ConstipationPhase 2NCT00596596
Trial to Evaluate the Efficacy and Safety of R093877 in Patients With Chronic Idiopathic Constipation
A Phase 2 study testing prucalopride, 2 mg prucalopride and 4 mg prucalopride in people with Constipation, run by Movetis.
Trial summary
The purpose of the study is to determine whether prucalopride is safe and effective in patients with chronic idiopathic constipation. Hypothesis: At all doses administered prucalopride given once daily for 4 weeks is safe and well tolerated in patients with chronic idiopathic constipation. 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, 2 mg prucalopride and 4 mg prucalopride
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 313 participants
- Where
- No sites listed yet
- Study dates
- Sep 1996to Jun 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
- Male and non-pregnant female outsubjects between 18 and 70 years of age.
- Documented history of constipation. The subject reports 2 or less SCBM/week with the occurrence of one or more of the following for at least 3 months before selection visit:
- lumpy (scyballae) and/or hard stools 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.
- These criteria were only applicable for spontaneous, complete bowel movements, i.e., not preceded within a period of 24 hours by the intake of a laxative agent.
Show all 10Show fewer
- 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).
- The subject's constipation was functional, i.e., idiopathic.
- Written informed consent, signed by the subject and/or legal guardian and by the investigator.
- Subject were available for follow-up during the trial period, as determined in the protocol.
Who cannot join
- Subjects in whom constipation was thought to have been drug-induced.
- Subject who suffered from types/causes of constipation other than idiopathic constipation, i.e.,presence of secondary causes of constipation including:
- Endocrine disorders
- Metabolic disorders
- Neurologic disorders including:
- Irritable bowel syndrome.
Show all 30Show fewer
- Subjects with congenital megacolon/megarectum or a diagnosis or pseudo-obstruction.
- History of previous abdominal surgery (excluding hysterectomy, surgery for Meckel's diverticle,appendectomy, cholecystectomy, inguinal hernia repair, splenectomy, nephrectomy, fundoplication)thought to have been the primary cause of constipation.
- Known or suspected organic disorders of the large bowel (i.e., obstruction, carcinoma, or inflammatory bowel disease). -Subjects with active proctological conditions thought to have been responsible for the constipation.
- Subjects with ECG abnormalities including:
- 2nd or 3rd degree AV block;
- prolonged QTc intervals (> 460 msec); or
- bradycardia (< or equal to 60 bpm).
- Subjects who were receiving concomitant medication which could cause QT prolongation
- Subjects on potassium-wasting diuretics.
- Subjects with known illnesses or conditions such as:
- severe cardiovascular or lung disease,
- neurologic or psychiatric disorders (including active alcohol or drug abuse),
- cancer,
- AIDS, or
- other gastrointestinal or endocrine disorders.
- Subjects with impaired renal function
- Subjects with a serum amylase, AST (SGOT), or ALT (SGPT) concentration >2 times the normal limit.
- Subjects with clinically significant abnormalities of hematology, urinalysis or blood chemistry.
- Females of childbearing potential without adequate contraceptive protection during the trial. Oral
- Females who were pregnant or lactating.
- Subjects who received an investigational drug in the 30 days preceding the run-in phase of this trial.
- Subjects who were unable or unwilling to return for required follow-up visits.
- Subjects whose reliability or physical state hindered adequate participation in a clinical trial.
- Subjects who had polyps discovered during the screening colonoscopy that were untreated (i.e., by polypectomy). Subjects who had polyps during the screening colonoscopy that were treated by polypectomy were allowed to enter the trial after the 4-week healing period. Any subject with polyp(s)documented to contain an invasive carcinoma (Duke's B or greater) was excluded from this trial.
About this study
Official title: A Double-Blind, Placebo-Controlled, Dose-Finding Trial to Evaluate the Efficacy and Safety of Prucalopride (R093877) in Subjects With Chronic Idiopathic Constipation
The purpose of the study is to determine whether prucalopride is safe and effective in patients with chronic idiopathic constipation.
Hypothesis:
At all doses administered prucalopride given once daily for 4 weeks is safe and well tolerated in patients with chronic idiopathic constipation.
Read the detailed description
This was a double-blind, placebo-controlled, randomized, parallel group, multicentre, Phase II, dose comparison trial, in which 313 subjects, with a history of chronic idiopathic constipation were enrolled. The trial was conducted in three phases:
- a 4-week drug-free run-in phase,
- a 4-week double-blind (DB) phase during which subjects were treated with R093877 (0.5 mg, 1 mg, 2 mg, or 4 mg capsule) or matching placebo once daily, prior to breakfast,
- a 4-week drug-free run-out phase (RO).
To qualify for the run-in phase (Visit 1, Week 1) subjects had to have experienced, for at least 3 months, 2 or less spontaneous, bowel movements (SBM)/week with the occurrence of lumpy (scyballae) and/or hard stools, a sensation of incomplete evacuation for at least a quarter of their stools, or straining during defecation at least a quarter of the time.
- Conditions
- Constipation
- Being tested
- prucalopride, 2 mg prucalopride, 4 mg prucalopride, Placebo
- Keywords
- Constipation, prucalopride
- 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 once daily
prucaloprideDrug
Also called Resolor
1 mg once daily
2 mg prucaloprideDrug
Also called Resolor
2 mg once daily
4 mg prucaloprideDrug
Also called Resolor
4 mg once daily
PlaceboOther
placebo once daily
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | 0,5 mg prucalopride Receives: Drug: prucalopride |
| 2 | Active comparator | 1 mg prucalopride Receives: Drug: prucalopride |
| 3 | Active comparator | 2 mg prucalopride Receives: Drug: 2 mg prucalopride |
| 5 | Placebo comparator | Placebo arm Receives: Other: Placebo |
| 4 | Active comparator | 4 mg prucalopride Receives: Drug: 4 mg prucalopride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the optimal dose of R093877 for the treatment of chronic idiopathic constipation by comparing the efficacy and safety of 0.5 mg, 1 mg, 2 mg, and 4 mg of R093877 versus placebo given orally once daily for 4 weeks.
Measured: 4 weeks
Secondary outcomes (1)
Evaluation of the effects of R093877 on symptoms associated with idiopathic constipation
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 posted17 Jan 2008 (estimated)
- Study startSep 1996
- Primary completionJun 1997
- Study completionJun 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
- 313 participants (actual)
Sponsor and investigators
- Lead sponsor
- Movetis
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Trent Nichols, MD, Principal investigator, Hanover General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00596596
- Sponsor's protocol ID
- PRU-USA-3
- Status last verified
- Jan 2008
- First submitted
- 8 Jan 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 Prucalopride (R093877) in Subjects With Chronic Idiopathic Constipation
- ClinicalTrials.gov ID
- NCT00596596
- Acronym / sponsor ID
- PRU-USA-3
- Conditions
- Constipation
- Keywords
- Constipation, prucalopride
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 313 participants (actual)
- Lead sponsor
- MovetisIndustry (pharma, biotech, devices)
- Study start
- Sep 1996
- Primary completion
- Jun 1997 (actual)
- Study completion
- Jun 1997 (actual)
- First posted
- 17 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 the study is to determine whether prucalopride is safe and effective in patients with chronic idiopathic constipation.
Hypothesis:
At all doses administered prucalopride given once daily for 4 weeks is safe and well tolerated in patients with chronic idiopathic constipation.
Detailed description
This was a double-blind, placebo-controlled, randomized, parallel group, multicentre, Phase II, dose comparison trial, in which 313 subjects, with a history of chronic idiopathic constipation were enrolled. The trial was conducted in three phases:
- a 4-week drug-free run-in phase,
- a 4-week double-blind (DB) phase during which subjects were treated with R093877 (0.5 mg, 1 mg, 2 mg, or 4 mg capsule) or matching placebo once daily, prior to breakfast,
- a 4-week drug-free run-out phase (RO).
To qualify for the run-in phase (Visit 1, Week 1) subjects had to have experienced, for at least 3 months, 2 or less spontaneous, bowel movements (SBM)/week with the occurrence of lumpy (scyballae) and/or hard stools, a sensation of incomplete evacuation for at least a quarter of their stools, or straining during defecation at least a quarter of the time.
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: prucalopride0,5 mg prucalopride |
| 2 | Active comparator | Drug: prucalopride1 mg prucalopride |
| 3 | Active comparator | Drug: 2 mg prucalopride2 mg prucalopride |
| 5 | Placebo comparator | Other: PlaceboPlacebo arm |
| 4 | Active comparator | Drug: 4 mg prucalopride4 mg prucalopride |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Male and non-pregnant female outsubjects between 18 and 70 years of age.
- Documented history of constipation. The subject reports 2 or less SCBM/week with the occurrence of one or more of the following for at least 3 months before selection visit:
- These criteria were only applicable for spontaneous, complete bowel movements, i.e., not preceded within a period of 24 hours by the intake of a laxative agent.
- 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).
- The subject's constipation was functional, i.e., idiopathic.
Key exclusion criteria (30 listed)
- Subjects in whom constipation was thought to have been drug-induced.
- Subject who suffered from types/causes of constipation other than idiopathic constipation, i.e.,presence of secondary causes of constipation including:
- Irritable bowel syndrome.
- Subjects with congenital megacolon/megarectum or a diagnosis or pseudo-obstruction.
- History of previous abdominal surgery (excluding hysterectomy, surgery for Meckel's diverticle,appendectomy, cholecystectomy, inguinal hernia repair, splenectomy, nephrectomy, fundoplication)thought to have been the primary cause of constipation.
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 once daily | Drug | 1 |
| prucaloprideAlso: Resolor1 mg once daily | Drug | 2 |
| 2 mg prucaloprideAlso: Resolor2 mg once daily | Drug | 3 |
| 4 mg prucaloprideAlso: Resolor4 mg once daily | Drug | 4 |
| Placeboplacebo once daily | Other | 5 |
Primary outcome
Evaluation of the optimal dose of R093877 for the treatment of chronic idiopathic constipation by comparing the efficacy and safety of 0.5 mg, 1 mg, 2 mg, and 4 mg of R093877 versus placebo given orally once daily for 4 weeks.
Time frame: 4 weeks
1 secondary outcome
Evaluation of the effects of R093877 on symptoms associated with idiopathic constipation
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 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.
Trent Nichols, MD principal investigator
Hanover General Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing prucalopride, 2 mg prucalopride and 4 mg 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 30 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 optimal dose of R093877 for the treatment of chronic idiopathic constipation by comparing the efficacy and safety of 0.5 mg, 1 mg, 2 mg, and 4 mg of R093877 versus placebo given orally once daily for 4 weeks. (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 NCT00596596, 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.