Limited Access Protocol for the Use of Oral Cisapride

Completed

• Conditions: Gastroparesis

• Registration Number: NCT02524496
• Lead Sponsor: Yale University

Brief Summary

Due to the lack of other drugs to treat gastroparesis Janssen and FDA approved the compassionate use of cisapride to treat patients who had no other effective therapy. For this observational study, 3 patients who had already been prescribed cisapride by outside physicians, were followed to determine the effectiveness of cisapride on their gastric emtpying.

Detailed Description

Not available

Study Timeline

• Study Start: 2001-03
• Study First Submitted: 2007-12-25
• Primary Completion: 2011-03
• Study Completion: 2011-03
• Status Verified: 2015-08
• Study First Submitted QC: 2015-08-13
• Last Update Submitted: 2015-08-13
• Study First Posted: 2015-08-14
• Last Update Posted: 2015-08-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3

Inclusion Criteria

• Clinical diagnosis of gastroparesis.

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Exclusion Criteria

• No diagnosis of gastroparesis.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Improvement in gastric emptying via self-report	ten years	Patients were asked at clinical appointments about problems and improvement with gastric emptying.