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

Abbott

Status and phase: Completed; Phase 2

Conditions: Irritable Bowel Syndrome

Treatments: Drug: Itopride HCI 100 mg; Drug: Placebo; Drug: Itopride HCI 50 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT01027260

R10-257

Details and patient eligibility

About

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

Enrollment: 268 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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268 participants in 3 patient groups, including a placebo group

Itopride 50 mg

Active Comparator group

Treatment:

Drug: Itopride HCI 50 mg

Itopride 100 mg

Active Comparator group

Treatment:

Drug: Itopride HCI 100 mg

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo