Non-constipation Irritable Bowel SyndromePhase 2NCT02079675
Study to Assess the Efficacy and Safety of SKI3246 in Subjects With Non-Constipation Irritable Bowel Syndrome
A Phase 2 study testing SKI3246 Low Dose and SKI3246 High Dose in people with Non-constipation Irritable Bowel Syndrome, run by SK Chemicals Co., Ltd. at 1 site in South Korea.
Trial summary
The purpose of this study is to determine the efficacy and safety of different doses of SKI3246 compared with placebo in the treatment of patients with irritable bowel syndrome with non-constipation. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Non-constipation Irritable Bowel Syndrome
- What is being tested?
- SKI3246 Low Dose and SKI3246 High Dose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 279 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2013to Apr 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 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have been diagnosed as non-constipation by ROME III.
- Patients who voluntarily signed written informed consent may participate in the study.
Who cannot join
- Pregnant or lactating female.
- Patients with a history of inflammatory bowel disease.
- Severe neurological or psychological disease
- History of allergic reaction to the medications used in this study
- Use of other investigational drugs within 30 days prior to the study.
- Patients that investigators consider ineligible for this study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multi-center, Randomized, Double Blinded, Parallel Group, Placebo-controlled, Phase II Trial to Assess the Efficacy and Safety of SKI3246 in Subjects With Non-Constipation Irritable Bowel Syndrome
The purpose of this study is to determine the efficacy and safety of different doses of SKI3246 compared with placebo in the treatment of patients with irritable bowel syndrome with non-constipation.
- Being tested
- SKI3246 Low Dose, SKI3246 High Dose, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SKI3246 Low DoseDrug
SKI3246 Low Dose will be taken for a 4-week duration (28 days) as 4 capsules a day: two capsules in the morning and two capsule in the evening
SKI3246 High DoseDrug
SKI3246 High Dose will be taken for a 4-week duration (28 days) as 4 capsules a day: two capsules in the morning and two capsule in the evening
PlaceboDrug
SKI3246 Placebo will be taken for a 4-week duration (28 days) as 4 capsules a day: two capsules in the morning and two capsule in the evening
| Study group | Role | What they receive |
|---|---|---|
| SKI3246 Low Dose | Experimental | Intervention: Drug: SKI3246 Low Dose Receives: Drug: SKI3246 Low Dose |
| SKI3246 High Dose | Experimental | Intervention: Drug: SKI3246 High Dose Receives: Drug: SKI3246 High Dose |
| Placebo | Placebo comparator | Intervention: Drug: Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global Assessment of Relief During the Double-Blind Treatment Phase Using the Subject Global Assessment (SGA)
Measured: 12 weeks
Secondary outcomes (4)
Patient satisfaction using 5- Likert Scale
Measured: 4 weeks
Subject Self Reported Adequate Relief of Pain
Measured: 4 weeks
Mean Change From Baseline in Quality of Life as Measured by the Medical Outcomes Survey
Measured: 12 weeks
Visual Analog Scale (VAS)
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 posted6 Mar 2014 (estimated)
- Study startJan 2013
- Primary completionMar 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-constipation 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
- 279 participants (actual)
Sponsor and investigators
- Lead sponsor
- SK Chemicals Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hyo Jin Park, M.D., Study chair, Gangnam Severance Hospital, Yonsei University College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02079675
- Sponsor's protocol ID
- SKI3246_IBS_II_2012
- Status last verified
- May 2015
- First submitted
- 4 Mar 2014
- Last updated
- 1 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-center, Randomized, Double Blinded, Parallel Group, Placebo-controlled, Phase II Trial to Assess the Efficacy and Safety of SKI3246 in Subjects With Non-Constipation Irritable Bowel Syndrome
- ClinicalTrials.gov ID
- NCT02079675
- Acronym / sponsor ID
- SKI3246_IBS_II_2012
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 279 participants (actual)
- Lead sponsor
- SK Chemicals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Jan 2013
- Primary completion
- Mar 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 6 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.
The purpose of this study is to determine the efficacy and safety of different doses of SKI3246 compared with placebo in the treatment of patients with irritable bowel syndrome with non-constipation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| SKI3246 Low Dose | Experimental | Drug: SKI3246 Low DoseIntervention: Drug: SKI3246 Low Dose |
| SKI3246 High Dose | Experimental | Drug: SKI3246 High DoseIntervention: Drug: SKI3246 High Dose |
| Placebo | Placebo comparator | Drug: PlaceboIntervention: Drug: Placebo |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Have been diagnosed as non-constipation by ROME III.
- Patients who voluntarily signed written informed consent may participate in the study.
Key exclusion criteria (6 listed)
- Pregnant or lactating female.
- Patients with a history of inflammatory bowel disease.
- Severe neurological or psychological disease
- History of allergic reaction to the medications used in this study
- Use of other investigational drugs within 30 days prior to the study.
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 |
|---|---|---|
| SKI3246 Low DoseSKI3246 Low Dose will be taken for a 4-week duration (28 days) as 4 capsules a day: two capsules in the morning and two capsule in the evening | Drug | SKI3246 Low Dose |
| SKI3246 High DoseSKI3246 High Dose will be taken for a 4-week duration (28 days) as 4 capsules a day: two capsules in the morning and two capsule in the evening | Drug | SKI3246 High Dose |
| PlaceboSKI3246 Placebo will be taken for a 4-week duration (28 days) as 4 capsules a day: two capsules in the morning and two capsule in the evening | Drug | Placebo |
Primary outcome
Global Assessment of Relief During the Double-Blind Treatment Phase Using the Subject Global Assessment (SGA)
Time frame: 12 weeks
4 secondary outcomes
Patient satisfaction using 5- Likert Scale
Time frame: 4 weeks
Subject Self Reported Adequate Relief of Pain
Time frame: 4 weeks
Mean Change From Baseline in Quality of Life as Measured by the Medical Outcomes Survey
Time frame: 12 weeks
Visual Analog Scale (VAS)
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 1 Jun 2015.
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. study chair
Gangnam Severance Hospital, Yonsei University College of Medicine
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 SKI3246 Low Dose and SKI3246 High Dose in people with Non-constipation Irritable Bowel Syndrome, 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 6 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 1 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?
Global Assessment of Relief During the Double-Blind Treatment Phase Using the Subject Global Assessment (SGA) (time frame: 12 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 1 Jun 2015; AzTrials last refreshed its copy on 8 Nov 2026.