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

Irritable Bowel Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01027260
• Other study ID #: R10-257
• Status: Completed
• Phase: Phase 2
• First received: December 4, 2009
• Last updated: June 17, 2013
• Start date: June 2008
• Est. completion date: September 2010

Study information

• Verified date: June 2013
• Source: Abbott
• Contact: n/a
• Is FDA regulated: No
• Health authority: Pakistan: Ministry of Health
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 268
• Est. completion date: September 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Constipation
• Irritable Bowel Syndrome
• Syndrome

Intervention

Drug:
• Itopride HCI 50 mg
Variable dosing
• Itopride HCI 100 mg
Variable dosing
• Placebo
Variable dosing

Locations

Country	Name	City	State
Pakistan	Site Reference ID/Investigator# 21441	Karachi
Pakistan	Site Reference ID/Investigator# 5870	Karachi
Pakistan	Site Reference ID/Investigator# 6130	Lahore
Pakistan	Site Reference ID/Investigator# 8535	Rawalpindi

Sponsors (1)

Lead Sponsor	Collaborator
Abbott

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Subjects will be assessed based on Irritable Bowel Syndrome Severity Score (IBSSS).		2 weeks and 4 weeks after the start of the treatment	No
Secondary	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.	Yes