Functional DyspepsiaPhase 3NCT06217393
Trial of Itopride 150mg Once a Day Versus Itopride 50 mg Thrice a Day; in Patients With Functional Dyspepsia
A Phase 3 study testing Itopride Hydrochloride 150 mg extended release tablets and Itopride Hydrochloride 50 mg film coated tablets in people with Functional Dyspepsia, run by Abbott at 19 sites in 5 countries.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Functional Dyspepsia
- What is being tested?
- Itopride Hydrochloride 150 mg extended release tablets and Itopride Hydrochloride 50 mg film coated tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 564 participants
- Where
- 19 sitesin 5 countries
- Study dates
- 28 Feb 2024to 28 Feb 2025
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult male and/or non-pregnant non-lactating female subjects aged above 18 years.
- Subjects provided written informed consent and are willing to participate in the study.
- 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,
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- bothersome epigastric burning for at least 12 weeks in the preceding 6 months
- 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.
- Baseline severity of at least moderate symptoms on LDQ (total score ≥ 9) at screening.
- H. pylori negative documented test report within 3 months prior to enrolment or during screening.
Who cannot join
- Known hypersensitivity to Itopride or any component of the formulation and to any other related drug.
- 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.
- Subjects who cannot be treated with Itopride in line with the prescribing information.
- Subjects scheduled for surgery during the study.
- Subjects with a history of difficulty in swallowing.
- Subject requiring concomitant treatment with anticholinergic drugs, drugs with narrow therapeutic index, sustained release or enteric-coated formulations.
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- 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).
- Subject with history of unusual bleeding and family history for bleeding disorders.
- Subjects with only reflux-related symptoms or who have predominantly reflux-related symptoms.
- Subjects with esophagitis, Barrett's esophagus, erosions or peptic ulcer disease within one year prior to the study or Zollinger-Ellison Syndrome.
- Dyspepsia that is exclusively relieved by defecation or associated with a change in stool frequency or stool form to exclude IBS.
- Clinically significant ECG abnormalities.
- Subjects treated with Itopride or any other gastroprokinetic within 4 weeks prior to screening.
- Subjects who took non-steroidal anti-inflammatory drugs for more than 2 weeks prior to screening
- 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
- History of or known inflammatory bowel disease (IBD) or coeliac disease.
- History of or known severe hepatic, renal, pancreatic, cardiac, metabolic, hematological or malignant disease or trimethylaminuria.
- Subjects with changed smoking status within the last three months.
- History of or known GI malignancy or ulcers associated to malignancy or any alarm features for GI malignancy, e.g. GI bleeding.
- Subjects who do not meet the criteria stated in concomitant medication section.
- Subjects with history of severe depression, anxiety or other psychological disorders.
- Females with child-bearing potential must agree to use an acceptable method of contraception during the study.
- Subjects in whom an increase in gastrointestinal motility could be harmful, e.g., (history of) gastrointestinal hemorrhage, mechanical obstruction or perforation.
- Specific food intolerance which is relieved by diet modifications (e.g. lactose intolerance, celiac disease).
- Subjects with confirmed IBS as per Rome IV criteria.
- Current alcohol or drug abuse.
- History of abdominal surgery except appendectomy, cholecystectomy or hysterectomy, tubal ligations, bladder slings or vasectomies.
- Hepatic cirrhosis or abnormal liver laboratory findings (defined as >3xULN of ALT or AST).
- Subjects under hemodialysis therapy or having advanced chronic kidney disease (defined as eGFR <60 mL/min).
- 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%).
- 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.
Trial locations and contacts
19 sites in 5 countries.
19 sites in 5 countries
Armenia4 sites
"Grigor Narekatsi" MC, CJSC
Yerevan
"Hera Med" LLC ("Medicus" Medical Center)
Yerevan
"Institute of Surgery Mickaelyan" CJSC
Yerevan
Polyclinic N 12 Health State, CJSC
Yerevan
Malaysia4 sites
Hospital Sultanah Bahiyah
Alor Star
Queen Elizabeth Hospital
Kota Kinabalu
Pantai Hospital Kuala Lumpur
Kuala Lumpur
UMMC
Petaling Jaya
Philippines4 sites
Cebu Doctors University Hospital
Cebu City, 6000
Davao Doctors Hospital
Davao City, 8000
Health Cube Medical Clinics
Manila
GreenCity Medical Center
Pampanga, 2000
Thailand4 sites
Phramongkulklao Hospital
Bangkok, 10400
King Chulalongkorn Memorial
Bangkok, 13300
Maharaj Nakorn Chiang Mai Hospital
Chiang Mai, 50200
Srinagarind Hospital
Khon Kaen, 40002
Vietnam3 sites
103 Military Hospital
Hanoi
Bach Mai Hospital
Hanoi
Nguyen Tri Phuong Hospital
Ho Chi Minh City, 70000
About this study
Official title: Randomized Multicentre Open-label Study to Investigate the Non-inferiority of Itopride Hydrochloride 150mg Once Daily Versus Itopride Hydrochloride 50 mg Thrice Daily in Subjects With Functional (Non-ulcer) Dyspepsia or Chronic Gastritis
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.
Read the detailed description
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
- Functional Dyspepsia
- Being tested
- Itopride Hydrochloride 150 mg extended release tablets, Itopride Hydrochloride 50 mg film coated tablets
- Keywords
- Functional Dyspepsia, gastrointestinal symptoms, gastric dysmotility, Bloating, Early satiety, postprandial fullness, upper abdominal pain, nausea and vomiting, anorexia, heartburn, chronic gastritis
- Medical subject headings
- Abdominal Pain, Nausea, Vomiting, Anorexia, Heartburn
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Itopride Hydrochloride 150 mg extended release tabletsDrug
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
Itopride Hydrochloride 50 mg film coated tabletsDrug
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
| Study group | Role | What they receive |
|---|---|---|
| Itopride Hydrochloride 150 mg extended release tablets once daily before one of the main meals | Experimental | Test group - Itopride Hydrochloride 150 mg extended release tablets once daily before one of the main meals (preferably the same meal throughout the treatment) Receives: Drug: Itopride Hydrochloride 150 mg extended release tablets |
| Active Control group - Itopride Hydrochloride 50 mg film | Active comparator | Not described Receives: Drug: Itopride Hydrochloride 50 mg film coated tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Overall Severity of Functional Dyspepsia Between Baseline and Week 8, as Measured by the LDQ Severity Score
Change in the overall severity of functional dyspepsia between baseline and week 8, as measured by the Leeds Dyspepsia Questionnaire (LDQ) severity score consisting of 15 questions, where questions 1-8 are used to measure the severity, on a scale of 0 to 5 (0= absence, 1= very mild, 5=very severe). End Result: Maximum severity score is 40, symptom free=0, very mild =1-4, mild=5-8, moderate=9-15, severe is 16-40
Measured: 8 weeks
Secondary outcomes (18)
Change in the Overall Severity of Functional Dyspepsia Between Baseline and Week 4, as Measured by the LDQ Severity Score
Change in the overall severity of functional dyspepsia between baseline and week 4, as measured by the Leeds Dyspepsia Questionnaire (LDQ) severity score. Change in the overall severity of functional dyspepsia between baseline and week 8, as measured by the Leeds Dyspepsia Questionnaire (LDQ) severity score consisting of 15 questions, where questions 1-8 are used to measure the severity, on a scale of 0 to 5 (0= absence, 1= very mild, 5=very severe). End Result: Maximum severity score is 40, symptom free=0, very mild =1-4, mild=5-8, moderate=9-15, severe is 16-40.
Measured: 4 weeks
Disease Specific Quality of Life (Nepean Dyspepsia Index NDI) Assessed at Baseline and Week 8 in Terms of Change in % of Functional Ability.
To assess quality of life for the two treatment arms using Disease Specific Quality of Life (Short Form - Nepean Dyspepsia Index SF-NDI) at baseline and end of treatment. The SF-NDI measures dyspepsia's impact on quality of life, with scores ranging from 10-50 (higher = worse). It includes five subscales-tension/anxiety, daily activities, eating/drinking, knowledge/control, and work/study-each with two questions rated on a 5-point Likert scale (1 = not at all, 5 = extremely). Step-1: sum of scores, step-2: converted to %disability, Step-3: convert to %functional ability (100-%disability). Higher score represents higher Quality of Life and lower scores lower Quality of Life.
Measured: 8 weeks
Change From Baseline of NRS 11 Score for Symptoms (Sensation of Bloating) After 4 Weeks of Treatment.
Change from baseline of NRS 11 score for symptoms (sensation of bloating, early satiety, postprandial fullness, upper abdominal pain or discomfort (epigastric pain, epigastric burning), anorexia (loss of appetite), heartburn, nausea and vomiting) after 4 and 8 weeks of treatment. NRS 11 will be used to assess responders' analysis for adequate/satisfactory relief. The Numerical Rating Scale (NRS) is widely used for self-reporting of pain intensity in clinical practices. 0-No, 1-Very mild, 2-Discomforting, 3-Tolerable, 4-Distressing, 5-Very Distressing, 6-Intense, 7-Very intense, 8-Horrible, 9-Unbearable, 10-Unspeakable.
Measured: 4 weeks
Change From Baseline of NRS 11 Score for Symptoms (Sensation of Bloating) After 8 Weeks of Treatment.
Participants assigned to Itopride Hydrochloride 150 mg extended release tablets group administered one tablet a day for 8 weeks. NRS 11 will be used to assess responders' analysis for adequate/satisfactory relief. The Numerical Rating Scale (NRS) is widely used for self-reporting of pain intensity in clinical practices. 0-No, 1-Very mild, 2-Discomforting, 3-Tolerable, 4-Distressing, 5-Very Distressing, 6-Intense, 7-Very intense, 8-Horrible, 9-Unbearable, 10-Unspeakable.
Measured: 8 weeks
Change From Baseline of NRS 11 Score for Symptoms (Early Satiety) After 4 Weeks of Treatment.
We have assessed the change from baseline of NRS 11 score for symptoms (Early Satiety) after 4 weeks of treatment. NRS 11 will be used to assess responders' analysis for adequate/satisfactory relief. The Numerical Rating Scale (NRS) is widely used for self-reporting of pain intensity in clinical practices. 0-No, 1-Very mild, 2-Discomforting, 3-Tolerable, 4-Distressing, 5-Very Distressing, 6-Intense, 7-Very intense, 8-Horrible, 9-Unbearable, 10-Unspeakable.
Measured: 4 weeks
Change From Baseline of NRS 11 Score for Symptoms (Early Satiety) After 8 Weeks of Treatment.
We have assessed the change from baseline of NRS 11 score for symptoms (Early Satiety) after 8 weeks of treatment. NRS 11 will be used to assess responders' analysis for adequate/satisfactory relief. The Numerical Rating Scale (NRS) is widely used for self-reporting of pain intensity in clinical practices. 0-No, 1-Very mild, 2-Discomforting, 3-Tolerable, 4-Distressing, 5-Very Distressing, 6-Intense, 7-Very intense, 8-Horrible, 9-Unbearable, 10-Unspeakable.
Measured: 8 weeks
Change From Baseline of NRS 11 Score for Symptoms (Postprandial Fullness) After 4 Weeks of Treatment.
We have assessed the change from baseline of NRS 11 score for symptoms (Postprandial Fullness) after 4 weeks of treatment. NRS 11 will be used to assess responders' analysis for adequate/satisfactory relief. The Numerical Rating Scale (NRS) is widely used for self-reporting of pain intensity in clinical practices. 0-No, 1-Very mild, 2-Discomforting, 3-Tolerable, 4-Distressing, 5-Very Distressing, 6-Intense, 7-Very intense, 8-Horrible, 9-Unbearable, 10-Unspeakable.
Measured: 4 weeks
Change From Baseline of NRS 11 Score for Symptoms (Postprandial Fullness) After 8 Weeks of Treatment.
We have assessed the change from baseline of NRS 11 score for symptoms (postprandial Fullness) after 8 weeks of treatment. NRS 11 will be used to assess responders' analysis for adequate/satisfactory relief. The Numerical Rating Scale (NRS) is widely used for self-reporting of pain intensity in clinical practices. 0-No, 1-Very mild, 2-Discomforting, 3-Tolerable, 4-Distressing, 5-Very Distressing, 6-Intense, 7-Very intense, 8-Horrible, 9-Unbearable, 10-Unspeakable.
Measured: 8 weeks
Change From Baseline of NRS 11 Score for Symptoms (Upper Abdominal Pain or Discomfort) After 4 Weeks of Treatment.
We have assessed the change from baseline of NRS 11 score for symptoms (Upper Abdominal Pain or Discomfort) after 4 weeks of treatment. NRS 11 will be used to assess responders' analysis for adequate/satisfactory relief. The Numerical Rating Scale (NRS) is widely used for self-reporting of pain intensity in clinical practices. 0-No, 1-Very mild, 2-Discomforting, 3-Tolerable, 4-Distressing, 5-Very Distressing, 6-Intense, 7-Very intense, 8-Horrible, 9-Unbearable, 10-Unspeakable.
Measured: 4 weeks
Change From Baseline of NRS 11 Score for Symptoms (Upper Abdominal Pain or Discomfort) After 8 Weeks of Treatment.
We have assessed the change from baseline of NRS 11 score for symptoms (Upper Abdominal Pain or Discomfort) after 8 weeks of treatment. NRS 11 will be used to assess responders' analysis for adequate/satisfactory relief. The Numerical Rating Scale (NRS) is widely used for self-reporting of pain intensity in clinical practices. 0-No, 1-Very mild, 2-Discomforting, 3-Tolerable, 4-Distressing, 5-Very Distressing, 6-Intense, 7-Very intense, 8-Horrible, 9-Unbearable, 10-Unspeakable.
Measured: 8 weeks
Change From Baseline of NRS 11 Score for Symptoms (Anorexia (Loss of Apetite)) After 4 Weeks of Treatment.
We have assessed the change from baseline of NRS 11 score for symptoms (Anorexia (Loss of Apetite)) after 4 weeks of treatment. NRS 11 will be used to assess responders' analysis for adequate/satisfactory relief. The Numerical Rating Scale (NRS) is widely used for self-reporting of pain intensity in clinical practices. 0-No, 1-Very mild, 2-Discomforting, 3-Tolerable, 4-Distressing, 5-Very Distressing, 6-Intense, 7-Very intense, 8-Horrible, 9-Unbearable, 10-Unspeakable.
Measured: 4 weeks
Change From Baseline of NRS 11 Score for Symptoms (Anorexia (Loss of Apetite)) After 8 Weeks of Treatment.
We have assessed the change from baseline of NRS 11 score for symptoms (Anorexia (Loss of Apetite)) after 8 weeks of treatment. NRS 11 will be used to assess responders' analysis for adequate/satisfactory relief. The Numerical Rating Scale (NRS) is widely used for self-reporting of pain intensity in clinical practices. 0-No, 1-Very mild, 2-Discomforting, 3-Tolerable, 4-Distressing, 5-Very Distressing, 6-Intense, 7-Very intense, 8-Horrible, 9-Unbearable, 10-Unspeakable.
Measured: 8 weeks
Change From Baseline of NRS 11 Score for Symptoms (Heartburn) After 4 Weeks of Treatment.
We have assessed the change from baseline of NRS 11 score for symptoms (Heartburn) after 4 weeks of treatment. NRS 11 will be used to assess responders' analysis for adequate/satisfactory relief. The Numerical Rating Scale (NRS) is widely used for self-reporting of pain intensity in clinical practices. 0-No, 1-Very mild, 2-Discomforting, 3-Tolerable, 4-Distressing, 5-Very Distressing, 6-Intense, 7-Very intense, 8-Horrible, 9-Unbearable, 10-Unspeakable.
Measured: 4 weeks
Change From Baseline of NRS 11 Score for Symptoms (Heartburn) After 8 Weeks of Treatment.
We have assessed the change from baseline of NRS 11 score for symptoms (Heartburn) after 8 weeks of treatment. NRS 11 will be used to assess responders' analysis for adequate/satisfactory relief. The Numerical Rating Scale (NRS) is widely used for self-reporting of pain intensity in clinical practices. 0-No, 1-Very mild, 2-Discomforting, 3-Tolerable, 4-Distressing, 5-Very Distressing, 6-Intense, 7-Very intense, 8-Horrible, 9-Unbearable, 10-Unspeakable.
Measured: 8 weeks
Change From Baseline of NRS 11 Score for Symptoms (Nausea) After 4 Weeks of Treatment.
We have assessed the change from baseline of NRS 11 score for symptoms (Nausea) after 4 weeks of treatment. NRS 11 will be used to assess responders' analysis for adequate/satisfactory relief. The Numerical Rating Scale (NRS) is widely used for self-reporting of pain intensity in clinical practices. 0-No, 1-Very mild, 2-Discomforting, 3-Tolerable, 4-Distressing, 5-Very Distressing, 6-Intense, 7-Very intense, 8-Horrible, 9-Unbearable, 10-Unspeakable.
Measured: 4 weeks
Change From Baseline of NRS 11 Score for Symptoms (Nausea) After 8 Weeks of Treatment.
We have assessed the change from baseline of NRS 11 score for symptoms (Nausea) after 8 weeks of treatment. NRS 11 will be used to assess responders' analysis for adequate/satisfactory relief. The Numerical Rating Scale (NRS) is widely used for self-reporting of pain intensity in clinical practices. 0-No, 1-Very mild, 2-Discomforting, 3-Tolerable, 4-Distressing, 5-Very Distressing, 6-Intense, 7-Very intense, 8-Horrible, 9-Unbearable, 10-Unspeakable.
Measured: 8 weeks
Change From Baseline of NRS 11 Score for Symptoms (Vomiting) After 4 Weeks of Treatment.
We have assessed the change from baseline of NRS 11 score for symptoms (Vomiting) after 4 weeks of treatment. NRS 11 will be used to assess responders' analysis for adequate/satisfactory relief. The Numerical Rating Scale (NRS) is widely used for self-reporting of pain intensity in clinical practices. 0-No, 1-Very mild, 2-Discomforting, 3-Tolerable, 4-Distressing, 5-Very Distressing, 6-Intense, 7-Very intense, 8-Horrible, 9-Unbearable, 10-Unspeakable.
Measured: 4 weeks
Change From Baseline of NRS 11 Score for Symptoms (Vomiting) After 8 Weeks of Treatment.
We have assessed the change from baseline of NRS 11 score for symptoms (Vomiting) after 8 weeks of treatment. NRS 11 will be used to assess responders' analysis for adequate/satisfactory relief. The Numerical Rating Scale (NRS) is widely used for self-reporting of pain intensity in clinical practices. 0-No, 1-Very mild, 2-Discomforting, 3-Tolerable, 4-Distressing, 5-Very Distressing, 6-Intense, 7-Very intense, 8-Horrible, 9-Unbearable, 10-Unspeakable.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2024
- Study start28 Feb 2024
- Primary completion28 Feb 2025
- Study completion28 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Functional DyspepsiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- None (open label)
- Enrolment
- 564 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Suntje Sander, Study director, Abbott Laboratories GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06217393
- Sponsor's protocol ID
- ITOP-322-0216
- Status last verified
- Mar 2026
- First submitted
- 24 Nov 2023
- Last updated
- 3 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No