A Post Marketing Surveillance Study on the Safety and Effectiveness of Prucalopride in the Treatment of Chronic Constipation
|ClinicalTrials.gov Identifier: NCT01692132|
Recruitment Status : Withdrawn (The company decided to cancel this study in conformity with PH FDA Circular 2013-004)
First Posted : September 25, 2012
Last Update Posted : December 2, 2015
|Condition or disease||Intervention/treatment||Phase|
|Chronic Constipation||Drug: Prucalopride||Phase 4|
|Study Type :||Observational|
|Actual Enrollment :||0 participants|
|Official Title:||A Study on the Safety and Effectiveness of Prucalopride in the Treatment of Chronic Constipation|
|Study Start Date :||February 2013|
|Estimated Primary Completion Date :||February 2014|
|Estimated Study Completion Date :||December 2014|
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.
- The incidence of patients discontinuing treatment due to adverse events, serious adverse events, or adverse drug reactions [ Time Frame: 12 weeks ]
- The percentage of patients having at least 3 spontaneous complete bowel movements (SCBM) in a week after treatment with prucalopride [ Time Frame: 12 weeks ]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 ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01692132
|Makati City, Philippines|
|Marikina City, Philippines|
|Quezon City, Philippines|
|San Juan, Philippines|
|Study Director:||Janssen Pharmaceutica Clinical Trial||Janssen Pharmaceutica|