ConstipationPhase 4NCT02228616
Efficacy and Safety of Prucalopride in Combination With Polyethylene Glycol or Lactulose in Women With Chronic Constipation
A Phase 4 study testing Prucalopride, Polyethylene glycol (PEG) and Lactulose in people with Constipation, run by Xian-Janssen Pharmaceutical Ltd. at 9 sites in China.
Trial summary
The purpose of this study is to evaluate the efficacy of prucalopride 2 mg, given orally once daily for 12 weeks, in combination with PEG or lactulose, in treatment of women with Chronic Constipation (CC) in whom laxatives fail to provide adequate relief, as measured by the percentage of subjects with a weekly average… Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Constipation
- What is being tested?
- Prucalopride, Polyethylene glycol (PEG) and Lactulose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- 9 sitesChina
- Study dates
- 14 Oct 2014to 28 Sep 2016
- Phase
- Phase 4
- 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 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women aged 18 to 65 years, inclusive
- History of chronic constipation (CC): The subject reports, a weekly average of 2 or fewer spontaneous bowel movement (SBMs) and 1 or more of the following within the preceding 3 months before the screening visit, while symptom onset was more than 6 months before the screening visit: 1. very hard (little balls) and/or hard stools in more than 25% of BMs; 2. sensation of incomplete evacuation in more than 25% of BMs; 3. straining at defecation in more than 25% of BMs; 4. sensation of a no-rectal obstruction or blockade in more than 25% of BMs; 5. A need for digital manipulation to facilitate evacuation in more than 25% of BMs
- Subjects who has been using PEG or lactulose treatment for more than 1 week at screening
- Be a non-pregnant, non-lactating woman. Sexually active women must be post menopausal, surgically sterile, or practicing an effective method of birth control (eg, prescription oral contraceptives, contraceptive injections, intrauterine device, double barrier method, contraceptive patch, male partner sterilization) before entry and throughout the study. Women must have a negative serum beta-human chorionic gonadotropin pregnancy test at screening and a negative urine pregnancy test immediately prior to study drug titration
- Inclusion Criteria for treatment phase: At Visit 2 (Week 0), the diary of Week -1 will be collected and examined for the presence of chronic constipation. The subject will be considered eligible for treatment phase if the following criteria are met: Number of SCBMs is 2 or fewer during the run-in phase (1 week)
- Subject had NO SBMs during the run-in phase is considered to be constipated
Who cannot join
- Potential subjects who meet any of the following criteria will be excluded from participating in the study
- Subjects in whom constipation is thought to be drug-induced
- Subjects suffering from secondary causes of CC
- Use of or intent to use disallowed medications that influence the bowel habit during the study (ie, anticholinergics [not including antihistamines], opioids, spasmolytics, prokinetics, and tricyclic antidepressants)
- Subjects with severe and clinically uncontrolled cardiovascular, liver, or lung disease, neurologic or psychiatric disorders (including active alcohol or drug abuse), cancer or acquired immune deficiency syndrome (AIDS), or other gastrointestinal or endocrine disorders
- Subjects with impaired renal function, i.e., serum creatinine >2 milligram/deciliter(>180 micromole/Liter)
Show all 9Show fewer
- Subjects with clinically significant abnormalities of hematology, urinalysis, or blood chemistry
- Known allergies, hypersensitivity, or intolerance to prucalopride or its excipients
- Women who are pregnant or breast-feeding
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
China9 sites
Study site
Beijing
Study site
Binzhou
Study site
Chongqing
Study site
Hangzhou
Study site
Nanjing
Study site
Shanghai
Study site
Tianjin
Study site
Wuhan
Study site
Zhengzhou
About this study
Official title: A Multicenter, Single-Arm, Interventional, Phase 4 Study to Evaluate the Efficacy and Safety of Prucalopride in Combination With PEG or Lactulose in Women With Chronic Constipation (CC)
The purpose of this study is to evaluate the efficacy of prucalopride 2 mg, given orally once daily for 12 weeks, in combination with PEG or lactulose, in treatment of women with Chronic Constipation (CC) in whom laxatives fail to provide adequate relief, as measured by the percentage of subjects with a weekly average increase of 1 or more spontaneous complete bowel movements (SCBMs) (responders) during the 12-week treatment phase as compared to the baseline.
Read the detailed description
This is a multicenter, open-labeled, single-arm, interventional study to evaluate the efficacy and safety of prucalopride in real clinical practice.
It consists of 2 phases: a 1-week run-in phase, a 12 week, open-label treatment phase. Study population is women with CC who have been treated with laxatives but failed to obtain adequate relief within the preceding 6 months. Patients who meet the inclusive and without exclusive criteria will be enrolled in the study and signed an Informed Consent Form. They are instructed not to change their diet, lifestyle during the study.
At the first week of the study, subjects will continue PEG or lactulose treatment, and they will not be allowed to use any other laxatives and drugs for CC. Subjects will be required to maintain a written stool diary as well as the use of PEG and lactulose. Any drug affecting the colonic motility will be prohibited during the study. Following this run-in phase, subjects enter the 12-week open-label treatment phase. During the treatment phase, subjects will be treated for 12 weeks with prucalopride 2 mg, given orally once daily with or without breakfast in the morning. Subjects will be required to continue PEG or lactulose treatment with the same dosage as that in the run-in period. If necessary, due to intolerable side effects (ie, severe diarrhea,), dosage decrements of PEG or lactulose treatment may be made at any time or the subject could discontinue the PEG or lactulose treatment, based on investigator's judgement. Subjects will record study drug and laxative medication dosing information and information related to BMs in a daily diary throughout the study. PAC-SYM and PAC QOL questionnaires will be completed at Weeks 0, 4, 12. Subject safety will be monitored throughout the study.
- Conditions
- Constipation
- Being tested
- Prucalopride, Polyethylene glycol (PEG), Lactulose
- Keywords
- Constipation, Chronic constipation, Prucalopride, Women
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrucaloprideDrug
During the 12-week treatment phase of the study, the daily dose of 1 tablet of 2-mg prucalopride will be administrated orally before breakfast.
Polyethylene glycol (PEG)Drug
Optimized dose of PEG will be administrated for 13 weeks (1 week run-in+12 weeks intervention).
LactuloseDrug
Optimized dose of Lactulose will be administrated for 13 weeks (1 week run-in+12 weeks intervention).
| Study group | Role | What they receive |
|---|---|---|
| Prucalopride plus Polyethylene glycol or lactulose | Experimental | Not described Receives: Drug: Prucalopride; Drug: Polyethylene glycol (PEG); Drug: Lactulose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of subjects with a weekly average increase of 1 or more Spontaneous Complete Bowel Movement (SCBM) during the 12-week treatment phase as compared to the baseline
Measured: 12 weeks
Secondary outcomes (10)
Percentage of subjects with a weekly 3 or more Spontaneous Complete Bowel Movement (SCBM) during the 12-week treatment phase as compared to the baseline
Measured: 12 weeks
Percentage of subjects with a weekly average increase of 1 or more Spontaneous Complete Bowel Movement (SCBM) during the first 4 weeks treatment phase as compared to the baseline
Measured: 4 weeks
Percentage of subjects with a weekly average increase of 1 or more Spontaneous Bowel Movement (SBM), Bowel Movement (BM) during the 12-week treatment phase as compared to the baseline
Measured: 12 weeks
Average number of Spontaneous Complete Bowel Movement (SCBM) per week
Measured: 12 weeks
Average number of SBMs per week
Measured: 12 weeks
Average number of all BMs per week
Measured: 12 weeks
Percentage of BMs with normal consistency (Types 3-4 based on Bristol Stool Scale) per week
Measured: 12 weeks
Average weekly change of PEG or lactulose frequency and dosage as compared to baseline during the 12-week treatment phase
Measured: 12 weeks
Improvement of constipation symptoms and higher satisfaction as measured by subject's global assessments and PAC-SYM scores. Improvement is defined as that the mean score reduction from baseline is ≥0.2
Measured: Baseline, 12 weeks
Improvement in physical, psychological, and emotional stress as measured by PAC QOL scores. Improvement is defined as that the mean score reduction from baseline is ≥0.3
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 posted29 Aug 2014 (estimated)
- Study start14 Oct 2014
- Primary completion28 Sep 2016
- Study completion28 Sep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 280 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xian-Janssen Pharmaceutical Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Xian-Janssen Pharmaceutical Ltd., China Clinical Trial, Study director, Xian-Janssen Pharmaceutical Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02228616
- Sponsor's protocol ID
- CR102381
- Other IDs
- PRUCOP4005, PRU-C-13-CN-004-V02
- Status last verified
- Sep 2017
- First submitted
- 26 Aug 2014
- Last updated
- 15 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Single-Arm, Interventional, Phase 4 Study to Evaluate the Efficacy and Safety of Prucalopride in Combination With PEG or Lactulose in Women With Chronic Constipation (CC)
- ClinicalTrials.gov ID
- NCT02228616
- Acronym / sponsor ID
- CR102381
- Conditions
- Constipation
- Keywords
- Constipation, Chronic constipation, Prucalopride, Women
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 280 participants (actual)
- Lead sponsor
- Xian-Janssen Pharmaceutical Ltd.Industry (pharma, biotech, devices)
- Study start
- 14 Oct 2014 (actual)
- Primary completion
- 28 Sep 2016 (actual)
- Study completion
- 28 Sep 2016 (actual)
- First posted
- 29 Aug 2014 (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 evaluate the efficacy of prucalopride 2 mg, given orally once daily for 12 weeks, in combination with PEG or lactulose, in treatment of women with Chronic Constipation (CC) in whom laxatives fail to provide adequate relief, as measured by the percentage of subjects with a weekly average increase of 1 or more spontaneous complete bowel movements (SCBMs) (responders) during the 12-week treatment phase as compared to the baseline.
Detailed description
This is a multicenter, open-labeled, single-arm, interventional study to evaluate the efficacy and safety of prucalopride in real clinical practice.
It consists of 2 phases: a 1-week run-in phase, a 12 week, open-label treatment phase. Study population is women with CC who have been treated with laxatives but failed to obtain adequate relief within the preceding 6 months. Patients who meet the inclusive and without exclusive criteria will be enrolled in the study and signed an Informed Consent Form. They are instructed not to change their diet, lifestyle during the study.
At the first week of the study, subjects will continue PEG or lactulose treatment, and they will not be allowed to use any other laxatives and drugs for CC. Subjects will be required to maintain a written stool diary as well as the use of PEG and lactulose. Any drug affecting the colonic motility will be prohibited during the study. Following this run-in phase, subjects enter the 12-week open-label treatment phase. During the treatment phase, subjects will be treated for 12 weeks with prucalopride 2 mg, given orally once daily with or without breakfast in the morning. Subjects will be required to continue PEG or lactulose treatment with the same dosage as that in the run-in period. If necessary, due to intolerable side effects (ie, severe diarrhea,), dosage decrements of PEG or lactulose treatment may be made at any time or the subject could discontinue the PEG or lactulose treatment, based on investigator's judgement. Subjects will record study drug and laxative medication dosing information and information related to BMs in a daily diary throughout the study. PAC-SYM and PAC QOL questionnaires will be completed at Weeks 0, 4, 12. Subject safety will be monitored throughout the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prucalopride plus Polyethylene glycol or lactulose | Experimental | Drug: Prucalopride, Drug: Polyethylene glycol (PEG), Drug: Lactulose |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Women aged 18 to 65 years, inclusive
- History of chronic constipation (CC): The subject reports, a weekly average of 2 or fewer spontaneous bowel movement (SBMs) and 1 or more of the following within the preceding 3 months before the screening visit, while symptom onset was more than 6 months before the screening visit: 1. very hard (little balls) and/or hard stools in more than 25% of BMs; 2. sensation of incomplete evacuation in more than 25% of BMs; 3. straining at defecation in more than 25% of BMs; 4. sensation of a no-rectal obstruction or blockade in more than 25% of BMs; 5. A need for digital manipulation to facilitate evacuation in more than 25% of BMs
- Subjects who has been using PEG or lactulose treatment for more than 1 week at screening
- Be a non-pregnant, non-lactating woman. Sexually active women must be post menopausal, surgically sterile, or practicing an effective method of birth control (eg, prescription oral contraceptives, contraceptive injections, intrauterine device, double barrier method, contraceptive patch, male partner sterilization) before entry and throughout the study. Women must have a negative serum beta-human chorionic gonadotropin pregnancy test at screening and a negative urine pregnancy test immediately prior to study drug titration
- Inclusion Criteria for treatment phase: At Visit 2 (Week 0), the diary of Week -1 will be collected and examined for the presence of chronic constipation. The subject will be considered eligible for treatment phase if the following criteria are met: Number of SCBMs is 2 or fewer during the run-in phase (1 week)
Key exclusion criteria (9 listed)
- Potential subjects who meet any of the following criteria will be excluded from participating in the study
- Subjects in whom constipation is thought to be drug-induced
- Subjects suffering from secondary causes of CC
- Use of or intent to use disallowed medications that influence the bowel habit during the study (ie, anticholinergics [not including antihistamines], opioids, spasmolytics, prokinetics, and tricyclic antidepressants)
- Subjects with severe and clinically uncontrolled cardiovascular, liver, or lung disease, neurologic or psychiatric disorders (including active alcohol or drug abuse), cancer or acquired immune deficiency syndrome (AIDS), or other gastrointestinal or endocrine disorders
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 |
|---|---|---|
| PrucaloprideDuring the 12-week treatment phase of the study, the daily dose of 1 tablet of 2-mg prucalopride will be administrated orally before breakfast. | Drug | Prucalopride plus Polyethylene glycol or lactulose |
| Polyethylene glycol (PEG)Optimized dose of PEG will be administrated for 13 weeks (1 week run-in+12 weeks intervention). | Drug | Prucalopride plus Polyethylene glycol or lactulose |
| LactuloseOptimized dose of Lactulose will be administrated for 13 weeks (1 week run-in+12 weeks intervention). | Drug | Prucalopride plus Polyethylene glycol or lactulose |
Primary outcome
Percentage of subjects with a weekly average increase of 1 or more Spontaneous Complete Bowel Movement (SCBM) during the 12-week treatment phase as compared to the baseline
Time frame: 12 weeks
10 secondary outcomes
Percentage of subjects with a weekly 3 or more Spontaneous Complete Bowel Movement (SCBM) during the 12-week treatment phase as compared to the baseline
Time frame: 12 weeks
Percentage of subjects with a weekly average increase of 1 or more Spontaneous Complete Bowel Movement (SCBM) during the first 4 weeks treatment phase as compared to the baseline
Time frame: 4 weeks
Percentage of subjects with a weekly average increase of 1 or more Spontaneous Bowel Movement (SBM), Bowel Movement (BM) during the 12-week treatment phase as compared to the baseline
Time frame: 12 weeks
Average number of Spontaneous Complete Bowel Movement (SCBM) per week
Time frame: 12 weeks
Average number of SBMs per week
Time frame: 12 weeks
Average number of all BMs per week
Time frame: 12 weeks
Percentage of BMs with normal consistency (Types 3-4 based on Bristol Stool Scale) per week
Time frame: 12 weeks
Average weekly change of PEG or lactulose frequency and dosage as compared to baseline during the 12-week treatment phase
Time frame: 12 weeks
Improvement of constipation symptoms and higher satisfaction as measured by subject's global assessments and PAC-SYM scores. Improvement is defined as that the mean score reduction from baseline is ≥0.2
Time frame: Baseline, 12 weeks
Improvement in physical, psychological, and emotional stress as measured by PAC QOL scores. Improvement is defined as that the mean score reduction from baseline is ≥0.3
Time frame: Baseline, 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2017.
- A Multicenter, Single-Arm, Interventional, Phase 4 Study to Evaluate the Efficacy and Safety of Prucalopride in Combination With PEG or Lactulose in Women With Chronic Constipation (CC)Link provided by the sponsor.
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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.
Xian-Janssen Pharmaceutical Ltd., China Clinical Trial study director
Xian-Janssen Pharmaceutical Ltd.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Prucalopride, Polyethylene glycol (PEG) and Lactulose in people with Constipation, run by Xian-Janssen Pharmaceutical Ltd. at 9 sites in China.
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 6 inclusion and 9 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: finished, as of the sponsor's last update on 15 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in China. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Percentage of subjects with a weekly average increase of 1 or more Spontaneous Complete Bowel Movement (SCBM) during the 12-week treatment phase as compared to the baseline (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 15 Sep 2017.