Limited Access Protocol for the Use of Oral Cisapride | NCT02524496

Studies
Limited Access Protocol for the Use of Oral Cisapride

NCT02524496

Sponsor

Yale University

Status

Completed

Last Update Posted

Aug 14, 2015Estimated

Enrollment

3Actual

Phase

Not provided

Conditions

Gastroparesis

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2001

Primary Completion Date

Mar 2011Actual

Completion Date

Mar 2011Actual

First Submitted Date

Dec 25, 2007

First Submission Date that Met QC Criteria

Aug 13, 2015

First Posted Date

Aug 14, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 13, 2015

Last Update Posted Date

Aug 14, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

3Actual

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Clinical diagnosis of gastroparesis.

Exclusion Criteria:

No diagnosis of gastroparesis.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Condition Browse Module

MeSH Terms

ID	Term
D018589	Gastroparesis

Ancestor Terms

ID	Term
D013272	Stomach Diseases
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases
D010243	Paralysis

Browse Leaves

Not provided

Browse Branches

Not provided