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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Abbott
ClinicalTrials.gov Identifier:
NCT01027260
First received: December 4, 2009
Last updated: June 17, 2013
Last verified: June 2013
  Purpose

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


Condition Intervention Phase
Irritable Bowel Syndrome
Drug: Itopride HCI 50 mg
Drug: Itopride HCI 100 mg
Drug: Placebo
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Abbott:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: Yes ]

Enrollment: 268
Study Start Date: June 2008
Study Completion Date: September 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Itopride 50 mg Drug: Itopride HCI 50 mg
Variable dosing
Other Names:
  • ABT-654
  • Itopride HCI
  • Ganaton
Active Comparator: Itopride 100 mg Drug: Itopride HCI 100 mg
Variable dosing
Other Names:
  • ABT-654
  • Itopride HCI
  • Ganaton
Placebo Comparator: Placebo Drug: Placebo
Variable dosing
Other Name: Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01027260

Locations
Pakistan
Site Reference ID/Investigator# 21441
Karachi, Pakistan
Site Reference ID/Investigator# 5870
Karachi, Pakistan, 74800
Site Reference ID/Investigator# 6130
Lahore, Pakistan
Site Reference ID/Investigator# 8535
Rawalpindi, Pakistan
Sponsors and Collaborators
Abbott
  More Information

No publications provided

Responsible Party: Abbott
ClinicalTrials.gov Identifier: NCT01027260     History of Changes
Other Study ID Numbers: R10-257
Study First Received: December 4, 2009
Last Updated: June 17, 2013
Health Authority: Pakistan: Ministry of Health

Additional relevant MeSH terms:
Constipation
Irritable Bowel Syndrome
Signs and Symptoms, Digestive
Signs and Symptoms
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on April 17, 2014