Irritable Bowel SyndromePhase 2YKPNCT02082457
Efficacy and Safety of YKP10811 in Subjects With Irritable Bowel Syndrome With Constipation
A Phase 2 study testing YKP10811 5mg and YKP10811 20mg in people with Irritable Bowel Syndrome and Constipation, run by SK Chemicals Co., Ltd. at 1 site in South Korea.
Trial summary
This trial is to investigate efficacy and safety of YKP10811 in Subjects With Irritable Bowel Syndrome With Constipation. The difference of responder rate between test group (10, 20 and 40mg) and placebo will be evaluated. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Irritable Bowel Syndrome, Constipation
- What is being tested?
- YKP10811 5mg and YKP10811 20mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 273 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2013to Dec 2014
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- more than 18 years old
- patients met with ROME III criteria for C-type IBS
Who cannot join
- pregnancy or lactation
- a history of surgery for gastrointestinal tract
- a history of gastrointestinal bleeding, diverticulitis and ileus within 1 year of screening visit
- inflammatory bowel disease or malignant tumor within 5 years of screening visit
- taking drugs that could have impact on efficacy assessment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multi-center, Randomized, Double Blinded, Placebo-controlled, Phase II Trial to Assess the Efficacy and Safety of YKP10811 in Subjects With Irritable Bowel Syndrome With Constipation
This trial is to investigate efficacy and safety of YKP10811 in Subjects With Irritable Bowel Syndrome With Constipation. The difference of responder rate between test group (10, 20 and 40mg) and placebo will be evaluated.
- Conditions
- Irritable Bowel Syndrome, Constipation
- Being tested
- YKP10811 5mg, YKP10811 20mg, YKP10811 placebo
- Keywords
- Irritable Bowel Syndrome, Constipation, C-IBS
- Medical subject headings
- Irritable Bowel Syndrome, Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YKP10811 5mgDrug
YKP10811 20mgDrug
YKP10811 placeboDrug
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Two tablets of YKP10811 placebo are administered orally once a day for 12 weeks. Receives: Drug: YKP10811 placebo |
| YKP10811 10mg | Experimental | Two tablets of YKP10811 5mg are administered orally once a day for 12 weeks. Receives: Drug: YKP10811 5mg |
| YKP10811 20mg | Experimental | One tablet of YKP10811 20mg and one tablet of placebo are administered orally once a day for 12 weeks. Receives: Drug: YKP10811 20mg; Drug: YKP10811 placebo |
| YKP10811 40mg | Experimental | Two tablets of YKP10811 20mg are administered orally once a day for 12 weeks. Receives: Drug: YKP10811 20mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Abdominal pain intensity & stool frequency responder
an improvement of equl and more than 30% from baseline in the average of the daily worst abdominal pain score and an increase of equal and more than 1 CSBM from baseline
Measured: 12weeks
Secondary outcomes (1)
subject global assessment
the degree of symptom relief on abdominal pain, bloating, stool frequency, stool consistency, etc.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2014 (estimated)
- Study startDec 2013
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irritable Bowel SyndromeStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 273 participants (actual)
Sponsor and investigators
- Lead sponsor
- SK Chemicals Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hyo jin Park, MD.PhD., Principal investigator, Gang Nam Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02082457
- Sponsor's protocol ID
- YKP10811_IBS_II_2013
- Acronym
- YKP
- Status last verified
- Jun 2015
- First submitted
- 10 Feb 2014
- Last updated
- 12 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-center, Randomized, Double Blinded, Placebo-controlled, Phase II Trial to Assess the Efficacy and Safety of YKP10811 in Subjects With Irritable Bowel Syndrome With Constipation
- ClinicalTrials.gov ID
- NCT02082457
- Acronym / sponsor ID
- YKP / YKP10811_IBS_II_2013
- Conditions
- Irritable Bowel Syndrome, Constipation
- Keywords
- Irritable Bowel Syndrome, Constipation, C-IBS
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 273 participants (actual)
- Lead sponsor
- SK Chemicals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Dec 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 10 Mar 2014 (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.
This trial is to investigate efficacy and safety of YKP10811 in Subjects With Irritable Bowel Syndrome With Constipation. The difference of responder rate between test group (10, 20 and 40mg) and placebo will be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: YKP10811 placeboTwo tablets of YKP10811 placebo are administered orally once a day for 12 weeks. |
| YKP10811 10mg | Experimental | Drug: YKP10811 5mgTwo tablets of YKP10811 5mg are administered orally once a day for 12 weeks. |
| YKP10811 20mg | Experimental | Drug: YKP10811 20mg, Drug: YKP10811 placeboOne tablet of YKP10811 20mg and one tablet of placebo are administered orally once a day for 12 weeks. |
| YKP10811 40mg | Experimental | Drug: YKP10811 20mgTwo tablets of YKP10811 20mg are administered orally once a day for 12 weeks. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- more than 18 years old
- patients met with ROME III criteria for C-type IBS
Key exclusion criteria (5 listed)
- pregnancy or lactation
- a history of surgery for gastrointestinal tract
- a history of gastrointestinal bleeding, diverticulitis and ileus within 1 year of screening visit
- inflammatory bowel disease or malignant tumor within 5 years of screening visit
- taking drugs that could have impact on efficacy assessment
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 |
|---|---|---|
| YKP10811 5mg | Drug | YKP10811 10mg |
| YKP10811 20mg | Drug | YKP10811 20mg, YKP10811 40mg |
| YKP10811 placebo | Drug | Placebo, YKP10811 20mg |
Primary outcome
Abdominal pain intensity & stool frequency responder
Time frame: 12weeks
an improvement of equl and more than 30% from baseline in the average of the daily worst abdominal pain score and an increase of equal and more than 1 CSBM from baseline
1 secondary outcome
subject global assessment
Time frame: 12 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 12 Jun 2015.
Related trials for Irritable Bowel Syndrome
RecruitingObservational study
Abdominal Symptoms and Rosacea: An Observational Study on the Association Between Irritable Bowel Syndrome (IBS) and the Gut-Skin Axis
IBS (Irritable Bowel Syndrome), Rosacea
Recruiting
Stress Reduction and Lifestyle Modification in Irritable Bowel Syndrome Patients
Irritable Bowel Syndrome
Recruiting
Exercise Interventions and Dietary Advice in Fibromyalgia and IBS
Fibromyalgia, Irritable Bowel Syndrome
RecruitingPhase 2
A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Constipation (IBS-C)
Irritable Bowel Syndrome, Constipation
RecruitingPhase 2
A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Diarrhea (IBS-D)
Irritable Bowel Syndrome, Diarrhea
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, MD.PhD. principal investigator
Gang Nam 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 YKP10811 5mg and YKP10811 20mg in people with Irritable Bowel Syndrome and Constipation, run by SK Chemicals Co., Ltd. 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 5 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 12 Jun 2015. 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?
Abdominal pain intensity & stool frequency responder (time frame: 12weeks). 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 12 Jun 2015.