ConstipationPhase 3NCT00577018
Efficacy and Safety Study of the Effect of Dose-Titration of Prucalopride for The Treatment of 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 the safety profile of 4 mg prucalopride in the treatment of chronic constipation. Read more about this study
- Who is it for?
- Ages 18 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
- 755 participants
- Where
- No sites listed yet
- Study dates
- Aug 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and non-pregnant, non-breast feeding female subjects at least 18 years of age (no upper age limit);
- History of constipation. The subject reported having on average, 2 or fewer spontaneous bowel movements per week that resulted in a feeling or sensation of complete evacuation, as well as the occurrence of one or more of the following for at least 6 months before the selection visit: very hard (little balls) and/or hard stools for at least a quarter of the stools; sensation of incomplete evacuation following at least a quarter of the stools; or straining at defecation at least a quarter of the time. The above criteria only applied to spontaneous bowel movements, (i.e., not preceded within a period of 24 hours by the intake of a laxative or use of an enema). A subject who never had spontaneous bowel movements was considered to be constipated and therefore eligible for the trial;
- Constipation that was functional (i.e., not secondary to other causes);
- Willingness and ability to fill out own diary and questionnaires;
- Written informed consent, signed by the subject or legally acceptable representative and by the investigator; and
- Availability for follow-up during the trial period, as determined in the protocol.
Who cannot join
- Subjects in whom constipation was thought to be drug-induced or who were using any disallowed medication;
- Subjects suffering from secondary causes of chronic constipation. For example:
- Endocrine disorders: insulin-dependent diabetes mellitus; hypopituitarism; hypothyroidism; hypercalcemia; pseudo-hypoparathyroidism; pheochromocytoma; or glucagon-producing tumors. Endocrine disorders controlled by appropriate medical therapy were not excluded, with the exception of insulin-dependent diabetes mellitus Metabolic disorders: porphyria; uremia; hypokalemia; or amyloid neuropathy. Metabolic disorders controlled by appropriate medical therapy were not excluded
- Exclusion criteria (cont'd): Neurologic disorders: Parkinson's disease; cerebral tumors; cerebrovascular accidents; multiple sclerosis; meningocele; aganglionosis; hypoganglionosis; hyperganglionosis; autonomic neuropathy; spinal cord injury; Chagas' disease; or major depression
- Presence of megacolon/megarectum or a diagnosis of pseudo-obstruction;
- Constipation as a result of surgery;
Show all 15Show fewer
- Known or suspected organic disorders of the large bowel (i.e., obstruction, carcinoma, or inflammatory bowel disease). Results of a barium enema with flexible sigmoidoscopy or of a colonoscopic examination performed within the last 12 months were needed to rule out organic disorders. An examination performed within the last 3 years was acceptable, if the examination had been performed for an evaluation of constipation, if there was no history or evidence of weight loss, anemia, or rectal bleeding, and if the subject had had three consecutively negative stool occult blood tests at screening. Subjects with polyps discovered by colonoscopy that were untreated (i.e., by polypectomy) were to be excluded;
- Presence of severe and clinically uncontrolled cardiovascular, liver or lung disease, neurologic or psychiatric disorders (including active alcohol or drug abuse);
- Clinically significant cancer within the past 5 years;
- Known HIV-positive status or AIDS;
- Impaired renal function;
- Clinically significant abnormalities of hematology, urinalysis or blood chemistry;
- Females of child-bearing potential without adequate contraceptive protection during the trial. Oral contraceptives, Depo-Provera®, or Norplant®) must have been used for at least 3 months prior to randomization. I.U.D.'s, sterilization, or a double-barrier method were other acceptable methods of birth control;
- Treatment with an investigational drug in the 30 days preceding the run-in phase of the trial; and
- Previous treatment with either R093877 (prucalopride hydrochloride) or R108512 (prucalopride succinate).
About this study
Official title: A Double-Blind, Placebo-Controlled Trial to Evaluate the Effect of Dose-Titration on the Safety and Efficacy and R108512 Tablets in Subjects With Chronic Constipation
The purpose of this study is to determine the safety profile of 4 mg prucalopride in the treatment of chronic constipation.
Read the detailed description
To evaluate the potential differences in the adverse event (safety) profile between 4 mg of prucalopride daily for 4 weeks; titration up to a 4-mg total daily dose of prucalopride by starting at 1 mg for 2 days, 2 mg for 2 days, to 4 mg thereafter; and placebo given as oral tablets once daily for 4 weeks in patients with chronic constipation
- 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
4 mg o.d.
PrucaloprideDrug
Also called Resolor
1 mg o.d. for 2 days, 2 mg o.d. for 2 days and 4 mg o.d. thereafter
PlaceboOther
o.d.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Not described Receives: Drug: Prucalopride |
| 2 | Active comparator | Not described Receives: Drug: Prucalopride |
| 3 | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with an average of ≥3 SCBM/week
Measured: 4 weeks
Secondary outcomes (1)
Proportion of patients with an average increase of ≥1 SCBM/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 startAug 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.
- 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
- 755 participants (actual)
Sponsor and investigators
- Lead sponsor
- Movetis
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- John F Johanson, MD, MSc, Principal investigator, Private Practice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00577018
- Sponsor's protocol ID
- PRU-USA-25
- Status last verified
- Dec 2007
- First submitted
- 17 Dec 2007
- Last updated
- 29 May 2008
- Results posted
- No
- Data monitoring committee
- No
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 Effect of Dose-Titration on the Safety and Efficacy and R108512 Tablets in Subjects With Chronic Constipation
- ClinicalTrials.gov ID
- NCT00577018
- Acronym / sponsor ID
- PRU-USA-25
- Conditions
- Constipation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 755 participants (actual)
- Lead sponsor
- MovetisIndustry (pharma, biotech, devices)
- Study start
- Aug 1998
- Primary completion
- Sep 1999 (actual)
- Study completion
- Sep 1999 (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 the safety profile of 4 mg prucalopride in the treatment of chronic constipation.
Detailed description
To evaluate the potential differences in the adverse event (safety) profile between 4 mg of prucalopride daily for 4 weeks; titration up to a 4-mg total daily dose of prucalopride by starting at 1 mg for 2 days, 2 mg for 2 days, to 4 mg thereafter; and placebo given as oral tablets once daily for 4 weeks in patients with chronic constipation
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: Prucalopride |
| 2 | Active comparator | Drug: Prucalopride |
| 3 | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male and non-pregnant, non-breast feeding female subjects at least 18 years of age (no upper age limit);
- History of constipation. The subject reported having on average, 2 or fewer spontaneous bowel movements per week that resulted in a feeling or sensation of complete evacuation, as well as the occurrence of one or more of the following for at least 6 months before the selection visit: very hard (little balls) and/or hard stools for at least a quarter of the stools; sensation of incomplete evacuation following at least a quarter of the stools; or straining at defecation at least a quarter of the time. The above criteria only applied to spontaneous bowel movements, (i.e., not preceded within a period of 24 hours by the intake of a laxative or use of an enema). A subject who never had spontaneous bowel movements was considered to be constipated and therefore eligible for the trial;
- Constipation that was functional (i.e., not secondary to other causes);
- Willingness and ability to fill out own diary and questionnaires;
- Written informed consent, signed by the subject or legally acceptable representative and by the investigator; and
Key exclusion criteria (15 listed)
- Subjects in whom constipation was thought to be drug-induced or who were using any disallowed medication;
- Subjects suffering from secondary causes of chronic constipation. For example:
- Endocrine disorders: insulin-dependent diabetes mellitus; hypopituitarism; hypothyroidism; hypercalcemia; pseudo-hypoparathyroidism; pheochromocytoma; or glucagon-producing tumors. Endocrine disorders controlled by appropriate medical therapy were not excluded, with the exception of insulin-dependent diabetes mellitus Metabolic disorders: porphyria; uremia; hypokalemia; or amyloid neuropathy. Metabolic disorders controlled by appropriate medical therapy were not excluded
- Exclusion criteria (cont'd): Neurologic disorders: Parkinson's disease; cerebral tumors; cerebrovascular accidents; multiple sclerosis; meningocele; aganglionosis; hypoganglionosis; hyperganglionosis; autonomic neuropathy; spinal cord injury; Chagas' disease; or major depression
- Presence of megacolon/megarectum or a diagnosis of pseudo-obstruction;
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 |
| PrucaloprideAlso: Resolor1 mg o.d. for 2 days, 2 mg o.d. for 2 days and 4 mg o.d. thereafter | Drug | 2 |
| Placeboo.d. | Other | 3 |
Primary outcome
Proportion of patients with an average of ≥3 SCBM/week
Time frame: 4 weeks
1 secondary outcome
Proportion of patients with an average increase of ≥1 SCBM/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.
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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.
John F Johanson, MD, MSc principal investigator
Private Practice
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 15 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 patients with an average of ≥3 SCBM/week (time frame: 4 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 29 May 2008.