Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Arnold, George, M.D. |
---|---|
Information provided by: | Arnold, George, M.D. |
ClinicalTrials.gov Identifier: | NCT00777439 |
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.
Condition | Intervention |
---|---|
Gastroparesis |
Drug: Domperidone |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Efficacy Study |
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 |
Estimated Enrollment: | 30 |
Study Start Date: | October 2008 |
Estimated Study Completion Date: | January 2010 |
Estimated Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Domperidone
All eligible subjects will receive domperidone in an open label, single group assignment.
|
Drug: Domperidone
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.
|
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Subject has signed informed consent for the administration of domperidone. The informed consent informs the subject of potential adverse events including:
Exclusion Criteria:
Contact: Mary R. Beaves, BSN | 412-623-1309 | beavesmr@upmc.edu |
Contact: George L. Arnold, MD | 412-621-2334 | arnoldgl@upmc.edu |
United States, Pennsylvania | |
Associates in Gastroenterology | Recruiting |
Pittsburgh, Pennsylvania, United States, 15232 | |
Contact: Mary R. Beaves, BSN 412-623-1309 beavesmr@upmc.edu | |
Principal Investigator: George L. Arnold, MD |
Principal Investigator: | George L. Arnold, MD | George L. Arnold, MD, FACP |
Responsible Party: | George L. Arnold, MD, FACP ( George L. Arnold, MD, FACP ) |
Study ID Numbers: | GLA102024, FDA IND#102024 |
Study First Received: | October 21, 2008 |
Last Updated: | October 21, 2008 |
ClinicalTrials.gov Identifier: | NCT00777439 |
Health Authority: | United States: Food and Drug Administration |
Dopamine Domperidone Gastroparesis Gastrointestinal Diseases Neurologic Manifestations |
Stomach Diseases Digestive System Diseases Esophagitis Esophageal Disorders Paralysis |
Esophageal disorder Gastrointestinal Diseases Gastroesophageal Reflux Paralysis Esophageal Motility Disorders Deglutition Disorders Esophagitis Signs and Symptoms |
Dopamine Domperidone Stomach Diseases Digestive System Diseases Neurologic Manifestations Esophageal Diseases Gastroparesis |
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Autonomic Agents Therapeutic Uses Physiological Effects of Drugs Gastrointestinal Agents |
Antiemetics Dopamine Agents Dopamine Antagonists Peripheral Nervous System Agents Central Nervous System Agents Pharmacologic Actions |