Trial Outcomes & Findings for Trial of Itopride 150mg Once a Day Versus Itopride 50 mg Thrice a Day; in Patients With Functional Dyspepsia (NCT NCT06217393)

Last Updated: 2026-04-03

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

564 participants

Primary outcome timeframe

8 weeks

Results posted on

2026-04-03

Participant Flow

This study enrolled 564 participants at 19 investigation sites across five countries (Armenia, Malaysia, Philippines, Thailand, Vietnam) from 28-Feb-2024 to 28-Feb-2025. Per protocol population (50 mg: N=263, 150 mg: N=261) Full analysis subject samples- 50 mg: N=280, 150 mg: N=277. Safety Subject sample- 50 mg: N=281, 150 mg: N=280

Participants with 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 were enrolled to receive either Itopride Hydrochloride 150 mg extended-release tablets once-daily or Itopride Hydrochloride 50 mg film-coated tablets thrice-daily for 8 weeks

Participant milestones

Participant milestones
Measure	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.	Itopride Hydrochloride 50 mg Film-coated Tablet Participants assigned to this group administered three tablets a day for 8 weeks.
Overall Study STARTED	282	282
Overall Study COMPLETED	269	274
Overall Study NOT COMPLETED	13	8

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	Itopride Hydrochloride 50 mg Film-coated Tablet Participants assigned to this group administered three tablets a day for 8 weeks.
Overall Study Withdrawal by Subject	3	3
Overall Study Adverse Event	6	2
Overall Study Lack of Efficacy	0	1
Overall Study Lost to Follow-up	2	0
Overall Study Failure to meet Randomization criteria	2	1
Overall Study Physician Decision	0	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Itopride Hydrochloride 150 mg Extended Release Tablets Once Daily Before One of the Main Meals n=282 Participants Participants assigned to Itopride Hydrochloride 150 mg extended release tablets once daily group administered one tablet a day for 8 weeks.	Active Control Group - Itopride Hydrochloride 50 mg Film Coated Tablets n=282 Participants Participants assigned to Itopride Hydrochloride 50 mg film coated tablets group administered three tablets a day for 8 weeks.	Total n=564 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=5 Participants	0 Participants n=10 Participants
Age, Categorical Between 18 and 65 years	261 Participants n=5 Participants	265 Participants n=5 Participants	526 Participants n=10 Participants
Age, Categorical >=65 years	21 Participants n=5 Participants	17 Participants n=5 Participants	38 Participants n=10 Participants
Sex: Female, Male Female	215 Participants n=5 Participants	192 Participants n=5 Participants	407 Participants n=10 Participants
Sex: Female, Male Male	67 Participants n=5 Participants	90 Participants n=5 Participants	157 Participants n=10 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=5 Participants	0 Participants n=10 Participants
Race (NIH/OMB) Asian	175 Participants n=5 Participants	178 Participants n=5 Participants	353 Participants n=10 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=5 Participants	0 Participants n=10 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=5 Participants	0 Participants n=10 Participants
Race (NIH/OMB) White	107 Participants n=5 Participants	104 Participants n=5 Participants	211 Participants n=10 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=5 Participants	0 Participants n=10 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=5 Participants	0 Participants n=10 Participants

PRIMARY outcome

Timeframe: 8 weeks

Outcome measures

Outcome measures
Measure	Active Control Group - Itopride Hydrochloride 50 mg Film n=263 Participants Participants assigned to this group administered three tablets a day for 8 weeks.	Itopride Hydrochloride 150 mg Extended Release Tablets Once Daily Before One of the Main Meals n=261 Participants Test group - Itopride Hydrochloride 150 mg extended release tablets once daily before one of the main meals (preferably the same meal throughout the treatment)
Change in the Overall Severity of Functional Dyspepsia Between Baseline and Week 8, as Measured by the LDQ Severity Score	-9.17 units on a scale Interval -9.78 to -8.56	-9.54 units on a scale Interval -10.17 to -8.91

SECONDARY outcome

Timeframe: 4 weeks

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.

Outcome measures

Outcome measures
Measure	Active Control Group - Itopride Hydrochloride 50 mg Film n=280 Participants Participants assigned to this group administered three tablets a day for 8 weeks.	Itopride Hydrochloride 150 mg Extended Release Tablets Once Daily Before One of the Main Meals n=277 Participants Test group - Itopride Hydrochloride 150 mg extended release tablets once daily before one of the main meals (preferably the same meal throughout the treatment)
Change in the Overall Severity of Functional Dyspepsia Between Baseline and Week 4, as Measured by the LDQ Severity Score	-6.78 units on a scale Interval -7.39 to -6.17	-6.99 units on a scale Interval -7.62 to -6.36

SECONDARY outcome

Timeframe: 8 weeks

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.

Outcome measures

Outcome measures
Measure	Active Control Group - Itopride Hydrochloride 50 mg Film n=280 Participants Participants assigned to this group administered three tablets a day for 8 weeks.	Itopride Hydrochloride 150 mg Extended Release Tablets Once Daily Before One of the Main Meals n=277 Participants Test group - Itopride Hydrochloride 150 mg extended release tablets once daily before one of the main meals (preferably the same meal throughout the treatment)
Disease Specific Quality of Life (Nepean Dyspepsia Index NDI) Assessed at Baseline and Week 8 in Terms of Change in % of Functional Ability. Baseline	67.96 Percentage of Functional ability Standard Deviation 19.651	68.27 Percentage of Functional ability Standard Deviation 19.795
Disease Specific Quality of Life (Nepean Dyspepsia Index NDI) Assessed at Baseline and Week 8 in Terms of Change in % of Functional Ability. Week 8	90.29 Percentage of Functional ability Standard Deviation 14.096	90.26 Percentage of Functional ability Standard Deviation 14.281

SECONDARY outcome

Timeframe: 4 weeks

Population: 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)

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.

Outcome measures

Outcome measures
Measure	Active Control Group - Itopride Hydrochloride 50 mg Film n=280 Participants Participants assigned to this group administered three tablets a day for 8 weeks.	Itopride Hydrochloride 150 mg Extended Release Tablets Once Daily Before One of the Main Meals n=277 Participants Test group - Itopride Hydrochloride 150 mg extended release tablets once daily before one of the main meals (preferably the same meal throughout the treatment)
Change From Baseline of NRS 11 Score for Symptoms (Sensation of Bloating) After 4 Weeks of Treatment. Baseline	1.91 units on a scale Standard Deviation 1.918	2 units on a scale Standard Deviation 2.102
Change From Baseline of NRS 11 Score for Symptoms (Sensation of Bloating) After 4 Weeks of Treatment. Week 4	0.46 units on a scale Standard Deviation 1.076	0.57 units on a scale Standard Deviation 1.212
Change From Baseline of NRS 11 Score for Symptoms (Sensation of Bloating) After 4 Weeks of Treatment. Change from Baseline to Week 4	-1.43 units on a scale Standard Deviation 1.699	-1.41 units on a scale Standard Deviation 2.013

SECONDARY outcome

Timeframe: 8 weeks

Population: 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)

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.

Outcome measures

Outcome measures
Measure	Active Control Group - Itopride Hydrochloride 50 mg Film n=280 Participants Participants assigned to this group administered three tablets a day for 8 weeks.	Itopride Hydrochloride 150 mg Extended Release Tablets Once Daily Before One of the Main Meals n=277 Participants Test group - Itopride Hydrochloride 150 mg extended release tablets once daily before one of the main meals (preferably the same meal throughout the treatment)
Change From Baseline of NRS 11 Score for Symptoms (Sensation of Bloating) After 8 Weeks of Treatment. Baseline	1.91 units on a scale Standard Deviation 1.918	2 units on a scale Standard Deviation 2.102
Change From Baseline of NRS 11 Score for Symptoms (Sensation of Bloating) After 8 Weeks of Treatment. Week 8	0.37 units on a scale Standard Deviation 0.951	0.35 units on a scale Standard Deviation 0.966
Change From Baseline of NRS 11 Score for Symptoms (Sensation of Bloating) After 8 Weeks of Treatment. Change from Baseline to Week 8	-1.54 units on a scale Standard Deviation 1.806	-1.63 units on a scale Standard Deviation 2.003

SECONDARY outcome

Timeframe: 4 weeks

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.

Outcome measures

Outcome measures
Measure	Active Control Group - Itopride Hydrochloride 50 mg Film n=280 Participants Participants assigned to this group administered three tablets a day for 8 weeks.	Itopride Hydrochloride 150 mg Extended Release Tablets Once Daily Before One of the Main Meals n=277 Participants Test group - Itopride Hydrochloride 150 mg extended release tablets once daily before one of the main meals (preferably the same meal throughout the treatment)
Change From Baseline of NRS 11 Score for Symptoms (Early Satiety) After 4 Weeks of Treatment. Baseline	1.83 units on a scale Standard Deviation 2.051	1.74 units on a scale Standard Deviation 2.01
Change From Baseline of NRS 11 Score for Symptoms (Early Satiety) After 4 Weeks of Treatment. Week 4	0.43 units on a scale Standard Deviation 1.138	0.53 units on a scale Standard Deviation 1.22
Change From Baseline of NRS 11 Score for Symptoms (Early Satiety) After 4 Weeks of Treatment. Change from Baseline to Week 4	-1.38 units on a scale Standard Deviation 1.867	-1.2 units on a scale Standard Deviation 1.896

SECONDARY outcome

Timeframe: 8 weeks

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.

Outcome measures

Outcome measures
Measure	Active Control Group - Itopride Hydrochloride 50 mg Film n=280 Participants Participants assigned to this group administered three tablets a day for 8 weeks.	Itopride Hydrochloride 150 mg Extended Release Tablets Once Daily Before One of the Main Meals n=277 Participants Test group - Itopride Hydrochloride 150 mg extended release tablets once daily before one of the main meals (preferably the same meal throughout the treatment)
Change From Baseline of NRS 11 Score for Symptoms (Early Satiety) After 8 Weeks of Treatment. Baseline	1.83 units on a scale Standard Deviation 2.051	1.74 units on a scale Standard Deviation 2.01
Change From Baseline of NRS 11 Score for Symptoms (Early Satiety) After 8 Weeks of Treatment. Week 8	0.33 units on a scale Standard Deviation 0.909	0.34 units on a scale Standard Deviation 0.995
Change From Baseline of NRS 11 Score for Symptoms (Early Satiety) After 8 Weeks of Treatment. Change from baseline to Week 8	-1.5 units on a scale Standard Deviation 1.881	-1.4 units on a scale Standard Deviation 1.888

SECONDARY outcome

Timeframe: 4 weeks

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.

Outcome measures

Outcome measures
Measure	Active Control Group - Itopride Hydrochloride 50 mg Film n=280 Participants Participants assigned to this group administered three tablets a day for 8 weeks.	Itopride Hydrochloride 150 mg Extended Release Tablets Once Daily Before One of the Main Meals n=277 Participants Test group - Itopride Hydrochloride 150 mg extended release tablets once daily before one of the main meals (preferably the same meal throughout the treatment)
Change From Baseline of NRS 11 Score for Symptoms (Postprandial Fullness) After 4 Weeks of Treatment. Week 4	0.44 Units on a scale Standard Deviation 1.131	0.58 Units on a scale Standard Deviation 1.194
Change From Baseline of NRS 11 Score for Symptoms (Postprandial Fullness) After 4 Weeks of Treatment. Baseline	2.35 Units on a scale Standard Deviation 2.182	2.21 Units on a scale Standard Deviation 2.155
Change From Baseline of NRS 11 Score for Symptoms (Postprandial Fullness) After 4 Weeks of Treatment. Change from Baseline to Week 4	-1.9 Units on a scale Standard Deviation 1.939	-1.61 Units on a scale Standard Deviation 2.097

SECONDARY outcome

Timeframe: 8 weeks

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.

Outcome measures

Outcome measures
Measure	Active Control Group - Itopride Hydrochloride 50 mg Film n=280 Participants Participants assigned to this group administered three tablets a day for 8 weeks.	Itopride Hydrochloride 150 mg Extended Release Tablets Once Daily Before One of the Main Meals n=277 Participants Test group - Itopride Hydrochloride 150 mg extended release tablets once daily before one of the main meals (preferably the same meal throughout the treatment)
Change From Baseline of NRS 11 Score for Symptoms (Postprandial Fullness) After 8 Weeks of Treatment. Baseline	2.35 units on a scale Standard Deviation 2.182	2.21 units on a scale Standard Deviation 2.155
Change From Baseline of NRS 11 Score for Symptoms (Postprandial Fullness) After 8 Weeks of Treatment. Week 8	0.36 units on a scale Standard Deviation 0.921	0.38 units on a scale Standard Deviation 1.023
Change From Baseline of NRS 11 Score for Symptoms (Postprandial Fullness) After 8 Weeks of Treatment. Change from Baseline to Week 8	-2 units on a scale Standard Deviation 1.973	-1.81 units on a scale Standard Deviation 1.996

SECONDARY outcome

Timeframe: 4 weeks

Population: 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)

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.

Outcome measures

Outcome measures
Measure	Active Control Group - Itopride Hydrochloride 50 mg Film n=280 Participants Participants assigned to this group administered three tablets a day for 8 weeks.	Itopride Hydrochloride 150 mg Extended Release Tablets Once Daily Before One of the Main Meals n=277 Participants Test group - Itopride Hydrochloride 150 mg extended release tablets once daily before one of the main meals (preferably the same meal throughout the treatment)
Change From Baseline of NRS 11 Score for Symptoms (Upper Abdominal Pain or Discomfort) After 4 Weeks of Treatment. Baseline	2.17 units on a scale Standard Deviation 2.08	1.96 units on a scale Standard Deviation 2.27
Change From Baseline of NRS 11 Score for Symptoms (Upper Abdominal Pain or Discomfort) After 4 Weeks of Treatment. Week 4	0.34 units on a scale Standard Deviation 0.804	0.48 units on a scale Standard Deviation 1.159
Change From Baseline of NRS 11 Score for Symptoms (Upper Abdominal Pain or Discomfort) After 4 Weeks of Treatment. Change from Baseline to Week 4	-1.81 units on a scale Standard Deviation 1.917	-1.46 units on a scale Standard Deviation 2.116

SECONDARY outcome

Timeframe: 8 weeks

Population: 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)

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.

Outcome measures

Outcome measures
Measure	Active Control Group - Itopride Hydrochloride 50 mg Film n=280 Participants Participants assigned to this group administered three tablets a day for 8 weeks.	Itopride Hydrochloride 150 mg Extended Release Tablets Once Daily Before One of the Main Meals n=277 Participants Test group - Itopride Hydrochloride 150 mg extended release tablets once daily before one of the main meals (preferably the same meal throughout the treatment)
Change From Baseline of NRS 11 Score for Symptoms (Upper Abdominal Pain or Discomfort) After 8 Weeks of Treatment. Baseline	2.17 units on a scale Standard Deviation 2.08	1.96 units on a scale Standard Deviation 2.27
Change From Baseline of NRS 11 Score for Symptoms (Upper Abdominal Pain or Discomfort) After 8 Weeks of Treatment. Week 8	0.32 units on a scale Standard Deviation 0.885	0.32 units on a scale Standard Deviation 0.985
Change From Baseline of NRS 11 Score for Symptoms (Upper Abdominal Pain or Discomfort) After 8 Weeks of Treatment. Change from Baseline to Week 8	0.32 units on a scale Standard Deviation 0.985	-1.63 units on a scale Standard Deviation 2.122

SECONDARY outcome

Timeframe: 4 weeks

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.

Outcome measures

Outcome measures
Measure	Active Control Group - Itopride Hydrochloride 50 mg Film n=280 Participants Participants assigned to this group administered three tablets a day for 8 weeks.	Itopride Hydrochloride 150 mg Extended Release Tablets Once Daily Before One of the Main Meals n=277 Participants Test group - Itopride Hydrochloride 150 mg extended release tablets once daily before one of the main meals (preferably the same meal throughout the treatment)
Change From Baseline of NRS 11 Score for Symptoms (Anorexia (Loss of Apetite)) After 4 Weeks of Treatment. Baseline	0.9 units on a scale Standard Deviation 1.755	1.05 units on a scale Standard Deviation 1.884
Change From Baseline of NRS 11 Score for Symptoms (Anorexia (Loss of Apetite)) After 4 Weeks of Treatment. Week 4	0.16 units on a scale Standard Deviation 0.631	0.24 units on a scale Standard Deviation 0.793
Change From Baseline of NRS 11 Score for Symptoms (Anorexia (Loss of Apetite)) After 4 Weeks of Treatment. Change from Baseline to Week 4	-0.72 units on a scale Standard Deviation 1.693	-0.78 units on a scale Standard Deviation 1.567

SECONDARY outcome

Timeframe: 8 weeks

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.

Outcome measures

Outcome measures
Measure	Active Control Group - Itopride Hydrochloride 50 mg Film n=280 Participants Participants assigned to this group administered three tablets a day for 8 weeks.	Itopride Hydrochloride 150 mg Extended Release Tablets Once Daily Before One of the Main Meals n=277 Participants Test group - Itopride Hydrochloride 150 mg extended release tablets once daily before one of the main meals (preferably the same meal throughout the treatment)
Change From Baseline of NRS 11 Score for Symptoms (Anorexia (Loss of Apetite)) After 8 Weeks of Treatment. Baseline	0.9 units on a scale Standard Deviation 1.755	1.05 units on a scale Standard Deviation 1.884
Change From Baseline of NRS 11 Score for Symptoms (Anorexia (Loss of Apetite)) After 8 Weeks of Treatment. Week 8	0.14 units on a scale Standard Deviation 0.763	0.19 units on a scale Standard Deviation 0.881
Change From Baseline of NRS 11 Score for Symptoms (Anorexia (Loss of Apetite)) After 8 Weeks of Treatment. Change from Baseline to Week 8	-0.76 units on a scale Standard Deviation 1.574	-0.83 units on a scale Standard Deviation 1.656

SECONDARY outcome

Timeframe: 4 weeks

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.

Outcome measures

Outcome measures
Measure	Active Control Group - Itopride Hydrochloride 50 mg Film n=280 Participants Participants assigned to this group administered three tablets a day for 8 weeks.	Itopride Hydrochloride 150 mg Extended Release Tablets Once Daily Before One of the Main Meals n=277 Participants Test group - Itopride Hydrochloride 150 mg extended release tablets once daily before one of the main meals (preferably the same meal throughout the treatment)
Change From Baseline of NRS 11 Score for Symptoms (Heartburn) After 4 Weeks of Treatment. Week 4	0.24 Units on a scale Standard Deviation 0.632	0.32 Units on a scale Standard Deviation 0.953
Change From Baseline of NRS 11 Score for Symptoms (Heartburn) After 4 Weeks of Treatment. Baseline	1.65 Units on a scale Standard Deviation 1.978	1.64 Units on a scale Standard Deviation 1.917
Change From Baseline of NRS 11 Score for Symptoms (Heartburn) After 4 Weeks of Treatment. Change from Baseline to Week 4	-1.41 Units on a scale Standard Deviation 1.883	-1.29 Units on a scale Standard Deviation 1.814

SECONDARY outcome

Timeframe: 8 weeks

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.

Outcome measures

Outcome measures
Measure	Active Control Group - Itopride Hydrochloride 50 mg Film n=280 Participants Participants assigned to this group administered three tablets a day for 8 weeks.	Itopride Hydrochloride 150 mg Extended Release Tablets Once Daily Before One of the Main Meals n=277 Participants Test group - Itopride Hydrochloride 150 mg extended release tablets once daily before one of the main meals (preferably the same meal throughout the treatment)
Change From Baseline of NRS 11 Score for Symptoms (Heartburn) After 8 Weeks of Treatment. Baseline	1.65 Units on a scale Standard Deviation 1.978	1.64 Units on a scale Standard Deviation 1.917
Change From Baseline of NRS 11 Score for Symptoms (Heartburn) After 8 Weeks of Treatment. Week 8	0.2 Units on a scale Standard Deviation 0.74	0.22 Units on a scale Standard Deviation 0.763
Change From Baseline of NRS 11 Score for Symptoms (Heartburn) After 8 Weeks of Treatment. Change from Baseline to Week 8	-1.44 Units on a scale Standard Deviation 1.911	-1.39 Units on a scale Standard Deviation 1.733

SECONDARY outcome

Timeframe: 4 weeks

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.

Outcome measures

Outcome measures
Measure	Active Control Group - Itopride Hydrochloride 50 mg Film n=280 Participants Participants assigned to this group administered three tablets a day for 8 weeks.	Itopride Hydrochloride 150 mg Extended Release Tablets Once Daily Before One of the Main Meals n=277 Participants Test group - Itopride Hydrochloride 150 mg extended release tablets once daily before one of the main meals (preferably the same meal throughout the treatment)
Change From Baseline of NRS 11 Score for Symptoms (Nausea) After 4 Weeks of Treatment. Baseline	1.01 Units on a scale Standard Deviation 1.604	0.85 Units on a scale Standard Deviation 1.529
Change From Baseline of NRS 11 Score for Symptoms (Nausea) After 4 Weeks of Treatment. Week 4	0.14 Units on a scale Standard Deviation 1.54	0.17 Units on a scale Standard Deviation 0.588
Change From Baseline of NRS 11 Score for Symptoms (Nausea) After 4 Weeks of Treatment. Change from Baseline to Week 4	-0.84 Units on a scale Standard Deviation 1.54	-0.69 Units on a scale Standard Deviation 1.498

SECONDARY outcome

Timeframe: 8 weeks

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.

Outcome measures

Outcome measures
Measure	Active Control Group - Itopride Hydrochloride 50 mg Film n=280 Participants Participants assigned to this group administered three tablets a day for 8 weeks.	Itopride Hydrochloride 150 mg Extended Release Tablets Once Daily Before One of the Main Meals n=277 Participants Test group - Itopride Hydrochloride 150 mg extended release tablets once daily before one of the main meals (preferably the same meal throughout the treatment)
Change From Baseline of NRS 11 Score for Symptoms (Nausea) After 8 Weeks of Treatment. Baseline	1.01 Units on a scale Standard Deviation 1.604	0.85 Units on a scale Standard Deviation 1.529
Change From Baseline of NRS 11 Score for Symptoms (Nausea) After 8 Weeks of Treatment. Week 8	0.13 Units on a scale Standard Deviation 0.593	0.15 Units on a scale Standard Deviation 0.581
Change From Baseline of NRS 11 Score for Symptoms (Nausea) After 8 Weeks of Treatment. Change from Baseline to Week 8	-0.87 Units on a scale Standard Deviation 1.566	-0.71 Units on a scale Standard Deviation 1.452

SECONDARY outcome

Timeframe: 4 weeks

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.

Outcome measures

Outcome measures
Measure	Active Control Group - Itopride Hydrochloride 50 mg Film n=280 Participants Participants assigned to this group administered three tablets a day for 8 weeks.	Itopride Hydrochloride 150 mg Extended Release Tablets Once Daily Before One of the Main Meals n=277 Participants Test group - Itopride Hydrochloride 150 mg extended release tablets once daily before one of the main meals (preferably the same meal throughout the treatment)
Change From Baseline of NRS 11 Score for Symptoms (Vomiting) After 4 Weeks of Treatment. Baseline	0.34 units on a scale Standard Deviation 1.222	0.31 units on a scale Standard Deviation 1.083
Change From Baseline of NRS 11 Score for Symptoms (Vomiting) After 4 Weeks of Treatment. Week 4	0.07 units on a scale Standard Deviation 0.66	0.07 units on a scale Standard Deviation 0.396
Change From Baseline of NRS 11 Score for Symptoms (Vomiting) After 4 Weeks of Treatment. Change from Baseline to Week 4	-0.27 units on a scale Standard Deviation 1.032	-0.25 units on a scale Standard Deviation 1.125

SECONDARY outcome

Timeframe: 8 weeks

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.

Outcome measures

Outcome measures
Measure	Active Control Group - Itopride Hydrochloride 50 mg Film n=280 Participants Participants assigned to this group administered three tablets a day for 8 weeks.	Itopride Hydrochloride 150 mg Extended Release Tablets Once Daily Before One of the Main Meals n=277 Participants Test group - Itopride Hydrochloride 150 mg extended release tablets once daily before one of the main meals (preferably the same meal throughout the treatment)
Change From Baseline of NRS 11 Score for Symptoms (Vomiting) After 8 Weeks of Treatment. Baseline	0.34 Units on a scale Standard Deviation 1.222	0.31 Units on a scale Standard Deviation 1.083
Change From Baseline of NRS 11 Score for Symptoms (Vomiting) After 8 Weeks of Treatment. Week 8	0.03 Units on a scale Standard Deviation 0.287	0.03 Units on a scale Standard Deviation 0.304
Change From Baseline of NRS 11 Score for Symptoms (Vomiting) After 8 Weeks of Treatment. Change from Baseline to Week 8	-0.31 Units on a scale Standard Deviation 1.149	-0.3 Units on a scale Standard Deviation 1.144

OTHER_PRE_SPECIFIED outcome

Timeframe: 8 weeks

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.)

Outcome measures

Outcome measures
Measure	Active Control Group - Itopride Hydrochloride 50 mg Film n=280 Participants Participants assigned to this group administered three tablets a day for 8 weeks.	Itopride Hydrochloride 150 mg Extended Release Tablets Once Daily Before One of the Main Meals n=277 Participants Test group - Itopride Hydrochloride 150 mg extended release tablets once daily before one of the main meals (preferably the same meal throughout the treatment)
Treatment Acceptance by Subjects Using 5-point Likert Scale at the End of the Treatment	3.83 Units on a scale Standard Deviation 1.045	4.22 Units on a scale Standard Deviation 0.791

OTHER_PRE_SPECIFIED outcome

Timeframe: 8 weeks

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.

Outcome measures

Outcome measures
Measure	Active Control Group - Itopride Hydrochloride 50 mg Film n=281 Participants Participants assigned to this group administered three tablets a day for 8 weeks.	Itopride Hydrochloride 150 mg Extended Release Tablets Once Daily Before One of the Main Meals n=280 Participants Test group - Itopride Hydrochloride 150 mg extended release tablets once daily before one of the main meals (preferably the same meal throughout the treatment)
Evaluation of Safety and Tolerability in Both Treatment Arms	49 Participants	73 Participants

Adverse Events

Itopride Hydrochloride 150 mg Extended Release Tablets Once Daily Before One of the Main Meals

Serious events: 0 serious events

Other events: 73 other events

Deaths: 0 deaths

Active Control Group - Itopride Hydrochloride 50 mg Film

Serious events: 2 serious events

Other events: 49 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Itopride Hydrochloride 150 mg Extended Release Tablets Once Daily Before One of the Main Meals n=280 participants at risk 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 n=281 participants at risk Participants assigned to this group administered three tablets a day for 8 weeks.
Infections and infestations Urinary tract infection	0.00% 0/280 • 8 weeks All participants who were exposed to the IMP. Participants were analyzed according to the treatment they actually received. Per protocol population (50 mg: N=263, 150 mg: N=261) Full analysis subject samples- 50 mg: N=280, 150 mg: N=277. Safety Subject sample- 50 mg: N=281, 150 mg: N=280	0.36% 1/281 • 8 weeks All participants who were exposed to the IMP. Participants were analyzed according to the treatment they actually received. Per protocol population (50 mg: N=263, 150 mg: N=261) Full analysis subject samples- 50 mg: N=280, 150 mg: N=277. Safety Subject sample- 50 mg: N=281, 150 mg: N=280
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/280 • 8 weeks All participants who were exposed to the IMP. Participants were analyzed according to the treatment they actually received. Per protocol population (50 mg: N=263, 150 mg: N=261) Full analysis subject samples- 50 mg: N=280, 150 mg: N=277. Safety Subject sample- 50 mg: N=281, 150 mg: N=280	0.36% 1/281 • 8 weeks All participants who were exposed to the IMP. Participants were analyzed according to the treatment they actually received. Per protocol population (50 mg: N=263, 150 mg: N=261) Full analysis subject samples- 50 mg: N=280, 150 mg: N=277. Safety Subject sample- 50 mg: N=281, 150 mg: N=280

Other adverse events

Additional Information

Suntje Sander

Abbott Laboratories GmBH

Phone: +49 (0) 511 6750 3254

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place