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

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 Overview

• Status: Completed
• Conditions: Chronic Idiopathic Constipation
• Intervention / Treatment: Drug: Placebo; Drug: YKP10811

• Study Type: Interventional
• Enrollment (Actual): 334
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35213
      • Alliance Clinical Research
  • Arizona
    • Chandler, Arizona, United States, 85224
      • Connect Clinical Research Center
    • Chandler, Arizona, United States, 85224
      • Clinical Research Advantage, Inc. / Warner Family Practice, PC
    • Phoenix, Arizona, United States, 85023
      • Arizona Research Center
    • Phoenix, Arizona, United States, 85020
      • Clinical Research Advantage, Inc. / Central Phoenix Medical Clinic, LLC
  • Arkansas
    • Little Rock, Arkansas, United States, 72212
      • Applied Research Center Arkansas, Inc.
  • California
    • Anaheim, California, United States, 92801
      • Digestive & Liver Disease Specialists, A Medical Group, Inc.
    • Chula Vista, California, United States, 91910
      • Precision Research Institute
    • El Cajon, California, United States, 92020
      • TriWest Research Associates, LLC
    • Encinitas, California, United States, 92024
      • Diagnamics Inc.
    • Laguna Hills, California, United States, 92653
      • Therapeutic Research Institute of Orange County
    • Lincoln, California, United States, 95648
      • Clinical Trials Research
    • Oceanside, California, United States, 92056
      • Alliance Clinical Research
    • Sacramento, California, United States, 95821
      • Northern California Research
  • Colorado
    • Colorado Springs, Colorado, United States, 80906
      • Clinical Research Advantage, Inc. / Colorado Springs Health Partners, SW
  • Florida
    • Bradenton, Florida, United States, 34208
      • Meridien Research
    • Hialeah, Florida, United States, 33012
      • Palm Springs Research Institute
    • Miami, Florida, United States, 33133
      • Prestige Clinical Research Center Inc.
    • Miami, Florida, United States, 33125
      • The Clinical Research Institute
    • Naples, Florida, United States, 34119
      • Physicians Regional Medical Group
    • Palm Harbor, Florida, United States, 34684
      • Advanced Gastroenterology Associates, LLC
    • Tampa, Florida, United States, 33607
      • Clinical Research Trials of Florida, Inc.
  • Georgia
    • Blue Ridge, Georgia, United States, 30513
      • River Birch Research Alliance, LLC
    • Macon, Georgia, United States, 31201
      • Gastroenterology Associates Of Central Georgia, LLC
    • Marietta, Georgia, United States, 30060
      • Gastrointestinal Specialists of Georgia
    • Woodstock, Georgia, United States, 30189
      • North Georgia Clinical Research
  • Illinois
    • Chicago, Illinois, United States, 60624
      • May Medical Center
    • Evergreen Park, Illinois, United States, 60805
      • Pharmakon Inc.
  • Indiana
    • Evansville, Indiana, United States, 47714
      • Clinical Research Advantage, Inc.
  • Louisiana
    • Natchitoches, Louisiana, United States, 71457
      • KAMP Medical Research, Inc.
  • Maryland
    • Towson, Maryland, United States, 21286
      • Clinical Associates Ambulatory Surgical Center
  • Massachusetts
    • Springfield, Massachusetts, United States, 01105
      • The Research Institute
    • Weymouth, Massachusetts, United States, 02190
      • Coastal Research Associates, Inc.
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan Health System
  • Missouri
    • St. Louis, Missouri, United States, 63141
      • Sundance Clinical Research, LLC
  • Nevada
    • Henderson, Nevada, United States, 89052
      • Clinical Research Advantage, Inc.
    • Las Vegas, Nevada, United States, 89119
      • AB Clinical Trials
    • Las Vegas, Nevada, United States, 89144
    • Las Vegas, Nevada, United States, 89130
      • Clinical Research Center of Nevada
  • New Jersey
    • Egg Harbor Township, New Jersey, United States, 08234
      • AGA Clinical Research Associates, LLC
  • New Mexico
    • Albuquerque, New Mexico, United States, 87102
      • HBSA, A Supporting Organization of Pacific Institute for Research and Evaluation
  • New York
    • Brooklyn, New York, United States, 11235
      • NY Scientific
    • New York, New York, United States, 10016
      • Medex Healthcare Research, Inc.
  • North Carolina
    • Charlotte, North Carolina, United States, 28209
      • PMG Research of Charlotte
    • Concord, North Carolina, United States, 28025
      • PMG Research of Charlotte
    • Hickory, North Carolina, United States, 28605
      • PMG Research of Hickory, LLC
    • Winston-Salem, North Carolina, United States, 27103
      • PMG Research of Winston-Salem
  • Ohio
    • Beavercreek, Ohio, United States, 45440
      • Dayton Gastroenterology, Inc.
    • Cincinnati, Ohio, United States, 45219
      • Consultants for Clinical Research
    • Cincinnati, Ohio, United States, 45242
      • New Horizons Clinical Research
    • Cincinnati, Ohio, United States, 45224
      • Hilltop Physicians IN / Hightop Medical Research Center
    • Columbus, Ohio, United States, 43213
      • Columbus Clinical Research Inc.
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73103
      • COR Clinical Research, LLC
    • Tulsa, Oklahoma, United States, 74104
      • Options Health Research, LLC
  • Oregon
    • Medford, Oregon, United States, 97504
      • Sunstone Medical Research, LLC
    • Portland, Oregon, United States, 97225
      • The Oregon Clinic, PC - Gastroenterology West
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15206
      • Clinical Trials Research Services, LLC
  • Rhode Island
    • Cumberland, Rhode Island, United States, 02864
      • Partners in Clinical Research, LLC
  • South Dakota
    • Rapid City, South Dakota, United States, 57702
      • Health Concepts
  • Tennessee
    • Clarksville, Tennessee, United States, 37043
      • Alpha Clinical Research, LLC
  • Texas
    • Austin, Texas, United States, 78756
      • Austin Center for Clinical Research
    • Beaumont, Texas, United States, 77702
      • MW Clinical Research Center
    • Houston, Texas, United States, 77079
      • Houston Endoscopy & Research Center
    • San Antonio, Texas, United States, 78215
      • Sun Research Institute
    • San Antonio, Texas, United States, 78229
      • Radiant Research Inc.
    • Tyler, Texas, United States, 75701
      • Digestive Health Specialists of Tyler, LLP
  • Utah
    • Ogden, Utah, United States, 84405
      • Advanced Research Institute
  • Virginia
    • Newport News, Virginia, United States, 23606
      • Health Research of Hampton Roads, Inc.
    • Norfolk, Virginia, United States, 23502
      • Digestive and Liver Disease Specialists

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Placebo Comparator	Drug: Placebo
EXPERIMENTAL: YKP10811 High Dose	Drug: YKP10811
EXPERIMENTAL: YKP10811 Mid Dose	Drug: YKP10811
EXPERIMENTAL: YKP10811 Low Dose	Drug: YKP10811

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The proportion of subjects with improved bowel movement frequency	12 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Stool frequency	12 weeks
Daily average ratings of stool consistency	12 weeks
Instances of rescue medicine usage	12 weeks
Onset time to CSBM	12 weeks
Onset time to SBM	12 weeks
Severity of straining	12 weeks
Abdominal discomfort	12 weeks
Abdominal pain	12 weeks
Bloating	12 weeks
Constipation severity	12 weeks

Collaborators and Investigators

• Sponsor: SK Life Science, Inc.

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (ACTUAL): September 1, 2014
• Study Completion (ACTUAL): December 1, 2014

Study Registration Dates

• First Submitted: October 30, 2013
• First Submitted That Met QC Criteria: November 13, 2013
• First Posted (ESTIMATE): November 20, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): December 19, 2014
• Last Update Submitted That Met QC Criteria: December 3, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Constipation
• Other Study ID Numbers: YKP10811C006