Limited Access Protocol for the Use of Oral Cisapride

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.

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Key information

Conditions

Gastroparesis Digestive System Diseases Gastrointestinal Diseases Neurologic Manifestations Paralysis Pathological Conditions, Signs and Symptoms Signs and Symptoms Stomach Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Clinical diagnosis of gastroparesis.

Exclusion criteria

No diagnosis of gastroparesis.

Treatment and study plan

Primary outcomes

Improvement in gastric emptying via self-report

Time frame: ten years

Patients were asked at clinical appointments about problems and improvement with gastric emptying.

Sponsors and collaborators

Lead sponsor

Yale University

Other

Registry information

Official study title

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

Important dates

Study start: 2001
Primary completion: 2011
Study completion: 2011
First posted: Aug 14, 2015
Registry last updated: Aug 14, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed