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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

564 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-28

Study Completion Date

2025-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The study is conducted in patients with functional dyspepsia or chronic gastritis. The purpose of this study is to:

* assess whether the dose of Itopride Hydrochloride 150 mg extended release tablets, taken once daily has a similar effect on gastrointestinal symptoms caused by gastric dysmotility and delayed gastric emptying, like bloating sensation, early satiety, postprandial fullness, upper abdominal pain or discomfort, anorexia, heartburn, nausea and vomiting in functional (non-ulcer) dyspepsia or chronic gastritis, as Itopride Hydrochloride 50 mg film coated tablets administered thrice a day.
* investigate assessment of the treatment provided to each participant.
* monitor safety and tolerability of Itopride Hydrochloride 150 mg extended release tablets, taken once daily before one of the main meals (preferably same meal throughout the treatment) and Itopride Hydrochloride 50 mg film coated tablets thrice daily before meals.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Itopride in Functional Dyspepsia:a Dose Finding Study

NCT00272103

Functional Dyspepsia

COMPLETED PHASE2/PHASE3

Treatment Outcomes For Functional Dyspepsia Based On Current International Guidelines In Multi-Ethnic Asian Patients

NCT04918017

Functional Dyspepsia

UNKNOWN PHASE4

Acotiamide vs Itopride in Postprandial Distress Syndrome

NCT07174297

Postprandial Distress Syndrome

NOT_YET_RECRUITING PHASE3

Effect of Nortriptyline on Abdominal Pain/Discomfort and Quality of Life in Patients With Nonulcer Dyspepsia

NCT00547703

Non Ulcer Dyspepsia

TERMINATED NA

A Trial of C13-CAC Breath Test in PPI Resistant GERD Patients

NCT03284177

Gastroesophageal Reflux Disease

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This is a muti-national study, in subjects with functional dyspepsia. The study will screen approximately 700 subjects and include 564 subjects (282 subjects in both arms Test and Active control arm) and the treatment will be given as follows.

* Test group - Itopride Hydrochloride 150 mg extended release tablets once daily before any of the main meals (preferably same meal throughout the treatment) OR
* Active Control group - Itopride Hydrochloride 50 mg film coated tablets thrice daily before meals Total study participation will include screening for two weeks, treatment duration of eight weeks and follow-up for one week after the end of treatment.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Functional Dyspepsia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This is a Phase 3, randomized, open-label, multicenter, parallel-group, active-controlled study to evaluate the non-inferiority efficacy of Itopride Hydrochloride 150mg extended release tablet ( administered once daily) compared to Itopride Hydrochloride 50 mg film coated tablets (administered TID) in subjects with gastrointestinal symptoms caused by gastric dysmotility and delayed gastric emptying, like sensation of bloating, early satiety, postprandial fullness, upper abdominal pain or discomfort, anorexia, heartburn, nausea and vomiting; functional (non-ulcer) dyspepsia or chronic gastritis. This study will enroll 564 subjects and the duration of subject participation will be approximately 11 weeks.

Test group - Itopride Hydrochloride 150 mg extended release tablets once daily before one of the main meals (preferably the same meal throughout the treatment) Active Control group - Itopride Hydrochloride 50 mg film coated tablets 3 times daily before meals

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Itopride Hydrochloride 150 mg extended release tablets once daily before one of the main meals

Test group - Itopride Hydrochloride 150 mg extended release tablets once daily before one of the main meals (preferably the same meal throughout the treatment)

The intervention in the study is in form of test and active control groups- see details below • Test group - Itopride Hydrochloride 150 mg extended release tablets once daily before one of the main meals (preferably the same meal throughout the treatment)

• Active Control group - Itopride Hydrochloride 50 mg film coated tablets 3 times daily before meals

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Adult male and/or non-pregnant non-lactating female subjects aged above 18 years.
2. Subjects provided written informed consent and are willing to participate in the study.
3. Subjects with functional (non-ulcer) dyspepsia according to Rome IV criteria including postprandial distress syndrome (PDS) and with or without EPS (epigastric pain syndrome) with one or more of the following:

* bothersome postprandial fullness,
* bothersome early satiation
* bothersome epigastric pain,
* bothersome epigastric burning for at least 12 weeks in the preceding 6 months
4. No evidence of organic, systemic, metabolic or structural disease likely to explain symptoms - Subjects who have to undergone physical examination and lab tests (including white-cell and red-cell counts, measurement of fasting blood sugar and liver-function tests), abdominal ultrasonography, and upper GI endoscopy\* in order to rule out structural cause for symptoms of FD.

\*history of upper GI endoscopy within 6 months prior to enrolment or at screening.
5. Baseline severity of at least moderate symptoms on LDQ (total score ≥ 9) at screening.
6. H. pylori negative documented test report within 3 months prior to enrolment or during screening.

Exclusion Criteria

1. Known hypersensitivity to Itopride or any component of the formulation and to any other related drug.
2. Subject with history or presence of clinically relevant evidence of cardiovascular, neurological, gastrointestinal/hepatic, renal, psychiatric, respiratory, urogenital, hematologic/immunologic, HEENT (head, ears, eyes, nose, throat), dermatological/ connective tissue, musculoskeletal, metabolic/nutritional, drug hypersensitivity, allergy, endocrine, major surgery or other relevant disease as revealed by medical history requiring treatment which at investigator's discretion might interfere with the study.
3. Subjects who cannot be treated with Itopride in line with the prescribing information.
4. Subjects scheduled for surgery during the study.
5. Subjects with a history of difficulty in swallowing.
6. Subject requiring concomitant treatment with anticholinergic drugs, drugs with narrow therapeutic index, sustained release or enteric-coated formulations.
7. Subjects taking Acid release inhibitors (e.g. histamine-2-receptor \[H2\]- antagonists, proton pump inhibitors \[PPI\], or potassium-competitive acid blockers), antacids (e.g. aluminium- or magnesium hydroxide, sodium bicarbonate), gastric mucosa protectors (e.g. sucralfate, rebamipide).
8. Subject with history of unusual bleeding and family history for bleeding disorders.
9. Subjects with only reflux-related symptoms or who have predominantly reflux-related symptoms.
10. Subjects with esophagitis, Barrett's esophagus, erosions or peptic ulcer disease within one year prior to the study or Zollinger-Ellison Syndrome.
11. Dyspepsia that is exclusively relieved by defecation or associated with a change in stool frequency or stool form to exclude IBS.
12. Clinically significant ECG abnormalities.
13. Subjects treated with Itopride or any other gastroprokinetic within 4 weeks prior to screening.
14. Subjects who took non-steroidal anti-inflammatory drugs for more than 2 weeks prior to screening
15. Subjects with refractory FD1 (defined as FD presenting symptoms continuing for at least 6 months, unresponsive to at least two medical treatments such as PPIs, prokinetics, or H. pylori eradication) as per investigator's discretion
16. History of or known inflammatory bowel disease (IBD) or coeliac disease.
17. History of or known severe hepatic, renal, pancreatic, cardiac, metabolic, hematological or malignant disease or trimethylaminuria.
18. Subjects with changed smoking status within the last three months.
19. History of or known GI malignancy or ulcers associated to malignancy or any alarm features for GI malignancy, e.g. GI bleeding.
20. Subjects who do not meet the criteria stated in concomitant medication section.
21. Subjects with history of severe depression, anxiety or other psychological disorders.
22. Females with child-bearing potential must agree to use an acceptable method of contraception during the study.
23. Subjects in whom an increase in gastrointestinal motility could be harmful, e.g., (history of) gastrointestinal hemorrhage, mechanical obstruction or perforation.
24. Specific food intolerance which is relieved by diet modifications (e.g. lactose intolerance, celiac disease).
25. Subjects with confirmed IBS as per Rome IV criteria.
26. Current alcohol or drug abuse.
27. History of abdominal surgery except appendectomy, cholecystectomy or hysterectomy, tubal ligations, bladder slings or vasectomies.
28. Hepatic cirrhosis or abnormal liver laboratory findings (defined as \>3xULN of ALT or AST).
29. Subjects under hemodialysis therapy or having advanced chronic kidney disease (defined as eGFR \<60 mL/min).
30. History of or known congestive heart failure NYHA class III and IV, or any other uncontrolled chronic diseases, such as: uncontrolled hypertension (systolic/diastolic blood pressure ≥160/100 mmHg); uncontrolled diabetes (HbA1c \>8%).
31. Subjects currently being known to be afflicted by serious infection(s), or any known severe illness(es) which are judged by the investigator could interfere with subjects' safety and/or study evaluation.

Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No