Digestive System DisorderPhase 3NCT01696734
Domperidone in Treating Patients With Gastrointestinal Disorders
A Phase 3 study testing Domperidone and Questionnaire Administration in people with Digestive System Disorder and Dyspepsia, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Digestive System Disorder, Dyspepsia, Esophagitis
- What is being tested?
- Domperidone and Questionnaire Administration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Oct 2012to 31 Oct 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treatment Protocol for the Compassionate Use of Domperidone
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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.
- Conditions
- Digestive System Disorder, Dyspepsia, Esophagitis, Gastroesophageal Reflux Disease, Gastroparesis, Heartburn
- Being tested
- Domperidone, Questionnaire Administration
- Medical subject headings
- Digestive System Diseases, Dyspepsia, Esophagitis, Gastroesophageal Reflux, Gastroparesis, Heartburn, Nausea, Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DomperidoneDrug
Also called KW 5338, Motilium, R 33,812
Given PO
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Treatment (domperidone) | Experimental | Patients receive domperidone PO TID or QID. Treatment continues in the absence of disease progression or unacceptable toxicity. Receives: Drug: Domperidone; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Attenuation of symptoms associated with disorder(s) of gastrointestinal motility, measured by change in Gastroparesis Cardinal Symptom Index (GSCI) score from baseline
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.
Measured: Baseline to 8 weeks
Secondary outcomes (2)
Change in patients' self-report of symptoms
Summary statistics including n, mean, standard deviation, median, minimum, and maximum will be computed. Bayesian 95% credible intervals will be computed.
Measured: Baseline to 30 days after completion of study treatment
Incidence of toxicities assessed according to the Common Terminology Criteria for Adverse Events version 4.0
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.
Measured: Up to 30 days after completion of study treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2012 (estimated)
- Study start23 Oct 2012
- Primary completion31 Oct 2027 (estimated)
- Study completion31 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Digestive System DisorderStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Mehnaz Shafi, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01696734
- Sponsor's protocol ID
- 2012-0261
- Other IDs
- NCI-2012-02093, 2012-0261
- Status last verified
- Sep 2026
- First submitted
- 27 Sep 2012
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment Protocol for the Compassionate Use of Domperidone
- ClinicalTrials.gov ID
- NCT01696734
- Acronym / sponsor ID
- 2012-0261
- Conditions
- Digestive System Disorder, Dyspepsia, Esophagitis, Gastroesophageal Reflux Disease, Gastroparesis, Heartburn
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 96 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 23 Oct 2012 (actual)
- Primary completion
- 31 Oct 2027 (estimated)
- Study completion
- 31 Oct 2027 (estimated)
- First posted
- 1 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVES:
- 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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (domperidone) | Experimental | Drug: Domperidone, Other: Questionnaire AdministrationPatients receive domperidone PO TID or QID. Treatment continues in the absence of disease progression or unacceptable toxicity. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DomperidoneAlso: KW 5338, Motilium, R 33,812Given PO | Drug | Treatment (domperidone) |
| Questionnaire AdministrationAncillary studies | Other | Treatment (domperidone) |
Primary outcome
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.
2 secondary outcomes
Change in patients' self-report of symptoms
Time frame: Baseline to 30 days after completion of study treatment
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
- MD Anderson Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mehnaz Shafi principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Domperidone and Questionnaire Administration in people with Digestive System Disorder and Dyspepsia, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026; AzTrials last refreshed its copy on 6 Nov 2026.