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

This study has been withdrawn prior to enrollment.
(The company decided to cancel this study in conformity with PH FDA Circular 2013-004)
Sponsor:
Information provided by (Responsible Party):
Janssen Pharmaceutica
ClinicalTrials.gov Identifier:
NCT01692132
First received: September 20, 2012
Last updated: June 18, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention Phase
Chronic Constipation
Drug: Prucalopride
Phase 4

Study Type: Observational
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

Resource links provided by NLM:


Further study details as provided by Janssen Pharmaceutica:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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.


Enrollment: 0
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)
Groups/Cohorts Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Filipino patients with chronic constipation

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01692132

Locations
Philippines
Makati City, Philippines
Manila, Philippines
Marikina City, Philippines
Muntinlupa, Philippines
Quezon City, Philippines
San Juan, Philippines
Taguig, Philippines
Sponsors and Collaborators
Janssen Pharmaceutica
Investigators
Study Director: Janssen Pharmaceutica Clinical Trial Janssen Pharmaceutica
  More Information

No publications provided

Responsible Party: Janssen Pharmaceutica
ClinicalTrials.gov Identifier: NCT01692132     History of Changes
Other Study ID Numbers: CR017521, PRUCOP4001
Study First Received: September 20, 2012
Last Updated: June 18, 2013
Health Authority: Philippines: Bureau of Food and Drugs

Keywords provided by Janssen Pharmaceutica:
Chronic Constipation
Prucalopride
Post Marketing Surveillance

Additional relevant MeSH terms:
Constipation
Signs and Symptoms, Digestive
Signs and Symptoms

ClinicalTrials.gov processed this record on August 21, 2014