Domperidone in Treating Patients With Gastrointestinal Disorders
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|ClinicalTrials.gov Identifier: NCT01696734|
Recruitment Status : Recruiting
First Posted : October 1, 2012
Last Update Posted : October 8, 2018
|Condition or disease||Intervention/treatment||Phase|
|Digestive System Disorder Dyspepsia Esophagitis Gastroesophageal Reflux Disease Gastroparesis Heartburn Nausea and Vomiting||Drug: Domperidone Other: Questionnaire Administration||Phase 3|
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.
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Treatment Protocol for the Compassionate Use of Domperidone|
|Actual Study Start Date :||October 23, 2012|
|Estimated Primary Completion Date :||October 31, 2019|
|Estimated Study Completion Date :||October 31, 2019|
Experimental: Treatment (domperidone)
Patients receive domperidone PO TID or QID. Treatment continues in the absence of disease progression or unacceptable toxicity.
Other: Questionnaire Administration
- Attenuation of symptoms associated with disorder(s) of gastrointestinal motility, measured by change in Gastroparesis Cardinal Symptom Index (GSCI) score from baseline [ Time Frame: Baseline to 8 weeks ]
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.
- Change in patients' self-report of symptoms [ Time Frame: Baseline to 30 days after completion of study treatment ]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 [ Time Frame: Up to 30 days after completion of study treatment ]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.
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): NCT01696734
|Contact: Mehnaz Shafiemail@example.com|
|United States, Texas|
|M D Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Mehnaz Shafi 713-794-5073|
|Principal Investigator: Mehnaz Shafi|
|Principal Investigator:||Mehnaz Shafi||M.D. Anderson Cancer Center|