A Post Marketing Surveillance Study on the Safety and Effectiveness of Prucalopride in the Treatment of Chronic Constipation

A 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 Overview

• Status: Withdrawn
• Conditions: Chronic Constipation
• Intervention / Treatment: Drug: Prucalopride

Detailed Description

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.

• Study Type: Observational

Contacts and Locations

Study Locations

• Philippines
  • Makati City, Philippines
  • Manila, Philippines
  • Marikina City, Philippines
  • Muntinlupa, Philippines
  • Quezon City, Philippines
  • San Juan, Philippines
  • Taguig, Philippines

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Filipino patients with chronic constipation

Description

Inclusion Criteria:

• Diagnosis of chronic constipation by history and physical examination, including rectal exam
• History of chronic constipation not satisfied with laxatives
• Patient reports, on average, 2 or fewer spontaneous bowel movements (SBMs) per week and 1 or more of the following for the last three months: very hard (little balls) and/or hard stools in more than 25% of bowel movements (BMs); sensation of incomplete evacuation in more than 25% of BMs; straining at defecation in more than 25% of BMs; sensation of ano-rectal obstruction or blockade in more than 25% of BMs; a need for digital manipulation to facilitate evacuation in more than 25% of BMs
• Females of childbearing potential agree to use highly effective contraceptive methods

Exclusion Criteria:

• Renal impairment requiring dialysis
• Secondary chronic constipation and organic gastrointestinal (GI) disorders
• Intestinal perforation / obstruction due to structural or functional disorder of the gut wall, obstructive ileus, severe inflammatory condition of the intestinal tract such as Crohn's disease, ulcerative colitis, toxic megacolon / rectum
• Hypersensitive to Prucalopride or to any of its components
• Patients receiving concomitant drugs known to cause QTc prolongation
• Pregnant or lactating

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Prucalopride	Drug: Prucalopride; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The incidence of patients discontinuing treatment due to adverse events, serious adverse events, or adverse drug reactions	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The percentage of patients having at least 3 spontaneous complete bowel movements (SCBM) in a week after treatment with prucalopride	SCBM is defined as a sense of complete evacuation of bowel without straining.	12 weeks
The change from baseline in the Patient Assessment of Constipation Symptoms (PAC-SYM) score after treatment with prucalopride	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.	Baseline, 12 weeks

Collaborators and Investigators

• Sponsor: Janssen Pharmaceutica

Study record dates

Study Major Dates

• Study Start: February 1, 2013
• Primary Completion (ANTICIPATED): February 1, 2014
• Study Completion (ANTICIPATED): December 1, 2014

Study Registration Dates

• First Submitted: September 20, 2012
• First Submitted That Met QC Criteria: September 20, 2012
• First Posted (ESTIMATE): September 25, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): December 2, 2015
• Last Update Submitted That Met QC Criteria: November 30, 2015
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Keywords: Chronic Constipation; Prucalopride; Post Marketing Surveillance
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Constipation; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Gastrointestinal Agents; Serotonin Agents; Serotonin Receptor Agonists; Laxatives; Serotonin 5-HT4 Receptor Agonists; Prucalopride
• Other Study ID Numbers: CR017521; PRUCOP4001 (OTHER: Janssen Pharmaceutica)