ConstipationPhase 3NCT00487422
Efficacy and Safety Study of Prucalopride for the Treatment of Elderly Patients With Chronic Constipation
A Phase 3 study testing prucalopride in people with Constipation, run by Movetis.
Trial summary
The purpose of this study is to determine whether prucalopride is safe and effective in the treatment of chronic constipation in elderly patients. Hypothesis: Prucalopride 2 mg and 4 mg given once daily for 12 weeks is superior to placebo for the treatment of patients with chronic constipation and is well tolerated in… Read more about this study
- Who is it for?
- Ages 65 years and older
- 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
- 303 participants
- Where
- No sites listed yet
- Study dates
- Oct 1998to Sep 1999
- Phase
- Phase 3
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Male and female subjects of 65 or over 65 years of age.
- History of constipation; the subject reports, on average, two or fewer spontaneous bowel movements per week that result in a feeling of complete evacuation and one or more of the following for at least 6 months before the selection visit:
- very hard (little balls) and/or hard stools at least a quarter of the stools
- sensation of incomplete evacuation following at least a quarter of the stools
- straining at defecation at least a quarter of the stools. The above criteria are only applicable for spontaneous bowel movements, i.e., not preceded within a period of 24 hours by the intake of a laxative agent or by the use of an enema.
- Subjects who never have spontaneous bowel movements are considered to be constipated and are eligible for the trial.
Who cannot join
- Subjects in whom constipation is thought to be drug-induced, or subjects using any disallowed medication.
- Subjects suffering from endocrine disorders, metabolic disorders or neurologic disorders.
- Subjects with the main complaint of abdominal pain.
- Subjects with a known megacolon/megarectum or a diagnosis of pseudo-obstruction.
- Constipation as a result of surgery.
- Known or suspected organic disorders of the large bowel, i.e. obstruction, carcinoma, or inflammatory bowel disease.
Show all 10Show fewer
- Malignancies or AIDS.
- Known serious illnesses: clinically significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurological, psychiatric or metabolic disturbances. Patients with known diverticulosis may be included.
- Subjects with a serum creatinine concentration > 2 mg/dL (> 180 micromol/L).
- Subjects with clinically significant abnormalities of haematology, urinalysis, or blood chemistry.
About this study
Official title: A Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy, Safety and Quality-of-Life of R108512 Tablets in Elderly Subjects With Chronic Constipation
The purpose of this study is to determine whether prucalopride is safe and effective in the treatment of chronic constipation in elderly patients.
Hypothesis:
Prucalopride 2 mg and 4 mg given once daily for 12 weeks is superior to placebo for the treatment of patients with chronic constipation and is well tolerated in those patients
Read the detailed description
This is a multicentre, randomised, Phase III trial with a parallel-group design, consisting of a 2 week drug-free run-in period, followed by a 4-week, double-blind, placebo-controlled treatment period.
During the run-in period, the subject's bowel habit will be documented and the existence of constipation confirmed. At the start of this period, all existing laxative medication will be withdrawn and subjects will be instructed not to change their diet or lifestyle during the trial.
Subjects will be allowed to take a laxative (Dulcolax®) as a rescue medication throughout the trial, but only if they have not had a bowel movement for three or more consecutive days. Subjects will enter the double-blind period if constipation is shown to be present during the run-in period. Patients will be randomly allocated to one of the 4 treatment arms: 1 mg, 2 mg, 4 mg of R108512 or placebo, with a 25% chance to each treatment group.
During the double-blind period, subjects will be treated for 4 weeks with either 1 mg, 2 mg or 4 mg R108512 or placebo, given once daily before breakfast.
- Conditions
- Constipation
- Being tested
- prucalopride, Placebo
- Keywords
- constipation, prucalopride, QOL, SCBM, PAC-SYM
- 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
2 mg o.d.
PrucaloprideDrug
Also called Resolor
4 mg o.d.
PlaceboOther
o.d.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Prucalopride Receives: Drug: prucalopride |
| 2 | Active comparator | Prucalopride Receives: Drug: Prucalopride |
| 3 | Placebo comparator | Placebo Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects with an average of 3 or more SCBM per week
Measured: 12 weeks
Secondary outcomes (1)
Secondary efficacy variables: 1)Symptom variables 2)QOL variables
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 posted18 Jun 2007 (estimated)
- Study startOct 1998
- Primary completionSep 1999
- Study completionSep 1999
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 303 participants (actual)
Sponsor and investigators
- Lead sponsor
- Movetis
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Gerald Demschik, M.D., Principal investigator, Geriatriezentrum am Wienerwald
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00487422
- Sponsor's protocol ID
- PRU-INT-12
- Status last verified
- Jun 2007
- First submitted
- 14 Jun 2007
- Last updated
- 29 May 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Muller-Lissner S, Rykx A, Kerstens R, Vandeplassche L. A double-blind, placebo-controlled study of prucalopride in elderly patients with chronic constipation. Neurogastroenterol Motil. 2010 Sep;22(9):991-8, e255. doi: 10.1111/j.1365-2982.2010.01533.x. Epub 2010 Jun 7.
PubMed 20529205
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, Safety and Quality-of-Life of R108512 Tablets in Elderly Subjects With Chronic Constipation
- ClinicalTrials.gov ID
- NCT00487422
- Acronym / sponsor ID
- PRU-INT-12
- Conditions
- Constipation
- Keywords
- constipation, prucalopride, QOL, SCBM, PAC-SYM
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 303 participants (actual)
- Lead sponsor
- MovetisIndustry (pharma, biotech, devices)
- Study start
- Oct 1998
- Primary completion
- Sep 1999 (actual)
- Study completion
- Sep 1999 (actual)
- First posted
- 18 Jun 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 the treatment of chronic constipation in elderly patients.
Hypothesis:
Prucalopride 2 mg and 4 mg given once daily for 12 weeks is superior to placebo for the treatment of patients with chronic constipation and is well tolerated in those patients
Detailed description
This is a multicentre, randomised, Phase III trial with a parallel-group design, consisting of a 2 week drug-free run-in period, followed by a 4-week, double-blind, placebo-controlled treatment period.
During the run-in period, the subject's bowel habit will be documented and the existence of constipation confirmed. At the start of this period, all existing laxative medication will be withdrawn and subjects will be instructed not to change their diet or lifestyle during the trial.
Subjects will be allowed to take a laxative (Dulcolax®) as a rescue medication throughout the trial, but only if they have not had a bowel movement for three or more consecutive days. Subjects will enter the double-blind period if constipation is shown to be present during the run-in period. Patients will be randomly allocated to one of the 4 treatment arms: 1 mg, 2 mg, 4 mg of R108512 or placebo, with a 25% chance to each treatment group.
During the double-blind period, subjects will be treated for 4 weeks with either 1 mg, 2 mg or 4 mg R108512 or placebo, given once daily before breakfast.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: prucalopridePrucalopride |
| 2 | Active comparator | Drug: PrucalopridePrucalopride |
| 3 | Placebo comparator | Other: PlaceboPlacebo |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- Male and female subjects of 65 or over 65 years of age.
- History of constipation; the subject reports, on average, two or fewer spontaneous bowel movements per week that result in a feeling of complete evacuation and one or more of the following for at least 6 months before the selection visit:
- Subjects who never have spontaneous bowel movements are considered to be constipated and are eligible for the trial.
Key exclusion criteria (10 listed)
- Subjects in whom constipation is thought to be drug-induced, or subjects using any disallowed medication.
- Subjects suffering from endocrine disorders, metabolic disorders or neurologic disorders.
- Subjects with the main complaint of abdominal pain.
- Subjects with a known megacolon/megarectum or a diagnosis of pseudo-obstruction.
- Constipation as a result of 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: Resolor2 mg o.d. | Drug | 1 |
| PrucaloprideAlso: Resolor4 mg o.d. | Drug | 2 |
| Placeboo.d. | Other | 3 |
Primary outcome
Proportion of subjects with an average of 3 or more SCBM per week
Time frame: 12 weeks
1 secondary outcome
Secondary efficacy variables: 1)Symptom variables 2)QOL variables
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 20529205Muller-Lissner S, Rykx A, Kerstens R, Vandeplassche L. A double-blind, placebo-controlled study of prucalopride in elderly patients with chronic constipation. Neurogastroenterol Motil. 2010 Sep;22(9):991-8, e255. doi: 10.1111/j.1365-2982.2010.01533.x. Epub 2010 Jun 7.
Related trials for Constipation
Recruiting
Effects of a Prebiotic-Probiotic Combination on Constipation Symptoms and Quality of Life
Constipation, Abdominal Pain
RecruitingPhase 2
A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Constipation (IBS-C)
Irritable Bowel Syndrome, Constipation
Recruiting
Outcome Research in Bowel Irrigation Techniques for the Treatment of Chronic Constipation and/or Faecal Incontinence
Faecal Incontinence, Chronic Constipation
Active, not recruitingPhase 2
This is a Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel-group Study of the Efficacy and Safety of 2 Weight-based Treatment Groups of Plecanatide Versus Placebo in Children and Adolescent Participants 6 to Less Than 18 Years of Age With FC
Functional Constipation (FC)
Not yet recruiting
Acupuncture Combined With Transcutaneous Electrical Acupoint Stimulation for Constipation-Predominant Irritable Bowel Syndrome With Anxiety State
IBS, Constipation Predominant, Anxiety State
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.
Gerald Demschik, M.D. principal investigator
Geriatriezentrum am Wienerwald
Questions about this trial
What is this clinical trial studying?
A Phase 3 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 6 inclusion and 10 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Proportion of subjects with an average of 3 or more SCBM per week (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 NCT00487422, 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.