ConstipationPhase 2NCT00627692
Evaluation of the Safety and Tolerability of Prucalopride in Constipated Elderly Subjects Living in a Nursing Facility
A Phase 2 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 constipation in elderly subjects living in a nursing facility. Hypothesis: Prucalopride up to a dose of 4 mg once daily is safe and well tolerated in in elderly subjects living in a nursing facility. 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
- 100 participants
- Where
- No sites listed yet
- Study dates
- Feb 1999to May 2000
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Male and female patients at least 65 years of age (no upper age limit).
- History of constipation. i.e., the patient should have received any treatment for constipation at any time during the 4 weeks (28 days) preceding entry into the study, including fibre/bulk forming supplements.
- The patient had to live in a nursing facility.
- The patient had to be clinically stable.
- The patient had to be able to take oral medications.
- The patient had to be continent of bowels the majority of time.
- The patient had to be able to reliably communicate AEs.
- The patient had to provide informed consent, signed by the patient or legally acceptable representative and by the investigator.
Who cannot join
- Patients who were known to be HIV positive or who had AIDS.
- Patients who were being actively treated with Propulsid (cisapride) or cancer chemotherapy other than hormonal agents.
- Patients with significantly impaired renal function, i.e., creatinine clearance <30 mL/min using the Cockcroft and Gault formula:
- Males: CLCR = [(140-age) x (weight in kg)] / 72 x (SCR).
- Females: CLCR = male value x 0.85
- Because the calculated value for creatinine clearance could be artificially high when serum creatinine concentrations were very low, patients with a serum creatinine <0.5 mg/dL were excluded from the study.
- Patients who received an investigational drug in the 30 days preceding the study.
- Patients who had previously received either R093877 or R108512.
About this study
Official title: A Double-Blind, Placebo-Controlled Trial to Evaluate the Safety and Tolerability of Oral Once-Daily Prucalopride (R108512) Solution in Constipated Elderly Subjects Living in a Nursing Facility
The purpose of this study is to determine whether prucalopride is safe and effective in the treatment of constipation in elderly subjects living in a nursing facility.
Hypothesis:
Prucalopride up to a dose of 4 mg once daily is safe and well tolerated in in elderly subjects living in a nursing facility.
Read the detailed description
This is a multicenter, Phase II, dose-escalation trial with a 4 week double-blind, placebo-controlled treatment period. There will be four treatment cohorts (0.5 mg, 1 mg, 2 mg, or 4 mg) with 25 subjects in each. The first cohort of 25 subjects will be randomly assigned to receive either 0.5 mg R108512 or placebo in a 4 to 1 ratio, respectively, for four weeks. After two weeks of treatment, the safety and tolerability of this dose will be evaluated for each subject by an independent (external) safety committee. If, at the completion of treatment, the safety committee grants approval to proceed to a higher dose, the second cohort will be randomly assigned to receive either 1 mg R108512 or placebo for four weeks. In a likewise manner, each dose will be evaluated for safety and tolerability before the next cohort will be treated with a higher dose. No subject can participate in more than one treatment cohort.
Subjects will be instructed not to change their diet or lifestyle during the trial. Subjects will be allowed to continue the use of routine stool softeners and fiber supplements during the trial; however, all existing stimulant or osmotic laxative medication will be withdrawn. If, during the trial, the subject does not have a complete bowel movement for three or more consecutive days, he/she will be allowed the use of his/her usual stimulant or osmotic laxative or an enema as a rescue medication. No laxatives or enemas should be used within the 24 hours before and 24 hours after the start of double-blind treatment.
- Conditions
- Constipation
- Being tested
- Prucalopride, Placebo
- Keywords
- Constipation in elderly patients
- 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 o.d.
PlaceboOther
o.d.
PrucaloprideDrug
Also called Resolor
1 mg o.d.
PrucaloprideDrug
Also called Resolor
2 mg o.d.
PrucaloprideDrug
Also called Resolor
4 mg o.d.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Prucalopride Receives: Drug: Prucalopride |
| 2 | Active comparator | Prucalopride Receives: Drug: Prucalopride |
| 3 | Active comparator | Prucalopride Receives: Drug: Prucalopride |
| 5 | Placebo comparator | Placebo Receives: Other: Placebo |
| 4 | Active comparator | Prucalopride Receives: Drug: Prucalopride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient's Global Assessment of severity of constipation and efficacy of treatment evaluated (for exploratory reasons only).
Measured: 4 weeks
Secondary outcomes (1)
Patient's symptom assessment(evaluated for exploratory reasons only).
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 posted3 Mar 2008 (estimated)
- Study startFeb 1999
- Primary completionMay 2000
- Study completionMay 2000
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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Movetis
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- D O'Neill, MD, Principal investigator, Riverside Regional Convalescent Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00627692
- Sponsor's protocol ID
- PRU-USA-26
- Status last verified
- Jan 2008
- First submitted
- 21 Feb 2008
- Last updated
- 29 May 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Camilleri M, Beyens G, Kerstens R, Robinson P, Vandeplassche L. Safety assessment of prucalopride in elderly patients with constipation: a double-blind, placebo-controlled study. Neurogastroenterol Motil. 2009 Dec;21(12):1256-e117. doi: 10.1111/j.1365-2982.2009.01398.x. Epub 2009 Sep 9.
PubMed 19751247
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 Safety and Tolerability of Oral Once-Daily Prucalopride (R108512) Solution in Constipated Elderly Subjects Living in a Nursing Facility
- ClinicalTrials.gov ID
- NCT00627692
- Acronym / sponsor ID
- PRU-USA-26
- Conditions
- Constipation
- Keywords
- Constipation in elderly patients
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- MovetisIndustry (pharma, biotech, devices)
- Study start
- Feb 1999
- Primary completion
- May 2000 (actual)
- Study completion
- May 2000 (actual)
- First posted
- 3 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 whether prucalopride is safe and effective in the treatment of constipation in elderly subjects living in a nursing facility.
Hypothesis:
Prucalopride up to a dose of 4 mg once daily is safe and well tolerated in in elderly subjects living in a nursing facility.
Detailed description
This is a multicenter, Phase II, dose-escalation trial with a 4 week double-blind, placebo-controlled treatment period. There will be four treatment cohorts (0.5 mg, 1 mg, 2 mg, or 4 mg) with 25 subjects in each. The first cohort of 25 subjects will be randomly assigned to receive either 0.5 mg R108512 or placebo in a 4 to 1 ratio, respectively, for four weeks. After two weeks of treatment, the safety and tolerability of this dose will be evaluated for each subject by an independent (external) safety committee. If, at the completion of treatment, the safety committee grants approval to proceed to a higher dose, the second cohort will be randomly assigned to receive either 1 mg R108512 or placebo for four weeks. In a likewise manner, each dose will be evaluated for safety and tolerability before the next cohort will be treated with a higher dose. No subject can participate in more than one treatment cohort.
Subjects will be instructed not to change their diet or lifestyle during the trial. Subjects will be allowed to continue the use of routine stool softeners and fiber supplements during the trial; however, all existing stimulant or osmotic laxative medication will be withdrawn. If, during the trial, the subject does not have a complete bowel movement for three or more consecutive days, he/she will be allowed the use of his/her usual stimulant or osmotic laxative or an enema as a rescue medication. No laxatives or enemas should be used within the 24 hours before and 24 hours after the start of double-blind treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: PrucalopridePrucalopride |
| 2 | Active comparator | Drug: PrucalopridePrucalopride |
| 3 | Active comparator | Drug: PrucalopridePrucalopride |
| 5 | Placebo comparator | Other: PlaceboPlacebo |
| 4 | Active comparator | Drug: PrucalopridePrucalopride |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (8 listed)
- Male and female patients at least 65 years of age (no upper age limit).
- History of constipation. i.e., the patient should have received any treatment for constipation at any time during the 4 weeks (28 days) preceding entry into the study, including fibre/bulk forming supplements.
- The patient had to live in a nursing facility.
- The patient had to be clinically stable.
- The patient had to be able to take oral medications.
Key exclusion criteria (8 listed)
- Patients who were known to be HIV positive or who had AIDS.
- Patients who were being actively treated with Propulsid (cisapride) or cancer chemotherapy other than hormonal agents.
- Patients with significantly impaired renal function, i.e., creatinine clearance <30 mL/min using the Cockcroft and Gault formula:
- Males: CLCR = [(140-age) x (weight in kg)] / 72 x (SCR).
- Females: CLCR = male value x 0.85
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 o.d. | Drug | 1 |
| Placeboo.d. | Other | 5 |
| PrucaloprideAlso: Resolor1 mg o.d. | Drug | 2 |
| PrucaloprideAlso: Resolor2 mg o.d. | Drug | 3 |
| PrucaloprideAlso: Resolor4 mg o.d. | Drug | 4 |
Primary outcome
Patient's Global Assessment of severity of constipation and efficacy of treatment evaluated (for exploratory reasons only).
Time frame: 4 weeks
1 secondary outcome
Patient's symptom assessment(evaluated for exploratory reasons only).
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.
- Derived from this study: PubMed 19751247Camilleri M, Beyens G, Kerstens R, Robinson P, Vandeplassche L. Safety assessment of prucalopride in elderly patients with constipation: a double-blind, placebo-controlled study. Neurogastroenterol Motil. 2009 Dec;21(12):1256-e117. doi: 10.1111/j.1365-2982.2009.01398.x. Epub 2009 Sep 9.
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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.
D O'Neill, MD principal investigator
Riverside Regional Convalescent Center
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 8 inclusion and 8 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?
Patient's Global Assessment of severity of constipation and efficacy of treatment evaluated (for exploratory reasons only). (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 NCT00627692, 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.