Domperidone in Refractory Gastroparesis
This study has suspended participant recruitment.
(Subjects currently unable to receive drug from dispensing pharmacy.)
Sponsor:
Yale University
Information provided by:
Yale University
ClinicalTrials.gov Identifier:
NCT00760461
First received: September 24, 2008
Last updated: March 28, 2011
Last verified: March 2011
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Purpose
The primary objective of this study is to prescribe oral domperidone for patients with gastroparesis who have failed or suffered adverse effects from standard medical therapy.
| Condition | Intervention | Phase |
|---|---|---|
|
Gastroparesis |
Drug: Domperidone |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Domperidone in Refractory Gastroparesis |
Resource links provided by NLM:
Further study details as provided by Yale University:
Primary Outcome Measures:
- Improvement in Gastroparesis Cardinal Symptom Index [ Time Frame: upon study completion ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 30 |
| Study Start Date: | October 2008 |
| Estimated Study Completion Date: | December 2011 |
| Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Domperidone |
Drug: Domperidone
10 mg 4 times daily 20 mg 4 times daily 30 mg 4 times daily
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Male or female
- Age 18 and older
- 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.
- 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.
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.
- 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. These include significant hypokalemia, hyperkalemia, hypomagnesemia, and hypermagnesemia that cannot be corrected with treatment of these electrolyte abnormalities.
- Gastrointestinal hemorrhage or obstruction.
- Presence of a prolactinoma (prolactin-releasing pituitary tumor).
- Pregnant or breast feedings female.
- Known allergy to domperidone
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00760461
Locations
| United States, Connecticut | |
| Yale Digestive Diseases 40 Temple St, Suite 1A | |
| New Haven, Connecticut, United States, 06510 | |
Sponsors and Collaborators
Yale University
Investigators
| Principal Investigator: | Anish A Sheth, MD | Yale University |
More Information
No publications provided
| Responsible Party: | Anish A Sheth M.D., Yale University |
| ClinicalTrials.gov Identifier: | NCT00760461 History of Changes |
| Other Study ID Numbers: | 0809004202 |
| Study First Received: | September 24, 2008 |
| Last Updated: | March 28, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Gastroparesis Stomach Diseases Gastrointestinal Diseases Digestive System Diseases Paralysis Neurologic Manifestations Signs and Symptoms 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