Itopride in Functional Dyspepsia:a Dose Finding Study
Launched by ROYAL ADELAIDE HOSPITAL · Jan 3, 2006
Trial Information
Current as of June 10, 2025
Completed
Keywords
ClinConnect Summary
Treatment of patients with functional dyspepsia remains unsatisfactory. We will assess the efficacy of Itopride, a D2 antagonist with acetylcholinesterase effects in patients with functional dyspepsia.
Patients with functional dyspepsia will be randomized to Itopride (50, 100 or 200 mg tid) or placebo. After 8 weeks of treatment, three primary efficacy endpoints will be analyzed: a) change of the severity of functional dyspepsia symptoms (assessed by the Leeds Dyspepsia Questionnaire), b) patient's global assessment of efficacy (proportion of patients symptom-free or markedly improved)and ...
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Diagnosis of functional dyspepsia (Rome criteria) -
- Exclusion Criteria:
- • structural or biochemical abnormalities explaining the symptoms, concomitant symptoms of gastroesophageal reflux disease or irritable bowel syndrome dominating the clinical picture
- • -
About Royal Adelaide Hospital
Royal Adelaide Hospital (RAH) is a leading tertiary healthcare facility in Australia, renowned for its commitment to advancing medical research and clinical excellence. As a prominent clinical trial sponsor, RAH facilitates innovative studies that aim to enhance patient care and outcomes across various medical disciplines. With a multidisciplinary team of experienced clinicians and researchers, the hospital is dedicated to fostering a collaborative environment that promotes the translation of scientific discoveries into effective treatments. RAH's strategic partnerships with academic institutions and industry stakeholders further enhance its capacity to conduct high-quality clinical trials that contribute to the global body of medical knowledge.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Essen, , Germany
Patients applied
Trial Officials
Gerald J Holtmann, MD
Principal Investigator
Royal Adelaide Hospital, University of Adelaide
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
Similar Trials