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Completed

NCT Number: NCT01027260

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

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

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Key information

Conditions

Irritable Bowel Syndrome Colonic Diseases Colonic Diseases, Functional Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Site Reference ID/Investigator# 21441, Karachi, Pakistan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Itopride HCI 50 mg

Drug

Variable dosing

Other names: ABT-654, Itopride HCI, Ganaton

Itopride HCI 100 mg

Drug

Variable dosing

Other names: ABT-654, Itopride HCI, Ganaton

Placebo

Drug

Variable dosing

Primary outcomes

  1. 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 outcomes

  1. 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. 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.

Sponsors and collaborators

Lead sponsor

Abbott

Industry

Registry information

Official study 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)

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Dec 7, 2009
Registry last updated
Jun 18, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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