The Use Of Domperidone For The Relief Of Refractory Upper Gastrointestinal GI Symptoms
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|ClinicalTrials.gov Identifier: NCT03810287|
Recruitment Status : Recruiting
First Posted : January 18, 2019
Last Update Posted : January 18, 2019
|Condition or disease||Intervention/treatment||Phase|
|Gastroparesis||Drug: Domperidone||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Use Of Domperidone For The Relief Of Refractory Upper Gastrointestinal GI Symptoms|
|Actual Study Start Date :||June 1, 2014|
|Estimated Primary Completion Date :||June 30, 2019|
|Estimated Study Completion Date :||June 30, 2020|
Experimental: Patients receiving Domperidone
Patients with upper GI symptoms who have failed or suffered adverse effects from standard medical therapy.
Domperidone will be prescribed for patients with upper GI symptoms at an initial dose of 10 mg up to 4 times a day (prior to each meal and at bedtime). It is possible that the dose of domperidone may be increased to 20 mg if symptoms are not adequately controlled on the initial dose.
- Reduction of upper GI symptoms [ Time Frame: 10 years ]Domperidone will be prescribed at an initial dose of 10 mg up to 4 times a day (prior to each meal and at bedtime). It is possible that the dose of domperidone may be increased to 20 mg if symptoms are not adequately controlled on the initial dose. This will be determined by the physician at follow up visits. Maximum dose that will be prescribed is 30 mg four times daily. The study will continue until the medication is FDA approved. The study will look for a 50% reduction of symptoms.
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): NCT03810287
|Contact: Mayra Sanchez, MDfirstname.lastname@example.org|
|Contact: Roman Ryabtsevemail@example.com|
|United States, Connecticut|
|Yale Digestive Diseases||Recruiting|
|New Haven, Connecticut, United States, 06510|
|Contact: Roman Ryabtsev, MD 203-785-4576 firstname.lastname@example.org|
|Principal Investigator: Mayra Sanchez, MD|
|Principal Investigator:||Mayra Sanchez, MD||Yale University|