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

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01027260
Enrollment
268
Registered
2009-12-07
Start date
2008-06-30
Completion date
2010-09-30
Last updated
2013-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Irritable Bowel Syndrome

Brief 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

Interventions

DRUGItopride HCI 50 mg

Variable dosing

DRUGItopride HCI 100 mg

Variable dosing

DRUGPlacebo

Variable dosing

Sponsors

Abbott
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Patients will be asked a simple but well validated question If there is a satisfactory relief of the symptoms2 weeks and 4 weeks after the start of the treatment

Secondary

MeasureTime frame
Subjects will be assessed based on Irritable Bowel Syndrome Severity Score (IBSSS).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.4 weeks during the treatment period and 4 weeks following post- therapy period.

Countries

Pakistan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026