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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

Primary Purpose

Chronic Idiopathic Constipation

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
YKP10811
Placebo
Sponsored by
SK Life Science, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Idiopathic Constipation

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Alliance Clinical Research
  • Clinical Research Advantage, Inc. / Warner Family Practice, PC
  • Connect Clinical Research Center
  • Clinical Research Advantage, Inc. / Central Phoenix Medical Clinic, LLC
  • Arizona Research Center
  • Applied Research Center Arkansas, Inc.
  • Digestive & Liver Disease Specialists, A Medical Group, Inc.
  • Precision Research Institute
  • Triwest Research Associates, LLC
  • Diagnamics Inc.
  • Therapeutic Research Institute of Orange County
  • Clinical Trials Research
  • Alliance Clinical Research
  • Northern California Research
  • Clinical Research Advantage, Inc. / Colorado Springs Health Partners, SW
  • Meridien Research
  • Palm Springs Research Institute
  • The Clinical Research Institute
  • Prestige Clinical Research Center Inc.
  • Physicians Regional Medical Group
  • Advanced Gastroenterology Associates, LLC
  • Clinical Research Trials of Florida, Inc.
  • River Birch Research Alliance, LLC
  • Gastroenterology Associates of Central Georgia, LLC
  • Gastrointestinal Specialists of Georgia
  • North Georgia Clinical Research
  • May Medical Center
  • Pharmakon Inc.
  • Clinical Research Advantage, Inc.
  • KAMP Medical Research, Inc.
  • Clinical Associates Ambulatory Surgical Center
  • The Research Institute
  • Coastal Research Associates, Inc.
  • University of Michigan Health System
  • Sundance Clinical Research, LLC
  • Clinical Research Advantage, Inc.
  • AB Clinical Trials
  • Clinical Research Center of Nevada
  • AGA Clinical Research Associates, LLC
  • HBSA, A Supporting Organization of Pacific Institute for Research and Evaluation
  • NY Scientific
  • Medex Healthcare Research, Inc.
  • PMG Research of Charlotte
  • PMG Research of Charlotte
  • PMG Research of Hickory, LLC
  • PMG Research of Winston-Salem
  • Dayton Gastroenterology, Inc.
  • Consultants for Clinical Research
  • Hilltop Physicians IN / Hightop Medical Research Center
  • New Horizons Clinical Research
  • Columbus Clinical Research Inc.
  • COR Clinical Research, LLC
  • Options Health Research, LLC
  • Sunstone Medical Research, LLC
  • The Oregon Clinic, PC - Gastroenterology West
  • Clinical Trials Research Services, LLC
  • Partners in Clinical Research, LLC
  • Health Concepts
  • Alpha Clinical Research, LLC
  • Austin Center for Clinical Research
  • MW Clinical Research Center
  • Houston Endoscopy & Research Center
  • Sun Research Institute
  • Radiant Research Inc.
  • Digestive Health Specialists of Tyler, LLP
  • Advanced Research Institute
  • Health Research of Hampton Roads, Inc.
  • Digestive and Liver Disease Specialists

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Experimental

Experimental

Arm Label

Placebo Comparator

YKP10811 High Dose

YKP10811 Mid Dose

YKP10811 Low Dose

Arm Description

Placebo Comparator

YKP10811 High Dose

YKP10811 Mid Dose

YKP10811 Low Dose

Outcomes

Primary Outcome Measures

The proportion of subjects with improved bowel movement frequency

Secondary Outcome Measures

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

Full Information

First Posted
October 30, 2013
Last Updated
December 3, 2014
Sponsor
SK Life Science, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01989234
Brief 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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
SK Life Science, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Idiopathic Constipation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
334 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo Comparator
Arm Type
Placebo Comparator
Arm Description
Placebo Comparator
Arm Title
YKP10811 High Dose
Arm Type
Experimental
Arm Description
YKP10811 High Dose
Arm Title
YKP10811 Mid Dose
Arm Type
Experimental
Arm Description
YKP10811 Mid Dose
Arm Title
YKP10811 Low Dose
Arm Type
Experimental
Arm Description
YKP10811 Low Dose
Intervention Type
Drug
Intervention Name(s)
YKP10811
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
The proportion of subjects with improved bowel movement frequency
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Stool frequency
Time Frame
12 weeks
Title
Daily average ratings of stool consistency
Time Frame
12 weeks
Title
Instances of rescue medicine usage
Time Frame
12 weeks
Title
Onset time to CSBM
Time Frame
12 weeks
Title
Onset time to SBM
Time Frame
12 weeks
Title
Severity of straining
Time Frame
12 weeks
Title
Abdominal discomfort
Time Frame
12 weeks
Title
Abdominal pain
Time Frame
12 weeks
Title
Bloating
Time Frame
12 weeks
Title
Constipation severity
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Alliance Clinical Research
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35213
Country
United States
Facility Name
Clinical Research Advantage, Inc. / Warner Family Practice, PC
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85224
Country
United States
Facility Name
Connect Clinical Research Center
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85224
Country
United States
Facility Name
Clinical Research Advantage, Inc. / Central Phoenix Medical Clinic, LLC
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85020
Country
United States
Facility Name
Arizona Research Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85023
Country
United States
Facility Name
Applied Research Center Arkansas, Inc.
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72212
Country
United States
Facility Name
Digestive & Liver Disease Specialists, A Medical Group, Inc.
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
Precision Research Institute
City
Chula Vista
State/Province
California
ZIP/Postal Code
91910
Country
United States
Facility Name
Triwest Research Associates, LLC
City
El Cajon
State/Province
California
ZIP/Postal Code
92020
Country
United States
Facility Name
Diagnamics Inc.
City
Encinitas
State/Province
California
ZIP/Postal Code
92024
Country
United States
Facility Name
Therapeutic Research Institute of Orange County
City
Laguna Hills
State/Province
California
ZIP/Postal Code
92653
Country
United States
Facility Name
Clinical Trials Research
City
Lincoln
State/Province
California
ZIP/Postal Code
95648
Country
United States
Facility Name
Alliance Clinical Research
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
Facility Name
Northern California Research
City
Sacramento
State/Province
California
ZIP/Postal Code
95821
Country
United States
Facility Name
Clinical Research Advantage, Inc. / Colorado Springs Health Partners, SW
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80906
Country
United States
Facility Name
Meridien Research
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34208
Country
United States
Facility Name
Palm Springs Research Institute
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33012
Country
United States
Facility Name
The Clinical Research Institute
City
Miami
State/Province
Florida
ZIP/Postal Code
33125
Country
United States
Facility Name
Prestige Clinical Research Center Inc.
City
Miami
State/Province
Florida
ZIP/Postal Code
33133
Country
United States
Facility Name
Physicians Regional Medical Group
City
Naples
State/Province
Florida
ZIP/Postal Code
34119
Country
United States
Facility Name
Advanced Gastroenterology Associates, LLC
City
Palm Harbor
State/Province
Florida
ZIP/Postal Code
34684
Country
United States
Facility Name
Clinical Research Trials of Florida, Inc.
City
Tampa
State/Province
Florida
ZIP/Postal Code
33607
Country
United States
Facility Name
River Birch Research Alliance, LLC
City
Blue Ridge
State/Province
Georgia
ZIP/Postal Code
30513
Country
United States
Facility Name
Gastroenterology Associates of Central Georgia, LLC
City
Macon
State/Province
Georgia
ZIP/Postal Code
31201
Country
United States
Facility Name
Gastrointestinal Specialists of Georgia
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
North Georgia Clinical Research
City
Woodstock
State/Province
Georgia
ZIP/Postal Code
30189
Country
United States
Facility Name
May Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60624
Country
United States
Facility Name
Pharmakon Inc.
City
Evergreen Park
State/Province
Illinois
ZIP/Postal Code
60805
Country
United States
Facility Name
Clinical Research Advantage, Inc.
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47714
Country
United States
Facility Name
KAMP Medical Research, Inc.
City
Natchitoches
State/Province
Louisiana
ZIP/Postal Code
71457
Country
United States
Facility Name
Clinical Associates Ambulatory Surgical Center
City
Towson
State/Province
Maryland
ZIP/Postal Code
21286
Country
United States
Facility Name
The Research Institute
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01105
Country
United States
Facility Name
Coastal Research Associates, Inc.
City
Weymouth
State/Province
Massachusetts
ZIP/Postal Code
02190
Country
United States
Facility Name
University of Michigan Health System
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Sundance Clinical Research, LLC
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Clinical Research Advantage, Inc.
City
Henderson
State/Province
Nevada
ZIP/Postal Code
89052
Country
United States
Facility Name
AB Clinical Trials
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89119
Country
United States
Facility Name
Clinical Research Center of Nevada
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89130
Country
United States
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89144
Country
United States
Facility Name
AGA Clinical Research Associates, LLC
City
Egg Harbor Township
State/Province
New Jersey
ZIP/Postal Code
08234
Country
United States
Facility Name
HBSA, A Supporting Organization of Pacific Institute for Research and Evaluation
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102
Country
United States
Facility Name
NY Scientific
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11235
Country
United States
Facility Name
Medex Healthcare Research, Inc.
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
PMG Research of Charlotte
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28209
Country
United States
Facility Name
PMG Research of Charlotte
City
Concord
State/Province
North Carolina
ZIP/Postal Code
28025
Country
United States
Facility Name
PMG Research of Hickory, LLC
City
Hickory
State/Province
North Carolina
ZIP/Postal Code
28605
Country
United States
Facility Name
PMG Research of Winston-Salem
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Dayton Gastroenterology, Inc.
City
Beavercreek
State/Province
Ohio
ZIP/Postal Code
45440
Country
United States
Facility Name
Consultants for Clinical Research
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Hilltop Physicians IN / Hightop Medical Research Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45224
Country
United States
Facility Name
New Horizons Clinical Research
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
Facility Name
Columbus Clinical Research Inc.
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43213
Country
United States
Facility Name
COR Clinical Research, LLC
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73103
Country
United States
Facility Name
Options Health Research, LLC
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74104
Country
United States
Facility Name
Sunstone Medical Research, LLC
City
Medford
State/Province
Oregon
ZIP/Postal Code
97504
Country
United States
Facility Name
The Oregon Clinic, PC - Gastroenterology West
City
Portland
State/Province
Oregon
ZIP/Postal Code
97225
Country
United States
Facility Name
Clinical Trials Research Services, LLC
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15206
Country
United States
Facility Name
Partners in Clinical Research, LLC
City
Cumberland
State/Province
Rhode Island
ZIP/Postal Code
02864
Country
United States
Facility Name
Health Concepts
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57702
Country
United States
Facility Name
Alpha Clinical Research, LLC
City
Clarksville
State/Province
Tennessee
ZIP/Postal Code
37043
Country
United States
Facility Name
Austin Center for Clinical Research
City
Austin
State/Province
Texas
ZIP/Postal Code
78756
Country
United States
Facility Name
MW Clinical Research Center
City
Beaumont
State/Province
Texas
ZIP/Postal Code
77702
Country
United States
Facility Name
Houston Endoscopy & Research Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77079
Country
United States
Facility Name
Sun Research Institute
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States
Facility Name
Radiant Research Inc.
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Digestive Health Specialists of Tyler, LLP
City
Tyler
State/Province
Texas
ZIP/Postal Code
75701
Country
United States
Facility Name
Advanced Research Institute
City
Ogden
State/Province
Utah
ZIP/Postal Code
84405
Country
United States
Facility Name
Health Research of Hampton Roads, Inc.
City
Newport News
State/Province
Virginia
ZIP/Postal Code
23606
Country
United States
Facility Name
Digestive and Liver Disease Specialists
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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