Domperidone for Relief of Gastrointestinal Disorders
This study has been terminated.
(PI withdrew due to increased responsibilities in clinical department.)
Sponsor:
Carle Physician Group
Information provided by (Responsible Party):
Carle Physician Group
ClinicalTrials.gov Identifier:
NCT00761254
First received: September 25, 2008
Last updated: September 11, 2012
Last verified: September 2012
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Gastroparesis GERD Esophagitis Dyspepsia Chronic Idiopathic Constipation Nausea Vomiting |
Drug: Domperidone |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Oral Domperidone for Relief of Gastrointestinal Disorders in Patients Who Failed Standard Therapy |
Resource links provided by NLM:
Further study details as provided by Carle Physician Group:
Primary Outcome Measures:
- Relief for patients with gastrointestinal disorders who have failed standard therapy [ Time Frame: As long as the subjects continue to take Domperidone. ] [ Designated as safety issue: No ]
| Enrollment: | 42 |
| Study Start Date: | August 2008 |
| Study Completion Date: | September 2012 |
| Estimated Primary Completion Date: | September 2012 (Final data collection date for primary outcome measure) |
Intervention Details:
Detailed Description:
-
Drug: Domperidone
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.
Other Name: Motilium
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00761254
Locations
| United States, Illinois | |
| Carle Health Care Incorporated d/b/a Carle Physician Group | |
| Urbana, Illinois, United States, 61801 | |
Sponsors and Collaborators
Carle Physician Group
Investigators
| Principal Investigator: | Andrew Batey, M.D. | Carle Health Care Incorporated d/b/a Carle Physician Group |
| Study Director: | Anna Keck, PhD | Carle Foundation Hospital |
| Study Director: | James Dougherty, MD | Carle Foundation Hospital |
| Principal Investigator: | Eugene Greenberg, MD | Carle Physician Group |
| Principal Investigator: | Vicki Shah, PA | Carle Physician Group |
More Information
Publications:
| Responsible Party: | Carle Physician Group |
| ClinicalTrials.gov Identifier: | NCT00761254 History of Changes |
| Other Study ID Numbers: | 08-153 |
| Study First Received: | September 25, 2008 |
| Last Updated: | September 11, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Carle Physician Group:
|
Domperidone Gastroparesis |
Additional relevant MeSH terms:
|
Constipation Dyspepsia Esophagitis Digestive System Diseases Gastrointestinal Diseases Nausea Vomiting Gastroparesis Signs and Symptoms, Digestive Signs and Symptoms Esophageal Diseases Gastroenteritis Stomach Diseases Paralysis |
Neurologic Manifestations Domperidone Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Gastrointestinal Agents Dopamine Antagonists Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on June 18, 2013