Limited Access Protocol for the Use of Oral Cisapride

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02524496

Enrollment

Registered

2015-08-14

Start date

2001-03-31

Completion date

2011-03-31

Last updated

2015-08-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastroparesis

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Clinical diagnosis of gastroparesis.

Exclusion criteria

* No diagnosis of gastroparesis.

Design outcomes

Primary

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

Outcome results