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

Primary Purpose

Irritable Bowel Syndrome

Status

Completed

Phase

Phase 2

Locations

Pakistan

Study Type

Interventional

Intervention

Itopride HCI 50 mg

Itopride HCI 100 mg

Placebo

About this trial

This is an interventional treatment trial for Irritable Bowel Syndrome

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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
Pregnancy or lactation
Women with childbearing potential who do not apply a medically accepted method of contraception.

Sites / Locations

Site Reference ID/Investigator# 5870
Site Reference ID/Investigator# 21441
Site Reference ID/Investigator# 6130
Site Reference ID/Investigator# 8535

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Itopride 50 mg

Itopride 100 mg

Placebo

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Subjects will be assessed based on Irritable Bowel Syndrome Severity Score (IBSSS).

Safety based on the laboratory tests before and at the end of the treatment.

Full Information

NCT ID

NCT01027260

First Posted

December 4, 2009

Last Updated

June 17, 2013

Sponsor

Abbott

1. Study Identification

Unique Protocol Identification Number

NCT01027260

Brief Title

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

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)

Study Type

Interventional

2. Study Status

Record Verification Date

June 2013

Overall Recruitment Status

Completed

Study Start Date

June 2008 (undefined)

Primary Completion Date

August 2010 (Actual)

Study Completion Date

September 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Abbott

4. Oversight

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Irritable Bowel Syndrome

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

268 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Itopride 50 mg

Arm Type

Active Comparator

Arm Title

Itopride 100 mg

Arm Type

Active Comparator

Arm Title

Placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Itopride HCI 50 mg

Other Intervention Name(s)

ABT-654, Itopride HCI, Ganaton

Intervention Description

Variable dosing

Intervention Type

Drug

Intervention Name(s)

Itopride HCI 100 mg

Other Intervention Name(s)

ABT-654, Itopride HCI, Ganaton

Intervention Description

Variable dosing

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Variable dosing

Primary Outcome Measure Information:

Title

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 Outcome Measure Information:

Title

Subjects will be assessed based on Irritable Bowel Syndrome Severity Score (IBSSS).

Time Frame

2 weeks and 4 weeks after the start of the treatment

Title

Safety based on the laboratory tests before and at the end of the treatment.

Time Frame

4 weeks during the treatment period and 4 weeks following post- therapy period.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

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 Pregnancy or lactation Women with childbearing potential who do not apply a medically accepted method of contraception.

Facility Information:

Facility Name

Site Reference ID/Investigator# 5870

City

Karachi

ZIP/Postal Code

74800

Country

Pakistan

Facility Name

Site Reference ID/Investigator# 21441

City

Karachi

Country

Pakistan

Facility Name

Site Reference ID/Investigator# 6130

City

Lahore

Country

Pakistan

Facility Name

Site Reference ID/Investigator# 8535

City

Rawalpindi

Country

Pakistan

12. IPD Sharing Statement

Learn more about this trial

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

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