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 range

18 Years – 50 Years

Sex

ALL

See this in plain English?

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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