Back to results

Domperidone for Refractory Gastrointestinal Disorders

Primary Purpose

Gastroparesis

Status

Unknown status

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 Dopamine, Domperidone, Gastroparesis, Gastrointestinal Diseases, Neurologic Manifestations, Stomach Diseases, Digestive System Diseases, Esophagitis, Esophageal Disorders, Paralysis

Eligibility Criteria

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

Inclusion Criteria:

Male or female
Age 18 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 are refractory to standard therapy.
Subjects must have a comprehensive evaluation to eliminate other causes of their symptoms.
Subject has signed informed consent for the administration of domperidone. The informed consent informs the subject of potential adverse events including:
- increased prolactin levels
- extrapyramidal side effects
- breast changes
- cardiac arrhythmias including QT prolongation
- there is a potential for increased risk of adverse events with the drugs listed in the addendum

Exclusion Criteria:

History of or current cardiac disease, including ischemic or valvular heart disease, other structural heart defects, cardiomyopathy or congestive heart failure.
History of or current arrhythmias including ventricular tachycardia, ventricular fibrillation and Torsade des Pointes. Subjects with minor forms of ectopy (PACs) are not necessarily excluded.
Clinically significant bradycardia, sinus node dysfunction, or heart block. Prolonged QT syndrome (QTc greater than 450 milliseconds for males, greater 470 milliseconds for females) or family history prolonged QT syndrome.
Presence of a prolactinoma (prolactin-releasing pituitary tumor).
Conditions that result in electrolyte disorders, such as severe dehydration, vomiting, malnutrition, eating disorders, renal diseases, or the use of potassium-wasting diuretics or insulin in acute settings. (Note that the presence of vomiting, that may accompany gastroparesis or pseudo- obstruction does not by itself exclude the subject - only if accompanied by electrolyte disturbance must the subject be excluded.)
Pregnant or breast feeding female.
Known allergy to domperidone or any components of the domperidone formulation.
Significantly significant electrolyte disorders.
Gastrointestinal hemorrhage or obstruction.

Sites / Locations

Division of Gastroenterology, Hepatology and Nutrition, UPMC Presbyterian Digesive Disorders Center, 3rd Floor, 200 Lothrop StreetRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Domperidone

Arm Description

All eligible subjects will receive domperidone in an open label, single group assignment.

Outcomes

Primary Outcome Measures

Improvement of symptoms for patients with gastrointestinal disorders who have failed or suffered adverse effects from standard medical treatment.

Secondary Outcome Measures

Full Information

NCT ID

NCT00777439

First Posted

October 21, 2008

Last Updated

August 17, 2016

Sponsor

Arnold, George, M.D.

1. Study Identification

Unique Protocol Identification Number

NCT00777439

Brief Title

Domperidone for Refractory Gastrointestinal Disorders

Official Title

An Investigational New Drug Program for the Use of Domperidone in the Treatment of Refractory Gastroesophageal Reflux Disease and Other Gastrointestinal Motility Disorders

Study Type

Interventional

2. Study Status

Record Verification Date

August 2016

Overall Recruitment Status

Unknown status

Study Start Date

October 2008 (undefined)

Primary Completion Date

January 2017 (Anticipated)

Study Completion Date

January 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Arnold, George, M.D.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this study is to prescribe oral domperidone for subjects with gastrointestinal disorders who have failed or suffered adverse effects from standard medical treatment.

Detailed Description

Domperidone is a dopamine-2 receptor antagonist. It acts as a prokinetic agent through its effects on the chemoreceptor trigger zone and the motor function of the stomach and small intestines. It does not cause any adverse neurological symptoms and has an excellent safety profile for long-term oral administration in recommended doses. In the United States, domperidone is not approved by the Food and Drug Administration (FDA) and cannot be obtained by routine prescriptions or covered by health care insurance plans. It is also illegal to write a prescription for the subject to obtain the drug outside the U.S. Domperidone can be administered legally by obtaining a FDA Investigational New Drug (IND) application with Institutional Review Board (IRB) approval. This study will follow FDA and IRB regulations and provide domperidone to subjects with gastrointestinal disorders who have failed from standard therapy.

6. Conditions and Keywords

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

Gastroparesis

Keywords

Dopamine, Domperidone, Gastroparesis, Gastrointestinal Diseases, Neurologic Manifestations, Stomach Diseases, Digestive System Diseases, Esophagitis, Esophageal Disorders, Paralysis

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

75 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Domperidone

Arm Type

Other

Arm Description

All eligible subjects will receive domperidone in an open label, single group assignment.

Intervention Type

Drug

Intervention Name(s)

Domperidone

Other Intervention Name(s)

Domperidone maleate, Motilium

Intervention Description

10 mg of oral domperidone will be administered 4 times daily. This dose may be increased to 20 mg 4 times daily or 30 mg 4 times daily, depending on how the subject responds to the drug.

Primary Outcome Measure Information:

Title

Improvement of symptoms for patients with gastrointestinal disorders who have failed or suffered adverse effects from standard medical treatment.

Time Frame

Domperidone will be prescrided as long as patients benefit from taking it.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male or female Age 18 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 are refractory to standard therapy. Subjects must have a comprehensive evaluation to eliminate other causes of their symptoms. Subject has signed informed consent for the administration of domperidone. The informed consent informs the subject of potential adverse events including: increased prolactin levels extrapyramidal side effects breast changes cardiac arrhythmias including QT prolongation there is a potential for increased risk of adverse events with the drugs listed in the addendum Exclusion Criteria: History of or current cardiac disease, including ischemic or valvular heart disease, other structural heart defects, cardiomyopathy or congestive heart failure. History of or current arrhythmias including ventricular tachycardia, ventricular fibrillation and Torsade des Pointes. Subjects with minor forms of ectopy (PACs) are not necessarily excluded. Clinically significant bradycardia, sinus node dysfunction, or heart block. Prolonged QT syndrome (QTc greater than 450 milliseconds for males, greater 470 milliseconds for females) or family history prolonged QT syndrome. Presence of a prolactinoma (prolactin-releasing pituitary tumor). Conditions that result in electrolyte disorders, such as severe dehydration, vomiting, malnutrition, eating disorders, renal diseases, or the use of potassium-wasting diuretics or insulin in acute settings. (Note that the presence of vomiting, that may accompany gastroparesis or pseudo- obstruction does not by itself exclude the subject - only if accompanied by electrolyte disturbance must the subject be excluded.) Pregnant or breast feeding female. Known allergy to domperidone or any components of the domperidone formulation. Significantly significant electrolyte disorders. Gastrointestinal hemorrhage or obstruction.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Kelly A Kolesar, BSN

Phone

412-864-7087

kolesarka2@upmc.edu

First Name & Middle Initial & Last Name or Official Title & Degree

George L. Arnold, MD

Phone

412-864-7087

arnoldgl@upmc.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

George L. Arnold, MD

Organizational Affiliation

George L. Arnold, MD, FACP

Official's Role

Principal Investigator

Facility Information:

Facility Name

Division of Gastroenterology, Hepatology and Nutrition, UPMC Presbyterian Digesive Disorders Center, 3rd Floor, 200 Lothrop Street

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15213

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Kelly A. Kolesar, BSN

Phone

412-864-7087

kolesarka2@upmc.edu

First Name & Middle Initial & Last Name & Degree

George L. Arnold, MD

12. IPD Sharing Statement

Citations:

PubMed Identifier

16553582

Citation

Abell TL, Bernstein RK, Cutts T, Farrugia G, Forster J, Hasler WL, McCallum RW, Olden KW, Parkman HP, Parrish CR, Pasricha PJ, Prather CM, Soffer EE, Twillman R, Vinik AI. Treatment of gastroparesis: a multidisciplinary clinical review. Neurogastroenterol Motil. 2006 Apr;18(4):263-83. doi: 10.1111/j.1365-2982.2006.00760.x.

Results Reference

result

PubMed Identifier

10332535

Citation

Barone JA. Domperidone: a peripherally acting dopamine2-receptor antagonist. Ann Pharmacother. 1999 Apr;33(4):429-40. doi: 10.1345/aph.18003.

Results Reference

result

PubMed Identifier

16997628

Citation

Ahmad N, Keith-Ferris J, Gooden E, Abell T. Making a case for domperidone in the treatment of gastrointestinal motility disorders. Curr Opin Pharmacol. 2006 Dec;6(6):571-6. doi: 10.1016/j.coph.2006.07.004. Epub 2006 Sep 25.

Results Reference

result

PubMed Identifier

17488253

Citation

Reddymasu SC, Soykan I, McCallum RW. Domperidone: review of pharmacology and clinical applications in gastroenterology. Am J Gastroenterol. 2007 Sep;102(9):2036-45. doi: 10.1111/j.1572-0241.2007.01255.x. Epub 2007 May 3.

Results Reference

result

PubMed Identifier

9177513

Citation

Soykan I, Sarosiek I, McCallum RW. The effect of chronic oral domperidone therapy on gastrointestinal symptoms, gastric emptying, and quality of life in patients with gastroparesis. Am J Gastroenterol. 1997 Jun;92(6):976-80.

Results Reference

result

Learn more about this trial

Domperidone for Refractory Gastrointestinal Disorders

We'll reach out to this number within 24 hrs