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.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Symptom Control of Chronic Gastrointestinal Disorders
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.
2 months
No
Mehnaz A. Shafi, MD
Principal Investigator
UT MD Anderson Cancer Center
United States: Food and Drug Administration
2012-0261
NCT01696734
October 2012
Name | Location |
---|---|
UT MD Anderson Cancer Center | Houston, Texas 77030 |