Constipated Irritable Bowel SyndromePhase 4NCT02433847
Effect of Mosapride on Gut Transit in Patients With Chronic Constipation or Constipated Irritable Bowel Syndrome and Healthy Subjects
A Phase 4 study testing Mosapride in people with Constipated Irritable Bowel Syndrome and Chronic Constipation, run by Seoul National University Hospital.
Trial summary
Effect of mosapride 30mg/day on the small bowel and colon transit time in patients with chronic constipation or constipated irritable bowel syndrome. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Constipated Irritable Bowel Syndrome, Chronic Constipation, Healthy
- What is being tested?
- Mosapride
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- May 2015to Dec 2016
- Phase
- Phase 4
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Functional constipation or constipated irritable bowel syndrome patients according to Rome III criteria
Who cannot join
- Intolerable or hypersensitive to mosapride
- Known Parkinson's ds
- Cardio- or cerebrovascular disease within 3 months
- Malignancy requiring surgery or chemotherapy or radiation within 5 years
- History of GI surgeries except hernia repair, appendectomy, primary closure due to perforation
- Refractory diabetes mellitus/hypertension/thyroid diseases
- Symptomatic heart failure, renal failure, arrhythmia
About this study
Effect of mosapride 30mg/day on the small bowel and colon transit time in patients with chronic constipation or constipated irritable bowel syndrome.
- Being tested
- Mosapride
- Keywords
- mosapride
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MosaprideDrug
| Study group | Role | What they receive |
|---|---|---|
| mosapride | Experimental | Not described Receives: Drug: Mosapride |
What is being measured
The primary outcome is the main question the study is designed to answer.
colonic transit time
the change of colonic transit time after mosapride 30mg/day administration
: whole colonic transit time, rt. colon / lt. colon / rectosigmoid colonic transit time
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2015 (estimated)
- Study startMay 2015
- Primary completionApr 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Constipated Irritable Bowel SyndromeStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02433847
- Sponsor's protocol ID
- Mosa_GIFx_1.0
- Status last verified
- Apr 2015
- First submitted
- 13 Apr 2015
- Last updated
- 5 May 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Mosapride on Gut Transit in Patients With Chronic Constipation or Constipated Irritable Bowel Syndrome and Healthy Subjects
- ClinicalTrials.gov ID
- NCT02433847
- Acronym / sponsor ID
- Mosa_GIFx_1.0
- Keywords
- mosapride
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- Apr 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 5 May 2015 (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.
Effect of mosapride 30mg/day on the small bowel and colon transit time in patients with chronic constipation or constipated irritable bowel syndrome.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| mosapride | Experimental | Drug: Mosapride |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Functional constipation or constipated irritable bowel syndrome patients according to Rome III criteria
Key exclusion criteria (7 listed)
- Intolerable or hypersensitive to mosapride
- Known Parkinson's ds
- Cardio- or cerebrovascular disease within 3 months
- Malignancy requiring surgery or chemotherapy or radiation within 5 years
- History of GI surgeries except hernia repair, appendectomy, primary closure due to perforation
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 |
|---|---|---|
| Mosapride | Drug | mosapride |
Primary outcome
colonic transit time
Time frame: 2 weeks
the change of colonic transit time after mosapride 30mg/day administration : whole colonic transit time, rt. colon / lt. colon / rectosigmoid colonic transit time
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Mosapride in people with Constipated Irritable Bowel Syndrome and Chronic Constipation, run by Seoul National University Hospital.
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 1 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 5 May 2015. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
colonic transit time (time frame: 2 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 5 May 2015.