Health Condition 1: K589- Irritable bowel syndrome without diarrhea
Conditions
Interventions
Intervention1: NIL: NIL
Control Intervention1: NIL: NIL
Sponsors
Abbott India Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Male and female patients above 18 up to 60 years Both male and female (of childbearing potential) patients willing to use appropriate method of contraception as per investigatorâ??s discretion, throughout the study. Female of childbearing potential must have a negative pregnancy test and be non-lactating at baseline Patients who are newly diagnosed with IBS along with anxiety and are recommended the study drug as per investigator discretion Patient willing to sign Patient Authorization Form (PAF)
Exclusion criteria
Exclusion criteria: Hypersensitivity to the active substances or any of the study drug excipients Severe respiratory insufficiency, organic brain damage, sleep apnea syndrome, severe, acute or chronic hepatic insufficiency (risk of occurrence of encephalopathy), myasthenia gravis, chronic psychosis, major depressive episodes, phobic or obsessional states, or dementia Other preexisting GI disorders, patients with history of GI surgery, abnormal upper, and lower GI endoscopy finding Family history of colon cancer or inflammatory bowel disease Patients with alarm symptoms (red flag or the symptoms that discriminates lower GI organic diseases from IBS) (Hammer et al 2004); e.g., a. Blood in stool b. Nighttime symptoms that wakes a person c. Unintentional weight loss d. Change in typical IBS symptoms will be noted. E.g. new and/or different pain History of chronic alcoholism or other drug related dependency History of excessive alcohol intake (women: >=8 drinks per week; men: >=15 drinks per week)a History of addiction to narcotics Patient who excessively drives or operate hazardous machinery Any past or present conditions or diseases that investigator considers not appropriate to enter the study Current use or past history of any medication in last 3 months which might interfere with the action of the study drug Pregnant and lactating women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint of the study is change in mean IBS SSS total scoreTimepoint: from baseline to week 8. | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in anxiety total scores on HAM A from baseline to Weeks 4 and 8 1IBS SSS responders: Patients are said to be IBS SSS responders when their overall symptom severity on the IBS SSS changes to â?¥ 50 points (Francis et al 1997). 2IBS 36 responders: Patients are said to be IBS 36 responders when they have the clinically meaningful change of â?¥ 10 points on IBS 36 (Passos et al 2009 Timepoint: NIL;Change in mean IBS 36 scoreTimepoint: from baseline to Week 8;Change in mean IBS SSS total scoreTimepoint: from baseline to week 4;Change in mean IBS-SSS score of abdominal pain, number of days of abdominal pain, severity of abdominal distention, dissatisfaction with bowel habits, and interference with QOLTimepoint: from baseline to Weeks 4 and 8;Number and percentage of 1IBS SSS respondersTimepoint: at Week 4 and Week 8;Number and percentage of 2IBS 36 respondersTimepoint: at Week 8;Socio-demographic profile of patients with IBS in terms ofTimepoint: Age, Gender, BMI, Socio economic status (Ghosh and Ghosh 2009), Marital status , Residence, Lifestyle habits, Diet habits, | — |
Countries
India
Contacts
Public ContactDr Shivani Acharya
Abbott India Ltd
Outcome results
None listed