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
- Registration Number
- NCT01989234
- Lead Sponsor
- SK Life Science, Inc.
- Brief 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 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 334
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description YKP10811 High Dose YKP10811 YKP10811 High Dose YKP10811 Mid Dose YKP10811 YKP10811 Mid Dose YKP10811 Low Dose YKP10811 YKP10811 Low Dose Placebo Comparator Placebo Placebo Comparator
- Primary Outcome Measures
Name Time Method The proportion of subjects with improved bowel movement frequency 12 weeks
- Secondary Outcome Measures
Name Time Method Abdominal pain 12 weeks Onset time to CSBM 12 weeks Daily average ratings of stool consistency 12 weeks Instances of rescue medicine usage 12 weeks Abdominal discomfort 12 weeks Constipation severity 12 weeks Stool frequency 12 weeks Severity of straining 12 weeks Bloating 12 weeks Onset time to SBM 12 weeks
Trial Locations
- Locations (65)
Digestive and Liver Disease Specialists
🇺🇸Norfolk, Virginia, United States
Columbus Clinical Research Inc.
🇺🇸Columbus, Ohio, United States
Clinical Trials Research Services, LLC
🇺🇸Pittsburgh, Pennsylvania, United States
Therapeutic Research Institute of Orange County
🇺🇸Laguna Hills, California, United States
Coastal Research Associates, Inc.
🇺🇸Weymouth, Massachusetts, United States
The Clinical Research Institute
🇺🇸Miami, Florida, United States
Applied Research Center Arkansas, Inc.
🇺🇸Little Rock, Arkansas, United States
Alliance Clinical Research
🇺🇸Oceanside, California, United States
Connect Clinical Research Center
🇺🇸Chandler, Arizona, United States
Triwest Research Associates, LLC
🇺🇸El Cajon, California, United States
Precision Research Institute
🇺🇸Chula Vista, California, United States
Gastroenterology Associates of Central Georgia, LLC
🇺🇸Macon, Georgia, United States
Clinical Research Advantage, Inc. / Colorado Springs Health Partners, SW
🇺🇸Colorado Springs, Colorado, United States
Digestive & Liver Disease Specialists, A Medical Group, Inc.
🇺🇸Anaheim, California, United States
Palm Springs Research Institute
🇺🇸Hialeah, Florida, United States
Medex Healthcare Research, Inc.
🇺🇸New York, New York, United States
Advanced Gastroenterology Associates, LLC
🇺🇸Palm Harbor, Florida, United States
NY Scientific
🇺🇸Brooklyn, New York, United States
Gastrointestinal Specialists of Georgia
🇺🇸Marietta, Georgia, United States
Health Research of Hampton Roads, Inc.
🇺🇸Newport News, Virginia, United States
AGA Clinical Research Associates, LLC
🇺🇸Egg Harbor Township, New Jersey, United States
Sunstone Medical Research, LLC
🇺🇸Medford, Oregon, United States
Prestige Clinical Research Center Inc.
🇺🇸Miami, Florida, United States
May Medical Center
🇺🇸Chicago, Illinois, United States
Houston Endoscopy & Research Center
🇺🇸Houston, Texas, United States
River Birch Research Alliance, LLC
🇺🇸Blue Ridge, Georgia, United States
Clinical Research Advantage, Inc.
🇺🇸Henderson, Nevada, United States
Clinical Research Advantage, Inc. / Warner Family Practice, PC
🇺🇸Chandler, Arizona, United States
Clinical Trials Research
🇺🇸Lincoln, California, United States
Partners in Clinical Research, LLC
🇺🇸Cumberland, Rhode Island, United States
Digestive Health Specialists of Tyler, LLP
🇺🇸Tyler, Texas, United States
Sundance Clinical Research, LLC
🇺🇸St. Louis, Missouri, United States
Meridien Research
🇺🇸Bradenton, Florida, United States
Physicians Regional Medical Group
🇺🇸Naples, Florida, United States
MW Clinical Research Center
🇺🇸Beaumont, Texas, United States
PMG Research of Charlotte
🇺🇸Concord, North Carolina, United States
PMG Research of Hickory, LLC
🇺🇸Hickory, North Carolina, United States
Dayton Gastroenterology, Inc.
🇺🇸Beavercreek, Ohio, United States
Options Health Research, LLC
🇺🇸Tulsa, Oklahoma, United States
Health Concepts
🇺🇸Rapid City, South Dakota, United States
Advanced Research Institute
🇺🇸Ogden, Utah, United States
North Georgia Clinical Research
🇺🇸Woodstock, Georgia, United States
Pharmakon Inc.
🇺🇸Evergreen Park, Illinois, United States
KAMP Medical Research, Inc.
🇺🇸Natchitoches, Louisiana, United States
Alpha Clinical Research, LLC
🇺🇸Clarksville, Tennessee, United States
Clinical Research Advantage, Inc. / Central Phoenix Medical Clinic, LLC
🇺🇸Phoenix, Arizona, United States
Arizona Research Center
🇺🇸Phoenix, Arizona, United States
Northern California Research
🇺🇸Sacramento, California, United States
Clinical Research Trials of Florida, Inc.
🇺🇸Tampa, Florida, United States
University of Michigan Health System
🇺🇸Ann Arbor, Michigan, United States
AB Clinical Trials
🇺🇸Las Vegas, Nevada, United States
Clinical Research Center of Nevada
🇺🇸Las Vegas, Nevada, United States
HBSA, A Supporting Organization of Pacific Institute for Research and Evaluation
🇺🇸Albuquerque, New Mexico, United States
PMG Research of Winston-Salem
🇺🇸Winston-Salem, North Carolina, 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
COR Clinical Research, LLC
🇺🇸Oklahoma City, Oklahoma, United States
The Oregon Clinic, PC - Gastroenterology West
🇺🇸Portland, Oregon, United States
Austin Center for Clinical Research
🇺🇸Austin, Texas, United States
Sun Research Institute
🇺🇸San Antonio, Texas, United States
Radiant Research Inc.
🇺🇸San Antonio, Texas, United States
The Research Institute
🇺🇸Springfield, Massachusetts, United States
Diagnamics Inc.
🇺🇸Encinitas, California, United States
Clinical Associates Ambulatory Surgical Center
🇺🇸Towson, Maryland, United States