The Plecanatide Chronic Idiopathic Constipation (CIC) Study

This study has been completed.
Sponsor:
Collaborator:
PAREXEL International
Information provided by (Responsible Party):
Synergy Pharmaceuticals Inc.
ClinicalTrials.gov Identifier:
NCT01429987
First received: September 6, 2011
Last updated: May 28, 2013
Last verified: May 2013
  Purpose

This is a randomized, double-blind, placebo controlled, 12 week repeat oral dose, dose ranging study to determine the efficacy and safety of 3 doses of plecanatide compared to placebo in patients with Chronic Idiopathic Constipation (CIC).


Condition Intervention Phase
Chronic Idiopathic Constipation
Drug: plecanatide
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Study SP304-20210: A Randomized, 12-Week, Double-Blind, Placebo-Controlled, Repeat-Dose, Oral, Dose-Ranging Study to Assess the Safety and Efficacy of Plecanatide in Patients With Chronic Idiopathic Constipation

Resource links provided by NLM:


Further study details as provided by Synergy Pharmaceuticals Inc.:

Primary Outcome Measures:
  • Complete Spontaneous Bowel Movement (CSBM) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    A complete spontaneous bowel movement occurs 24 hours away from laxative use and the patient reports a feeling of complete evacuation. A weekly responder will have 3 or more CSBMs and an increase of at least one CSBM from baseline. A monthly responder achieves this for 3 of the 4 weeks in a month. An overall responder must achieve this in 2 of the 3 months of treatment with one of those months being the latest treatment period.


Secondary Outcome Measures:
  • Reduction in straining and abdominal symptoms such as pain, discomfort and bloating. [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
    To demonstrate the reduction in straining and abdominal symptoms such as pain, discomfort and bloating as determined via patient reported outcome (PRO) measures collected via an Interactive Voice Response System (IVRS). To demonstrate an improvement in the hardness of stool , the frequency of spontaneous movements, and a reduction in time to first bowel movement. To monitor and report all treatment emergent adverse events.


Enrollment: 951
Study Start Date: October 2011
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: plecanatide 0.3 mg
Subjects receive plecanatide 0.3 mg for 12 consecutive weeks
Drug: plecanatide
Subjects receive experimental study drug for 12 weeks.
Experimental: plecanatide 1.0 mg
Subjects receive plecanatide 1.0 mg for 12 consecutive weeks
Drug: plecanatide
Subjects receive experimental study drug for 12 weeks.
Experimental: plecanatide 3.0 mg
Subjects receive plecanatide 3.0 mg for 12 consecutive weeks
Drug: plecanatide
Subjects receive experimental study drug for 12 weeks.
Experimental: Placebo
Subjects receive placebo for 12 consecutive weeks
Drug: plecanatide
Subjects receive experimental study drug for 12 weeks.

Detailed Description:

This is a Phase IIb/III, randomized, double-blind, placebo-controlled, 12-Week, Repeat, Oral Dose Ranging, study to determine the safety and efficacy of plecanatide in patients with chronic idiopathic constipation (CIC). Subjects diagnosed with CIC via modified Rome III criteria will be screened against the inclusion and exclusion criteria for the study and enter a 2 Week pre treatment screening. During this phase patients will be required to call in their bowel movements (BM diary) as they occur, and call at least once daily to complete a patient diary of questions on their symptoms (Symptom Diary) associated with CC, as they will throughout the trial. Patients who complete at least 5 days of dosing per week, 6 of each 7 day period of BM diary calls, and continue to have less than 3 complete spontaneous movements per week (as well as meeting other inclusion and exclusion criteria) will be enrolled and randomized to one of three plecanatide doses 0.3 mg, 1.0 mg, and 3.0 mg or placebo. 880 patients will be randomized with the intent of having 200 patients per treatment group (each group the same size) included in efficacy analyses. All subjects receiving at least one dose of plecanatide or matching placebo will be included in the safety analyses.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female aged 18-75, inclusive
  • Body Mass Index = 18-35 kg/m2, inclusive
  • Meets modified Rome III criteria for functional chronic idiopathic constipation for at least 3 months with symptom onset for at least 6 months. Note: For this trial, patients with manual maneuvers required for >25% of defecations will not be eligible for participation.
  • Less than 3 CSBMs per week at baseline and during pretreatment
  • Completed a colonoscopy in accordance with medical guidelines as appropriate, with no clinically significant findings
  • Patient is willing to discontinue use of supplemental fiber, laxatives, prescription and nonprescription medications, herbal or dietary supplements intended to treat constipation during the screening, pre-treatment, treatment and 2-week post-treatment periods
  • Willing to maintain a stable diet during the study.
  • Patients with hemorrhoids and/or diverticulosis (NOT diverticulitis) CAN be entered into the study.

Exclusion Criteria:

  • Loose stool (mushy) or watery (Bristol score- 6 or 7) stool in the absence of any laxative or prohibited medicine for > 25% of BMs during the 3 months prior to screening visit OR during the 14 day treatment period
  • Patient meets the Rome III criteria for Irritable Bowel Syndrome (IBS-C)
  • Active peptic ulcer disease not adequately treated or not stable
  • History of cathartic colon, laxative, enema abuse, or ischemic colitis.
  • Fecal impaction within 3 months of screening
  • Patient has had /has any: diseases or conditions associated with constipation (GI or CNS), structural abnormality of the GI tract or gastric bypass surgery, pelvic floor dysfunction, pseudo-obstruction, active infectious gastritis, diverticulitis, anal fissures or any disease or condition that can affect GI motility or defecation or can be associated with abdominal pain
  • Unexplained and clinically significant "alarm symptoms" including lower GI bleeding, iron-deficiency anemia, weight loss or systemic signs of infection or colitis.
  • Major surgery within 60 days of screening.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01429987

  Hide Study Locations
Locations
United States, Alabama
Coastal Clinical Research, Inc
Mobile, Alabama, United States, 36608
United States, Arizona
East Valley Gastroenterology and Hepatology Associates, PC
Chandler, Arizona, United States, 85224
Genova Clinical Research
Tucson, Arizona, United States, 85704
Adobe Clinical Research, LLC
Tucson, Arizona, United States, 85712
Desert Sun Clinical Research, LLC
Tucson, Arizona, United States, 85710
United States, Arkansas
Preferred Research Partners, Inc
Little Rock, Arkansas, United States, 72211
United States, California
ACRI-Phase 1,LLC
Anaheim, California, United States, 92801
Translational Research Group, INC., d/b/a Providence Clinical Research
Burbank, CA 91505, California, United States, 91505
GW Research, Inc
Chula Vista, California, United States, 91910
Community Clinical Trials
Orange, California, United States, 92868
Inland Gastroenterology Medical Associates, Inc.
Redlands, California, United States, 92374
Dormir Clinical Trials, Inc
Redlands, California, United States, 92373
Superior Research LLC
Sacramento, California, United States, 95825
Medical Center for Clinical Research
San Diego, California, United States, 92108
Medical Associates Research Group, Inc.
San Diego, California, United States, 92123
Progressive Clinical Research
Vista, California, United States, 92083
United States, Colorado
Horizons Clinical Research Center, LLC
Denver, Colorado, United States, 80220
United States, Florida
Consultants for Clinical Research of S. Florida
Boynton Beach, Florida, United States, 33426
Medical Research Unlimited, LLC
Hialeah, Florida, United States, 33012
Nature Coast Clinical Research
Inverness, Florida, United States, 34452
Jupiter Research, Inc.
Jupiter, Florida, United States, 33458
Health Awareness, Inc.
Jupiter, Florida, United States, 33458
Advance Medical Research Service
Miami, Florida, United States, 33165
South Medical Research Group, Inc
Miami, Florida, United States, 33186
Columbus Clinical Services, LLC
Miami, Florida, United States, 33174
Advance Medical Research Service Corp
Miami, Florida, United States, 33165
Miami Gastroenterology Consultants, PA
Miami, Florida, United States, 33156
Florida International Research Center
Miami, Florida, United States, 33166
Compass Research, LLC
Orlando, Florida, United States, 32806
Gold Coast Research, LLC
Plantation, Florida, United States, 33317
DMI Research
Seminole, Florida, United States, 33777
Meridien Research
Tampa, Florida, United States, 33606
Palm Beach Research Center
West Palm Beach, Florida, United States, 33409
United States, Georgia
Gastro Specialists Research Center, LLC
Decatur, Georgia, United States, 30032
Mount Vernon Clinical Research, LLC
Sandy Springs, Georgia, United States, 30328
United States, Idaho
CTL Research
Eagle, Idaho, United States, 83616
Advanced Clinical Research
Meridian, Idaho, United States, 83642
United States, Illinois
Medex Healthcare Research, Inc.
Chicago, Illinois, United States, 60602
Southwest Gastroenterology Assoc
Oak Lawn, Illinois, United States, 60453
Rockford Gastroenterology Associates, Ltd.
Rockford, Illinois, United States, 61107
United States, Indiana
Investigators Research Group, LLC
Brownsburg, Indiana, United States, 46112
MediSphere Medical Research Center, LLC
Evansville, Indiana, United States, 47714
Memorial Health System, Inc., d/b/a LaPorte Medical Group
LaPorte, Indiana, United States, 46350
Memorial Health System, Inc., d/b/a Ireland Road Medical Group
South Bend, Indiana, United States, 46614
United States, Iowa
Iowa Digestive Disease Center
Clive, Iowa, United States, 50325
United States, Kansas
Heartland Research Associates, LLC
Augusta, Kansas, United States, 67010
Hutchinson Clinic, P.A
Hutchinson, Kansas, United States, 67502
Heartland Research Associates, LLC
Newton, Kansas, United States, 67114
Heartland Research Associates, LLC
Wichita, Kansas, United States, 67205
Heartland Research Associates, LLC
Wichita, Kansas, United States, 67207
United States, Kentucky
Research Integrity
Owensboro, Kentucky, United States, 42303
United States, Louisiana
Gastroenterology Associates, LLC
Baton Rouge, Louisiana, United States, 70809
Horizon Research Group, LLC
Baton Rouge, Louisiana, United States, 70808
Women Under Study, LLC
New Orleans, Louisiana, United States, 70115
Willis-Knighton Physician Network / Pinnacle Gastroenterology
Shreveport, Louisiana, United States, 71103
United States, Maryland
Mid-Atlantic Medical Research Centers
Hollywood, Maryland, United States, 20636
United States, Massachusetts
Boston Clinical Trials, Inc
Boston, Massachusetts, United States, 02135
NECCR Internal Medicine and Cardiology Associates, LLC
Fall River, Massachusetts, United States, 02720
United States, Michigan
Clinical Research Institute of Michigan, LLC
Chesterfield, Michigan, United States, 48047
Beyer Research
Kalamazoo, Michigan, United States, 49009
Remedica LLC
Rochester, Michigan, United States, 48307
American Center for Clinical Trials
Southfield, Michigan, United States, 48034
United States, Minnesota
Ridgeview Research
Chaska, Minnesota, United States, 55318
United States, Missouri
The Center for Pharmaceutical Research, PC
Kansas City, Missouri, United States, 64114
Midwest Center for Clinical Research
Lee's Summit, Missouri, United States, 64064
St. Louis Center for Clinical Research
St. Louis, Missouri, United States, 63128
United States, Nebraska
Internal Medical Associates of Grand Island, PC
Grand Island, Nebraska, United States, 68803
Quality Clinical Research Inc.
Omaha, Nebraska, United States, 68114
United States, New Jersey
Central Jersey Medical Research Center
Elizabeth, New Jersey, United States, 07202
South Jersey Gastroenterology, PA
Marlton, New Jersey, United States, 08053
Jeffrey Danzig
Ridgewood, New Jersey, United States, 07450
United States, New Mexico
Lovelace Scientific Resources, Inc
Albuquerque, New Mexico, United States, 87108
Albuquerque Clinical Trials, Inc
Albuquerque, New Mexico, United States, 87102
United States, New York
NY Total Medical Care
Brooklyn, New York, United States, 11215
Synergy First
Brooklyn, New York, United States, 11230
Long Island Gastrointestinal Research Group LLP
Great Neck, New York, United States, 11023
Premier Medical Group of the Hudson Valley, PC
Poughkeepsie, New York, United States, 12601
North American Partners in Pain Management
Valley Stream, New York, United States, 11580
Paddu and Associates, LLP
Woodside, New York, United States, 11377
United States, North Carolina
MediSpect, LLC
Boone, North Carolina, United States, 28607
Clinical and Translational Research Center Hospital
Chapel Hill, North Carolina, United States, 27599-7600
Carolina Digestive Health Associates
Charlotte, North Carolina, United States, 28210
Carolina Digestive Health Associates
Davidson, North Carolina, United States, 28036
Medoff Medical / Vital re:Search
Greensboro, North Carolina, United States, 27408
LeBauer Research Associates, PA
Greensboro, North Carolina, United States, 27403
Carolina Digestive Health Associates
Harrisburg, North Carolina, United States, 28075
Burke Primary Care
Morgantown, North Carolina, United States, 28655
Wake Research associates, LLC
Raleigh, North Carolina, United States, 27612
PMG Research of Wilmington
Wilmington, North Carolina, United States, 28401
PMG Research of Winston-Salem
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
Valley Medical Research
Centerville, Ohio, United States, 45459
Hometown Urgent Care
Columbus, Ohio, United States, 43214
Hometown Urgent Care and Research
Dayton, Ohio, United States, 45432
Hometown Urgent Care
Groveport, Ohio, United States, 43125
Great Lakes Gastroenterology
Mentor, Ohio, United States, 44060
Hometown Urgent Care and Research
Springfield, Ohio, United States, 45504
United States, Oklahoma
Clinical Research Associates, LLC
Oklahoma City, Oklahoma, United States, 73112
United States, South Carolina
Consultants in Gastroenerology
Columbia, South Carolina, United States, 29203
United States, Tennessee
ClinSearch, LLC
Chattanooga, Tennessee, United States, 37421
Associates in Gastroenterology
Hermitage, Tennessee, United States, 37076
HCCA Clinical Research Solutions
Jackson, Tennessee, United States, 38305
PMG Research of Knoxville
Knoxville, Tennessee, United States, 37912
St. Thomas Medical Group
Nashville, Tennessee, United States, 37205
United States, Texas
KRK Medical Research
Dallas, Texas, United States, 75230
Research Across America
Dallas, Texas, United States, 75234
Reasearch Across America
El Paso, Texas, United States, 79902
Pioneer Research Solutions, Inc.
Houston, Texas, United States, 77098
Gastroenterology Consultants
Houston, Texas, United States, 77034
Research Across America
Katy, Texas, United States, 77450
DCOL Center for Clinical Research
Longview, Texas, United States, 75605
Digestive Health Center
Pasadena, Texas, United States, 77505
Quality Research Inc.
San Antonio, Texas, United States, 78209
Spring Gastroenterology PA
Spring, Texas, United States, 77386
United States, Utah
Jean Brown Research
Salt Lake City, Utah, United States, 84124
Utah Clinical Trials. LLC
Salt Lake City, Utah, United States, 84107
Advanced Clinical Research
West Jordan, Utah, United States, 84088
United States, Virginia
New River Valley Research Institute
Christiansburg, Virginia, United States, 24073
Clinical Research Partners, LLC
Henrico, Virginia, United States, 23233
Blue Ridge Medical Research / Gastroenterology Associates of Central Virginia
Lynchburg, Virginia, United States, 24502
National Clinical Research-Norfolk, Inc
Norfolk, Virginia, United States, 23502
National Clinical Research-Richmond, Inc.
Richmond, Virginia, United States, 23294
Sponsors and Collaborators
Synergy Pharmaceuticals Inc.
PAREXEL International
  More Information

Additional Information:
No publications provided

Responsible Party: Synergy Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT01429987     History of Changes
Other Study ID Numbers: SP304-20210, SP-SP30420210
Study First Received: September 6, 2011
Last Updated: May 28, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Synergy Pharmaceuticals Inc.:
Chronic Idiopathic Constipation
Constipation
Sign and Symptoms: Digestive

Additional relevant MeSH terms:
Constipation
Signs and Symptoms, Digestive
Signs and Symptoms

ClinicalTrials.gov processed this record on October 02, 2014