A Randomized, Placebo Controlled Study on the Efficacy of Itopride HCI on Irritable Bowel in Patients of Irritable Bowel Syndrome With Constipation (IBS-C)

Abbott4 sites in 1 country268 target enrollmentJune 2008

ConditionsIrritable Bowel Syndrome

InterventionsItopride HCI 50 mg Itopride HCI 100 mg Placebo

DrugsItopride HCI 50 mg Itopride HCI 100 mg Placebo

Overview

Phase: Phase 2
Intervention: Itopride HCI 50 mg
Conditions: Irritable Bowel Syndrome
Sponsor: Abbott
Enrollment: 268
Locations: 4
Primary Endpoint: Patients will be asked a simple but well validated question "If there is a satisfactory relief of the symptoms"
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

June 2008

End Date

September 2010

Last Updated

12 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Abbott

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

•Patients having significant diarrhea at least 25% of the time during the past 3 months
•Patients having alarm symptoms or signs
•Chronic diarrhea
•History of gastrointestinal haemorrhage, mechanical obstruction or perforation
•Patient with clinically relevant ECG abnormalities (prolonged QT interval)
•Active psychiatric disorder that would interfere with the study objectives
•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
•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
•Patient with hypokalemia (serum potassium \< 3.5 mmol/l).
•History of any known hypersensitivity to the ingredients of the investigational drug

Arms & Interventions

Itopride 50 mg

Intervention: Itopride HCI 50 mg

Itopride 100 mg

Intervention: Itopride HCI 100 mg

Placebo

Intervention: Placebo

Outcomes

Primary Outcomes

Patients will be asked a simple but well validated question "If there is a satisfactory relief of the symptoms"

Time Frame: 2 weeks and 4 weeks after the start of the treatment

Secondary Outcomes

Subjects will be assessed based on Irritable Bowel Syndrome Severity Score (IBSSS).(2 weeks and 4 weeks after the start of the treatment)
Safety based on the laboratory tests before and at the end of the treatment.(4 weeks during the treatment period and 4 weeks following post- therapy period.)