara, Unit of Ortho-McNeil, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Recurrence at one year of Schatzki's ring One year No
Secondary GERD score at 1,3,6,9,12 month time intervals one year No
Secondary Dysphagia score at 1,3,6,9,12 month time intervals one year No
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