NCT02524496

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2001

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2001

Completed
6.8 years until next milestone

First Submitted

Initial submission to the registry

December 25, 2007

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
4.5 years until next milestone

First Posted

Study publicly available on registry

August 14, 2015

Completed
Last Updated

August 14, 2015

Status Verified

August 1, 2015

Enrollment Period

10 years

First QC Date

December 25, 2007

Last Update Submit

August 13, 2015

Conditions

Gastroparesis

Outcome Measures

Primary Outcomes (1)

  • Improvement in gastric emptying via self-report

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

    ten years

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Clinical diagnosis of gastroparesis.

You may not qualify if:

  • No diagnosis of gastroparesis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Gastroparesis

Condition Hierarchy (Ancestors)

Stomach DiseasesGastrointestinal DiseasesDigestive System DiseasesParalysisNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 25, 2007

First Posted

August 14, 2015

Study Start

March 1, 2001

Primary Completion

March 1, 2011

Study Completion

March 1, 2011

Last Updated

August 14, 2015

Record last verified: 2015-08