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

June 17, 2013 updated by: Abbott

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

268

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
      • Karachi, Pakistan, 74800
        • Site Reference ID/Investigator# 5870
      • Karachi, Pakistan
        • Site Reference ID/Investigator# 21441
      • Lahore, Pakistan
        • Site Reference ID/Investigator# 6130
      • Rawalpindi, Pakistan
        • Site Reference ID/Investigator# 8535

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 46 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Variable dosing
Active Comparator: Itopride 50 mg
Drug: Itopride HCI 50 mg
Variable dosing
Other Names:
  • Ganaton
  • ABT-654
  • Itopride HCI
Active Comparator: Itopride 100 mg
Drug: Itopride HCI 100 mg
Variable dosing
Other Names:
  • Ganaton
  • ABT-654
  • Itopride HCI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
2 weeks and 4 weeks after the start of the treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
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
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.
Time Frame: 4 weeks during the treatment period and 4 weeks following post- therapy period.
4 weeks during the treatment period and 4 weeks following post- therapy period.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2008

Primary Completion (Actual)

August 1, 2010

Study Completion (Actual)

September 1, 2010

Study Registration Dates

First Submitted

December 4, 2009

First Submitted That Met QC Criteria

December 4, 2009

First Posted (Estimate)

December 7, 2009

Study Record Updates

Last Update Posted (Estimate)

June 18, 2013

Last Update Submitted That Met QC Criteria

June 17, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R10-257

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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