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Domperidone in Treating Patients With Gastrointestinal Disorders

StatusActive, Not Recruiting
PhasePhase 3
Started2012-10-23
View on ClinicalTrials.gov ↗

Amendment history

2026-09-25
Enrollment closed, study ongoing
Final enrollment: 96 participants (planned 200)
2026-04-10
3 amendments v39-v41
3 re-verifications since 2025-11-24, no change to tracked fields
2025-10-22
Study Status, Oversight v38
Primary completion date2025-10-31→2027-10-31
Completion date2025-10-31→2027-10-31
2025-08-20
7 amendments v31-v37
7 re-verifications since 2023-08-09, no change to tracked fields
2022-12-14
Study Status, Eligibility v30
Eligibility criteria+87 characters
[...] cardiac diagnoses: ventricular tachycardia or fibrillation; TorsadesTorsade dedes pointesPointes; clinically significant bradycardia; sinus node dysfunction; heart block; prolonged corrected QT (QTc) interval (QTc > 450 milliseconds for males, QTc > 470 milliseconds for females); prior specific cardiovascular conditions of clinically significant valvular heart disease requiring medication, ischemic, or pulmonary heart disease; cardiomyopathy; hist [...]
Show 29 earlier versions
2022-11-07
Study Status, References v29
Re-verified, no change to tracked fields
2022-10-18
Study Status v28
Primary completion date2022-10-31→2025-10-31
Completion date2022-10-31→2025-10-31
2022-10-11
Study Status v27
Re-verified, no change to tracked fields
2022-04-27
Study Status v26
Primary completion date2021-10-31→2022-10-31
Completion date2021-10-31→2022-10-31
2020-07-21
Study Identification, Study Status v25
Re-verified, no change to tracked fields
2019-12-04
Study Status v24
Primary completion date2019-10-31→2021-10-31
Completion date2019-10-31→2021-10-31
2018-10-04
2 amendments v22-v23
2 re-verifications since 2018-10-01, no change to tracked fields
2018-09-27
Study Identification, Study Status, Sponsor/Collaborators, Study Description, Conditions, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations, References v21
Primary completion date2019-10→2019-10-31
Completion date2019-10→2019-10-31
Start date2012-10→2012-10-23
InterventionsDomperidone (Drug), Phone Calls (Other), Questionnaires (Behavioral)→Domperidone (Drug), Questionnaire Administration (Other)
Eligibility criteria+120 characters
Inclusion Criteria: Patients with GI disorders who have failed standard therapy. Age 16 or older Symptoms or manifestations of: a) gastroparesis; b) refractory gastroesophageal reflux disease (GERD) including persistent esophagitis, refractory heartburn, ref [...] laryngitis, and respiratory symptoms; or c) severe dyspepsia. Completion of a comprehensive evaluation, including clinica [...] cal examination, to eliminate other causes of their symptoms. Patient has signed the informed consent document agreeing to the use of the study drug, domperidone. White blood cell (WBC) with differential greater than 3,00 [...] [...]
Secondary endpoints+152 characters
Change in patients' self-report of symptoms Incidence of toxicities assessed according to the Common Terminology Criteria for Adverse Events version 4.0
Primary endpoints1 entry, revised
Symptom ControlAttenuation of Chronicsymptoms Gastrointestinalassociated Disorderswith disorder(s) of gastrointestinal motility, measured by change in Gastroparesis Cardinal Symptom Index (GSCI) score from baseline
Study description-1,644 characters
StudyPRIMARY Drug AdministrationOBJECTIVES: IfI. youTo areprovide foundtreatment with domperidone to bepatients eligible>= 16 years of age where, according to takethe partinvestigators' judgment, a prokinetic effect is needed for the relief of gastrointestinal (GI) motility disorders. OUTLINE: Patients receive domperidone orally (PO) thrice daily (TID) or four times daily (QID). Treatment continues in thisthe study,absence youof willdisease takeprogression domperidoneor tabletsunacceptable with water about 30 minutes before a mealtoxicity. YouAfter may be asked to take the tablets before bed. [...] [...]
Study sites1 entry, revised
UniversityM of Texas MDD Anderson Cancer Center
Collaborators+31 characters
National Cancer Institute (NCI)
Study title+5 characters
TreatmentDomperidone Protocolin forTreating thePatients CompassionateWith UseGastrointestinal of DomperidoneDisorders
2017-10-27
Study Status, Oversight, Study Description v20
Primary completion date2018-10→2019-10
Completion datenot stated→2019-10
Study description-234 characters
[...] you will be referred to the cardiology department for tests. This is an investigational study. Domperidone is not FDA approved or commercially available. It is currently being used for research purposes only. Up to 200 patients will be enrolled in this study. All will take part at MD Anderson.
2016-12-13
Study Status v19
Primary completion date2017-10→2018-10
2016-06-29
2 amendments v17-v18
2 re-verifications since 2016-04-20, no change to tracked fields
2016-04-14
Study Status, Study Description v16
Study description+419 characters
[...] Your medical history will be recorded. You will have an EKG at 2 months, 6 months, and 12 months in the first year and every 6 months from then on. If the doctor thinks it is needed, this EKG will be repeated. You can have the EKG at your regular doctor. You will be asked about any drugs you may be taking and side [...] ou will complete the 2 questionnaires about your GI symptoms. Blood (about 3 tablespoons) will be drawn for routine tests at 2 months, 6 months, and 12 months in the first year and then at every follow-up visits from then on. If the doctor thinks it is needed, this blood test will be [...] [...]
2015-11-04
2 amendments v14-v15
2 re-verifications since 2015-10-16, no change to tracked fields
2015-09-01
Study Status, Eligibility v13
Eligibility criteria+64 characters
[...] or equal to 8.0 g/dl; potassium between range of 3.0 to 5.5, magnesium level between 1.8-2.9 mg. Exclusion Criteria: Patients with the following cardiac di [...] including sodium <130 or >145 and/or potassium <3.0 or >5.5 and /or magnesium <1.8 or >2.9. GI hemorrhage or obstruction experienced within the previou [...]
2015-05-11
Study Status v12
Re-verified, no change to tracked fields
2014-11-10
Active, Not Recruiting→Recruiting Study Status, Contacts/Locations v11
Trial statusActive, Not Recruiting→Recruiting
Study sitesdetails revised at 1 of 1 site
2014-10-10
Study Status v10
Re-verified, no change to tracked fields
2014-09-24
Study Status, Study Description, Eligibility, Contacts/Locations, References v9
Eligibility criteria+106 characters
[...] repolarization times (with prolongation of the QTc interval such as Amiodarone, Disopyramide, Dofetilide, Flecainide, Ibutilide, Quinidine, Sotalol, Dronedarone etc.) Patients who are receiving monoamine oxidase (MAO) inhibit [...]
Study description+54 characters
[...] diary will be reviewed at clinic visits. Study Procedures: About 2 and 4 weeks after your first dose, the doctor will call you to ask you about symptoms you may be having. AboutStarting 8 weeks after your first dose of the study drug, atyou Monthwill 6have a study visit every 2 months for the first year of taking the study drug, and then every 6 months after that. During these visits, the following tests and procedures will be performed: You will have a physical exam, including measurement of yo [...]
Study sites1 entry, revised
UTUniversity of Texas MD Anderson Cancer Center
2014-02-12
Study Identification, Study Status v8
Re-verified, no change to tracked fields
2014-02-10
Recruiting→Active, Not Recruiting Study Status, Contacts/Locations v7
Trial statusRecruiting→Active, Not Recruiting
Study sitesdetails revised at 1 of 1 site
2013-08-07
2 amendments v5-v6
2 re-verifications since 2013-02-06, no change to tracked fields
2013-01-25
Study Status, Study Description, Eligibility v4
Eligibility criteria-41 characters
[...] ocument agreeing to the use of the study drug, domperidone. White blood cell (WBC) with differential greater than 3,000/ml; alkaline phosphata [...] bilirubin less than or equal to 2 x upper limit of normal; blood urea nitrogen (BUN) less than 2 x upper limit of normal; creatinine less than 1 [...]
2012-10-23
Not Yet Recruiting→Recruiting Study Status, Arms and Interventions, Contacts/Locations v3
Trial statusNot Yet Recruiting→Recruiting
Primary completion date2017-12→2017-10
Start date2012-12→2012-10
Study sitesdetails revised at 1 of 1 site
2012-10-18
Study Status, Study Description, Outcome Measures, Eligibility v2
Eligibility criteria+41 characters
[...] ocument agreeing to the use of the study drug, domperidone. White blood cell (WBC) with differential greater than 3,000/ml; alkaline phosphata [...] bilirubin less than or equal to 2 x upper limit of normal; blood urea nitrogen (BUN) less than 2 x upper limit of normal; creatinine less than 1 [...]
2012-10-08
Study Status v1
Re-verified, no change to tracked fields
2012-09-27
Original filing
This phase III trial studies how well domperidone works in treating patients with gastrointestinal disorders. Domperidone may help control chronic gastrointestinal disorders and their symptoms, such as pain, bloating, and nausea and vomiting, by stimulating contraction of the stomach to increase its ability to empty itself of food.
Trial Details
NCT Number NCT01696734
Lead Sponsor M.D. Anderson Cancer Center
Collaborators: National Cancer Institute (NCI)
Conditions Digestive System Disorder, Dyspepsia, Esophagitis, Gastroesophageal Reflux Disease, Gastroparesis, Heartburn, Nausea and Vomiting
Enrollment 96 participants
Start Date 2012-10-23
Primary Completion 2027-10-31 (estimated)
Study Completion 2027-10-31 (estimated)
Updated on ClinicalTrials.gov 2026-09-24