Limited Access Protocol for the Use of Oral Cisapride

August 13, 2015 updated by: Yale University

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

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The subjects of the study were diagonosed with gastroparesis that was not being adequately treated.

Description

Inclusion Criteria:

  • Clinical diagnosis of gastroparesis.

Exclusion Criteria:

  • No diagnosis of gastroparesis.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement in gastric emptying via self-report
Time Frame: ten years
Patients were asked at clinical appointments about problems and improvement with gastric emptying.
ten years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yale University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2001

Primary Completion (Actual)

March 1, 2011

Study Completion (Actual)

March 1, 2011

Study Registration Dates

First Submitted

December 25, 2007

First Submitted That Met QC Criteria

August 13, 2015

First Posted (Estimate)

August 14, 2015

Study Record Updates

Last Update Posted (Estimate)

August 14, 2015

Last Update Submitted That Met QC Criteria

August 13, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0009012025

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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