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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
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

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.

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

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Drug Information available for: Domperidone

Arm Intervention/treatment
Experimental: Treatment (domperidone)
Patients receive domperidone PO TID or QID. Treatment continues in the absence of disease progression or unacceptable toxicity.
Drug: Domperidone
Given PO
Other Names:
  • KW 5338
  • Motilium
  • R 33,812

Other: Questionnaire Administration
Ancillary studies




Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. 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.

  2. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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; Torsades de pointes; clinically significant bradycardia; sinus node dysfunction; heart block; prolonged corrected QT (QTc) interval (QTc > 450 milliseconds for males, QTc > 470 milliseconds for females); valvular, 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

Information from the National Library of Medicine

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


Contacts
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Contact: Mehnaz Shafi 713-794-5073 mashafi@mdanderson.orgs

Locations
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United States, Texas
M D Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Mehnaz Shafi    713-794-5073      
Principal Investigator: Mehnaz Shafi         
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Mehnaz Shafi M.D. Anderson Cancer Center

Additional Information:
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01696734     History of Changes
Other Study ID Numbers: 2012-0261
NCI-2012-02093 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2012-0261 ( Other Identifier: M D Anderson Cancer Center )
P30CA016672 ( U.S. NIH Grant/Contract )
First Posted: October 1, 2012    Key Record Dates
Last Update Posted: October 8, 2018
Last Verified: October 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Vomiting
Gastroesophageal Reflux
Esophagitis
Dyspepsia
Gastroparesis
Heartburn
Digestive System Diseases
Gastrointestinal Diseases
Signs and Symptoms, Digestive
Signs and Symptoms
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastroenteritis
Stomach Diseases
Paralysis
Neurologic Manifestations
Domperidone
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action