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Trial record 21 of 444 for:    Expanded Access Studies

Use of Domperidone for Treatment of Upper Gastrointestinal Disorders (Domperidone)

Expanded access is temporarily not available for this treatment.
Sponsor:
ClinicalTrials.gov Identifier:
NCT03128398
First Posted: April 25, 2017
Last Update Posted: April 25, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Palo Alto Medical Foundation
  Purpose
This is an Expanded Access to Investigational Drug program available through the FDA. Some specific conditions to qualify for this program includes gastroesophageal reflux disease with upper GI symptoms, gastroparesis, and chronic constipation. Patients failing standard therapies for these conditions may be eligible to receive domperidone. This program facilitates availability of investigational drugs, (such as domperidone) to patients with serious diseases or conditions when there is no comparable or satisfactory alternative therapy to diagnose, monitor or treat the patients's disease or condition. Authorization must be obtained from FDA prior to the importation, interstate shipment and administration of domperidone.

Condition Intervention
Gastroparesis Drug: Domperidone

Study Type: Expanded Access     What is Expanded Access?
Available for Intermediate-size Population
Official Title: Use of Domperidone for Treatment of Upper Gastrointestinal Disorders

Resource links provided by NLM:


Further study details as provided by Palo Alto Medical Foundation:

Study Start Date: October 2014
Estimated Study Completion Date: December 2034
Estimated Primary Completion Date: December 2034 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Domperidone
    Availability of Domperidone to patients with serious gastrointestinal diseases or conditions when there is no comparable or satisfactory alternative therapy to diagnose, monitor, or treat the patient's disease or condition.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female
  2. Age 18 and older
  3. Symptoms or manifestations secondary to motility disorders of the upper GI tract. These include gastroparesis, functional dyspepsia, gastroesophageal reflux disease that are refractory to standard therapy.
  4. Patients must have a comprehensive evaluation to eliminate other causes of their symptoms. This includes a history and physical examination. A recent (within 3 years) evaluation of the upper GI tract with either upper endoscopy or upper GI radiographic series. Baseline blood tests suggested are electrolytes, magnesium, and prolactin level.
  5. Patient has signed informed consent for the administration of domperidone that informs the patient of potential adverse events including:

    • Increased prolactin levels
    • Breast changes
    • Extrapyramidal side effects
    • Cardiac arrhythmias including QT prolongation (increased risk with the drugs listed in the appendix)

Exclusion Criteria:

History of, or current, arrhythmias including ventricular tachycardia, ventricular fibrillation and Torsade des Pointes. Patients with minor forms of ectopy (PACs) are not necessarily excluded.

2. Clinically significant bradycardia, sinus node dysfunction, or heart block. Prolonged QTc (QTc > 450 milliseconds for males, QTc > 470 milliseconds for females).

3. Clinically significant electrolyte disorders. These include significant hypokalemia, hyperkalemia, hypomagnesemia, and hypermagnesemia that cannot be corrected with treatment of these electrolyte abnormalities.

4. Gastrointestinal hemorrhage or obstruction. 5. Presence of a prolactinoma (prolactin-releasing pituitary tumor). 6. Pregnant or breast feedings female. 7. Known allergy to domperidone.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03128398


Sponsors and Collaborators
Palo Alto Medical Foundation
Investigators
Principal Investigator: Katerina Shetler, MD Palo Alto Medical Foundation
  More Information

Responsible Party: Palo Alto Medical Foundation
ClinicalTrials.gov Identifier: NCT03128398     History of Changes
Other Study ID Numbers: PACR-14-04-311
First Submitted: April 6, 2017
First Posted: April 25, 2017
Last Update Posted: April 25, 2017
Last Verified: April 2017

Keywords provided by Palo Alto Medical Foundation:
Gastroparesis

Additional relevant MeSH terms:
Gastroparesis
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Paralysis
Neurologic Manifestations
Signs and Symptoms
Domperidone
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action


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