Trial of Itopride 150mg Once a Day Versus Itopride 50 mg... | NCT06217393

Description Module

Label	Type	Description	Intervention Names
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)	Drug: Itopride Hydrochloride 150 mg extended release tablets
Active Control group - Itopride Hydrochloride 50 mg film	Active Comparator		Drug: Itopride Hydrochloride 50 mg film coated tablets

Name	Type	Description	Arm Group Labels	Other Names
Itopride Hydrochloride 150 mg extended release tablets	Drug	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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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	8 weeks

Secondary Outcomes

Measure	Description	Time Frame
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.

Other Outcomes

Measure	Description	Time Frame
Treatment Acceptance by Subjects Using 5-point Likert Scale at the End of the Treatment	Treatment acceptance and ease of use assessed by subjects using 5-point Likert scale (1. Not at all satisfied, 2. Slightly satisfied, 3. Neutral, 4. Very satisfied, 5. Extremely satisfied.)	8 weeks
Evaluation of Safety and Tolerability in Both Treatment Arms

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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,
- 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.

Exclusion Criteria:

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.
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.

Name	Affiliation	Role
Suntje Sander	Abbott Laboratories GmbH	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
"Grigor Narekatsi" MC, CJSC		Yerevan			Armenia
"Hera Med" LLC ("Medicus" Medical Center)

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Itopride Hydrochloride 150 mg Extended Release Tablets Once Daily Before One of the Main Meals	Participants assigned to Itopride Hydrochloride 150 mg extended release tablets once daily group administered one tablet a day for 8 weeks.
FG001	Itopride Hydrochloride 50 mg Film-coated Tablet

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Sep 5, 2023	Nov 10, 2025

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

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

Posted

Mean

95% Confidence Interval

units on a scale

8 weeks

ID	Title	Description
OG000	Itopride Hydrochloride 150 mg Extended Release Tablets Once Daily Before One of the Main Meals	Participants assigned to Itopride Hydrochloride 150 mg extended release tablets group administered one tablet a day for 8 weeks.
OG001	Active Control Group - Itopride Hydrochloride 50 mg Film	Participants assigned to this group administered three tablets a day for 8 weeks.

Units	Counts
Participants	OG000261 OG001263

Title

Denominators

Categories

Title	Measurements
	OG000-9.54(-10.17 to -8.91) OG001-9.17(-9.78 to -8.56)

Secondary

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.

Posted

Mean

95% Confidence Interval

units on a scale

4 weeks

ID	Title	Description
OG000	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)
OG001	Active Control Group - Itopride Hydrochloride 50 mg Film	Participants assigned to this group administered three tablets a day for 8 weeks.

Units	Counts

Secondary

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.

Posted

Mean

Standard Deviation

Percentage of Functional ability

8 weeks

ID	Title	Description
OG000	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)
OG001	Active Control Group - Itopride Hydrochloride 50 mg Film	Participants assigned to this group administered three tablets a day for 8 weeks.

Secondary

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.

Full analysis population: 277 subjects in 150mg group and 280 subjects in 50mg group. (Completed subjects: 274 in 150 mg and 276 in 50mg. Analysis data for 3 subjects in 150mg group and 4 subjects in 50mg group is missing)

Posted

Mean

Standard Deviation

units on a scale

4 weeks

ID	Title	Description
OG000	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)
OG001	Active Control Group - Itopride Hydrochloride 50 mg Film	Participants assigned to this group administered three tablets a day for 8 weeks.

Secondary

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.

Full analysis population: 277 subjects in 150mg group and 280 subjects in 50mg group. (Completed subjects: 270 in 150 mg and 276 in 50mg. Analysis data for 7 subjects in 150mg group and 4 subjects in 50mg group is missing)

Posted

Mean

Standard Deviation

units on a scale

8 weeks

ID	Title	Description
OG000	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)
OG001	Active Control Group - Itopride Hydrochloride 50 mg Film	Participants assigned to this group administered three tablets a day for 8 weeks.

Other Pre-specified

Treatment Acceptance by Subjects Using 5-point Likert Scale at the End of the Treatment

Treatment acceptance and ease of use assessed by subjects using 5-point Likert scale (1. Not at all satisfied, 2. Slightly satisfied, 3. Neutral, 4. Very satisfied, 5. Extremely satisfied.)

Posted

Mean

Standard Deviation

Units on a scale

8 weeks

ID	Title	Description
OG000	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)
OG001	Active Control Group - Itopride Hydrochloride 50 mg Film	Participants assigned to this group administered three tablets a day for 8 weeks.

Units	Counts
Participants	OG000

Other Pre-specified

Evaluation of Safety and Tolerability in Both Treatment Arms

Evaluation of the safety and tolerability of the two treatments by assessing the following safety endpoints: Treatment emergent adverse events (TEAEs) as detected by physical examination, laboratory assessments and vital signs. For each unique treatment, treatment emergent AEs will be summarized per primary standard of care, Highest Level Term by primary Standard of care and per preferred term by highest level term and primary standard of care.

Posted

Count of Participants

Participants

8 weeks

ID	Title	Description
OG000	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)
OG001	Active Control Group - Itopride Hydrochloride 50 mg Film	Participants assigned to this group administered three tablets a day for 8 weeks.

Units	Counts
Participants

Secondary

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.

Posted

Mean

Standard Deviation

units on a scale

4 weeks

ID	Title	Description
OG000	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)
OG001	Active Control Group - Itopride Hydrochloride 50 mg Film	Participants assigned to this group administered three tablets a day for 8 weeks.

Secondary

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.

Posted

Mean

Standard Deviation

units on a scale

8 weeks

ID	Title	Description
OG000	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)
OG001	Active Control Group - Itopride Hydrochloride 50 mg Film	Participants assigned to this group administered three tablets a day for 8 weeks.

Secondary

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.

Posted

Mean

Standard Deviation

Units on a scale

4 weeks

ID	Title	Description
OG000	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)
OG001	Active Control Group - Itopride Hydrochloride 50 mg Film	Participants assigned to this group administered three tablets a day for 8 weeks.

Secondary

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.

Posted

Mean

Standard Deviation

units on a scale

8 weeks

ID	Title	Description
OG000	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)
OG001	Active Control Group - Itopride Hydrochloride 50 mg Film	Participants assigned to this group administered three tablets a day for 8 weeks.

Secondary

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.

Full analysis population is used. (N= 277 for 150mg and N=280 for 50mg group. Out of this population, Data of 3 subjects in 150mg and 4 subjects in 50mg group is missing, hence the total number of subjects are 274 in 150mg and 276 in 50mg group)

Posted

Mean

Standard Deviation

units on a scale

4 weeks

ID	Title	Description
OG000	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)
OG001	Active Control Group - Itopride Hydrochloride 50 mg Film	Participants assigned to this group administered three tablets a day for 8 weeks.

Secondary

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.

Full analysis population is used. (N= 277 for 150mg and N=280 for 50mg group. Out of this population, Data of 7 subjects in 150mg and 4 subjects in 50mg group is missing, hence the total number of subjects are 270 in 150mg and 276 in 50mg group)

Posted

Mean

Standard Deviation

units on a scale

8 weeks

ID	Title	Description
OG000	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)
OG001	Active Control Group - Itopride Hydrochloride 50 mg Film	Participants assigned to this group administered three tablets a day for 8 weeks.

Secondary

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.

Posted

Mean

Standard Deviation

units on a scale

4 weeks

ID	Title	Description
OG000	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)
OG001	Active Control Group - Itopride Hydrochloride 50 mg Film	Participants assigned to this group administered three tablets a day for 8 weeks.

Secondary

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.

Posted

Mean

Standard Deviation

units on a scale

8 weeks

ID	Title	Description
OG000	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)
OG001	Active Control Group - Itopride Hydrochloride 50 mg Film	Participants assigned to this group administered three tablets a day for 8 weeks.

Secondary

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.

Posted

Mean

Standard Deviation

Units on a scale

4 weeks

ID	Title	Description
OG000	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)
OG001	Active Control Group - Itopride Hydrochloride 50 mg Film	Participants assigned to this group administered three tablets a day for 8 weeks.

Secondary

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.

Posted

Mean

Standard Deviation

Units on a scale

8 weeks

ID	Title	Description
OG000	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)
OG001	Active Control Group - Itopride Hydrochloride 50 mg Film	Participants assigned to this group administered three tablets a day for 8 weeks.

Secondary

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.

Posted

Mean

Standard Deviation

Units on a scale

4 weeks

ID	Title	Description
OG000	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)
OG001	Active Control Group - Itopride Hydrochloride 50 mg Film	Participants assigned to this group administered three tablets a day for 8 weeks.

Secondary

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.

Posted

Mean

Standard Deviation

Units on a scale

8 weeks

ID	Title	Description
OG000	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)
OG001	Active Control Group - Itopride Hydrochloride 50 mg Film	Participants assigned to this group administered three tablets a day for 8 weeks.

Secondary

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.

Posted

Mean

Standard Deviation

units on a scale

4 weeks

ID	Title	Description
OG000	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)
OG001	Active Control Group - Itopride Hydrochloride 50 mg Film	Participants assigned to this group administered three tablets a day for 8 weeks.

Secondary

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.

Posted

Mean

Standard Deviation

Units on a scale

8 weeks

ID	Title	Description
OG000	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)
OG001	Active Control Group - Itopride Hydrochloride 50 mg Film	Participants assigned to this group administered three tablets a day for 8 weeks.

Other Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Diarrhoea	Gastrointestinal disorders	Systematic Assessment	EG00016 affected280 at risk EG00110 affected281 at risk
Abdominal pain upper	Gastrointestinal disorders	Systematic Assessment	EG0003 affected280 at risk EG0011 affected281 at risk
Abdominal pain	Gastrointestinal disorders	Systematic Assessment	EG0005 affected280 at risk EG0011 affected281 at risk
Nausea	Gastrointestinal disorders	Systematic Assessment	EG0005 affected280 at risk EG0012 affected281 at risk
Abdominal discomfort	Gastrointestinal disorders	Systematic Assessment	EG0002 affected280 at risk EG0011 affected281 at risk
Dyspepsia	Gastrointestinal disorders	Systematic Assessment	EG0001 affected280 at risk EG0011 affected281 at risk
Epigastric discomfort	Gastrointestinal disorders	Systematic Assessment	EG0001 affected280 at risk EG0010 affected281 at risk
Anal fissure	Gastrointestinal disorders	Systematic Assessment	EG0002 affected280 at risk EG0010 affected281 at risk
Toothache	Gastrointestinal disorders	Systematic Assessment	EG0001 affected280 at risk EG0010 affected281 at risk
Gastrointestinal disorder	Gastrointestinal disorders	Systematic Assessment	EG0001 affected280 at risk EG0010 affected281 at risk
Irritable bowel syndrome	Gastrointestinal disorders	Systematic Assessment	EG0001 affected280 at risk EG0010 affected281 at risk
Nasopharyngitis	Gastrointestinal disorders	Systematic Assessment	EG0002 affected280 at risk EG0013 affected281 at risk
Laryngitis	Infections and infestations	Systematic Assessment	EG0001 affected280 at risk EG0010 affected281 at risk
Pharyngotonsillitis	Infections and infestations	Systematic Assessment	EG0001 affected280 at risk EG0010 affected281 at risk
Influenza	Infections and infestations	Systematic Assessment	EG0003 affected280 at risk EG0011 affected281 at risk
Systemic viral infection	Infections and infestations	Systematic Assessment	EG0001 affected280 at risk EG0010 affected281 at risk
Tracheobronchitis viral	Infections and infestations	Systematic Assessment	EG0001 affected280 at risk EG0010 affected281 at risk
Gastroenteritis	Infections and infestations	Systematic Assessment	EG0001 affected280 at risk EG0011 affected281 at risk
Conjunctivitis	Infections and infestations	Systematic Assessment	EG0001 affected280 at risk EG0011 affected281 at risk
Otitis media	Infections and infestations	Systematic Assessment	EG0001 affected280 at risk EG0010 affected281 at risk
Headache	Nervous system disorders	Systematic Assessment	EG0006 affected280 at risk EG0017 affected281 at risk
Dizziness	Nervous system disorders	Systematic Assessment	EG0008 affected280 at risk EG0013 affected281 at risk
Hypertonia	Nervous system disorders	Systematic Assessment	EG0001 affected280 at risk EG0010 affected281 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0003 affected280 at risk EG0011 affected281 at risk
Rhinitis allergic	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0002 affected280 at risk EG0012 affected281 at risk
Asphyxia	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 affected280 at risk EG0010 affected281 at risk
Cough	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 affected280 at risk EG0011 affected281 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 affected280 at risk EG0011 affected281 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 affected280 at risk EG0010 affected281 at risk
Laryngeal oedema	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 affected280 at risk EG0010 affected281 at risk
Dyslipidaemia	Metabolism and nutrition disorders	Systematic Assessment	EG0001 affected280 at risk EG0012 affected281 at risk
Type 2 diabetes mellitus	Metabolism and nutrition disorders	Systematic Assessment	EG0001 affected280 at risk EG0011 affected281 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 affected280 at risk EG0010 affected281 at risk
Costochondritis	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 affected280 at risk EG0010 affected281 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 affected280 at risk EG0010 affected281 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 affected280 at risk EG0010 affected281 at risk
Myalgia	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 affected280 at risk EG0010 affected281 at risk
Pyrexia	General disorders	Systematic Assessment	EG0001 affected280 at risk EG0011 affected281 at risk
Early satiety	General disorders	Systematic Assessment	EG0001 affected280 at risk EG0010 affected281 at risk
Face oedema	General disorders	Systematic Assessment	EG0001 affected280 at risk EG0010 affected281 at risk
Palpitations	Cardiac disorders	Systematic Assessment	EG0001 affected280 at risk EG0011 affected281 at risk
Tachycardia	Cardiac disorders	Systematic Assessment	EG0001 affected280 at risk EG0010 affected281 at risk
Hyperprolactinaemia	Endocrine disorders	Systematic Assessment	EG0001 affected280 at risk EG0013 affected281 at risk
Aspartate aminotransferase increased	Investigations	Systematic Assessment	EG0001 affected280 at risk EG0011 affected281 at risk
Heart rate decreased	Investigations	Systematic Assessment	EG0001 affected280 at risk EG0010 affected281 at risk
Hypertension	Vascular disorders	Systematic Assessment	EG0003 affected280 at risk EG0010 affected281 at risk
Anaemia	Blood and lymphatic system disorders	Systematic Assessment	EG0001 affected280 at risk EG0010 affected281 at risk
Confusional state	Psychiatric disorders	Systematic Assessment	EG0001 affected280 at risk EG0010 affected281 at risk
Insomnia	Psychiatric disorders	Systematic Assessment	EG0001 affected280 at risk EG0010 affected281 at risk
Acne	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0002 affected280 at risk EG0010 affected281 at risk
Atrophic vulvovaginitis	Reproductive system and breast disorders	Systematic Assessment	EG0001 affected280 at risk EG0010 affected281 at risk
Tooth restoration	Surgical and medical procedures	Systematic Assessment	EG0001 affected280 at risk EG0010 affected281 at risk
Upper respiratory tract infection	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 affected280 at risk EG0012 affected281 at risk
Gastritis	Gastrointestinal disorders	Systematic Assessment	EG0000 affected280 at risk EG0011 affected281 at risk
Pharyngitis	Infections and infestations	Systematic Assessment	EG0000 affected280 at risk EG0011 affected281 at risk
Respiratory tract infection viral	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 affected280 at risk EG0011 affected281 at risk
Vulvovaginal candidiasis	Reproductive system and breast disorders	Systematic Assessment	EG0000 affected280 at risk EG0011 affected281 at risk
COVID-19	Infections and infestations	Systematic Assessment	EG0000 affected280 at risk EG0011 affected281 at risk
Vitamin D deficiency	Metabolism and nutrition disorders	Systematic Assessment	EG0000 affected280 at risk EG0011 affected281 at risk
Back pain	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 affected280 at risk EG0011 affected281 at risk
Chest Pain	General disorders	Systematic Assessment	EG0000 affected280 at risk EG0011 affected281 at risk
Eosinophilia	Blood and lymphatic system disorders	Systematic Assessment	EG0000 affected280 at risk EG0011 affected281 at risk
Dermoid cyst	Congenital, familial and genetic disorders	Systematic Assessment	EG0000 affected280 at risk EG0011 affected281 at risk
Hyperbilirubinaemia	Hepatobiliary disorders	Systematic Assessment	EG0000 affected280 at risk EG0011 affected281 at risk
Ligament sprain	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 affected280 at risk EG0011 affected281 at risk
Parathyroid tumour benign	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0000 affected280 at risk EG0011 affected281 at risk

ID	Title	Description
BG000	Itopride Hydrochloride 150 mg Extended Release Tablets Once Daily Before One of the Main Meals	Participants assigned to Itopride Hydrochloride 150 mg extended release tablets once daily group administered one tablet a day for 8 weeks.
BG001	Active Control Group - Itopride Hydrochloride 50 mg Film Coated Tablets	Participants assigned to Itopride Hydrochloride 50 mg film coated tablets group administered three tablets a day for 8 weeks.
BG002	Total	Total of all reporting groups

ID	Term
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms
D012817	Signs and Symptoms, Digestive

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	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)	0	280	0	280	73	280
EG001	Active Control Group - Itopride Hydrochloride 50 mg Film	Participants assigned to this group administered three tablets a day for 8 weeks.	0	281	2	281	49	281

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Urinary tract infection	Infections and infestations		Systematic Assessment		EG0000 affected280 at risk EG0011 affected281 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders		Systematic Assessment		EG0000 affected280 at risk EG0011 affected281 at risk

ID	Term
D015746	Abdominal Pain
D009325	Nausea
D014839	Vomiting
D000855	Anorexia
D006356	Heartburn