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

Last updated: June 17, 2013
Sponsor: Abbott
Overall Status: Completed

Phase

2

Condition

Gastrointestinal Diseases And Disorders

Lactose Intolerance

Colic

Treatment

N/A

Clinical Study ID

NCT01027260
R10-257
  • Ages 18-50
  • All Genders

Study 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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Male or female patient fulfilling the Rome III criteria for IBS-C

  2. Signed informed consent at screening visit

Exclusion

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 wouldinterfere 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 inlaboratory values (AST/ALT greater than twice the upper limit of normal, serumcreatinine * 2 mg/dl [177 µmol/l] according to the medical judgement of theinvestigator

  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 ofcontraception.

Study Design

Total Participants: 268
Study Start date:
June 01, 2008
Estimated Completion Date:
September 30, 2010

Connect with a study center

  • Site Reference ID/Investigator# 21441

    Karachi,
    Pakistan

    Site Not Available

  • Site Reference ID/Investigator# 5870

    Karachi, 74800
    Pakistan

    Site Not Available

  • Site Reference ID/Investigator# 6130

    Lahore,
    Pakistan

    Site Not Available

  • Site Reference ID/Investigator# 8535

    Rawalpindi,
    Pakistan

    Site Not Available

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