Ondansetron for symptoms of gastroparesis in patients with chronic kidney disease undergoing hemodialysis

Status

Unknown

Phases

Phase 3

Study type

Interventional

Source

TCTR

Registry ID

TCTR20240712001

Enrollment

Registered

2024-07-12

Start date

2024-05-31

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastroparesis in patients with chronic kidney disease. Ondansetron Gastroparesis Gastric accommodation Chronic kidney disease Hemodialysis

Interventions

Receive Ondansetron 8 mg,Receive Placebo.

Experimental Drug,Placebo Comparator Drug

Group A,Group B

Eligibility

Sex/Gender

All

Age

20 Years to No maximum

Inclusion criteria

Inclusion criteria: 1) Patients with chronic kidney failure who come to use hemodialysis services at the Hemodialysis Center Faculty of Medicine Chiang Mai University (March - December 2024) 2) Have symptoms of early satiety and distension after meals. (postprandial fullness) and abnormal symptoms caused by the stomach (nausea, distension, bloating, and epigastric pain) for a period of at least 3 months. 3) Have an average total score from the Gastroparesis Cardinal Symptom Index (GCSI) questionnaire that is greater than or equal to 2 points.

Exclusion criteria

Exclusion criteria: 1) Unable to reposition in a supine position. 2) Unable to communicate to answer questionnaires. 3) Ever stomach surgery or stomach cancer 4) Use drugs that reduce nausea and vomiting or drugs that increase gastrointestinal function (prokinetic drugs) during the 2 weeks before participating in the study. 5) There are restrictions on eating before hemodialysis, such as a history of low blood pressure during hemodialysis. or have excess fluid that requires hemodialysis to remove more than 4 kilograms of water 6) Unable to eat food by mouth 7) Have nausea and vomiting and cannot eat. 8) No water or food for less than 6 hours.

Design outcomes

Primary

Measure	Time frame
Patient assessment of upper gastrointestinal symptom severity index (PAGI-SYM) 2 Weeks PAGI-SYM questionnaire	—

Secondary

Measure	Time frame
Gastric expansion (Proximal stomach and Distal stomach) 2 Weeks Ultrasound,Patient Assessment of Upper Gastrointestinal Disorders-Quality of Life 2 Weeks PAGI-QOL questionnaire	—

Countries

Thailand

Contacts

Public ContactKittitat Pongpanth

Faculty of Medicine, Chiang Mai University

ktppt13@hotmail.com053936120

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026