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

NCT06217393 | Active Not Recruiting Phase 3

• 1 other identifier: ITOP-322-0216
• Study Type: interventional
• Target: 564
• Locations: 5 countries
• Sites: 19

Brief 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 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.

Conditions

Functional Dyspepsia

Keywords

Functional Dyspepsia; gastrointestinal symptoms; gastric dysmotility; Bloating; Early satiety; postprandial fullness; upper abdominal pain; nausea and vomiting; anorexia; heartburn; chronic gastritis

Outcome Measures

Primary Outcomes (1)

• To assess the comparable efficacy of Itopride Hydrochloride 150 mg extended release tablet (administered once daily) and Itopride Hydrochloride 50 mg film coated tablets (administered TID) after 8 weeks' treatment

  Change in the overall severity of functional dyspepsia between baseline and week 8, as measured by the Leeds Dyspepsia Questionnaire (LDQ) severity score

  8 weeks

Secondary Outcomes (4)

• To assess the comparable efficacy of Itopride Hydrochloride 150mg extended release tablet (administered once daily) and Itopride Hydrochloride 50 mg film coated tablets (administered TID) after 4 weeks treatment.

  4 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

  8 weeks

• Assess the symptomatology (sensation of bloating, early satiety, abdominal pain or discomfort, epigastric pain, epigastric burning, anorexia, heartburn, nausea and vomiting) of the disease in both treatment arms after 4 and 8 weeks of treatment.

  8 weeks

• Change in the overall severity of functional dyspepsia between baseline and week 4, as measured by the Leeds Dyspepsia Questionnaire (LDQ) severity score (range 0-40), where 0 is symptom free and 40 is severe dyspepsia

  8 weeks

Other Outcomes (2)

• Treatment acceptance by subjects using 5-point Likert scale at the end of the treatment; (1. Not at all satisfied, 2. Slightly satisfied, 3. Neutral, 4. Very satisfied, 5. Extremely satisfied.)

  8 weeks

• To evaluate safety and tolerability in both treatment arms

  8 weeks

Study Arms (2)

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

Interventions

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

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

Itopride Hydrochloride 50 mg film coated 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

Active Control group - Itopride Hydrochloride 50 mg film

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Abbott: lead

Study Sites (19)

"Grigor Narekatsi" MC, CJSC

Yerevan, Armenia

Location

"Hera Med" LLC ("Medicus" Medical Center)

Yerevan, Armenia

Location

"Institute of Surgery Mickaelyan" CJSC

Yerevan, Armenia

Location

Polyclinic N 12 Health State, CJSC

Yerevan, Armenia

Location

Hospital Sultanah Bahiyah

Alor Star, Malaysia

Location

Queen Elizabeth Hospital

Kota Kinabalu, Malaysia

Location

Pantai Hospital Kuala Lumpur

Kuala Lumpur, Malaysia

Location

UMMC

Petaling Jaya, Malaysia

Location

Cebu Doctors University Hospital

Cebu City, 6000, Philippines

Location

Davao Doctors Hospital

Davao City, 8000, Philippines

Location

Health Cube Medical Clinics

Manila, Philippines

Location

GreenCity Medical Center

Pampanga, 2000, Philippines

Location

Phramongkulklao Hospital

Bangkok, 10400, Thailand

Location

King Chulalongkorn Memorial

Bangkok, 13300, Thailand

Location

Maharaj Nakorn Chiang Mai Hospital

Chiang Mai, 50200, Thailand

Location

Srinagarind Hospital

Khon Kaen, 40002, Thailand

Location

103 Military Hospital

Hanoi, Vietnam

Location

Bach Mai Hospital

Hanoi, Vietnam

Location

Nguyen Tri Phuong Hospital

Ho Chi Minh City, 70000, Vietnam

Location

MeSH Terms

Conditions

Abdominal Pain; Nausea; Vomiting; Anorexia; Heartburn

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive

Study Officials

• Suntje Sander

  Abbott Laboratories GmbH

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: November 24, 2023
• First Posted: January 22, 2024
• Study Start: February 28, 2024
• Primary Completion: February 28, 2025
• Study Completion: February 28, 2025
• Last Updated: January 29, 2025

Record last verified: 2025-01

Locations

TH (4); AR (4); PH (4); MY (4); VN (3)