ConstipationPhase 2NCT00631813
Efficacy and Safety Study of Prucalopride for the Treatment of Chronic Constipation
A Phase 2 study testing Prucalopride in people with Constipation, run by Movetis.
Trial summary
The purpose of this study is to determine which dose of prucalopride is safe and effective in patients with chronic constipation. Hypothesis: Prucalopride 1 and 2 mg bid are safe and effective for the treatment of chronic constipation whereas 0,5 mg is a suboptimal dose. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Constipation
- What is being tested?
- Prucalopride
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 253 participants
- Where
- No sites listed yet
- Study dates
- Nov 1995to Apr 1997
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18-70 years;
- History of constipation, i.e., the subject reported the occurrence of two or more of the following criteria for at least 6 months before the selection visit:
- two or fewer spontaneous* bowel movements a week,
- lumpy (scyballae) and/or hard stools at least ¼ of the stools,
- sensation of incomplete evacuation after at least ¼ of the stools,
- straining at defaecation at least ¼ of the time. *The above criteria were only applicable for spontaneous bowel movements i.e., not preceded within a 24-hour period by the intake of a laxative agent. Subjects who never had a spontaneous bowel movement were considered constipated and eligible to enter the double-blind phase of the trial.
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- Constipation being severe and causing disability; the subject's occupational, social and recreational activities were governed by his/her constipation and efforts to attain relief;
- Normal inhibition pattern of the external anal sphincter during straining i.e., relaxation of the m.puborectalis and a distal displacement of the rectal canal (digital examination and/or electromyographic and/or manometric evidence was acceptable);
- Poor results with routine laxative treatment and diet counselling;
- Constipation of a functional, i.e., idiopathic nature;
- Written or oral witnessed informed consent;
- Availability for follow-up during the trial period.
Who cannot join
- Constipation thought to be drug-induced;
- Presence of secondary causes of constipation, i.e., subjects suffering from types or causes of constipation other than idiopathic constipation, for instance: endocrine disorders, metabolic disorders, or neurologic disorders;
- Congenital megacolon/megarectum;
- History of previous abdominal surgery (other than hysterectomy, surgery for Meckel's diverticle, appendectomy, cholecystectomy, inguinal hernia repair, splenectomy, nephrectomy or fundoplication) thought to be the primary cause of constipation;
- Known or suspected organic disorders of the large bowel, i.e., obstruction, carcinoma or inflammatory bowel disease;
- Active proctological conditions thought to be responsible for the constipation;
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- Presence of the following ECG abnormalities:
- 2nd or 3rd degree of AV-block,
- prolonged QT-times (> 460 ms),
- bradycardia;
- Use of concomitant medication that might cause QT-prolongation;
- Use of diuretics not associated with potassium sparing effects;
- Known illnesses or conditions such as severe cardiovascular or lung disease, neurologic or psychiatric disorders (including substance abused dependence but with the exception of nicotine), alcoholism, cancer or AIDS and other gastrointestinal or endocrine disorders;
- Impaired renal function;
- Presence of a serum amylase, a serum glutamic-oxaloacetic transaminase (SGOT) or a serum glutamic-pyruvic transaminase (SGPT) concentration of > 2 times the normal limit;
- Presence of clinically significant abnormalities of blood chemistry, other than those mentioned under 9-10, haematology or urinalysis at selection;
- Pregnancy or wish to become pregnant during the trial. ;
- Breast-feeding;
- Investigational drug received in the 30 days preceding the trial;
- Inability or unwillingness to return for required follow-up visits;
- Reliability and physical state preventing proper evaluation of a drug trial.
About this study
Official title: A Double-Blind Placebo-Controlled Dose-Finding Trial to Evaluate the Efficacy and Safety of R093877 in Patients With Chronic Idiopathic Constipation
The purpose of this study is to determine which dose of prucalopride is safe and effective in patients with chronic constipation.
Hypothesis:
Prucalopride 1 and 2 mg bid are safe and effective for the treatment of chronic constipation whereas 0,5 mg is a suboptimal dose.
Read the detailed description
This is a phase II trial with a parallel-group design, consisting of a drug-free run-in phase (phase 1), followed by a placebo controlled double-blind phase (phase 2). Patients will receive either R093877 0.5 mg b.i.d., 1 mg b.i.d. or 2 mg b.i.d. or placebo for a period of 12 weeks.
Phase 1 is a run-in period of 4 weeks duration, during which the bowel habit is documented and the existence of constipation confirmed. At the start of this period all existing laxative medication is withdrawn and patients will be instructed not to change their dietary habits, in particular their fiber intake during the trial. Patients will enter the double-blind phase if constipation has been shown to be present during the run-in period.
If the definition of constipation was not met during the 4 weeks of the run-in period, the patient will be considered ineligible for the double-blind period.
Phase 2 is a double-blind, randomized, placebo-controlled phase, in which patients will be treated for 12 weeks with either 0.5 mg, 1 mg or 2 mg of R093877 or placebo given twice daily (one capsule is taken before breakfast and one is to be taken before the evening meal).
Patients admitted to the double blind treatment period will be randomly allocated to one of the 4 treatment arms.
- Conditions
- Constipation
- Being tested
- Prucalopride, Placebo
- 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
0.5 mg bid
PrucaloprideDrug
Also called Resolor
1 mg bid
PrucaloprideDrug
Also called Resolor
2 mg bid
PlaceboDrug
bid
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Prucalopride 0.5 mg Receives: Drug: Prucalopride |
| 2 | Active comparator | Prucalopride 1 mg Receives: Drug: Prucalopride |
| 3 | Active comparator | Prucalopride 2 mg Receives: Drug: Prucalopride |
| 4 | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the efficacy and to compare the effects of 0.5 mg, 1 mg or 2 mg of R093877 versus placebo
Measured: 12 weeks
Secondary outcomes (1)
Evaluation of the effects of R093877 on symptoms associated with chronic constipation
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2008 (estimated)
- Study startNov 1995
- Primary completionApr 1997
- Study completionApr 1997
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 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
- 253 participants (actual)
Sponsor and investigators
- Lead sponsor
- Movetis
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- P. Van Eeghem, MD, Principal investigator, Onze Lieve Vrouw Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00631813
- Sponsor's protocol ID
- PRU-INT-2
- Status last verified
- Feb 2008
- First submitted
- 6 Feb 2008
- Last updated
- 29 May 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Emmanuel A, Cools M, Vandeplassche L, Kerstens R. Prucalopride improves bowel function and colonic transit time in patients with chronic constipation: an integrated analysis. Am J Gastroenterol. 2014 Jun;109(6):887-94. doi: 10.1038/ajg.2014.74. Epub 2014 Apr 15.
PubMed 24732867
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 Dose-Finding Trial to Evaluate the Efficacy and Safety of R093877 in Patients With Chronic Idiopathic Constipation
- ClinicalTrials.gov ID
- NCT00631813
- Acronym / sponsor ID
- PRU-INT-2
- Conditions
- Constipation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 253 participants (actual)
- Lead sponsor
- MovetisIndustry (pharma, biotech, devices)
- Study start
- Nov 1995
- Primary completion
- Apr 1997 (actual)
- Study completion
- Apr 1997 (actual)
- First posted
- 10 Mar 2008 (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 which dose of prucalopride is safe and effective in patients with chronic constipation.
Hypothesis:
Prucalopride 1 and 2 mg bid are safe and effective for the treatment of chronic constipation whereas 0,5 mg is a suboptimal dose.
Detailed description
This is a phase II trial with a parallel-group design, consisting of a drug-free run-in phase (phase 1), followed by a placebo controlled double-blind phase (phase 2). Patients will receive either R093877 0.5 mg b.i.d., 1 mg b.i.d. or 2 mg b.i.d. or placebo for a period of 12 weeks.
Phase 1 is a run-in period of 4 weeks duration, during which the bowel habit is documented and the existence of constipation confirmed. At the start of this period all existing laxative medication is withdrawn and patients will be instructed not to change their dietary habits, in particular their fiber intake during the trial. Patients will enter the double-blind phase if constipation has been shown to be present during the run-in period.
If the definition of constipation was not met during the 4 weeks of the run-in period, the patient will be considered ineligible for the double-blind period.
Phase 2 is a double-blind, randomized, placebo-controlled phase, in which patients will be treated for 12 weeks with either 0.5 mg, 1 mg or 2 mg of R093877 or placebo given twice daily (one capsule is taken before breakfast and one is to be taken before the evening meal).
Patients admitted to the double blind treatment period will be randomly allocated to one of the 4 treatment arms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: PrucalopridePrucalopride 0.5 mg |
| 2 | Active comparator | Drug: PrucalopridePrucalopride 1 mg |
| 3 | Active comparator | Drug: PrucalopridePrucalopride 2 mg |
| 4 | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Age between 18-70 years;
- History of constipation, i.e., the subject reported the occurrence of two or more of the following criteria for at least 6 months before the selection visit:
- Constipation being severe and causing disability; the subject's occupational, social and recreational activities were governed by his/her constipation and efforts to attain relief;
- Normal inhibition pattern of the external anal sphincter during straining i.e., relaxation of the m.puborectalis and a distal displacement of the rectal canal (digital examination and/or electromyographic and/or manometric evidence was acceptable);
- Poor results with routine laxative treatment and diet counselling;
Key exclusion criteria (21 listed)
- Constipation thought to be drug-induced;
- Presence of secondary causes of constipation, i.e., subjects suffering from types or causes of constipation other than idiopathic constipation, for instance: endocrine disorders, metabolic disorders, or neurologic disorders;
- Congenital megacolon/megarectum;
- History of previous abdominal surgery (other than hysterectomy, surgery for Meckel's diverticle, appendectomy, cholecystectomy, inguinal hernia repair, splenectomy, nephrectomy or fundoplication) thought to be the primary cause of constipation;
- Known or suspected organic disorders of the large bowel, i.e., obstruction, carcinoma or inflammatory bowel disease;
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: Resolor0.5 mg bid | Drug | 1 |
| PrucaloprideAlso: Resolor1 mg bid | Drug | 2 |
| PrucaloprideAlso: Resolor2 mg bid | Drug | 3 |
| Placebobid | Drug | 4 |
Primary outcome
Evaluation of the efficacy and to compare the effects of 0.5 mg, 1 mg or 2 mg of R093877 versus placebo
Time frame: 12 weeks
1 secondary outcome
Evaluation of the effects of R093877 on symptoms associated with chronic constipation
Time frame: 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 29 May 2008.
- Derived from this study: PubMed 24732867Emmanuel A, Cools M, Vandeplassche L, Kerstens R. Prucalopride improves bowel function and colonic transit time in patients with chronic constipation: an integrated analysis. Am J Gastroenterol. 2014 Jun;109(6):887-94. doi: 10.1038/ajg.2014.74. Epub 2014 Apr 15.
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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.
P. Van Eeghem, MD principal investigator
Onze Lieve Vrouw Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Prucalopride in people with 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 12 inclusion and 21 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?
Evaluation of the efficacy and to compare the effects of 0.5 mg, 1 mg or 2 mg of R093877 versus placebo (time frame: 12 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 NCT00631813, 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.