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
NCT ID: NCT01989234
Last Updated: 2014-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
334 participants
INTERVENTIONAL
2013-10-31
2014-12-31
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo Comparator
Placebo Comparator
Placebo
YKP10811 High Dose
YKP10811 High Dose
YKP10811
YKP10811 Mid Dose
YKP10811 Mid Dose
YKP10811
YKP10811 Low Dose
YKP10811 Low Dose
YKP10811
Interventions
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YKP10811
Placebo
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
65 Years
ALL
No
Sponsors
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SK Life Science, Inc.
INDUSTRY
Responsible Party
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Locations
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Alliance Clinical Research
Birmingham, Alabama, United States
Clinical Research Advantage, Inc. / Warner Family Practice, PC
Chandler, Arizona, United States
Connect Clinical Research Center
Chandler, Arizona, United States
Clinical Research Advantage, Inc. / Central Phoenix Medical Clinic, LLC
Phoenix, Arizona, United States
Arizona Research Center
Phoenix, Arizona, United States
Applied Research Center Arkansas, Inc.
Little Rock, Arkansas, United States
Digestive & Liver Disease Specialists, A Medical Group, Inc.
Anaheim, California, United States
Precision Research Institute
Chula Vista, California, United States
Triwest Research Associates, LLC
El Cajon, California, United States
Diagnamics Inc.
Encinitas, California, United States
Therapeutic Research Institute of Orange County
Laguna Hills, California, United States
Clinical Trials Research
Lincoln, California, United States
Alliance Clinical Research
Oceanside, California, United States
Northern California Research
Sacramento, California, United States
Clinical Research Advantage, Inc. / Colorado Springs Health Partners, SW
Colorado Springs, Colorado, United States
Meridien Research
Bradenton, Florida, United States
Palm Springs Research Institute
Hialeah, Florida, United States
The Clinical Research Institute
Miami, Florida, United States
Prestige Clinical Research Center Inc.
Miami, Florida, United States
Physicians Regional Medical Group
Naples, Florida, United States
Advanced Gastroenterology Associates, LLC
Palm Harbor, Florida, United States
Clinical Research Trials of Florida, Inc.
Tampa, Florida, United States
River Birch Research Alliance, LLC
Blue Ridge, Georgia, United States
Gastroenterology Associates of Central Georgia, LLC
Macon, Georgia, United States
Gastrointestinal Specialists of Georgia
Marietta, Georgia, United States
North Georgia Clinical Research
Woodstock, Georgia, United States
May Medical Center
Chicago, Illinois, United States
Pharmakon Inc.
Evergreen Park, Illinois, United States
Clinical Research Advantage, Inc.
Evansville, Indiana, United States
KAMP Medical Research, Inc.
Natchitoches, Louisiana, United States
Clinical Associates Ambulatory Surgical Center
Towson, Maryland, United States
The Research Institute
Springfield, Massachusetts, United States
Coastal Research Associates, Inc.
Weymouth, Massachusetts, United States
University of Michigan Health System
Ann Arbor, Michigan, United States
Sundance Clinical Research, LLC
St Louis, Missouri, United States
Clinical Research Advantage, Inc.
Henderson, Nevada, United States
AB Clinical Trials
Las Vegas, Nevada, United States
Clinical Research Center of Nevada
Las Vegas, Nevada, United States
Las Vegas, Nevada, United States
AGA Clinical Research Associates, LLC
Egg Harbor, New Jersey, United States
HBSA, A Supporting Organization of Pacific Institute for Research and Evaluation
Albuquerque, New Mexico, United States
NY Scientific
Brooklyn, New York, United States
Medex Healthcare Research, Inc.
New York, New York, United States
PMG Research of Charlotte
Charlotte, North Carolina, United States
PMG Research of Charlotte
Concord, North Carolina, United States
PMG Research of Hickory, LLC
Hickory, North Carolina, United States
PMG Research of Winston-Salem
Winston-Salem, North Carolina, United States
Dayton Gastroenterology, Inc.
Beavercreek, Ohio, United States
Consultants for Clinical Research
Cincinnati, Ohio, United States
Hilltop Physicians IN / Hightop Medical Research Center
Cincinnati, Ohio, United States
New Horizons Clinical Research
Cincinnati, Ohio, United States
Columbus Clinical Research Inc.
Columbus, Ohio, United States
COR Clinical Research, LLC
Oklahoma City, Oklahoma, United States
Options Health Research, LLC
Tulsa, Oklahoma, United States
Sunstone Medical Research, LLC
Medford, Oregon, United States
The Oregon Clinic, PC - Gastroenterology West
Portland, Oregon, United States
Clinical Trials Research Services, LLC
Pittsburgh, Pennsylvania, United States
Partners in Clinical Research, LLC
Cumberland, Rhode Island, United States
Health Concepts
Rapid City, South Dakota, United States
Alpha Clinical Research, LLC
Clarksville, Tennessee, United States
Austin Center for Clinical Research
Austin, Texas, United States
MW Clinical Research Center
Beaumont, Texas, United States
Houston Endoscopy & Research Center
Houston, Texas, United States
Sun Research Institute
San Antonio, Texas, United States
Radiant Research Inc.
San Antonio, Texas, United States
Digestive Health Specialists of Tyler, LLP
Tyler, Texas, United States
Advanced Research Institute
Ogden, Utah, United States
Health Research of Hampton Roads, Inc.
Newport News, Virginia, United States
Digestive and Liver Disease Specialists
Norfolk, Virginia, United States
Countries
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Other Identifiers
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YKP10811C006
Identifier Type: -
Identifier Source: org_study_id