Irritable Bowel Syndrome Without DiarrheaPhase 2NCT01505777
Exploratory Clinical Study to Evaluate the Optimal Dosage of Mosapride and Probiotics in Irritable Bowel Syndrome Without Predominant Diarrhea
A Phase 2 study testing Probiotics (Medirac) in people with Irritable Bowel Syndrome Without Diarrhea, run by Hanmi Pharmaceutical Company Limited at 1 site in South Korea.
Trial summary
The purpose of this study is to Evaluate the Optimal Dosage of Mosapride (Medirac) and Probitics in Irritable Bowel Syndrome Without Predominant Diarrhea. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Irritable Bowel Syndrome Without Diarrhea
- What is being tested?
- Probiotics (Medirac)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 280 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2011to Jun 2012
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18-75 years who satisfied RomeIII criteria for the diagnosis of IBS
- Signed informed consent
Who cannot join
- IBS-D
- evidence of cathartic colon or history laxative abuse
Trial locations and contacts
1 site in 1 country.
South Korea1 site
16 institutions including Gangnam Severance hospital
Seoul
About this study
Official title: Exploratory Clinical Study to Evaluate the Optimal Dosage of Mosapride and Probiotics in Irritable Bowel Syndrome Without Predominant Diarrhea: Double Blinded, Randomized, Placebo Drug Controlled, Parallel Designed, Multi-centered, Phase 2 Study
The purpose of this study is to Evaluate the Optimal Dosage of Mosapride (Medirac) and Probitics in Irritable Bowel Syndrome Without Predominant Diarrhea.
- Being tested
- Probiotics (Medirac), Probiotics (Medirac) placebo/mosapride placebo
- Keywords
- irritable bowel syndrome without predominant diarrhea, Probiotics(Medirac) 10/mosapride 10mg, Probiotics(Medirac) 15/mosapride 10mg, Probiotics(Medirac) 15/mosapride 15mg, Probiotics(Medirac) 30/mosapride 15mg, Probiotics(Medirac) placebo/mosapride placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotics (Medirac)Drug
10/mosapride 10mg three times a day, P.O. 4week
Probiotics (Medirac)Drug
15/mosapride 10mg three times a day, P.O. 4week
Probiotics (Medirac)Drug
15/mosapride 15mg three times a day, P.O. 4week
Probiotics (Medirac)Drug
30/mosapride 15mg three times a day, P.O. 4week
Probiotics (Medirac) placebo/mosapride placeboDrug
three times a day, P.O. 4week
| Study group | Role | What they receive |
|---|---|---|
| Probiotics(Medirac) 10/mosapride 10mg | Experimental | Not described Receives: Drug: Probiotics (Medirac) |
| Probiotics(Medirac) 15/mosapride 10mg | Experimental | Not described Receives: Drug: Probiotics (Medirac) |
| Probiotics(Medirac) 15/mosapride 15mg | Experimental | Not described Receives: Drug: Probiotics (Medirac) |
| Probiotics(Medirac) 30/mosapride 15mg | Experimental | Not described Receives: Drug: Probiotics (Medirac) |
| Probiotics(Medirac) placebo/mosapride placebo | Placebo comparator | Not described Receives: Drug: Probiotics (Medirac) placebo/mosapride placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in patient's overall satisfaction relief over 4 weeks of treatment of IBS symptoms
Measured: baseline and 4 week
Secondary outcomes (1)
Change from Baseline in improvment of abdominal discomfort, pain, bloating, stool frequency, stool consistency, straining urgency over 4 weeks of treatment and during each week(4 weeks,6 weeks)
Measured: baseline and 4 weeks, 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2012 (estimated)
- Study startMay 2011
- Primary completionJun 2012
- Study completionJun 2012
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 Irritable Bowel Syndrome Without DiarrheaStudies of the same condition, open and under way.
- More trials run by Hanmi Pharmaceutical Company LimitedThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hanmi Pharmaceutical Company Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hyo Jin Park, M.D., Ph.D., Principal investigator, Gangnam Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01505777
- Sponsor's protocol ID
- HM-MEMO-201
- Status last verified
- Apr 2013
- First submitted
- 3 Jan 2012
- Last updated
- 5 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Choi CH, Kwon JG, Kim SK, Myung SJ, Park KS, Sohn CI, Rhee PL, Lee KJ, Lee OY, Jung HK, Jee SR, Jeen YT, Choi MG, Choi SC, Huh KC, Park H. Efficacy of combination therapy with probiotics and mosapride in patients with IBS without diarrhea: a randomized, double-blind, placebo-controlled, multicenter, phase II trial. Neurogastroenterol Motil. 2015 May;27(5):705-16. doi: 10.1111/nmo.12544. Epub 2015 Mar 25.
PubMed 25809913
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Clinical Study to Evaluate the Optimal Dosage of Mosapride and Probiotics in Irritable Bowel Syndrome Without Predominant Diarrhea: Double Blinded, Randomized, Placebo Drug Controlled, Parallel Designed, Multi-centered, Phase 2 Study
- ClinicalTrials.gov ID
- NCT01505777
- Acronym / sponsor ID
- HM-MEMO-201
- Keywords
- irritable bowel syndrome without predominant diarrhea, Probiotics(Medirac) 10/mosapride 10mg, Probiotics(Medirac) 15/mosapride 10mg, Probiotics(Medirac) 15/mosapride 15mg, Probiotics(Medirac) 30/mosapride 15mg, Probiotics(Medirac) placebo/mosapride placebo
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- Hanmi Pharmaceutical Company LimitedIndustry (pharma, biotech, devices)
- Study start
- May 2011
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 9 Jan 2012 (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 Evaluate the Optimal Dosage of Mosapride (Medirac) and Probitics in Irritable Bowel Syndrome Without Predominant Diarrhea.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Probiotics(Medirac) 10/mosapride 10mg | Experimental | Drug: Probiotics (Medirac) |
| Probiotics(Medirac) 15/mosapride 10mg | Experimental | Drug: Probiotics (Medirac) |
| Probiotics(Medirac) 15/mosapride 15mg | Experimental | Drug: Probiotics (Medirac) |
| Probiotics(Medirac) 30/mosapride 15mg | Experimental | Drug: Probiotics (Medirac) |
| Probiotics(Medirac) placebo/mosapride placebo | Placebo comparator | Drug: Probiotics (Medirac) placebo/mosapride placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Aged 18-75 years who satisfied RomeIII criteria for the diagnosis of IBS
- Signed informed consent
Key exclusion criteria (2 listed)
- IBS-D
- evidence of cathartic colon or history laxative abuse
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 |
|---|---|---|
| Probiotics (Medirac)10/mosapride 10mg three times a day, P.O. 4week | Drug | Probiotics(Medirac) 10/mosapride 10mg |
| Probiotics (Medirac)15/mosapride 10mg three times a day, P.O. 4week | Drug | Probiotics(Medirac) 15/mosapride 10mg |
| Probiotics (Medirac)15/mosapride 15mg three times a day, P.O. 4week | Drug | Probiotics(Medirac) 15/mosapride 15mg |
| Probiotics (Medirac)30/mosapride 15mg three times a day, P.O. 4week | Drug | Probiotics(Medirac) 30/mosapride 15mg |
| Probiotics (Medirac) placebo/mosapride placebothree times a day, P.O. 4week | Drug | Probiotics(Medirac) placebo/mosapride placebo |
Primary outcome
Change from Baseline in patient's overall satisfaction relief over 4 weeks of treatment of IBS symptoms
Time frame: baseline and 4 week
1 secondary outcome
Change from Baseline in improvment of abdominal discomfort, pain, bloating, stool frequency, stool consistency, straining urgency over 4 weeks of treatment and during each week(4 weeks,6 weeks)
Time frame: baseline and 4 weeks, 6 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 5 Apr 2013.
- Derived from this study: PubMed 25809913Choi CH, Kwon JG, Kim SK, Myung SJ, Park KS, Sohn CI, Rhee PL, Lee KJ, Lee OY, Jung HK, Jee SR, Jeen YT, Choi MG, Choi SC, Huh KC, Park H. Efficacy of combination therapy with probiotics and mosapride in patients with IBS without diarrhea: a randomized, double-blind, placebo-controlled, multicenter, phase II trial. Neurogastroenterol Motil. 2015 May;27(5):705-16. doi: 10.1111/nmo.12544. Epub 2015 Mar 25.
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.
Hyo Jin Park, M.D., Ph.D. principal investigator
Gangnam Severance Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Probiotics (Medirac) in people with Irritable Bowel Syndrome Without Diarrhea, run by Hanmi Pharmaceutical Company Limited at 1 site in South Korea.
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 2 inclusion and 2 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 5 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Change from Baseline in patient's overall satisfaction relief over 4 weeks of treatment of IBS symptoms (time frame: baseline and 4 week). 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 NCT01505777, 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 5 Apr 2013.