Domperidone in Treating Patients With Gastrointestinal Disorders
Primary Purpose
Digestive System Disorder, Dyspepsia, Esophagitis
Status
Recruiting
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Domperidone
Questionnaire Administration
Sponsored by
About this trial
This is an interventional treatment trial for Digestive System Disorder
Eligibility Criteria
Inclusion Criteria:
- Patients with GI disorders who have failed standard therapy
- Symptoms or manifestations of: a) gastroparesis; b) refractory gastroesophageal reflux disease (GERD) including persistent esophagitis, refractory heartburn, reflux-related laryngitis, and respiratory symptoms; or c) severe dyspepsia
- Completion of a comprehensive evaluation, including clinical history and physical 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 3,000/ml
- Alkaline phosphatase less than 1.5 x upper limit of normal
- Alanine aminotransferase (ALT) less than 2 x upper limit of normal
- Aspartate aminotransferase (AST) less than 2 x upper limit of normal
- 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 1.5 x upper limit of normal
- Stable hemoglobin greater than or equal to 8.0 g/dl
- Potassium between range of 3.0 to 5.5
- Magnesium level between 1.6-2.6 mg
Exclusion Criteria:
- Patients with the following cardiac diagnoses: ventricular tachycardia or fibrillation; Torsade des Pointes; clinically significant bradycardia; sinus node dysfunction; heart block; prolonged 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; history of heart failure
- Patients who are receiving antiarrhythmic medications with action on 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) inhibitors
- Patients with a history of or active liver failure
- Clinically significant electrolyte disorders including sodium < 130 or > 145 and/or potassium < 3.0 or > 5.5 and/or magnesium < 1.6 or > 2.6
- GI hemorrhage or obstruction experienced within the previous 6 weeks
- Presence of a prolactinoma (prolactin-releasing pituitary tumor)
- Pregnant or breast-feeding female (women of childbearing potential [WOCBP], defined as not post-menopausal for 12 months or without previous surgical sterilization, must have a negative urine pregnancy test within 30 days of the first administration of domperidone and must either commit to continued abstinence from heterosexual intercourse or use an effective method of birth control during the course of the study)
- Known allergy to domperidone
Sites / Locations
- M D Anderson Cancer CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment (domperidone)
Arm Description
Patients receive domperidone PO TID or QID. Treatment continues in the absence of disease progression or unacceptable toxicity.
Outcomes
Primary Outcome Measures
Attenuation of symptoms associated with disorder(s) of gastrointestinal motility, measured by change in Gastroparesis Cardinal Symptom Index (GSCI) score from baseline
Scale ranges from "0" meaning "None" to "5" meaning "Very Severe".
Patients will be classified as either "new" or "continuing" at the baseline visit. A new patient will have a "response" if he/she has a 25% reduction in GCSI at 8 weeks. A continuing patient will already have early benefit to treatment so will have a "response" if the GCSI score does not increase more than 20% over baseline at 8 weeks. Summary statistics including number (n), mean, standard deviation, median, minimum, and maximum will be computed. Bayesian 95% credible intervals will be computed.
Secondary Outcome Measures
Change in patients' self-report of symptoms
Summary statistics including n, mean, standard deviation, median, minimum, and maximum will be computed. Bayesian 95% credible intervals will be computed.
Incidence of toxicities assessed according to the Common Terminology Criteria for Adverse Events version 4.0
Summary statistics including n, mean, standard deviation, median, minimum, and maximum will be computed. Bayesian 95% credible intervals will be computed. Patient adverse events will be tabulated by symptom, grade, and relationship to study drug.
Full Information
NCT ID
NCT01696734
First Posted
September 27, 2012
Last Updated
October 11, 2023
Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT01696734
Brief Title
Domperidone in Treating Patients With Gastrointestinal Disorders
Official Title
Treatment Protocol for the Compassionate Use of Domperidone
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 23, 2012 (Actual)
Primary Completion Date
October 31, 2025 (Anticipated)
Study Completion Date
October 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
PRIMARY OBJECTIVES:
I. To provide treatment with domperidone to patients >= 16 years of age where, according to the investigators' 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 the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for at least 30 days.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Digestive System Disorder, Dyspepsia, Esophagitis, Gastroesophageal Reflux Disease, Gastroparesis, Heartburn, Nausea and Vomiting
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment (domperidone)
Arm Type
Experimental
Arm Description
Patients receive domperidone PO TID or QID. Treatment continues in the absence of disease progression or unacceptable toxicity.
Intervention Type
Drug
Intervention Name(s)
Domperidone
Other Intervention Name(s)
KW 5338, Motilium, R 33,812
Intervention Description
Given PO
Intervention Type
Other
Intervention Name(s)
Questionnaire Administration
Intervention Description
Ancillary studies
Primary Outcome Measure Information:
Title
Attenuation of symptoms associated with disorder(s) of gastrointestinal motility, measured by change in Gastroparesis Cardinal Symptom Index (GSCI) score from baseline
Description
Scale ranges from "0" meaning "None" to "5" meaning "Very Severe".
Patients will be classified as either "new" or "continuing" at the baseline visit. A new patient will have a "response" if he/she has a 25% reduction in GCSI at 8 weeks. A continuing patient will already have early benefit to treatment so will have a "response" if the GCSI score does not increase more than 20% over baseline at 8 weeks. Summary statistics including number (n), mean, standard deviation, median, minimum, and maximum will be computed. Bayesian 95% credible intervals will be computed.
Time Frame
Baseline to 8 weeks
Secondary Outcome Measure Information:
Title
Change in patients' self-report of symptoms
Description
Summary statistics including n, mean, standard deviation, median, minimum, and maximum will be computed. Bayesian 95% credible intervals will be computed.
Time Frame
Baseline to 30 days after completion of study treatment
Title
Incidence of toxicities assessed according to the Common Terminology Criteria for Adverse Events version 4.0
Description
Summary statistics including n, mean, standard deviation, median, minimum, and maximum will be computed. Bayesian 95% credible intervals will be computed. Patient adverse events will be tabulated by symptom, grade, and relationship to study drug.
Time Frame
Up to 30 days after completion of study treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with GI disorders who have failed standard therapy
Symptoms or manifestations of: a) gastroparesis; b) refractory gastroesophageal reflux disease (GERD) including persistent esophagitis, refractory heartburn, reflux-related laryngitis, and respiratory symptoms; or c) severe dyspepsia
Completion of a comprehensive evaluation, including clinical history and physical 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 3,000/ml
Alkaline phosphatase less than 1.5 x upper limit of normal
Alanine aminotransferase (ALT) less than 2 x upper limit of normal
Aspartate aminotransferase (AST) less than 2 x upper limit of normal
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 1.5 x upper limit of normal
Stable hemoglobin greater than or equal to 8.0 g/dl
Potassium between range of 3.0 to 5.5
Magnesium level between 1.6-2.6 mg
Exclusion Criteria:
Patients with the following cardiac diagnoses: ventricular tachycardia or fibrillation; Torsade des Pointes; clinically significant bradycardia; sinus node dysfunction; heart block; prolonged 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; history of heart failure
Patients who are receiving antiarrhythmic medications with action on 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) inhibitors
Patients with a history of or active liver failure
Clinically significant electrolyte disorders including sodium < 130 or > 145 and/or potassium < 3.0 or > 5.5 and/or magnesium < 1.6 or > 2.6
GI hemorrhage or obstruction experienced within the previous 6 weeks
Presence of a prolactinoma (prolactin-releasing pituitary tumor)
Pregnant or breast-feeding female (women of childbearing potential [WOCBP], defined as not post-menopausal for 12 months or without previous surgical sterilization, must have a negative urine pregnancy test within 30 days of the first administration of domperidone and must either commit to continued abstinence from heterosexual intercourse or use an effective method of birth control during the course of the study)
Known allergy to domperidone
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mehnaz Shafi
Phone
713-794-5073
Email
mashafi@mdanderson.orgs
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mehnaz Shafi
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
M D Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mehnaz Shafi
Phone
713-794-5073
First Name & Middle Initial & Last Name & Degree
Mehnaz Shafi
12. IPD Sharing Statement
Links:
URL
http://www.mdanderson.org
Description
MD Anderson Cancer Center
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Domperidone in Treating Patients With Gastrointestinal Disorders
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