CompletedPhase 2

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

Pakistan268 participantsStarted 2008-06

Plain-language 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

Who can participate

Age range18 Years – 50 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Patients will be asked a simple but well validated question "If there is a satisfactory relief of the symptoms"

Timeframe: 2 weeks and 4 weeks after the start of the treatment

Trial details

NCT IDNCT01027260

SponsorAbbott

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2010-08

View on ClinicalTrials.gov More Irritable Bowel Syndrome trials