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

NCT ID: NCT01692132

Last Updated: 2015-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2013-02-28

Study Completion Date

2014-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Chronic Constipation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Prucalopride

Prucalopride

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Janssen Pharmaceutica

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Janssen Pharmaceutica Clinical Trial

Role: STUDY_DIRECTOR

Janssen Pharmaceutica

Locations

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City of Muntinlupa, , Philippines

Site Status

City of Taguig, , Philippines

Site Status

Makati City, , Philippines

Site Status

Manila, , Philippines

Site Status

Marikina City, , Philippines

Site Status

Quezon City, , Philippines

Site Status

San Juan City, , Philippines

Site Status

Countries

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Philippines

Other Identifiers

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PRUCOP4001

Identifier Type: OTHER

Identifier Source: secondary_id

CR017521

Identifier Type: -

Identifier Source: org_study_id