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Domperidone for Relief of Gastrointestinal Disorders

Primary Purpose

Gastroparesis, GERD, Esophagitis

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Domperidone

About this trial

This is an interventional treatment trial for Gastroparesis focused on measuring Domperidone, Gastroparesis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

18 years or older
symptoms or manifestations secondary to GERD (e.g., persistent esophagitis, heartburn, upper airway signs or symptoms or respiratory symptoms, gastrointestinal motility disorders such as nausea, vomiting, severe dyspepsia or severe chronic constipation that is refractory to standard therapy
subjects must have a comprehensive evaluation to eliminate other causes of their symptoms.

Exclusion Criteria:

history of, or current, arrhythmias including ventricular tachycardia, ventricular fibrillation, and Torsade de pointes. Subjects with minor forms of ectopy (PACs) are not necessarily excluded.
clinically significant bradycardia, sinus node dysfunction, or heart block. Prolonged QTc (QTc > 450 milliseconds for males, QTc > 470 milliseconds for females.)
clinically significant electrolyte disorders.
gastrointestinal hemorrhage or obstruction.
presence of a prolactinoma (prolactin-releasing pituitary tumor.)
pregnant or breast feeding female.
known allergy to Domperidone.

Sites / Locations

Carle Health Care Incorporated d/b/a Carle Physician Group

Outcomes

Primary Outcome Measures

Relief for patients with gastrointestinal disorders who have failed standard therapy

Secondary Outcome Measures

Full Information

NCT ID

NCT00761254

First Posted

September 25, 2008

Last Updated

September 11, 2012

Sponsor

Carle Physician Group

1. Study Identification

Unique Protocol Identification Number

NCT00761254

Brief Title

Domperidone for Relief of Gastrointestinal Disorders

Official Title

Oral Domperidone for Relief of Gastrointestinal Disorders in Patients Who Failed Standard Therapy

Study Type

Interventional

2. Study Status

Record Verification Date

September 2012

Overall Recruitment Status

Terminated

Why Stopped

PI withdrew due to increased responsibilities in clinical department.

Study Start Date

August 2008 (undefined)

Primary Completion Date

September 2012 (Anticipated)

Study Completion Date

September 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Carle Physician Group

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to make Domperidone available to patients with gastrointestinal disorders who have failed standard therapy and who might benefit from it.

Detailed Description

Domperidone is the only medication that is a true prokinetic with a low percentage of side effects that is useful in the treatment of certain GI conditions, including gastroparesis and other motility disorders. According to recent regulations, writing prescriptions for subject to obtain domperidone outside the United States has been determined to be illegal and the FDA has issued warnings against pharmacies compounding domperidone. The legal way of administering domperidone is by obtaining an Investigational New Drug Application. This study is an effort to both follow federal regulations and provide the medication to subjects who would benefit from it where standard therapy has failed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gastroparesis, GERD, Esophagitis, Dyspepsia, Chronic Idiopathic Constipation, Nausea, Vomiting

Keywords

Domperidone, Gastroparesis

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

42 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Domperidone

Other Intervention Name(s)

Motilium

Intervention Description

Initially, 10mg of oral Domperidone will be administered 2-4 times a day as needed. This dosage may be increased or decreased depending on how the subject responds to the drug.

Primary Outcome Measure Information:

Title

Relief for patients with gastrointestinal disorders who have failed standard therapy

Time Frame

As long as the subjects continue to take Domperidone.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 18 years or older symptoms or manifestations secondary to GERD (e.g., persistent esophagitis, heartburn, upper airway signs or symptoms or respiratory symptoms, gastrointestinal motility disorders such as nausea, vomiting, severe dyspepsia or severe chronic constipation that is refractory to standard therapy subjects must have a comprehensive evaluation to eliminate other causes of their symptoms. Exclusion Criteria: history of, or current, arrhythmias including ventricular tachycardia, ventricular fibrillation, and Torsade de pointes. Subjects with minor forms of ectopy (PACs) are not necessarily excluded. clinically significant bradycardia, sinus node dysfunction, or heart block. Prolonged QTc (QTc > 450 milliseconds for males, QTc > 470 milliseconds for females.) clinically significant electrolyte disorders. gastrointestinal hemorrhage or obstruction. presence of a prolactinoma (prolactin-releasing pituitary tumor.) pregnant or breast feeding female. known allergy to Domperidone.

Overall Study Officials: