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The Plecanatide Chronic Idiopathic Constipation (CIC) Study

Primary Purpose

Chronic Idiopathic Constipation

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
plecanatide
Placebo
Sponsored by
Bausch Health Americas, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Idiopathic Constipation focused on measuring Chronic Idiopathic Constipation, Constipation, Sign and Symptoms: Digestive

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Coastal Clinical Research, Inc.
  • East Valley Gastroenterology and Hepatology Associates, PC
  • Genova Clinical Research
  • Desert Sun Clinical Research, LLC
  • Adobe Clinical Research, LLC
  • Preferred Research Partners, Inc
  • ACRI-Phase 1,LLC
  • Translational Research Group, INC., d/b/a Providence Clinical Research
  • GW Research, Inc
  • Community Clinical Trials
  • Dormir Clinical Trials, Inc
  • Inland Gastroenterology Medical Associates, Inc.
  • Superior Research LLC
  • Medical Center for Clinical Research
  • Medical Associates Research Group, Inc.
  • Progressive Clinical Research
  • Horizons Clinical Research Center, LLC
  • Consultants for Clinical Research of S. Florida
  • Medical Research Unlimited, LLC
  • Nature Coast Clinical Research
  • Health Awareness, Inc.
  • Jupiter Research, Inc.
  • Miami Gastroenterology Consultants, PA
  • Advance Medical Research Service Corp
  • Advance Medical Research Service
  • Florida International Research Center
  • Columbus Clinical Services, LLC
  • South Medical Research Group, Inc
  • Compass Research, LLC
  • Gold Coast Research, LLC
  • DMI Research
  • Meridien Research
  • Palm Beach Research Center
  • Gastro Specialists Research Center, LLC
  • Mount Vernon Clinical Research, LLC
  • CTL Research
  • Advanced Clinical Research
  • Medex Healthcare Research, Inc.
  • Southwest Gastroenterology Assoc
  • Rockford Gastroenterology Associates, Ltd.
  • Investigators Research Group, LLC
  • MediSphere Medical Research Center, LLC
  • Memorial Health System, Inc., d/b/a LaPorte Medical Group
  • Memorial Health System, Inc., d/b/a Ireland Road Medical Group
  • Iowa Digestive Disease Center
  • Heartland Research Associates, LLC
  • Hutchinson Clinic, P.A
  • Heartland Research Associates, LLC
  • Heartland Research Associates, LLC
  • Heartland Research Associates, LLC
  • Research Integrity
  • Horizon Research Group, LLC
  • Gastroenterology Associates, LLC
  • Women Under Study, LLC
  • Willis-Knighton Physician Network / Pinnacle Gastroenterology
  • Mid-Atlantic Medical Research Centers
  • Boston Clinical Trials, Inc
  • NECCR Internal Medicine and Cardiology Associates, LLC
  • Clinical Research Institute of Michigan, LLC
  • Beyer Research
  • Remedica LLC
  • American Center for Clinical Trials
  • Ridgeview Research
  • The Center for Pharmaceutical Research, PC
  • Midwest Center for Clinical Research
  • St. Louis Center for Clinical Research
  • Internal Medical Associates of Grand Island, PC
  • Quality Clinical Research Inc.
  • Central Jersey Medical Research Center
  • South Jersey Gastroenterology, PA
  • Jeffrey Danzig
  • Albuquerque Clinical Trials, Inc
  • Lovelace Scientific Resources, Inc
  • NY Total Medical Care
  • Synergy First
  • Long Island Gastrointestinal Research Group LLP
  • Premier Medical Group of the Hudson Valley, PC
  • North American Partners in Pain Management
  • Paddu and Associates, LLP
  • MediSpect, LLC
  • Clinical and Translational Research Center Hospital
  • Carolina Digestive Health Associates
  • Carolina Digestive Health Associates
  • LeBauer Research Associates, PA
  • Medoff Medical / Vital re:Search
  • Carolina Digestive Health Associates
  • Burke Primary Care
  • Wake Research associates, LLC
  • PMG Research of Wilmington
  • PMG Research of Winston-Salem
  • Valley Medical Research
  • Hometown Urgent Care
  • Hometown Urgent Care and Research
  • Hometown Urgent Care
  • Great Lakes Gastroenterology
  • Hometown Urgent Care and Research
  • Clinical Research Associates, LLC
  • Consultants in Gastroenerology
  • ClinSearch, LLC
  • Associates in Gastroenterology
  • HCCA Clinical Research Solutions
  • PMG Research of Knoxville
  • St. Thomas Medical Group
  • KRK Medical Research
  • Research Across America
  • Reasearch Across America
  • Gastroenterology Consultants
  • Pioneer Research Solutions, Inc.
  • Research Across America
  • DCOL Center for Clinical Research
  • Digestive Health Center
  • Quality Research Inc.
  • Spring Gastroenterology PA
  • Utah Clinical Trials. LLC
  • Jean Brown Research
  • Advanced Clinical Research
  • New River Valley Research Institute
  • Clinical Research Partners, LLC
  • Blue Ridge Medical Research / Gastroenterology Associates of Central Virginia
  • National Clinical Research-Norfolk, Inc
  • National Clinical Research-Richmond, Inc.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

plecanatide 0.3 mg

plecanatide 1.0 mg

plecanatide 3.0 mg

Placebo

Arm Description

Subjects receive plecanatide 0.3 mg for 12 consecutive weeks

Subjects receive plecanatide 1.0 mg for 12 consecutive weeks

Subjects receive plecanatide 3.0 mg for 12 consecutive weeks

Subjects receive placebo for 12 consecutive weeks

Outcomes

Primary Outcome Measures

Overall Responder 9/12 Weeks
A Complete Spontaneous Bowel Movement (CSBM) is a Bowel Movement (BM) that occurs in the absence of laxative use within 24 hours of the BM 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 in the same week. An overall responder is a patient who is a weekly responder for at least 9 of the 12 treatment weeks, including at least 3 of the last 4 weeks.

Secondary Outcome Measures

Change From Baseline in 12-week CSBM Weekly Frequency Rate
The number of Complete Spontaneous Bowel Movements (CSBMs) per week
Change From Baseline in 12-week SBM Weekly Frequency Rate
The number of Spontaneous Bowl Movements experienced per week.
Change From Baseline in Stool Consistency (BSFS) to Over Treatment Period
The stool consistency of each bowel movement (BM) was assessed by patients using the 7-point Bristol Stool Form Scale [BSFS] from 1 to 7. = separate hard lumps like nuts (difficult to pass) = sausage shaped but lumpy = like a sausage but with cracks on its surface = like a sausage or snake, smooth and soft = soft blobs with clear-cut edges (passed easily) = fluffy pieces with ragged edges, a mushy stool = watery, no solid pieces (entirely liquid)
Change From Baseline in 12-week Patient Reported Symptoms Associated With Constipation - Straining Score
The severity of straining (Straining Score) was reported by the patients using a 11-point scale (0-10) where 0 = none and 10 = the worst

Full Information

First Posted
September 6, 2011
Last Updated
May 23, 2019
Sponsor
Bausch Health Americas, Inc.
Collaborators
Parexel
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1. Study Identification

Unique Protocol Identification Number
NCT01429987
Brief Title
The Plecanatide Chronic Idiopathic Constipation (CIC) Study
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bausch Health Americas, Inc.
Collaborators
Parexel

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Idiopathic Constipation
Keywords
Chronic Idiopathic Constipation, Constipation, Sign and Symptoms: Digestive

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
951 (Actual)

8. Arms, Groups, and Interventions

Arm Title
plecanatide 0.3 mg
Arm Type
Experimental
Arm Description
Subjects receive plecanatide 0.3 mg for 12 consecutive weeks
Arm Title
plecanatide 1.0 mg
Arm Type
Experimental
Arm Description
Subjects receive plecanatide 1.0 mg for 12 consecutive weeks
Arm Title
plecanatide 3.0 mg
Arm Type
Experimental
Arm Description
Subjects receive plecanatide 3.0 mg for 12 consecutive weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Subjects receive placebo for 12 consecutive weeks
Intervention Type
Drug
Intervention Name(s)
plecanatide
Other Intervention Name(s)
Trulance
Intervention Description
Subjects receive experimental study drug for 12 weeks.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Subjects receive experimental study drug for 12 weeks.
Primary Outcome Measure Information:
Title
Overall Responder 9/12 Weeks
Description
A Complete Spontaneous Bowel Movement (CSBM) is a Bowel Movement (BM) that occurs in the absence of laxative use within 24 hours of the BM 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 in the same week. An overall responder is a patient who is a weekly responder for at least 9 of the 12 treatment weeks, including at least 3 of the last 4 weeks.
Time Frame
12-Week Treatment Period
Secondary Outcome Measure Information:
Title
Change From Baseline in 12-week CSBM Weekly Frequency Rate
Description
The number of Complete Spontaneous Bowel Movements (CSBMs) per week
Time Frame
12-Week Treatment Period
Title
Change From Baseline in 12-week SBM Weekly Frequency Rate
Description
The number of Spontaneous Bowl Movements experienced per week.
Time Frame
12-Week Treatment Period
Title
Change From Baseline in Stool Consistency (BSFS) to Over Treatment Period
Description
The stool consistency of each bowel movement (BM) was assessed by patients using the 7-point Bristol Stool Form Scale [BSFS] from 1 to 7. = separate hard lumps like nuts (difficult to pass) = sausage shaped but lumpy = like a sausage but with cracks on its surface = like a sausage or snake, smooth and soft = soft blobs with clear-cut edges (passed easily) = fluffy pieces with ragged edges, a mushy stool = watery, no solid pieces (entirely liquid)
Time Frame
12-Week Treatment Period
Title
Change From Baseline in 12-week Patient Reported Symptoms Associated With Constipation - Straining Score
Description
The severity of straining (Straining Score) was reported by the patients using a 11-point scale (0-10) where 0 = none and 10 = the worst
Time Frame
12-Week Treatment Period

10. Eligibility

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

12. IPD Sharing Statement

Links:
URL
http://www.synergypharma.com
Description
Sponsor website

Learn more about this trial

The Plecanatide Chronic Idiopathic Constipation (CIC) Study

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