Clinical trial NCT01989234: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Idiopathic Constipation
Lead sponsor: SK Life Science, Inc.
Sponsor class: INDUSTRY
First posted: 2013-11-20
Enrollment: 334
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: The proportion of subjects with improved bowel movement frequency
timeFrame: 12 weeks
Secondary outcomes:
measure: Stool frequency
timeFrame: 12 weeks
measure: Daily average ratings of stool consistency
timeFrame: 12 weeks
measure: Instances of rescue medicine usage
timeFrame: 12 weeks
measure: Onset time to CSBM
timeFrame: 12 weeks
measure: Onset time to SBM
timeFrame: 12 weeks
measure: Severity of straining
timeFrame: 12 weeks
measure: Abdominal discomfort
timeFrame: 12 weeks
measure: Abdominal pain
timeFrame: 12 weeks
measure: Bloating
timeFrame: 12 weeks
measure: Constipation severity
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Alliance Clinical Research
state: Alabama
city: Chandler
country: United States
facility: Clinical Research Advantage, Inc. / Warner Family Practice, PC
state: Arizona
city: Chandler
country: United States
facility: Connect Clinical Research Center
state: Arizona
city: Phoenix
country: United States
facility: Clinical Research Advantage, Inc. / Central Phoenix Medical Clinic, LLC
state: Arizona
city: Phoenix
country: United States
facility: Arizona Research Center
state: Arizona
city: Little Rock
country: United States
facility: Applied Research Center Arkansas, Inc.
state: Arkansas
city: Anaheim
country: United States
facility: Digestive & Liver Disease Specialists, A Medical Group, Inc.
state: California
city: Chula Vista
country: United States
facility: Precision Research Institute
state: California
city: El Cajon
country: United States
facility: Triwest Research Associates, LLC
state: California
city: Encinitas
country: United States
facility: Diagnamics Inc.
state: California
city: Laguna Hills
country: United States
facility: Therapeutic Research Institute of Orange County
state: California
city: Lincoln
country: United States
facility: Clinical Trials Research
state: California
city: Oceanside
country: United States
facility: Alliance Clinical Research
state: California
city: Sacramento
country: United States
facility: Northern California Research
state: California
city: Colorado Springs
country: United States
facility: Clinical Research Advantage, Inc. / Colorado Springs Health Partners, SW
state: Colorado
city: Bradenton
country: United States
facility: Meridien Research
state: Florida
city: Hialeah
country: United States
facility: Palm Springs Research Institute
state: Florida
city: Miami
country: United States
facility: The Clinical Research Institute
state: Florida
city: Miami
country: United States
facility: Prestige Clinical Research Center Inc.
state: Florida
city: Naples
country: United States
facility: Physicians Regional Medical Group
state: Florida
city: Palm Harbor
country: United States
facility: Advanced Gastroenterology Associates, LLC
state: Florida
city: Tampa
country: United States
facility: Clinical Research Trials of Florida, Inc.
state: Florida
city: Blue Ridge
country: United States
facility: River Birch Research Alliance, LLC
state: Georgia
city: Macon
country: United States
facility: Gastroenterology Associates of Central Georgia, LLC
state: Georgia
city: Marietta
country: United States
facility: Gastrointestinal Specialists of Georgia
state: Georgia
city: Woodstock
country: United States
facility: North Georgia Clinical Research
state: Georgia
city: Chicago
country: United States
facility: May Medical Center
state: Illinois
city: Evergreen Park
country: United States
facility: Pharmakon Inc.
state: Illinois
city: Evansville
country: United States
facility: Clinical Research Advantage, Inc.
state: Indiana
city: Natchitoches
country: United States
facility: KAMP Medical Research, Inc.
state: Louisiana
city: Towson
country: United States
facility: Clinical Associates Ambulatory Surgical Center
state: Maryland
city: Springfield
country: United States
facility: The Research Institute
state: Massachusetts
city: Weymouth
country: United States
facility: Coastal Research Associates, Inc.
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan Health System
state: Michigan
city: St. Louis
country: United States
facility: Sundance Clinical Research, LLC
state: Missouri
city: Henderson
country: United States
facility: Clinical Research Advantage, Inc.
state: Nevada
city: Las Vegas
country: United States
facility: AB Clinical Trials
state: Nevada
city: Las Vegas
country: United States
facility: Clinical Research Center of Nevada
state: Nevada
city: Las Vegas
country: United States
state: Nevada
city: Egg Harbor Township
country: United States
facility: AGA Clinical Research Associates, LLC
state: New Jersey
city: Albuquerque
country: United States
facility: HBSA, A Supporting Organization of Pacific Institute for Research and Evaluation
state: New Mexico
city: Brooklyn
country: United States
facility: NY Scientific
state: New York
city: New York
country: United States
facility: Medex Healthcare Research, Inc.
state: New York
city: Charlotte
country: United States
facility: PMG Research of Charlotte
state: North Carolina
city: Concord
country: United States
facility: PMG Research of Charlotte
state: North Carolina
city: Hickory
country: United States
facility: PMG Research of Hickory, LLC
state: North Carolina
city: Winston-Salem
country: United States
facility: PMG Research of Winston-Salem
state: North Carolina
city: Beavercreek
country: United States
facility: Dayton Gastroenterology, Inc.
state: Ohio
city: Cincinnati
country: United States
facility: Consultants for Clinical Research
state: Ohio
city: Cincinnati
country: United States
facility: Hilltop Physicians IN / Hightop Medical Research Center
state: Ohio
city: Cincinnati
country: United States
facility: New Horizons Clinical Research
state: Ohio
city: Columbus
country: United States
facility: Columbus Clinical Research Inc.
state: Ohio
city: Oklahoma City
country: United States
facility: COR Clinical Research, LLC
state: Oklahoma
city: Tulsa
country: United States
facility: Options Health Research, LLC
state: Oklahoma
city: Medford
country: United States
facility: Sunstone Medical Research, LLC
state: Oregon
city: Portland
country: United States
facility: The Oregon Clinic, PC - Gastroenterology West
state: Oregon
city: Pittsburgh
country: United States
facility: Clinical Trials Research Services, LLC
state: Pennsylvania
city: Cumberland
country: United States
facility: Partners in Clinical Research, LLC
state: Rhode Island
city: Rapid City
country: United States
facility: Health Concepts
state: South Dakota
city: Clarksville
country: United States
facility: Alpha Clinical Research, LLC
state: Tennessee
city: Austin
country: United States
facility: Austin Center for Clinical Research
state: Texas
city: Beaumont
country: United States
facility: MW Clinical Research Center
state: Texas
city: Houston
country: United States
facility: Houston Endoscopy & Research Center
state: Texas
city: San Antonio
country: United States
facility: Sun Research Institute
state: Texas
city: San Antonio
country: United States
facility: Radiant Research Inc.
state: Texas
city: Tyler
country: United States
facility: Digestive Health Specialists of Tyler, LLP
state: Texas
city: Ogden
country: United States
facility: Advanced Research Institute
state: Utah
city: Newport News
country: United States
facility: Health Research of Hampton Roads, Inc.
state: Virginia
city: Norfolk
country: United States
facility: Digestive and Liver Disease Specialists
state: Virginia
Study officials:
References: