Phase 3 Gastroparesis Trial, Recruiting NCT01696734 Sponsor: M.D. Anderson Cancer Center Condition: Gastroparesis
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Phase 3 Gastroparesis Trial, Recruiting

NCT01696734
Recruiting Phase 3

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You have a digestive system disorder and standard treatments have not worked for you
  • You have symptoms of one of the following: delayed stomach emptying (gastroparesis); heartburn or acid reflux that hasn't responded to treatment, including throat or breathing problems related to reflux; or severe indigestion
  • You have had a thorough medical evaluation, including your health history and a physical exam, to rule out other causes of your symptoms
  • You are willing to sign a consent form agreeing to take the study drug, domperidone
  • Your white blood cell count is above a certain level (confirm with trial site)
  • Your liver-related blood test results (alkaline phosphatase, ALT, AST, and bilirubin) are within acceptable ranges (confirm with trial site)
  • Your kidney-related blood test results (BUN and creatinine) are within acceptable ranges (confirm with trial site)
  • Your hemoglobin (a measure of healthy red blood cells) is at or above a minimum level (confirm with trial site)
  • Your potassium and magnesium levels are within a specific healthy range (confirm with trial site)

Who may not be able to join:

  • You have certain heart conditions, such as dangerous heart rhythm problems, a slower-than-normal heart rate, problems with your heart's electrical system, an abnormal heart rhythm reading on an ECG, significant heart valve disease, heart disease related to poor blood flow or lung problems, a weakened heart muscle, or a history of heart failure
  • You are currently taking certain medications used to treat irregular heartbeats that can affect heart rhythm (such as amiodarone, quinidine, sotalol, or similar drugs)
  • You are currently taking a type of antidepressant or other medication called a monoamine oxidase (MAO) inhibitor
  • You have a history of liver failure or currently have liver failure
  • Your sodium, potassium, or magnesium levels are outside of a safe range (confirm with trial site)
  • You had bleeding in your digestive tract or a blockage in your digestive system within the past 6 weeks
  • You have a type of brain tumor that causes the body to produce too much of a hormone called prolactin (called a prolactinoma)
  • You are pregnant or breastfeeding; women who could become pregnant must have a negative pregnancy test before starting the study and must use effective birth control or remain abstinent during the study
  • You have a known allergy to domperidone (the study drug)

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 28 July 2026
Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Mehnaz Shafi, M.D. Anderson Cancer Center

Phone: 713-794-5073

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 3
Registry
ClinicalTrials.gov
Start date
23 October 2012
Est. completion
31 October 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Attenuation of symptoms associated with disorder(s) of gastrointestinal motility, measured by change in Gastroparesis Cardinal Symptom Index (GSCI) score from baseline

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov