Itopride

Generic Name: Itopride

Drug Type: Small Molecule

Chemical Formula: C_₂₀H_₂₆N_₂O_₄

CAS Number: 122898-67-3

Unique Ingredient Identifier: 81BMQ80QRL

Background: Itopride is a dopamine D2 antagonist with acetylcholinesterase inhibitory actions.

Indication: Investigated for use/treatment in gastrointestinal diseases and disorders (miscellaneous).

Associated Conditions: Abdominal Pain, Anorexia, Dyspepsia, Functional Dyspepsia, Gastroenteritis, Nausea, Nausea and vomiting, Vomiting, Abdominal bloating, Pyrosis, Stomach discomfort

Clinical Trials

Trial of Itopride 150mg Once a Day Versus Itopride 50 mg Thrice a Day; in Patients With Functional Dyspepsia

Phase 3

Active, not recruiting

Conditions: Functional Dyspepsia

Interventions: Drug: Itopride Hydrochloride 150 mg extended release tablets
Drug: Itopride Hydrochloride 50 mg film coated tablets

First Posted Date: 2024-01-22

Last Posted Date: 2025-01-29

Lead Sponsor: Abbott

Target Recruit Count: 564

Registration Number: NCT06217393

Locations: 🇻🇳
103 Military Hospital, Hanoi, Vietnam
🇻🇳
Bach Mai Hospital, Hanoi, Vietnam
🇦🇲
"Grigor Narekatsi" MC, CJSC, Yerevan, Armenia

and more 16 locations

Potential Benefits of Itopride in the Management of Patients With Metabolic Associated Fatty Liver Disease (MAFLD)

Phase 2

Not yet recruiting

Conditions: Fatty Liver
Fatty Liver Disease

Interventions: Drug: Itopride
Drug: conventional therapy

First Posted Date: 2023-07-28

Last Posted Date: 2023-10-31

Lead Sponsor: October 6 University

Target Recruit Count: 60

Registration Number: NCT05966025

Locations: 🇪🇬
Maha Youssif Fekry, Giza, Egypt

Efficacy of Linaclotide in Patients With Overlapping Functional Gastrointestinal Disorders

Phase 4

Conditions: Constipation-predominant Irritable Bowel Syndrome
Functional Dyspepsia

Interventions: Drug: Linaclotide
Drug: Lactulose
Drug: Omeprazol
Drug: Itopride

First Posted Date: 2021-11-26

Last Posted Date: 2021-12-13

Lead Sponsor: RenJi Hospital

Target Recruit Count: 78

Registration Number: NCT05134584

Locations: 🇨🇳
RenJiH, Shanghai, Shanghai, China

Helicobacter Pylori Eradication in Functional Dyspepsia

Not Applicable

Completed

Conditions: Dyspepsia
Helicobacter Pylori Infection

Interventions: Drug: Pantoprazole 40mg
Drug: Clarithromycin 500mg
Drug: Amoxicillin 1000 MG
Drug: Levosulpiride
Drug: Acotiamide
Drug: Itopride

First Posted Date: 2021-01-06

Last Posted Date: 2021-01-14

Lead Sponsor: Sir Ganga Ram Hospital

Target Recruit Count: 202

Registration Number: NCT04697641

Locations: 🇮🇳
Department of Gastroenterology & Hepatology, Sir Ganga Ram Hospital, New Delhi, India

Functional Dyspepsia: Validation of a Questionnaire for Symptom Assessment in FD PDS Subgroup

Phase 4

Completed

Conditions: Functional Dyspepsia
Postprandial Fullness Syndrome

Interventions: Drug: Placebo
Drug: Itopride

First Posted Date: 2020-12-01

Last Posted Date: 2020-12-01

Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

Target Recruit Count: 100

Registration Number: NCT04647955

Functional Dyspepsia: Validation of the Leuven Postprandial Distress Scale (LPDS) in a Placebo-controlled Trial

Phase 4

Completed

Conditions: Functional Dyspepsia

Interventions: Drug: Placebo
Drug: itopride

First Posted Date: 2020-07-09

Last Posted Date: 2020-07-09

Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

Target Recruit Count: 105

Registration Number: NCT04464369

Locations: 🇧🇪
University Hospitals Leuven, Leuven, Vlaams-Brabant, Belgium

Norfloxacin With Itopride Versus Norfloxacin in Secondary Prophylaxis of Spontaneous Bacterial Peritonitis

Phase 3

Recruiting

Conditions: Spontaneous Bacterial Peritonitis

Interventions: Drug: Norfloxacin
Drug: Itopride

First Posted Date: 2019-11-13

Last Posted Date: 2019-11-13

Lead Sponsor: Tanta University

Target Recruit Count: 80

Registration Number: NCT04161768

Locations: 🇪🇬
Sherief Abd-Elsalam, Tanta, Egypt

Effectiveness of Prokinetic Agents in Improving Abdominal Discomfort at Colonoscopy

Not Applicable

Conditions: Abdominal Pain

Interventions: Other: Placebo
Drug: Itopride
Drug: Domperidone

First Posted Date: 2019-09-26

Last Posted Date: 2021-09-02

Lead Sponsor: Mahidol University

Target Recruit Count: 525

Registration Number: NCT04104867

Locations: 🇹🇭
Chairat Supsamutchai, Bangkok, Bankok, Thailand

Itopride in Feeding Intolerance of Critically-ill Patients Receiving Enteral Nutrition

Not Applicable

Conditions: Critically-ill Patients

Interventions: Drug: Metoclopramide 10mg
Drug: Itopride

First Posted Date: 2018-10-05

Last Posted Date: 2018-10-05

Lead Sponsor: Ain Shams University

Target Recruit Count: 60

Registration Number: NCT03698292

Locations: 🇪🇬
Kasr Al Ainy Hospital, Cairo, Egypt

Itopride as an Adjuvant for Bowel Preparation in Patients With Chronic Constipation is Effective

Phase 2

Completed

Conditions: Constipation

Interventions: Drug: itopride and polyethylene glycol electrolyte solutions
Drug: Polyethylene glycol electrolyte solutions

First Posted Date: 2012-01-20

Last Posted Date: 2012-04-19

Lead Sponsor: Shanghai Jiao Tong University School of Medicine

Target Recruit Count: 115

Registration Number: NCT01513811

Locations: 🇨🇳
Shanghai Jiao-Tong University School of Medicine Renji Hospital, Shanghai, Shanghai, China

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