Irritable Bowel Syndrome Clinical Trial
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)
Verified date | June 2013 |
Source | Abbott |
Contact | n/a |
Is FDA regulated | No |
Health authority | Pakistan: Ministry of Health |
Study type | Interventional |
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
Status | Completed |
Enrollment | 268 |
Est. completion date | September 2010 |
Est. primary completion date | August 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 50 Years |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Pakistan | Site Reference ID/Investigator# 21441 | Karachi | |
Pakistan | Site Reference ID/Investigator# 5870 | Karachi | |
Pakistan | Site Reference ID/Investigator# 6130 | Lahore | |
Pakistan | Site Reference ID/Investigator# 8535 | Rawalpindi |
Lead Sponsor | Collaborator |
---|---|
Abbott |
Pakistan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Patients will be asked a simple but well validated question "If there is a satisfactory relief of the symptoms" | 2 weeks and 4 weeks after the start of the treatment | No | |
Secondary | Subjects will be assessed based on Irritable Bowel Syndrome Severity Score (IBSSS). | 2 weeks and 4 weeks after the start of the treatment | No | |
Secondary | Safety based on the laboratory tests before and at the end of the treatment. | 4 weeks during the treatment period and 4 weeks following post- therapy period. | Yes |
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