The Plecanatide Irritable Bowel Syndrome With Constipation Study (IBS-C) (CIBS)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Synergy Pharmaceuticals Inc.
ClinicalTrials.gov Identifier:
NCT01722318
First received: November 2, 2012
Last updated: April 29, 2014
Last verified: April 2014
  Purpose

This is a randomized, 12-week, double-blind, placebo-controlled, dose-ranging study in patients with IBS-C.


Condition Intervention Phase
Irritable Bowel Syndrome Characterized by Constipation
Drug: Plecanatide
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, 12-Week, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Assess the Safety and Efficacy of Plecanatide in Patients With Irritable Bowel Syndrome With Constipation (IBS-C)

Resource links provided by NLM:


Further study details as provided by Synergy Pharmaceuticals Inc.:

Primary Outcome Measures:
  • Change from baseline in the mean number of Complete Spontaneous Bowel Movement (CSBM) over the 12 week treatment period [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of patients who are overall responders during the 12 week Treatment period [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Abdominal pain intensity and stool frequency are co-endpoints for the responder analysis. A patient is categorized as a weekly responder on both pain intensity and stool frequency.


Other Outcome Measures:
  • Other secondary endpoints [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Change from baseline in Spontaneous Bowel Movement (SBM) frequency, stool consistency (BSFS), time to first SBM/CSBM, patient IVRS reported symptoms,and patient questionnaires ( QoL, Irritable Bowel Syndrome Severity Score (IBSSS), global severity, relief and treatment assessment) over the 12 week treatment period.


Estimated Enrollment: 350
Study Start Date: November 2012
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Plecanatide 0.3mg
Plecanatide 0.3mg, one tablet by mouth daily for 12 weeks
Drug: Plecanatide
Active Comparator: Plecanatide 1.0mg
Plecanatide 1.0mg one tablet by mouth daily for 12 weeks
Drug: Plecanatide
Active Comparator: Plecanatide 3.0mg
Plecanatide 3.0mg, one tablet by mouth daily for 12 weeks
Drug: Plecanatide
Active Comparator: Plecanatide 9.0mg
Plecanatide 9.0mg, one tablet by mouth daily for 12 weeks
Drug: Plecanatide
Placebo Comparator: Placebo
Placebo, one tablet by mouth daily for 12 weeks
Drug: Placebo

Detailed Description:

This is a randomized, 12-week, double-blind, placebo-controlled, dose-ranging study in patients with IBS-C. Patients will undergo a Screening Period to determine eligibility. After completing a Screening Visit patients will undergo a 2-week Pre-Treatment assessment using the Interactive Voice Response System (IVRS) during which they will complete daily assessments of bowel movements (BMs), stool consistency (Bristol Stool Form Scale- BSFS), abdominal pain or abdominal discomfort and other symptoms associated with IBS-C. Data from the two-week IVRS Pre-treatment assessment are used to define the patient's baseline from which change will be determined. Patients who meet all entry criteria will be randomized to one of five treatment groups ( 0.3mg,1.0mg,3.0mg,9mg,or Placebo) on Day 1 of the Treatment Period. Patients will take an oral dose of study drug daily (QD) for 12 weeks and continue the daily IVRS diaries (BMs, abdominal pain, other symptoms). On Weeks 2, 4, 8, and 12, patients will return to the clinic to undergo safety and efficacy assessments. For 2 weeks after completing dosing, (i.e., Post-Treatment Period), patients will continue to complete daily IVRS diaries. Patients will then return to the clinical site for a final follow-up visit (End of Study Visit). The planned duration of participation in this study will be approximately 112 days from signing of informed consent through post-treatment or 145 days if 30 day washout of a prohibited concomitant medication or stabilization of a medical condition is required before Pre-Treatment (up to 148 days, with all windows considered).

  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 irritable bowel syndrome with constipation which includes abdominal pain or discomfort for at least 3 days/month in the last 3 months with symptom onset for at least 6 months.
  • Less than 3 CSBMs and less than 6 SBMs per week during the last 3 months.
  • Hard or lumpy stools ≥ 25 % of defecations
  • Patient has average abdominal pain intensity scores ≥ 3 (scale 0-10)for the combined 2 week pre-treatment period
  • 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 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 pre-treatment period
  • Patient has diarrhea-predominant or mixed ( diarrhea and constipation cycling or diarrhea and normal cycling) IBS.
  • 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: 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: NCT01722318

  Hide Study Locations
Locations
United States, Alabama
Cahaba Research
Birmingham, Alabama, United States, 35242
Digestive Health Specialists of the Southeast
Dothan, Alabama, United States, 36305
United States, Arizona
Arrowhead Family Health Center PC dba Arrowhead Health Centers
Glendale, Arizona, United States, 85306
Advanced Research Associates, LLC
Glendale, Arizona, United States, 85308
Elite Clinical Trials, LLC
Phoenix, Arizona, United States, 85018
Genova Clinical Research, Inc.
Tucson, Arizona, United States, 85704
Adobe Clinical Research, LLC
Tucson, Arizona, United States, 85712
United States, Arkansas
Lynn Institute of the Ozarks
Little Rock, Arkansas, United States, 72205
United States, California
Anaheim Clinical Trials, LLC
Anaheim, California, United States, 92801
Advanced Rx Clinical Research, Inc.
Artesia, California, United States, 90701
GW Research, Inc.
Chula Vista, California, United States, 91910
SC Clinical Research, Inc.
Garden Grove, California, United States, 92844
Grossmont Center for Clinical Research
La Mesa, California, United States, 91942
Community Clinical Trials
Orange, California, United States, 92868
Healthcare Partners Medical Group
Pasadena, California, United States, 91105
Medical Center for Clinical Research
San Diego, California, United States, 92108
Memorial Research Medical Clinic d/b/a Orange Country Research Center
Tustin, California, United States, 92780
United States, Colorado
Lynn Institute of the Rockies
Colorado Springs, Colorado, United States, 80907
Horizons Clinical Research Center, LLC
Denver, Colorado, United States, 80220
United States, Florida
Consultants for Clinical Research of South Florida
Boynton Beach, Florida, United States, 33426
Medical Research Unlimited, LLC
Hialeah, Florida, United States, 33012
Eastern Research, Inc
Hialeah, Florida, United States, 33013
Jupiter Research, Inc.
Jupiter, Florida, United States, 33458
Health Awareness, Inc.
Jupiter, Florida, United States, 33458
MNH Surgical Center
Maitland, Florida, United States, 32751
Genoma Research Group, Inc.
Miami, Florida, United States, 33165
San Marcus Research Clinic, Inc.
Miami, Florida, United States, 33015
Columbus Clinical Services, LLC
Miami, Florida, United States, 33174
South Medical Research Group, Inc.
Miami, Florida, United States, 33186
Compass Research, LLC
Orlando, Florida, United States, 32806
Urology Center of Florida
Pompano Beach, Florida, United States, 33060
Accord Clinical Research, LLC
Port Orange, Florida, United States, 32129
Meridien Research
Tampa, Florida, United States, 33606
Palm Beach Research Center
West Palm Beach, Florida, United States, 33409
Clinical Research of Central Florida
Winter Haven, Florida, United States, 33880
United States, Georgia
Georgia Regents University
Augusta, Georgia, United States, 30912
Mount Vernon Clinical Research, LLC
Sandy Springs, Georgia, United States, 30328
United States, Idaho
CTL Research
Eagle, Idaho, United States, 83616
United States, Illinois
Medex Healthcare Research, Inc
Chicago, Illinois, United States, 60602
Rockford Gastroenterology Associates
Rockford, Illinois, United States, 61107
United States, Kansas
Heartland Research Associates, LLC
Augusta, Kansas, United States, 67010
United States, Kentucky
Research Integrity, LLC
Owensboro, Kentucky, United States, 42303
United States, Louisiana
Delta Research Partners, LLC
Bastrop, Louisiana, United States, 71220
Gastroenterology Research of New Orleans
Hammond, Louisiana, United States, 70403
Centex Studies, Inc.
Lake Charles, Louisiana, United States, 70601
Women Under Study, LLC
New Orleans, Louisiana, United States, 70115
Louisiana Research Center, LLC
Shreveport, Louisiana, United States, 71103
United States, Maryland
MGG Group Co., Inc., Chevy Chase Clinical Research
Chevy Chase, Maryland, United States, 20815
United States, Massachusetts
Boston Clinical Trials
Boston, Massachusetts, United States, 02131
Novex Clinical Research, LLC
New Bedford, Massachusetts, United States, 02740
Bay State Clinical Trials, Inc.
Watertown, Massachusetts, United States, 02472
United States, Michigan
IHA Chelsea Family & Internal Medicine
Chelsea, Michigan, United States, 48118
Clinical Research Institute of Michigan, LLC
Chesterfield, Michigan, United States, 48047
United States, Minnesota
Ridgeview Research
Chaska, Minnesota, United States, 55318
Prism Research
St. Paul, Minnesota, United States, 55114
United States, Mississippi
The Center for Clinical Trials
Biloxi, Mississippi, United States, 39531
Gastrointestinal Associates, PA
Jackson, Mississippi, United States, 39202
United States, Missouri
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 Hampshire
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
United States, New York
St. Luke's Hospital
New York, New York, United States, 10025
United States, North Carolina
Asheville Gastroenterology Associates, PA
Asheville, North Carolina, United States, 28801
MediSpect Medical Research, LLC
Boone, North Carolina, United States, 28607
Clinical Trials of North Carolina, LLC
Cary, North Carolina, United States, 27518
Carolina Digestive Health Associates
Charlotte, North Carolina, United States, 28210
On Site Clinical, LLC
Charlotte, North Carolina, United States, 28277
Carolina Digestive Health Associates
Davidson, North Carolina, United States, 28036
Cumberland Research Associates, LLC
Fayetteville, North Carolina, United States, 28304
LeBauer Research Associates, P.A.
Greensboro, North Carolina, United States, 27403
Medoff Medical / Vital re:Search
Greensboro, North Carolina, United States, 27408
Wake Research Associates, LLC
Raleigh, North Carolina, United States, 27612
PMG Research of Winston-Salem, LLC
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
Hometown Urgent Care and Occupational Health
Columbus, Ohio, United States, 43214
Great Lakes Gastroenterology
Mentor, Ohio, United States, 44060
United States, Oklahoma
Central Sooner Research
Norman, Oklahoma, United States, 73071
Oklahoma Foundation for Digestive Research
Oklahoma City, Oklahoma, United States, 73104
Lynn Health Science Institute
Oklahoma City, Oklahoma, United States, 73112
Options Health Research, LLC
Tulsa, Oklahoma, United States, 74104
United States, South Carolina
Consultants in Gastroenterology
Columbia, South Carolina, United States, 29203
Southeast Medical Research
North Charleston, South Carolina, United States, 29406
Palmetto Clinical Research
Summerville, South Carolina, United States, 29485
United States, Tennessee
ClinSearch, LLC
Chattanooga, Tennessee, United States, 37421
Chattanooga Medical Research LLC
Chattanooga, Tennessee, United States, 37404
Franklin Gastroenterology, PLLC
Franklin, Tennessee, United States, 37067
Memphis Gastroenterology Group, PC
Germantown, Tennessee, United States, 38138
Associates in Gastroenterology
Hermitage, Tennessee, United States, 37076
United States, Texas
Austin Center for Clinical Research
Austin, Texas, United States, 78756
DCT-AACT, LLC dba Discovery Clinical Trials
Austin, Texas, United States, 78758
Texas Tech Medical Center
El Paso, Texas, United States, 79905
Centex Studies, Inc.
Houston, Texas, United States, 77062
North Texas Family Medicine
Plano, Texas, United States, 75093
Quality Research, Inc.
San Antonio, Texas, United States, 78209
Physician PrimeCare Research Institute, PLLC dba Health Texas Research Institute
San Antonio, Texas, United States, 78228
Pioneer Research Solutions, Inc.
Sugar Land, Texas, United States, 77479
United States, Virginia
New River Valley Research Institute
Christiansburg, Virginia, United States, 24073
Blue Ridge Medical Research/Gastroenterology Associates of Central Virginia
Lynchburg, Virginia, United States, 24502
Sponsors and Collaborators
Synergy Pharmaceuticals Inc.
Investigators
Principal Investigator: Philip B Miner, MD Oklahoma Foundation for Digestive Research
  More Information

No publications provided

Responsible Party: Synergy Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT01722318     History of Changes
Other Study ID Numbers: SP304-20212
Study First Received: November 2, 2012
Last Updated: April 29, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Constipation
Irritable Bowel Syndrome
Syndrome
Colonic Diseases
Colonic Diseases, Functional
Digestive System Diseases
Disease
Gastrointestinal Diseases
Intestinal Diseases
Pathologic Processes
Signs and Symptoms
Signs and Symptoms, Digestive

ClinicalTrials.gov processed this record on October 21, 2014