Domperidone in Treating Patients With Gastrointestinal Disorders

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT01696734
Phase
PHASE3
Status
Recruiting
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Conditions

  • Digestive System Disorder
  • Dyspepsia
  • Esophagitis
  • Gastroesophageal Reflux Disease
  • Gastroparesis
  • Heartburn
  • Nausea and Vomiting

Eligibility Criteria

Sex
ALL
Age
16 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Domperidone — DRUG
    Given PO
  • Questionnaire Administration — OTHER
    Ancillary studies

Study Details

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.

Key Dates

Start date
Oct 23, 2012
Status verified
Apr 2026
Primary completion
Oct 31, 2027
Completion
Oct 31, 2027

Study Design

Enrollment
200 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • Experimental: Treatment (domperidone)
    Patients receive domperidone PO TID or QID. Treatment continues in the absence of disease progression or unacceptable toxicity.

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 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
M D Anderson Cancer CenterHoustonTexas77030
Mehnaz Shafi
713-794-5073
Mehnaz Shafi (PRINCIPAL_INVESTIGATOR)

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By research site
M D Anderson Cancer Center· Houston, TX

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