ConstipationPhase 3NCT00598338
Efficacy and Safety Study of Prucalopride for the Re-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 whether prucalopride is safe and effective in the re-treatment of chronic constipation. Hypothesis: Retreatment is as effective and safe as treatment with prucalopride in patients with 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
- 516 participants
- Where
- No sites listed yet
- Study dates
- Apr 1999to Feb 2000
- 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 outpatients at least 18 years of age (no upper age limit).
- History of constipation; the patient reported having, on average, 2 or fewer spontaneous bowel movements per week that resulted in a feeling 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 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 time. The above criteria were 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.
- Patients who never had spontaneous bowel movements were considered to be constipated and were eligible for the study.
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- Having functional constipation. Constipation that was not induced by secondary causes of constipation (see exclusion criteria 1 through 7).
- Willing and able to fill out his/her own diary and questionnaires without help, and able to read and write English.
- Written informed consent, signed by the patient or legally acceptable representative and by the investigator.
- Availability for follow-up during the study period as determined in the protocol.
Who cannot join
- Patients in whom constipation was thought to be drug-induced, or who were using any disallowed medication
- Patients with insulin-dependent diabetes mellitus.
- Patients suffering from endocrine disorders.
- Patients suffering from neurologic disorders
- Presence of a megacolon/megarectum or a diagnosis of pseudo-obstruction.
- Constipation as a result of surgery.
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- 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. A colonoscopic examination or barium enema with flexible sigmoidoscopy performed within the last 3 years was acceptable if the examination was performed for an evaluation of constipation, and there was no history or evidence of weight loss, anaemia, or rectal bleeding, and the patient had 3 consecutively negative stool occult blood tests at screening. Patients with polyps discovered by colonoscopy that were untreated (i.e. by polypectomy) were to be excluded.
- Presence of known serious, uncontrolled illnesses: clinically significant cardiac, vascular, pulmonary, endocrine, psychiatric disorders (including active alcohol or drug abuse) or metabolic disturbances.
- Clinically significant cancer within the past 5 years.
- Subjects known to be HIV positive.
- Impaired renal function, i.e. serum creatinine concentration >2 mg/dL (>180 micromol/L) or creatinine clearance ≤50 mL/min.
- Clinically significant abnormalities of haematology, urinalysis, or blood chemistry.
- Females of child-bearing potential without adequate contraceptive protection during the study. Oral contraceptives, Depo Provera® and Norplant® had to be used for at least 3 months prior to randomisation. Intrauterine devices (IUDs), 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 study.
- Previous treatment with either prucalopride formulation.
About this study
Official title: A Two-Period, Double-Blind, Placebo-Controlled Trial to Evaluate the Effects of re-Treatment of Prucalopride on Efficacy and Safety in Subjects With Chronic Constipation.
The purpose of this study is to determine whether prucalopride is safe and effective in the re-treatment of chronic constipation.
Hypothesis:
Retreatment is as effective and safe as treatment with prucalopride in patients with chronic constipation.
Read the detailed description
This is a multicentre, 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, a drug-free washout period of at least 2 weeks, and a second 4-week double-blind treatment period.
During the initial run-in period, the subject's bowel habit will be documented in a daily diary and the existence of constipation will be confirmed. Eligible subjects will be randomly allocated to double-blind treatment with either 4 mg prucalopride or placebo, given orally once daily before breakfast, for 4 weeks.
After 4 weeks of treatment, each subject will enter a drug-free washout period. The length of the washout period will be either 2 or 4 weeks, depending on how long it takes for the subject to meet the criteria for constipation. If the subject is unable to re-qualify after a 4-week washout, the subject must be discontinued from the trial.
Subjects who qualify for the second double-blind treatment period will receive the same treatment as during the first treatment period, once-daily for an additional four weeks.
- 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.
PlaceboOther
o.d.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Prucalopride Receives: Drug: Prucalopride |
| 2 | 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 three or more spontaneous, complete bowel movements per week.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2008 (estimated)
- Study startApr 1999
- Primary completionFeb 2000
- Study completionFeb 2000
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
- 516 participants (actual)
Sponsor and investigators
- Lead sponsor
- Movetis
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Miner, Jr. B Miner, MD, Principal investigator, Oklahoma Foundation for Digestive Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00598338
- Sponsor's protocol ID
- PRU-USA-28
- Status last verified
- Jan 2008
- First submitted
- 10 Jan 2008
- 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 Two-Period, Double-Blind, Placebo-Controlled Trial to Evaluate the Effects of re-Treatment of Prucalopride on Efficacy and Safety in Subjects With Chronic Constipation.
- ClinicalTrials.gov ID
- NCT00598338
- Acronym / sponsor ID
- PRU-USA-28
- Conditions
- Constipation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 516 participants (actual)
- Lead sponsor
- MovetisIndustry (pharma, biotech, devices)
- Study start
- Apr 1999
- Primary completion
- Feb 2000 (actual)
- Study completion
- Feb 2000 (actual)
- First posted
- 21 Jan 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 re-treatment of chronic constipation.
Hypothesis:
Retreatment is as effective and safe as treatment with prucalopride in patients with chronic constipation.
Detailed description
This is a multicentre, 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, a drug-free washout period of at least 2 weeks, and a second 4-week double-blind treatment period.
During the initial run-in period, the subject's bowel habit will be documented in a daily diary and the existence of constipation will be confirmed. Eligible subjects will be randomly allocated to double-blind treatment with either 4 mg prucalopride or placebo, given orally once daily before breakfast, for 4 weeks.
After 4 weeks of treatment, each subject will enter a drug-free washout period. The length of the washout period will be either 2 or 4 weeks, depending on how long it takes for the subject to meet the criteria for constipation. If the subject is unable to re-qualify after a 4-week washout, the subject must be discontinued from the trial.
Subjects who qualify for the second double-blind treatment period will receive the same treatment as during the first treatment period, once-daily for an additional four weeks.
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 | Other: PlaceboPlacebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Male and non-pregnant, non-breast-feeding female outpatients at least 18 years of age (no upper age limit).
- History of constipation; the patient reported having, on average, 2 or fewer spontaneous bowel movements per week that resulted in a feeling of complete evacuation as well as the occurrence of one or more of the following for at least 6 months before the selection visit:
- Patients who never had spontaneous bowel movements were considered to be constipated and were eligible for the study.
- Having functional constipation. Constipation that was not induced by secondary causes of constipation (see exclusion criteria 1 through 7).
- Willing and able to fill out his/her own diary and questionnaires without help, and able to read and write English.
Key exclusion criteria (15 listed)
- Patients in whom constipation was thought to be drug-induced, or who were using any disallowed medication
- Patients with insulin-dependent diabetes mellitus.
- Patients suffering from endocrine disorders.
- Patients suffering from neurologic disorders
- Presence of a 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 |
| Placeboo.d. | Other | 2 |
Primary outcome
Proportion (%) of subjects with three or more spontaneous, complete bowel movements per week.
Time frame: 8 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.
Miner, Jr. B Miner, MD principal investigator
Oklahoma Foundation for Digestive Research
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 10 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 subjects with three or more spontaneous, complete bowel movements per week. (time frame: 8 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.