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

Primary Purpose

Irritable Bowel Syndrome Characterized by 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 Irritable Bowel Syndrome Characterized by Constipation

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 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.

Sites / Locations

  • Cahaba Research
  • Digestive Health Specialists of the Southeast
  • Arrowhead Family Health Center PC dba Arrowhead Health Centers
  • Advanced Research Associates, LLC
  • Elite Clinical Trials, LLC
  • Genova Clinical Research, Inc.
  • Adobe Clinical Research, LLC
  • Lynn Institute of the Ozarks
  • Anaheim Clinical Trials, LLC
  • Advanced Rx Clinical Research, Inc.
  • GW Research, Inc.
  • SC Clinical Research, Inc.
  • Grossmont Center for Clinical Research
  • Community Clinical Trials
  • Healthcare Partners Medical Group
  • Medical Center for Clinical Research
  • Memorial Research Medical Clinic d/b/a Orange Country Research Center
  • Lynn Institute of the Rockies
  • Horizons Clinical Research Center, LLC
  • Consultants for Clinical Research of South Florida
  • Medical Research Unlimited, LLC
  • Eastern Research, Inc
  • Health Awareness, Inc.
  • Jupiter Research, Inc.
  • MNH Surgical Center
  • San Marcus Research Clinic, Inc.
  • Genoma Research Group, Inc.
  • Columbus Clinical Services, LLC
  • South Medical Research Group, Inc.
  • Compass Research, LLC
  • Urology Center of Florida
  • Accord Clinical Research, LLC
  • Meridien Research
  • Palm Beach Research Center
  • Clinical Research of Central Florida
  • Georgia Regents University
  • Mount Vernon Clinical Research, LLC
  • CTL Research
  • Medex Healthcare Research, Inc
  • Rockford Gastroenterology Associates
  • Heartland Research Associates, LLC
  • Research Integrity, LLC
  • Delta Research Partners, LLC
  • Gastroenterology Research of New Orleans
  • Centex Studies, Inc.
  • Women Under Study, LLC
  • Louisiana Research Center, LLC
  • MGG Group Co., Inc., Chevy Chase Clinical Research
  • Boston Clinical Trials
  • Novex Clinical Research, LLC
  • Bay State Clinical Trials, Inc.
  • IHA Chelsea Family & Internal Medicine
  • Clinical Research Institute of Michigan, LLC
  • Center for Digestive Health
  • Ridgeview Research
  • Prism Research
  • The Center for Clinical Trials
  • Gastrointestinal Associates, PA
  • St. Louis Center for Clinical Research
  • Montana Health Research Institute, Inc.
  • Internal Medical Associates of Grand Island, PC
  • Quality Clinical Research, Inc.
  • Dartmouth-Hitchcock Medical Center
  • St. Luke's Hospital
  • Asheville Gastroenterology Associates, PA
  • MediSpect Medical Research, LLC
  • Clinical Trials of North Carolina, LLC
  • Carolina Digestive Health Associates
  • On Site Clinical, LLC
  • Carolina Digestive Health Associates
  • Cumberland Research Associates, LLC
  • LeBauer Research Associates, P.A.
  • Medoff Medical / Vital re:Search
  • Wake Research Associates, LLC
  • PMG Research of Winston-Salem, LLC
  • Hometown Urgent Care and Occupational Health
  • Great Lakes Gastroenterology
  • Central Sooner Research
  • Oklahoma Foundation for Digestive Research
  • Lynn Health Science Institute
  • Options Health Research, LLC
  • Consultants in Gastroenterology
  • Southeast Medical Research
  • Palmetto Clinical Research
  • Chattanooga Medical Research LLC
  • ClinSearch, LLC
  • Franklin Gastroenterology, PLLC
  • Memphis Gastroenterology Group, PC
  • Associates in Gastroenterology
  • Austin Center for Clinical Research
  • DCT-AACT, LLC dba Discovery Clinical Trials
  • Texas Tech Medical Center
  • Centex Studies, Inc.
  • North Texas Family Medicine
  • Quality Research, Inc.
  • Physician PrimeCare Research Institute, PLLC dba Health Texas Research Institute
  • Pioneer Research Solutions, Inc.
  • New River Valley Research Institute
  • Blue Ridge Medical Research/Gastroenterology Associates of Central Virginia

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

Plecanatide 0.3mg

Plecanatide 1.0mg

Plecanatide 3.0mg

Plecanatide 9.0mg

Placebo

Arm Description

Plecanatide 0.3mg, one tablet by mouth daily for 12 weeks

Plecanatide 1.0mg one tablet by mouth daily for 12 weeks

Plecanatide 3.0mg, one tablet by mouth daily for 12 weeks

Plecanatide 9.0mg, one tablet by mouth daily for 12 weeks

Placebo, one tablet by mouth daily for 12 weeks

Outcomes

Primary Outcome Measures

Change From Baseline in Weekly CSBMs Frequency Over the 12-Week Treatment Period (mITT Population)
The primary efficacy endpoint was the change from baseline in the weekly CSBM frequency (CSBMs per week minus CSBMs per week at baseline) over a 12-week Treatment Period. 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.

Secondary Outcome Measures

Change From Baseline in Abdominal Pain Intensity Scores Over 12-Week Treatment Period (mITT Population)
Abdominal Pain was assessed in the patient's daily response on a scale of 0 to 10 where 0 is did not experience the symptom at all and 10 is experienced the worst.
Change From Baseline in Stool Consistency (BSFS) Over 12-Week Treatment Period (mITT Population)
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 Straining Scores Over 12-Week Treatment Period (mITT Population)
The severity of straining (Straining Score) was rated by the patients using a 11-point scale (0-10) where 0 = none and 10 = very severe

Full Information

First Posted
November 2, 2012
Last Updated
May 23, 2019
Sponsor
Bausch Health Americas, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01722318
Brief Title
The Plecanatide Irritable Bowel Syndrome With Constipation Study (IBS-C)
Acronym
CIBS
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)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
November 2012 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
October 2014 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome Characterized by Constipation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
428 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Plecanatide 0.3mg
Arm Type
Active Comparator
Arm Description
Plecanatide 0.3mg, one tablet by mouth daily for 12 weeks
Arm Title
Plecanatide 1.0mg
Arm Type
Active Comparator
Arm Description
Plecanatide 1.0mg one tablet by mouth daily for 12 weeks
Arm Title
Plecanatide 3.0mg
Arm Type
Active Comparator
Arm Description
Plecanatide 3.0mg, one tablet by mouth daily for 12 weeks
Arm Title
Plecanatide 9.0mg
Arm Type
Active Comparator
Arm Description
Plecanatide 9.0mg, one tablet by mouth daily for 12 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo, one tablet by mouth daily for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Plecanatide
Other Intervention Name(s)
Trulance
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Change From Baseline in Weekly CSBMs Frequency Over the 12-Week Treatment Period (mITT Population)
Description
The primary efficacy endpoint was the change from baseline in the weekly CSBM frequency (CSBMs per week minus CSBMs per week at baseline) over a 12-week Treatment Period. 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.
Time Frame
12 weeks Treatment Period
Secondary Outcome Measure Information:
Title
Change From Baseline in Abdominal Pain Intensity Scores Over 12-Week Treatment Period (mITT Population)
Description
Abdominal Pain was assessed in the patient's daily response on a scale of 0 to 10 where 0 is did not experience the symptom at all and 10 is experienced the worst.
Time Frame
12-Week Treatment Period
Title
Change From Baseline in Stool Consistency (BSFS) Over 12-Week Treatment Period (mITT Population)
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 Straining Scores Over 12-Week Treatment Period (mITT Population)
Description
The severity of straining (Straining Score) was rated by the patients using a 11-point scale (0-10) where 0 = none and 10 = very severe
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 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philip B Miner, MD
Organizational Affiliation
Oklahoma Foundation for Digestive Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cahaba Research
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35242
Country
United States
Facility Name
Digestive Health Specialists of the Southeast
City
Dothan
State/Province
Alabama
ZIP/Postal Code
36305
Country
United States
Facility Name
Arrowhead Family Health Center PC dba Arrowhead Health Centers
City
Glendale
State/Province
Arizona
ZIP/Postal Code
85306
Country
United States
Facility Name
Advanced Research Associates, LLC
City
Glendale
State/Province
Arizona
ZIP/Postal Code
85308
Country
United States
Facility Name
Elite Clinical Trials, LLC
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85018
Country
United States
Facility Name
Genova Clinical Research, Inc.
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85704
Country
United States
Facility Name
Adobe Clinical Research, LLC
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
Lynn Institute of the Ozarks
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Anaheim Clinical Trials, LLC
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
Advanced Rx Clinical Research, Inc.
City
Artesia
State/Province
California
ZIP/Postal Code
90701
Country
United States
Facility Name
GW Research, Inc.
City
Chula Vista
State/Province
California
ZIP/Postal Code
91910
Country
United States
Facility Name
SC Clinical Research, Inc.
City
Garden Grove
State/Province
California
ZIP/Postal Code
92844
Country
United States
Facility Name
Grossmont Center for Clinical Research
City
La Mesa
State/Province
California
ZIP/Postal Code
91942
Country
United States
Facility Name
Community Clinical Trials
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Healthcare Partners Medical Group
City
Pasadena
State/Province
California
ZIP/Postal Code
91105
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
Memorial Research Medical Clinic d/b/a Orange Country Research Center
City
Tustin
State/Province
California
ZIP/Postal Code
92780
Country
United States
Facility Name
Lynn Institute of the Rockies
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80907
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 South 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
Eastern Research, Inc
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33013
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
MNH Surgical Center
City
Maitland
State/Province
Florida
ZIP/Postal Code
32751
Country
United States
Facility Name
San Marcus Research Clinic, Inc.
City
Miami
State/Province
Florida
ZIP/Postal Code
33015
Country
United States
Facility Name
Genoma Research Group, Inc.
City
Miami
State/Province
Florida
ZIP/Postal Code
33165
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
Urology Center of Florida
City
Pompano Beach
State/Province
Florida
ZIP/Postal Code
33060
Country
United States
Facility Name
Accord Clinical Research, LLC
City
Port Orange
State/Province
Florida
ZIP/Postal Code
32129
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
Clinical Research of Central Florida
City
Winter Haven
State/Province
Florida
ZIP/Postal Code
33880
Country
United States
Facility Name
Georgia Regents University
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
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
Medex Healthcare Research, Inc
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60602
Country
United States
Facility Name
Rockford Gastroenterology Associates
City
Rockford
State/Province
Illinois
ZIP/Postal Code
61107
Country
United States
Facility Name
Heartland Research Associates, LLC
City
Augusta
State/Province
Kansas
ZIP/Postal Code
67010
Country
United States
Facility Name
Research Integrity, LLC
City
Owensboro
State/Province
Kentucky
ZIP/Postal Code
42303
Country
United States
Facility Name
Delta Research Partners, LLC
City
Bastrop
State/Province
Louisiana
ZIP/Postal Code
71220
Country
United States
Facility Name
Gastroenterology Research of New Orleans
City
Hammond
State/Province
Louisiana
ZIP/Postal Code
70403
Country
United States
Facility Name
Centex Studies, Inc.
City
Lake Charles
State/Province
Louisiana
ZIP/Postal Code
70601
Country
United States
Facility Name
Women Under Study, LLC
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70115
Country
United States
Facility Name
Louisiana Research Center, LLC
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71103
Country
United States
Facility Name
MGG Group Co., Inc., Chevy Chase Clinical Research
City
Chevy Chase
State/Province
Maryland
ZIP/Postal Code
20815
Country
United States
Facility Name
Boston Clinical Trials
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02131
Country
United States
Facility Name
Novex Clinical Research, LLC
City
New Bedford
State/Province
Massachusetts
ZIP/Postal Code
02740
Country
United States
Facility Name
Bay State Clinical Trials, Inc.
City
Watertown
State/Province
Massachusetts
ZIP/Postal Code
02472
Country
United States
Facility Name
IHA Chelsea Family & Internal Medicine
City
Chelsea
State/Province
Michigan
ZIP/Postal Code
48118
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
Center for Digestive Health
City
Troy
State/Province
Michigan
ZIP/Postal Code
48098
Country
United States
Facility Name
Ridgeview Research
City
Chaska
State/Province
Minnesota
ZIP/Postal Code
55318
Country
United States
Facility Name
Prism Research
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55114
Country
United States
Facility Name
The Center for Clinical Trials
City
Biloxi
State/Province
Mississippi
ZIP/Postal Code
39531
Country
United States
Facility Name
Gastrointestinal Associates, PA
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39202
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
Montana Health Research Institute, Inc.
City
Billings
State/Province
Montana
ZIP/Postal Code
59102
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
Dartmouth-Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
St. Luke's Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10025
Country
United States
Facility Name
Asheville Gastroenterology Associates, PA
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28801
Country
United States
Facility Name
MediSpect Medical Research, LLC
City
Boone
State/Province
North Carolina
ZIP/Postal Code
28607
Country
United States
Facility Name
Clinical Trials of North Carolina, LLC
City
Cary
State/Province
North Carolina
ZIP/Postal Code
27518
Country
United States
Facility Name
Carolina Digestive Health Associates
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28210
Country
United States
Facility Name
On Site Clinical, LLC
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28277
Country
United States
Facility Name
Carolina Digestive Health Associates
City
Davidson
State/Province
North Carolina
ZIP/Postal Code
28036
Country
United States
Facility Name
Cumberland Research Associates, LLC
City
Fayetteville
State/Province
North Carolina
ZIP/Postal Code
28304
Country
United States
Facility Name
LeBauer Research Associates, P.A.
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
Wake Research Associates, LLC
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
PMG Research of Winston-Salem, LLC
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Hometown Urgent Care and Occupational Health
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43214
Country
United States
Facility Name
Great Lakes Gastroenterology
City
Mentor
State/Province
Ohio
ZIP/Postal Code
44060
Country
United States
Facility Name
Central Sooner Research
City
Norman
State/Province
Oklahoma
ZIP/Postal Code
73071
Country
United States
Facility Name
Oklahoma Foundation for Digestive Research
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Lynn Health Science Institute
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Options Health Research, LLC
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74104
Country
United States
Facility Name
Consultants in Gastroenterology
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29203
Country
United States
Facility Name
Southeast Medical Research
City
North Charleston
State/Province
South Carolina
ZIP/Postal Code
29406
Country
United States
Facility Name
Palmetto Clinical Research
City
Summerville
State/Province
South Carolina
ZIP/Postal Code
29485
Country
United States
Facility Name
Chattanooga Medical Research LLC
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37404
Country
United States
Facility Name
ClinSearch, LLC
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37421
Country
United States
Facility Name
Franklin Gastroenterology, PLLC
City
Franklin
State/Province
Tennessee
ZIP/Postal Code
37067
Country
United States
Facility Name
Memphis Gastroenterology Group, PC
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
Facility Name
Associates in Gastroenterology
City
Hermitage
State/Province
Tennessee
ZIP/Postal Code
37076
Country
United States
Facility Name
Austin Center for Clinical Research
City
Austin
State/Province
Texas
ZIP/Postal Code
78756
Country
United States
Facility Name
DCT-AACT, LLC dba Discovery Clinical Trials
City
Austin
State/Province
Texas
ZIP/Postal Code
78758
Country
United States
Facility Name
Texas Tech Medical Center
City
El Paso
State/Province
Texas
ZIP/Postal Code
79905
Country
United States
Facility Name
Centex Studies, Inc.
City
Houston
State/Province
Texas
ZIP/Postal Code
77062
Country
United States
Facility Name
North Texas Family Medicine
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States
Facility Name
Quality Research, Inc.
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78209
Country
United States
Facility Name
Physician PrimeCare Research Institute, PLLC dba Health Texas Research Institute
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78228
Country
United States
Facility Name
Pioneer Research Solutions, Inc.
City
Sugar Land
State/Province
Texas
ZIP/Postal Code
77479
Country
United States
Facility Name
New River Valley Research Institute
City
Christiansburg
State/Province
Virginia
ZIP/Postal Code
24073
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

12. IPD Sharing Statement

Learn more about this trial

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

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