Using domperidone to treat gastrointestinal disorders
Treatment Protocol for the Compassionate Use of Domperidone
This study is testing if the medication domperidone can help people aged 16 and older with gastrointestinal disorders feel better when other treatments haven't worked.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 16 Years and up |
| Sex | All |
| Sponsor | M.D. Anderson Cancer Center Academic / other |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT01696734 on ClinicalTrials.gov |
What this trial studies
This phase III trial investigates the effectiveness of domperidone in treating patients aged 16 and older with gastrointestinal motility disorders who have not responded to standard therapies. The study aims to alleviate symptoms such as pain, bloating, nausea, and vomiting by enhancing stomach contractions to improve food emptying. Participants will receive domperidone orally three to four times daily, with follow-up assessments conducted for at least 30 days after treatment completion.
Who should consider this trial
Good fit: Ideal candidates are patients aged 16 and older with gastrointestinal disorders like gastroparesis or refractory gastroesophageal reflux disease who have not found relief from standard treatments.
Not a fit: Patients with gastrointestinal disorders who have not failed standard therapy or those with other underlying causes for their symptoms may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the quality of life for patients suffering from chronic gastrointestinal disorders.
How similar studies have performed: Other studies have shown promise with domperidone in treating similar gastrointestinal conditions, indicating a potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Houston, Texas
- M D Anderson Cancer Center — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Mehnaz Shafi — M.D. Anderson Cancer Center
- Study coordinator: Mehnaz Shafi
- Email: mashafi@mdanderson.orgs
- Phone: 713-794-5073
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.