Limited Access Protocol for the Use of Oral Cisapride

Gastroparesis Clinical Trial

Official title:

Limited Access, Open-label, Compassionate Use of Cisapride in the Treatment of Gastroparesis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02524496
• Other study ID #: 0009012025
• Status: Completed
• Phase: Phase 4
• First received: December 25, 2007
• Last updated: August 13, 2015
• Start date: March 2001
• Est. completion date: March 2011

Study information

• Verified date: August 2015
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Clinical diagnosis of gastroparesis.

Exclusion Criteria:

• No diagnosis of gastroparesis.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Gastroparesis

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Yale University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement in gastric emptying via self-report	Patients were asked at clinical appointments about problems and improvement with gastric emptying.	ten years	No