NCT00777439

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

October 1, 2008

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

October 21, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 22, 2008

Completed
8.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

August 18, 2016

Status Verified

August 1, 2016

Enrollment Period

8.3 years

First QC Date

October 21, 2008

Last Update Submit

August 17, 2016

Conditions

Gastroparesis

Keywords

DopamineDomperidoneGastroparesisGastrointestinal DiseasesNeurologic ManifestationsStomach DiseasesDigestive System DiseasesEsophagitisEsophageal DisordersParalysis

Outcome Measures

Primary Outcomes (1)

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

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

Study Arms (1)

Domperidone

OTHER

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

Drug: Domperidone

Interventions

DomperidoneDRUG

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.

Also known as: Domperidone maleate, Motilium
Domperidone

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Pittsburgh, Pennsylvania, 15213, United States

RECRUITING

Related Publications (5)

  • 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.

    PMID: 16553582RESULT

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

    PMID: 10332535RESULT

  • 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.

    PMID: 16997628RESULT

  • 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.

    PMID: 17488253RESULT

  • 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.

    PMID: 9177513RESULT

MeSH Terms

Conditions

GastroparesisGastrointestinal DiseasesNeurologic ManifestationsStomach DiseasesDigestive System DiseasesEsophagitisEsophageal DiseasesParalysis

Interventions

Domperidone

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and SymptomsNervous System DiseasesGastroenteritis

Intervention Hierarchy (Ancestors)

PiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • George L. Arnold, MD

    George L. Arnold, MD, FACP

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kelly A Kolesar, BSN

CONTACT

412-864-7087kolesarka2@upmc.edu

George L. Arnold, MD

CONTACT

412-864-7087arnoldgl@upmc.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDIV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 21, 2008

First Posted

October 22, 2008

Study Start

October 1, 2008

Primary Completion

January 1, 2017

Study Completion

January 1, 2018

Last Updated

August 18, 2016

Record last verified: 2016-08

Locations

US(1)