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| Sponsor: | Yale University |
|---|---|
| Information provided by: | Yale University |
| ClinicalTrials.gov Identifier: | NCT00760461 |
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 II |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label, Single Group Assignment |
| Official Title: | Domperidone in Refractory Gastroparesis |
| Estimated Enrollment: | 30 |
| Study Start Date: | October 2008 |
| Estimated Study Completion Date: | December 2009 |
| Estimated Primary Completion Date: | December 2009 (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 |
Inclusion Criteria:
Patient has signed informed consent for the administration of domperidone that informs the patient of potential adverse events including:
Exclusion Criteria:
Contacts and Locations| Contact: Christal M Esposito | 203-785-4576 | christal.esposito@yale.edu |
| United States, Connecticut | |
| Yale Digestive Diseases 40 Temple St, Suite 1A | Recruiting |
| New Haven, Connecticut, United States, 06510 | |
| Contact: Christal M Esposito 203-785-4576 christal.esposito@yale.edu | |
| Principal Investigator: | Anish A Sheth, MD | Yale University |
More Information
| Responsible Party: | Yale University ( Anish A Sheth M.D. ) |
| Study ID Numbers: | 0809004202 |
| Study First Received: | September 24, 2008 |
| Last Updated: | February 2, 2009 |
| ClinicalTrials.gov Identifier: | NCT00760461 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Gastrointestinal Diseases Physiological Effects of Drugs Gastrointestinal Agents Antiemetics Dopamine Antagonists Pharmacologic Actions Paralysis Signs and Symptoms |
Stomach Diseases Digestive System Diseases Domperidone Autonomic Agents Therapeutic Uses Neurologic Manifestations Dopamine Agents Peripheral Nervous System Agents Central Nervous System Agents Gastroparesis |