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Treatment Protocol for the Compassionate Use of Domperidone


Phase 3
16 Years
N/A
Open (Enrolling)
Both
Gastrointestinal Diseases

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Trial Information

Treatment Protocol for the Compassionate Use of Domperidone


Study Drug Administration:

If you are found to be eligible to take part in this study, you will take domperidone
tablets with water about 30 minutes before a meal. You may be asked to take the tablets
before bed.

During the study, the doctor may increase the amount of study drug you are taking.

You will need to record when you take the study drug in a study drug diary. This 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.

About 8 weeks after your first dose, at Month 6, and then every 6 months after that:

- You will have a physical exam, including measurement of your vital signs.

- Your medical history will be recorded.

- You will have an EKG.

- You will be asked about any drugs you may be taking and side effects you may be having.

- You will complete the 2 questionnaires about your GI symptoms.

- Blood (about 3 tablespoons) will be drawn for routine tests.

Length of Study:

You may continue to take the study drug for as long as you are benefitting. You will no
longer be able to take the study drug if intolerable side effects occur or if you are unable
to follow study directions.

Follow-Up:

About 30 days after your last dose of study drug:

- You will have a physical exam, including measurement of your vital signs.

- Your medical history will be recorded.

- You will have an EKG.

- You will be asked about any drugs you may be taking and side effects you may be having.

- Blood (about 3 tablespoons) will be drawn for routine tests.

If you are taken off study due to results of an EKG, 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.


Inclusion Criteria:



1. Patients with GI disorders who have failed standard therapy.

2. Age 16 or older

3. Symptoms or manifestations of: a) gastroparesis; b) refractory GERD including
persistent esophagitis, refractory heartburn, reflux-related laryngitis, and
respiratory symptoms; or c) severe dyspepsia.

4. Completion of a comprehensive evaluation, including clinical history and physical
examination, to eliminate other causes of their symptoms.

5. Patient has signed the informed consent document agreeing to the use of the study
drug, domperidone.

6. WBC with differential greater than 3,000/ml; alkaline phosphatase less than 1.5 x
upper limit of normal; ALT less than 2 x upper limit of normal; AST less than 2 x
upper limit of normal; bilirubin less than or equal to 2 x upper limit of normal; 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.

Exclusion Criteria:

1. 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); valvular, ischemic, or pulmonary heart disease;
cardiomyopathy; history of heart failure

2. Patients who are receiving antiarrhythmic medications with action on repolarization
times (with prolongation of the QTc interval)

3. Patients who are receiving monoamine oxidase (MAO) inhibitors

4. Patients with a history of or active liver failure

5. Clinically significant electrolyte disorders including sodium < 130 or > 145 and/or
potassium < 3.0 or > 5.5

6. GI hemorrhage or obstruction experienced within the previous 6 weeks

7. Presence of a prolactinoma (prolactin-releasing pituitary tumor)

8. 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)

9. Known allergy to domperidone

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Symptom Control of Chronic Gastrointestinal Disorders

Outcome Description:

Symptom control is defined as a 25% reduction in Gastroparesis Cardinal Symptom Index (GCSI) score compared to baseline. For discrete or categorical factors, descriptive statistics include tabulations of frequencies. For continuous data, summary statistics including n, mean, standard deviation, median, minimum, and maximum are computed. Bayesian 95% credible intervals for response rates and extreme toxicity rates are computed. Patient adverse events are tabulated by symptom, grade, and relationship to study drug. All outcome endpoints are examined by patient baseline characteristics such as gender, age, race/ethnicity, symptom manifestations, diagnosis subtype, and prior therapies.

Outcome Time Frame:

2 months

Safety Issue:

No

Principal Investigator

Mehnaz A. Shafi, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

UT MD Anderson Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

2012-0261

NCT ID:

NCT01696734

Start Date:

October 2012

Completion Date:

Related Keywords:

  • Gastrointestinal Diseases
  • Gastrointestinal diseases
  • GI
  • Compassionate use
  • GI motility disorders
  • GI disorders
  • Gastroparesis
  • Gastroesophageal reflux disease
  • GERD
  • Chronic nausea and vomiting
  • Questionnaires
  • Surveys
  • Phone calls
  • Domperidone
  • Gastrointestinal Diseases
  • Digestive System Diseases

Name

Location

UT MD Anderson Cancer CenterHouston, Texas  77030