Study to Evaluate the Role of Itopride HCI in Patients With Irritable Bowel Syndrome With Predominant Constipation

Study Results

Results pending

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

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

268 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Study Completion Date

2010-09-30

Brief Summary

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Patients suffering from Irritable Bowel Syndrome with predominant constipation will be provided with the study medication. The study medication will be evaluated for its efficacy in relieving the symptoms

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Detailed Description

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Conditions

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Irritable Bowel Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Itopride 50 mg

Group Type ACTIVE_COMPARATOR

Itopride HCI 50 mg

Intervention Type DRUG

Variable dosing

Itopride 100 mg

Group Type ACTIVE_COMPARATOR

Itopride HCI 100 mg

Intervention Type DRUG

Variable dosing

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Variable dosing

Interventions

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Itopride HCI 50 mg

Variable dosing

Intervention Type DRUG

Itopride HCI 100 mg

Variable dosing

Intervention Type DRUG

Placebo

Variable dosing

Intervention Type DRUG

Other Intervention Names

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ABT-654 Itopride HCI Ganaton ABT-654 Itopride HCI Ganaton

Eligibility Criteria

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Inclusion Criteria

1. Male or female patient fulfilling the Rome III criteria for IBS-C
2. Signed informed consent at screening visit

Exclusion Criteria

1. Patients having significant diarrhea at least 25% of the time during the past 3 months
2. Patients having alarm symptoms or signs
3. Chronic diarrhea
4. History of gastrointestinal haemorrhage, mechanical obstruction or perforation
5. Patient with clinically relevant ECG abnormalities (prolonged QT interval)
6. Active psychiatric disorder that would interfere with the study objectives
7. Health conditions (e.g. age related impairment of cognitive functions) that would interfere with the study objectives or might impair the compliance of the patient
8. Severe hepatic, renal, cardiac, metabolic, haematological or malignant diseases (including prolactin dependent tumours) or clinically relevant deviations in laboratory values (AST/ALT greater than twice the upper limit of normal, serum creatinine \* 2 mg/dl \[177 µmol/l\] according to the medical judgement of the investigator
9. Patient with hypokalemia (serum potassium \< 3.5 mmol/l).
10. History of any known hypersensitivity to the ingredients of the investigational drug
11. Pregnancy or lactation
12. Women with childbearing potential who do not apply a medically accepted method of contraception.

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No