Health Condition 1: K590- Constipation
Conditions
Interventions
Intervention1: Prucalopride Succinate: 2 mg tablet,Once daily,
Oral route,
Treatment duration: 12 weeks
Control Intervention1: Placebo of Prucalopride succinate: Once daily,
Oral route,
Treatment
Sponsors
Torrent Pharamceutical Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or female patients having age 18 years to 65 years 2. Patient and/or his/her legally accepted representative willing to give written informed consent. 3. Patients with a diagnosis of chronic idiopathic constipation as per modified Rome II criteria. Modified Rome II criteria: Patient reports fewer than three bowel movements (BMs) per week (with each BM occurring in the absence of any laxative, suppository, or enema use during the preceding 24 hr) and reports one or more of the following symptoms for at least 12 weeks, which need not be consecutive, in the 12 months before screening visit or before starting any chronic treatment for constipation. • very hard (little balls) and/or hard stools for at least 25% of the bowel movements • sensation of incomplete evacuation following at least 25% of the bowel movements • straining at least 25% of defecations 4. History of poor results with laxative treatment and diet counseling 5. Patients who report fewer than three complete spontaneous bowel movement (CSBMs) per week during pre-treatment period of 2 weeks after screening (verified at the time of enrolment visit).
Exclusion criteria
Exclusion criteria: 1. Patient with history of hypersensitivity to prucalopride or to any of the excipient. 2. Patients with mechanical bowel obstruction, megacolon/megarectum, or diagnosis of pseudo-obstruction (as per colonoscopy). 3. Patients with known or suspected organic disorders of the large or small bowel (e.g., inflammatory bowel disease, ulcerative colitis, Crohnâ??s Disease) 4. Patients with history of weight loss 10% of body weight over a period of 6 months. 5. Patients having history of anemia and Hb 6. Patients on treatment with drugs which are likely to cause constipation e.g tricyclic antidepressants, anticholinergics, narcotic analgesics or calcium channel blockers. 7. Patients with active peptic ulcer. 8. Patient with history of bowel resection or rectal bleeding. 9. Patient with history of Hospitalization for any gastrointestinal or abdominal surgical procedure during the 3 months prior to screening. 10. Patients with TSH 6 µIU/ml or symptoms of hyperthyroidism or hypothyroidism and the same confirmed with laboratory investigation. 11. Patients with clinically significant ECG abnormalities or QTc 450 msec for male or QTc480 msec for female. 12. Clinically significant medical disorder or clinically significant abnormal laboratory finding. 13. History of faecal impaction that required hospitalization or have a history of laxative or enema abuse, ischemia colitis and pelvic floor dysfunction. 14. Patients with liver enzymes (ALT and AST) more than 2.5 times of the normal value and/or bilirubin more than 1.5 times of the normal value. 15. Patient with Serum creatinine more than upper limit of normal value (UNL). 16. Patient with history of malignancy except basal cell carcinoma 17. Pregnant or lactating women. 18. Female patients who are of childbearing potential and who are neither surgically sterilized nor willing to use reliable contraceptive methods (hormonal, barrier methods or intrauterine device) 19. Patient with history of alcohol or drug abuse in the opinion of the investigator. 20. Participation in any clinical study during last three months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| â?¢ Proportion (%) of the patients having an average of at least three or more complete spontaneous bowel movements (CSBMs)/week over the 12 weeks of treatment periodTimepoint: It is observed at Week 12 (End of treatment) visit | — |
Secondary
| Measure | Time frame |
|---|---|
| â?¢ Weekly average score of straining â?¢ Weekly average score of stool consitency â?¢ Proportion (%) of bowel movements with incomplete evacuation/week â?¢ Frequency of rescue therapy except bulk laxatives used per week for constipation â?¢ Investigatorâ??s global assessment of efficacyTimepoint: It is observed at Week 12 (End of treatment) visit | — |
Countries
India
Contacts
Public ContactDr Sushilkumar Anand
Torrent Pharmaceuticals Ltd.
Outcome results
None listed