A Post Marketing Surveillance Study on the Safety and Effectiveness of Prucalopride in the Treatment of Chronic Constipation
The purpose of this study is to determine the safety and effectiveness of prucalopride in the treatment of Filipino patients with chronic constipation whom prior laxatives fail to provide adequate relief.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||A Study on the Safety and Effectiveness of Prucalopride in the Treatment of Chronic Constipation|
- The incidence of patients discontinuing treatment due to adverse events, serious adverse events, or adverse drug reactions [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- The percentage of patients having at least 3 spontaneous complete bowel movements (SCBM) in a week after treatment with prucalopride [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]SCBM is defined as a sense of complete evacuation of bowel without straining.
- The change from baseline in the Patient Assessment of Constipation Symptoms (PAC-SYM) score after treatment with prucalopride [ Time Frame: Baseline, 12 weeks ] [ Designated as safety issue: No ]The PAC-SYM questionnaire is a 12-item survey that measures constipation symptoms and associated severity across three domains: stool symptoms, rectal symptoms, and abdominal symptoms. Symptom items are rated on a 5-point Likert severity scale. Item values are scored from 0 to 4, with 0 indicating absence of symptom, 1 = mild, 2 = moderate, 3 = severe, and 4 = very severe indicating the worst severity of that symptom.
|Study Start Date:||December 2012|
|Estimated Study Completion Date:||December 2014|
|Estimated Primary Completion Date:||February 2014 (Final data collection date for primary outcome measure)|
Prucalopride 2 mg tablet/day orally for 12 weeks. For elderly patients (>65 years old), patients with renal impairment not requiring dialysis or patients with severe hepatic impairment, 1mg prucalopride once daily should be given.
This is a 12-week open label (all people know the identity of the intervention), multi-center, prospective (the patients are identified and then followed forward in time for the outcome of the study) observational study assessing the safety and effectiveness of prucalopride among Filipino patients with chronic constipation. Chronic constipation is a condition in which bowel movements are infrequent or incomplete for a prolonged time. The use of prucalopride should be used in accordance with the approved product label and will follow the normal medical practice of the investigators. Patients should take 2 mg prucalopride tablet orally once daily. For elderly patients (>65 years old), patients with renal impairment not requiring dialysis or patients with severe hepatic impairment, 1mg prucalopride once daily should be given. Patients will be asked to fill-up a patient diary daily for 12-weeks to monitor the bowel movement during the study period. All adverse events and concomitant medications taken by the patients during the study will be documented accordingly. Patients will be monitored during the 12-week period of observation while the patients are in prucalopride treatment.
|Makati City, Philippines|
|Marikina City, Philippines|
|Quezon City, Philippines|
|San Juan, Philippines|
|Study Director:||Janssen Pharmaceutica Clinical Trial||Janssen Pharmaceutica|