Chronic ConstipationNCT01692132
A Post Marketing Surveillance Study on the Safety and Effectiveness of Prucalopride in the Treatment of Chronic Constipation
An observational study of Chronic Constipation, run by Janssen Pharmaceutica at 7 sites in Philippines.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Constipation
- What is being tested?
- Prucalopride
- Type of treatment
- Pill or oral medicine
- How many people
- 0 participants
- Where
- 7 sitesPhilippines
- Study dates
- Feb 2013to Dec 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Filipino patients with chronic constipation
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Philippines7 sites
Study site
City of Muntinlupa
Study site
City of Taguig
Study site
Makati City
Study site
Manila
Study site
Marikina City
Study site
Quezon City
Study site
San Juan City
About this study
Official title: 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.
Read the 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.
- Conditions
- Chronic Constipation
- Being tested
- Prucalopride
- Keywords
- Chronic Constipation, Prucalopride, Post Marketing Surveillance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrucaloprideDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Prucalopride | Not described Receives: Drug: Prucalopride |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of patients discontinuing treatment due to adverse events, serious adverse events, or adverse drug reactions
Measured: 12 weeks
Secondary outcomes (2)
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.
Measured: 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.
Measured: Baseline, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2012 (estimated)
- Study startFeb 2013
- Primary completionFeb 2014 (estimated)
- Study completionDec 2014 (estimated)
Why it stopped: The company decided to cancel this study in conformity with PH FDA Circular 2013-004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic ConstipationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Pharmaceutica
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Pharmaceutica Clinical Trial, Study director, Janssen Pharmaceutica
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01692132
- Sponsor's protocol ID
- CR017521
- Other IDs
- PRUCOP4001
- Status last verified
- Nov 2015
- First submitted
- 20 Sep 2012
- Last updated
- 2 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on the Safety and Effectiveness of Prucalopride in the Treatment of Chronic Constipation
- ClinicalTrials.gov ID
- NCT01692132
- Acronym / sponsor ID
- CR017521
- Conditions
- Chronic Constipation
- Keywords
- Chronic Constipation, Prucalopride, Post Marketing Surveillance
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: The company decided to cancel this study in conformity with PH FDA Circular 2013-004
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Janssen PharmaceuticaIndustry (pharma, biotech, devices)
- Study start
- Feb 2013
- Primary completion
- Feb 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 25 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prucalopride | – | Drug: Prucalopride |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Filipino patients with chronic constipation
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PrucalopridePrucalopride 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. | Drug | Prucalopride |
Primary outcome
The incidence of patients discontinuing treatment due to adverse events, serious adverse events, or adverse drug reactions
Time frame: 12 weeks
2 secondary outcomes
The percentage of patients having at least 3 spontaneous complete bowel movements (SCBM) in a week after treatment with prucalopride
Time frame: 12 weeks
The change from baseline in the Patient Assessment of Constipation Symptoms (PAC-SYM) score after treatment with prucalopride
Time frame: Baseline, 12 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janssen Pharmaceutica Clinical Trial study director
Janssen Pharmaceutica
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Constipation, run by Janssen Pharmaceutica at 7 sites in Philippines.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 2 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Philippines. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of patients discontinuing treatment due to adverse events, serious adverse events, or adverse drug reactions (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2015.