Chronic Idiopathic ConstipationPhase 2NCT01989234
A Multicenter, Double-Blind, Randomized, Placebo-Controlled, 12-Week, Dose-Range-Finding Trial of YKP10811 Capsules Administered Once Daily to Subjects With Chronic Idiopathic Constipation
A Phase 2 study testing YKP10811 in people with Chronic Idiopathic Constipation, run by SK Life Science, Inc. at 69 sites in United States.
Trial summary
This will be a multi-center, randomized, double-blind, placebo-controlled study of YKP10811 capsules in patients with chronic idiopathic constipation. Following a 2-week baseline period, approximately 320 eligible patients with <3 complete spontaneous bowel movements (CSBM) and ≤ 5 SBMs per week will be randomly… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Idiopathic Constipation
- What is being tested?
- YKP10811
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 334 participants
- Where
- 69 sitesUnited States
- Study dates
- Oct 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who meet modified Rome II criteria for Chronic Constipation.
- Patients who are male or female, 18 to 65 years of age inclusive.
- At Visit 3, patients must have < 3 CSBMs per week and ≤ 5 SBMs per week during the 2-week baseline period.
Who cannot join
- Patients who meet Rome II criteria for Irritable Bowel Syndrome (IBS-C).
- Patients with constipation that is drug-induced, or secondary to endocrine, metabolic or, surgery.
- Patients with a clinically significant diseases that would limit the patient's ability to complete and/or participate in the study, including gastrointestinal disorder or surgery, an endocrine abnormality (e.g., diabetes), impaired renal function (GFR of < 55mL/minute/1.73m2), uncontrolled pulmonary diseases (including asthma), uncontrolled cardiovascular disease (a history of myocardial infarction or cerebrovascular accident within 6 months prior to screening) or significant neurological diseases.
- Patients with a history of inflammatory bowel disease.
- Patients with a history of cancer (other than basal cell or squamous cell carcinoma of the skin completely excised) unless the malignancy has been in complete remission for at least 5 years prior to screening.
- Patients who started a special diet and/or an intense physical workout program within 30 days prior to the beginning of the baseline period or who are intending to substantially modify their dietary habits at any time during the study (patients on a stable, continuous regimen of fiber therapy for at least 30 days prior to the pretreatment baseline period are allowed to continue that therapy, provided that they continue at a constant dose throughout the study.
- Patients with a history of clinically significant hypersensitivity or allergy (facial swelling, hives, breathing difficulty, Stevens-Johnson syndrome etc), in response to any medication, either prescription or nonprescription including an investigational drug, dietary supplement, or herbal medicine.
Trial locations and contacts
69 sites in 1 country.
69 sites in 1 country
United States69 sites
HBSA, A Supporting Organization of Pacific Institute for Research and Evaluation
Albuquerque, New Mexico, 87102
Digestive & Liver Disease Specialists, A Medical Group, Inc.
Anaheim, California, 92801
University of Michigan Health System
Ann Arbor, Michigan, 48109
Austin Center for Clinical Research
Austin, Texas, 78756
MW Clinical Research Center
Beaumont, Texas, 77702
Dayton Gastroenterology, Inc.
Beavercreek, Ohio, 45440
Alliance Clinical Research
Birmingham, Alabama, 35213
River Birch Research Alliance, LLC
Blue Ridge, Georgia, 30513
Meridien Research
Bradenton, Florida, 34208
NY Scientific
Brooklyn, New York, 11235
Clinical Research Advantage, Inc. / Warner Family Practice, PC
Chandler, Arizona, 85224
Connect Clinical Research Center
Chandler, Arizona, 85224
PMG Research of Charlotte
Charlotte, North Carolina, 28209
May Medical Center
Chicago, Illinois, 60624
Precision Research Institute
Chula Vista, California, 91910
Consultants for Clinical Research
Cincinnati, Ohio, 45219
Hilltop Physicians IN / Hightop Medical Research Center
Cincinnati, Ohio, 45224
New Horizons Clinical Research
Cincinnati, Ohio, 45242
Alpha Clinical Research, LLC
Clarksville, Tennessee, 37043
Clinical Research Advantage, Inc. / Colorado Springs Health Partners, SW
Colorado Springs, Colorado, 80906
Columbus Clinical Research Inc.
Columbus, Ohio, 43213
PMG Research of Charlotte
Concord, North Carolina, 28025
Partners in Clinical Research, LLC
Cumberland, Rhode Island, 02864
AGA Clinical Research Associates, LLC
Egg Harbor, New Jersey, 08234
Triwest Research Associates, LLC
El Cajon, California, 92020
Diagnamics Inc.
Encinitas, California, 92024
Clinical Research Advantage, Inc.
Evansville, Indiana, 47714
Pharmakon Inc.
Evergreen Park, Illinois, 60805
Clinical Research Advantage, Inc.
Henderson, Nevada, 89052
Palm Springs Research Institute
Hialeah, Florida, 33012
PMG Research of Hickory, LLC
Hickory, North Carolina, 28605
Houston Endoscopy & Research Center
Houston, Texas, 77079
Therapeutic Research Institute of Orange County
Laguna Hills, California, 92653
AB Clinical Trials
Las Vegas, Nevada, 89119
Clinical Research Center of Nevada
Las Vegas, Nevada, 89130
Study site
Las Vegas, Nevada, 89144
Clinical Trials Research
Lincoln, California, 95648
Applied Research Center Arkansas, Inc.
Little Rock, Arkansas, 72212
Gastroenterology Associates of Central Georgia, LLC
Macon, Georgia, 31201
Gastrointestinal Specialists of Georgia
Marietta, Georgia, 30060
Sunstone Medical Research, LLC
Medford, Oregon, 97504
The Clinical Research Institute
Miami, Florida, 33125
Prestige Clinical Research Center Inc.
Miami, Florida, 33133
Physicians Regional Medical Group
Naples, Florida, 34119
KAMP Medical Research, Inc.
Natchitoches, Louisiana, 71457
Medex Healthcare Research, Inc.
New York, New York, 10016
Health Research of Hampton Roads, Inc.
Newport News, Virginia, 23606
Digestive and Liver Disease Specialists
Norfolk, Virginia, 23502
Alliance Clinical Research
Oceanside, California, 92056
Advanced Research Institute
Ogden, Utah, 84405
COR Clinical Research, LLC
Oklahoma City, Oklahoma, 73103
Advanced Gastroenterology Associates, LLC
Palm Harbor, Florida, 34684
Clinical Research Advantage, Inc. / Central Phoenix Medical Clinic, LLC
Phoenix, Arizona, 85020
Arizona Research Center
Phoenix, Arizona, 85023
Clinical Trials Research Services, LLC
Pittsburgh, Pennsylvania, 15206
The Oregon Clinic, PC - Gastroenterology West
Portland, Oregon, 97225
Health Concepts
Rapid City, South Dakota, 57702
Northern California Research
Sacramento, California, 95821
Sun Research Institute
San Antonio, Texas, 78215
Radiant Research Inc.
San Antonio, Texas, 78229
The Research Institute
Springfield, Massachusetts, 01105
Sundance Clinical Research, LLC
St Louis, Missouri, 63141
Clinical Research Trials of Florida, Inc.
Tampa, Florida, 33607
Clinical Associates Ambulatory Surgical Center
Towson, Maryland, 21286
Options Health Research, LLC
Tulsa, Oklahoma, 74104
Digestive Health Specialists of Tyler, LLP
Tyler, Texas, 75701
Coastal Research Associates, Inc.
Weymouth, Massachusetts, 02190
PMG Research of Winston-Salem
Winston-Salem, North Carolina, 27103
North Georgia Clinical Research
Woodstock, Georgia, 30189
About this study
This will be a multi-center, randomized, double-blind, placebo-controlled study of YKP10811 capsules in patients with chronic idiopathic constipation. Following a 2-week baseline period, approximately 320 eligible patients with <3 complete spontaneous bowel movements (CSBM) and ≤ 5 SBMs per week will be randomly assigned equally to receive one of the following oral treatments; placebo or YKP10811 capsules once daily for 12 weeks followed by a 2 week follow-up period.
The objectives of this study are:
- To assess the efficacy of YKP10811 once daily at relieving constipation and associated symptoms in subjects with chronic idiopathic constipation.
- To determine the safety and tolerability of YKP10811 once daily in subjects with chronic idiopathic constipation.
- Conditions
- Chronic Idiopathic Constipation
- Being tested
- YKP10811, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YKP10811Drug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Placebo Comparator | Placebo comparator | Placebo Comparator Receives: Drug: Placebo |
| YKP10811 High Dose | Experimental | YKP10811 High Dose Receives: Drug: YKP10811 |
| YKP10811 Mid Dose | Experimental | YKP10811 Mid Dose Receives: Drug: YKP10811 |
| YKP10811 Low Dose | Experimental | YKP10811 Low Dose Receives: Drug: YKP10811 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of subjects with improved bowel movement frequency
Measured: 12 weeks
Secondary outcomes (10)
Stool frequency
Measured: 12 weeks
Daily average ratings of stool consistency
Measured: 12 weeks
Instances of rescue medicine usage
Measured: 12 weeks
Onset time to CSBM
Measured: 12 weeks
Onset time to SBM
Measured: 12 weeks
Severity of straining
Measured: 12 weeks
Abdominal discomfort
Measured: 12 weeks
Abdominal pain
Measured: 12 weeks
Bloating
Measured: 12 weeks
Constipation severity
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 posted20 Nov 2013 (estimated)
- Study startOct 2013
- Primary completionSep 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 Chronic Idiopathic 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 334 participants (actual)
Sponsor and investigators
- Lead sponsor
- SK Life Science, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01989234
- Sponsor's protocol ID
- YKP10811C006
- Status last verified
- Dec 2014
- First submitted
- 30 Oct 2013
- Last updated
- 19 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Double-Blind, Randomized, Placebo-Controlled, 12-Week, Dose-Range-Finding Trial of YKP10811 Capsules Administered Once Daily to Subjects With Chronic Idiopathic Constipation
- ClinicalTrials.gov ID
- NCT01989234
- Acronym / sponsor ID
- YKP10811C006
- Conditions
- Chronic Idiopathic Constipation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 334 participants (actual)
- Lead sponsor
- SK Life Science, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2013
- Primary completion
- Sep 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 20 Nov 2013 (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 will be a multi-center, randomized, double-blind, placebo-controlled study of YKP10811 capsules in patients with chronic idiopathic constipation. Following a 2-week baseline period, approximately 320 eligible patients with <3 complete spontaneous bowel movements (CSBM) and ≤ 5 SBMs per week will be randomly assigned equally to receive one of the following oral treatments; placebo or YKP10811 capsules once daily for 12 weeks followed by a 2 week follow-up period.
The objectives of this study are:
- To assess the efficacy of YKP10811 once daily at relieving constipation and associated symptoms in subjects with chronic idiopathic constipation.
- To determine the safety and tolerability of YKP10811 once daily in subjects with chronic idiopathic constipation.
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 Comparator | Placebo comparator | Drug: PlaceboPlacebo Comparator |
| YKP10811 High Dose | Experimental | Drug: YKP10811YKP10811 High Dose |
| YKP10811 Mid Dose | Experimental | Drug: YKP10811YKP10811 Mid Dose |
| YKP10811 Low Dose | Experimental | Drug: YKP10811YKP10811 Low Dose |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients who meet modified Rome II criteria for Chronic Constipation.
- Patients who are male or female, 18 to 65 years of age inclusive.
- At Visit 3, patients must have < 3 CSBMs per week and ≤ 5 SBMs per week during the 2-week baseline period.
Key exclusion criteria (7 listed)
- Patients who meet Rome II criteria for Irritable Bowel Syndrome (IBS-C).
- Patients with constipation that is drug-induced, or secondary to endocrine, metabolic or, surgery.
- Patients with a clinically significant diseases that would limit the patient's ability to complete and/or participate in the study, including gastrointestinal disorder or surgery, an endocrine abnormality (e.g., diabetes), impaired renal function (GFR of < 55mL/minute/1.73m2), uncontrolled pulmonary diseases (including asthma), uncontrolled cardiovascular disease (a history of myocardial infarction or cerebrovascular accident within 6 months prior to screening) or significant neurological diseases.
- Patients with a history of inflammatory bowel disease.
- Patients with a history of cancer (other than basal cell or squamous cell carcinoma of the skin completely excised) unless the malignancy has been in complete remission for at least 5 years prior to screening.
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 | Drug | YKP10811 High Dose, YKP10811 Low Dose, YKP10811 Mid Dose |
| Placebo | Drug | Placebo Comparator |
Primary outcome
The proportion of subjects with improved bowel movement frequency
Time frame: 12 weeks
10 secondary outcomes
Stool frequency
Time frame: 12 weeks
Daily average ratings of stool consistency
Time frame: 12 weeks
Instances of rescue medicine usage
Time frame: 12 weeks
Onset time to CSBM
Time frame: 12 weeks
Onset time to SBM
Time frame: 12 weeks
Severity of straining
Time frame: 12 weeks
Abdominal discomfort
Time frame: 12 weeks
Abdominal pain
Time frame: 12 weeks
Bloating
Time frame: 12 weeks
Constipation severity
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 19 Dec 2014.
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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.
69 sites 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 in people with Chronic Idiopathic Constipation, run by SK Life Science, Inc. at 69 sites in United States.
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 3 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: finished, as of the sponsor's last update on 19 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 69 sites in United States. 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?
The proportion of subjects with improved bowel movement frequency (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 19 Dec 2014.