Chronic ConstipationPhase 2NCT00576511
Effect of Prucalopride in Patients With Severe Chronic Idiopathic Constipation
A Phase 2 study testing prucalopride in people with Chronic Constipation, run by Movetis.
Trial summary
The purpose of this study is to determine whether prucalopride is safe and effective in patients with severe chronic constipation. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Constipation
- What is being tested?
- prucalopride
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 53 participants
- Where
- No sites listed yet
- Study dates
- Dec 1994to Feb 1996
- Phase
- Phase 2
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients were eligible for inclusion if they were aged 18-75 years with a history of constipation, defined as the occurrence 2 of the following criteria during the previous 6 months or more:
- 2 spontaneous (i.e. not induced by a laxative within 24 hours) bowel movements per week;
- 25% of stools were lumpy and/or hard;
- sensation of incomplete evacuation following 25% of stool;
- straining at defaecation for 25% of the time.
- All the patients screened for the study were dependent on osmotic laxatives (macrogol, milk of magnesia, lactulose), paraffin oil, glycerol or stimulant laxatives (antranoids, diphenylmethanes) given orally or rectally. The osmotic laxatives were taken on a daily base while the stimulant laxatives were restricted to 2, eventually 3 intakes per week. And although these laxatives, all or not combined promoted defaecation in the majority of patients, these regimens did not provide relief of constipation symptoms in none of the patients. Furthermore, many patients reported that the effect of the laxatives declined over time, that the intake of even stimulant laxatives was not consistently followed by rectal evacuation or that the intake of even stimulant laxatives was not consistently followed by rectal evacuation of that the dose and frequency of intake of laxatives had to be limited because of intolerable side effects including vomiting and abdominal cramps.
- Eligible patients were also required to have constipation causing disability, with the patient's occupational, social and recreational activities governed by constipation and efforts to attain relief, and to have poor results with laxative treatment and diet counseling as determined by physician interview.
- Patients also had to have a normal electromyographic inhibition pattern of the external anal sphincter during straining (assessed at the start of the treatment phase) and an absence of organic abnormalities of the colon (as assessed by barium enema or total colonoscopy).
Who cannot join
- Drug-induced constipation
- Secondary causes of constipation
- Known or suspected organic large bowel disorders
- Congenital or acquired megacolon/megarectum
- History of previous abdominal surgery
- Evidence of a non-relaxing pelvic floor as the main cause of constipation
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- Active proctological conditions
- Impaired renal function or clinically significant abnormalities of blood chemistry, hematology, urinalysis or ECG.
- Patients who were pregnant, breast feeding, not using acceptable methods of birth control or who had known illnesses or conditions that might interfere with adequate assessment of the study drug were also excluded.
About this study
Official title: A Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of R093877 in Patients With Severe Chronic Constipation
The purpose of this study is to determine whether prucalopride is safe and effective in patients with severe chronic constipation.
Read the detailed description
This is a phase II trial with a parallel-group design, consisting of a run-in phase (phase I), followed by a placebo controlled double-blind phase (phase 2). Patients will receive either R093877 4 mg or placebo o.d. for a period of 4 weeks.
Phase 1 is a run-in period of 4 weeks duration, during which the bowel habit is documented and the existence of constipation determined. If the definition of constipation was not met during the 4 weeks of the run-in period, double-blind treatment will not be started.
Phase 2 is a double-blind, randomized, placebo-controlled phase, in which patients will be treated for 4 weeks with either 4 mg of R093877 or placebo given o.d. (two capsules of 2 mg are taken before breakfast).
- Conditions
- Chronic Constipation
- Being tested
- prucalopride, placebo
- Keywords
- Constipation, Prucalopride, Colonic Transit Time
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
prucaloprideDrug
Also called Resolor
4 mg o.d.
placeboDrug
Placebo o.d.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Prucalopride Receives: Drug: prucalopride |
| 2 | Placebo comparator | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Constipation severity (VAS)
Measured: 4 weeks
Secondary outcomes (1)
Stool frequency (stool/week)
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2007 (estimated)
- Study startDec 1994
- Primary completionFeb 1996
- Study completionFeb 1996
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Movetis
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Georges Coremans, MD, Principal investigator, Department of Gastroenterology, University Hospital Gasthuisberg, Catholic University Leuven, Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00576511
- Sponsor's protocol ID
- PRU-BEL-6
- Status last verified
- Dec 2007
- First submitted
- 17 Dec 2007
- Last updated
- 29 May 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Coremans G, Kerstens R, De Pauw M, Stevens M. Prucalopride is effective in patients with severe chronic constipation in whom laxatives fail to provide adequate relief. Results of a double-blind, placebo-controlled clinical trial. Digestion. 2003;67(1-2):82-9. doi: 10.1159/000070202.
PubMed 12743445
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of R093877 in Patients With Severe Chronic Constipation
- ClinicalTrials.gov ID
- NCT00576511
- Acronym / sponsor ID
- PRU-BEL-6
- Conditions
- Chronic Constipation
- Keywords
- Constipation, Prucalopride, Colonic Transit Time
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- MovetisIndustry (pharma, biotech, devices)
- Study start
- Dec 1994
- Primary completion
- Feb 1996 (actual)
- Study completion
- Feb 1996 (actual)
- First posted
- 19 Dec 2007 (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 whether prucalopride is safe and effective in patients with severe chronic constipation.
Detailed description
This is a phase II trial with a parallel-group design, consisting of a run-in phase (phase I), followed by a placebo controlled double-blind phase (phase 2). Patients will receive either R093877 4 mg or placebo o.d. for a period of 4 weeks.
Phase 1 is a run-in period of 4 weeks duration, during which the bowel habit is documented and the existence of constipation determined. If the definition of constipation was not met during the 4 weeks of the run-in period, double-blind treatment will not be started.
Phase 2 is a double-blind, randomized, placebo-controlled phase, in which patients will be treated for 4 weeks with either 4 mg of R093877 or placebo given o.d. (two capsules of 2 mg are taken before breakfast).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: prucalopridePrucalopride |
| 2 | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients were eligible for inclusion if they were aged 18-75 years with a history of constipation, defined as the occurrence 2 of the following criteria during the previous 6 months or more:
- All the patients screened for the study were dependent on osmotic laxatives (macrogol, milk of magnesia, lactulose), paraffin oil, glycerol or stimulant laxatives (antranoids, diphenylmethanes) given orally or rectally. The osmotic laxatives were taken on a daily base while the stimulant laxatives were restricted to 2, eventually 3 intakes per week. And although these laxatives, all or not combined promoted defaecation in the majority of patients, these regimens did not provide relief of constipation symptoms in none of the patients. Furthermore, many patients reported that the effect of the laxatives declined over time, that the intake of even stimulant laxatives was not consistently followed by rectal evacuation or that the intake of even stimulant laxatives was not consistently followed by rectal evacuation of that the dose and frequency of intake of laxatives had to be limited because of intolerable side effects including vomiting and abdominal cramps.
- Eligible patients were also required to have constipation causing disability, with the patient's occupational, social and recreational activities governed by constipation and efforts to attain relief, and to have poor results with laxative treatment and diet counseling as determined by physician interview.
- Patients also had to have a normal electromyographic inhibition pattern of the external anal sphincter during straining (assessed at the start of the treatment phase) and an absence of organic abnormalities of the colon (as assessed by barium enema or total colonoscopy).
Key exclusion criteria (9 listed)
- Drug-induced constipation
- Secondary causes of constipation
- Known or suspected organic large bowel disorders
- Congenital or acquired megacolon/megarectum
- History of previous abdominal surgery
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 |
|---|---|---|
| prucaloprideAlso: Resolor4 mg o.d. | Drug | 1 |
| placeboPlacebo o.d. | Drug | 2 |
Primary outcome
Constipation severity (VAS)
Time frame: 4 weeks
1 secondary outcome
Stool frequency (stool/week)
Time frame: 4 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 29 May 2008.
- Results publication: PubMed 12743445Coremans G, Kerstens R, De Pauw M, Stevens M. Prucalopride is effective in patients with severe chronic constipation in whom laxatives fail to provide adequate relief. Results of a double-blind, placebo-controlled clinical trial. Digestion. 2003;67(1-2):82-9. doi: 10.1159/000070202.
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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.
Georges Coremans, MD principal investigator
Department of Gastroenterology, University Hospital Gasthuisberg, Catholic University Leuven, Leuven
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing prucalopride in people with Chronic Constipation, run by Movetis.
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 8 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 29 May 2008. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Constipation severity (VAS) (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00576511, which also lists 1 linked publication.
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 29 May 2008.