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

Phase 2

Completed

• Conditions: Irritable Bowel Syndrome
• Interventions: Drug: Itopride HCI 50 mg; Drug: Itopride HCI 100 mg; Drug: Placebo

• Registration Number: NCT01027260
• Lead Sponsor: Abbott

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

Detailed Description

Not available

Study Timeline

• Study Start: 2008-06
• Study First Submitted: 2009-12-04
• Study First Submitted QC: 2009-12-04
• Study First Posted: 2009-12-07
• Primary Completion: 2010-08
• Study Completion: 2010-09
• Status Verified: 2013-06
• Last Update Submitted: 2013-06-17
• Last Update Posted: 2013-06-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 268

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Itopride 50 mg	Itopride HCI 50 mg	-
Itopride 100 mg	Itopride HCI 100 mg	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Patients will be asked a simple but well validated question "If there is a satisfactory relief of the symptoms"	2 weeks and 4 weeks after the start of the treatment

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (4)

Site Reference ID/Investigator# 21441; 🇵🇰 Karachi, Pakistan

Site Reference ID/Investigator# 6130; 🇵🇰 Lahore, Pakistan

Site Reference ID/Investigator# 5870; 🇵🇰 Karachi, Pakistan

Site Reference ID/Investigator# 8535; 🇵🇰 Rawalpindi, Pakistan