Clinical Trials Logo

Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT01692132
Other study ID # CR017521
Secondary ID PRUCOP4001
Status Withdrawn
Phase Phase 4
First received September 20, 2012
Last updated November 30, 2015
Start date February 2013
Est. completion date December 2014

Study information

Verified date November 2015
Source Janssen Pharmaceutica
Contact n/a
Is FDA regulated No
Health authority Philippines: Bureau of Food and Drugs
Study type Observational

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date December 2014
Est. primary completion date February 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Janssen Pharmaceutica

Country where clinical trial is conducted

Philippines, 

Outcome

Type Measure Description Time frame Safety issue
Primary The incidence of patients discontinuing treatment due to adverse events, serious adverse events, or adverse drug reactions 12 weeks No
Secondary 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 No
Secondary 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 No
See also
  Status Clinical Trial Phase
Completed NCT05980988 - Effectiveness and Safety of Probiotic in Regulating Chronic Constipation N/A
Recruiting NCT03819062 - Sacral Neuromodulation as Treatment for Chronic Constipation N/A
Completed NCT00765882 - Phase III, Randomized, Double-Blind, Placebo-Controlled, Trial of Linaclotide Administered to Patients With Chronic Constipation Phase 3
Completed NCT00730171 - An Open-label, Long-term Safety Study of Linaclotide in Patients With Chronic Constipation or Irritable Bowel Syndrome With Constipation Phase 3
Completed NCT00354575 - Effect of Chinese Herb on Chronic Constipation for Residents in Long-Term Care Units Phase 2
Active, not recruiting NCT03119584 - Efficacy of Linaclotide in Type II Diabetics With Chronic Constipation Phase 4
Completed NCT00765999 - An Open-Label, Long-Term Safety Study of Linaclotide in Patients With Chronic Constipation or Irritable Bowel Syndrome With Constipation Phase 3
Completed NCT01793753 - Effect of Propofol on Internal Anal Sphincter Pressure During ARM N/A
Completed NCT00746200 - Acupuncture for Chronic Constipation Phase 3
Enrolling by invitation NCT00671684 - Endoscopic Mucosal Resection (EMR) for Diagnosis of Hirschsprung's Disease Phase 1/Phase 2
Completed NCT00391820 - Evaluate the Safety and Efficacy of a 5-HT4 Agonist in Chronic Constipation (ACCORD Trial) Phase 2
Completed NCT00404040 - Movicol in Childhood Constipation (ProMotion Study) Phase 2
Completed NCT02281630 - Phase II Dose-Finding Study of KWA-0711 in Patients With Chronic Constipation (CC) Phase 2
Completed NCT00256984 - Study of Stapled Transanal Rectal Resection (STARR) Surgery in Refractory Constipation Associated With Obstructive Defecation Syndrome (ODS) Phase 4
Recruiting NCT05192317 - Administration of a Natural Molecular Complex in Functional Chronic Constipation N/A
Active, not recruiting NCT05202028 - The Efficacy of Massage and Reflexology Applications in Children With Cerebral Palsy N/A
Completed NCT05734859 - Drinking Effect of Electrolyzed Alkaline Reduced Water on Functional Constipation N/A
Completed NCT01007123 - Study of A3309 in Patients With Chronic Idiopathic Constipation Phase 2
Completed NCT00402337 - Dose-range-finding, Phase 2 Trial of Oral Linaclotide Acetate Administered to Patients With Chronic Constipation Phase 2
Completed NCT02961556 - General Clinical Study of AJG555 in Pediatric Patients With Chronic Constipation Phase 3