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

Primary Purpose

Irritable Bowel Syndrome Characterized by Constipation

Status
Completed
Phase
Phase 3
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 - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

• Adult patients between the ages of 18 and 85 years (inclusive) with a diagnosis of IBS based on ROME III diagnostic criteria and meeting criteria for diagnosis of the constipation predominant subtype - IBS-C

Exclusion Criteria:

  • Refusal or inability to sign informed consent for the trial
  • Refusal or inability to complete daily Episodic (real-time) BM / RM calls, End of Day daily Calls, and/or complete electronic questionnaires
  • BMI ≥ 40 or < 18
  • Women of child bearing potential who refuse to use an acceptable method of birth control for the duration of the trial
  • Women who are pregnant or lactating
  • Diagnosis of IBS-D or IBS-M
  • Organic or obstructive disease of the small or large intestine
  • Use of laxatives other than the study-supplied rescue medication (Dulcolax®, bisacodyl)
  • Use of a prohibited concomitant medication within the time frame prior to screening outlined in the study protocol for that medication
  • Unstable medical illness
  • Bilirubin > 3X ULN in the absence of a conjugation defect
  • Any laboratory value > 3X ULN unless discussed and approved by the study Medical Monitor

Sites / Locations

  • Synergy Research Site
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Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

3.0 mg plecanatide

6.0 mg plecanatide

Matching placebo

Arm Description

Plecanatide 3.0 mg dosed daily for 12 weeks

Plecanatide 6.0 mg dosed daily for 12 weeks

Placebo dosed daily for 12 weeks

Outcomes

Primary Outcome Measures

Number of Overall Responders - ITT Population
An Overall Responder was a patient who was a weekly responder (i.e., decrease of 30% from baseline for abdominal pain intensity and an increase of at least 1 complete spontaneous bowel movement in the same week) for at least 6 of the 12 treatment weeks.
Number of Abdominal Pain Responders for at Least 6 of 12 Treatment Weeks
An Abdominal Pain Intensity Responder was a patient who had a decrease of 30 % from baseline for abdominal pain intensity. Baseline is the mean of non-missing abdominal pain scores recorded during the 2-week baseline diary assessment period prior to the first dose of study drug.
Number of Stool Frequency Responder for at Least 6 of the 12 Treatment Weeks
A Stool Frequency Responder was a patient who experienced an increase of at least one CSBM (complete spontaneous bowel movement) per week from baseline. Baseline was the mean number of CSBMs recorded during the 2-week baseline diary assessment period prior to the first dose of study drug.

Secondary Outcome Measures

Number of Sustained Efficacy Responders
A Sustained Efficacy Responder was a patient who was an Overall Responder who also was a Weekly Responder, i.e., decreased of 30% from baseline for abdominal pain intensity and increased of at least one CSBM (complete spontaneous bowel movement) in the same week for at least 2 of the 4 weeks in month 3 of the Treatment Period.
Change From Baseline in Stool Consistency
Change from baseline in stool consistency based upon the Bristol Stool Form Scale (BSFS). Baseline was the mean BSFS score recorded during the 2-week baseline diary assessment period prior to the first dose of study drug. BSFS Rating 1 to 7: Separate hard lumps, like nuts (hard 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
Change from baseline in Straining Score over the 12-week treatment period. Baseline was the mean of non-missing straining scores recorded during the 2-week baseline diary assessment period prior to the first dose of study drug. The severity of straining during a bowel movement was measured using an 11-point scale (0-10 rating; 0 = no straining; 10 = worst straining).
Change From Baseline in CSBMs (CSBMs/Week)Complete Spontaneous Bowel Movement
Change from baseline over the 12-week Treatment Period in CSBM (Complete Spontaneous Bowel Movement) Frequency Rate (CSBMs/Week). Baseline was the mean number of CSBMs recorded during the 2-week baseline diary assessment period prior to the first dose of study drug.
Number of Patients With a SBM Within 24 Hours After First Dose of Study Medication
A responder was any patient with a SBM within 24 hours after the first dose of study drug.
Change From Baseline in Abdominal Pain
Change from baseline in abdominal pain as measured with an 11-point (0-10) Numerical Rating Scale from 0 (None) to 10 (Worst Possible). Baseline was the mean of the non-missing abdominal pain scores recorded during the 2-week baseline diary assessment period prior to the first dose of study drug. The average daily abdominal pain score was the average of the non-missing worst daily abdominal pain scores (on a 0 to 10 scale) in the given week.

Full Information

First Posted
June 23, 2015
Last Updated
June 13, 2019
Sponsor
Bausch Health Americas, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02493452
Brief Title
Second Plecanatide Study In Irritable Bowel Syndrome With Constipation (IBS-C)
Acronym
IBS-C
Official Title
Second Phase 3 Randomized, 12-Week, Double-Blind, Placebo-Controlled Study of 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
June 2019
Overall Recruitment Status
Completed
Study Start Date
June 2015 (undefined)
Primary Completion Date
November 2016 (Actual)
Study Completion Date
February 2017 (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 study in patients with IBS-C is a randomized, double-blind, placebo-controlled, parallel-group clinical trial with 12 weeks of study drug therapy.
Detailed Description
This study in patients with IBS-C is a randomized, double-blind, placebo-controlled, parallel-group clinical trial with 12 weeks of study drug therapy. Screening/Baseline: Patients will undergo an up to 28-day Screening/Baseline period to allow for any necessary diagnostic procedures, allow for required washout of medications and to determine study eligibility. If otherwise eligible based on screening criteria, patients will undergo a 2-week baseline assessment using an electronic diary where they will record daily assessments of bowel movements (BMs), stool consistency (Bristol Stool Form Scale-BSFS), abdominal pain and other IBS-related symptoms. Data from the two-week electronic diary assessment just prior to the randomization visit will be used to confirm IBS-C and study eligibility as well as define the patient's baseline from which change will be determined. Treatment: Patients who meet all entry criteria will be randomized (1:1:1) to one of three blinded treatment groups on Day 1 of the Treatment period. Patients will take an oral dose of study drug OD for 12 weeks and continue the daily electronic diaries (BMs, rescue medication use, abdominal pain, and other symptoms). During treatment weeks 4, 8, and 12, patients will return to the clinic to undergo safety and efficacy assessments. Post-Treatment: For 2 weeks after completing dosing, patients will continue to complete daily electronic diaries. Patients will then return to the clinical site for a final follow-up visit during Week 14 following randomization. The planned duration of participation in this study will be at least 116 days from signing of informed consent through post-treatment or up to approximately 135 days with visit 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 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
1135 (Actual)

8. Arms, Groups, and Interventions

Arm Title
3.0 mg plecanatide
Arm Type
Active Comparator
Arm Description
Plecanatide 3.0 mg dosed daily for 12 weeks
Arm Title
6.0 mg plecanatide
Arm Type
Active Comparator
Arm Description
Plecanatide 6.0 mg dosed daily for 12 weeks
Arm Title
Matching placebo
Arm Type
Active Comparator
Arm Description
Placebo dosed daily for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Plecanatide
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Number of Overall Responders - ITT Population
Description
An Overall Responder was a patient who was a weekly responder (i.e., decrease of 30% from baseline for abdominal pain intensity and an increase of at least 1 complete spontaneous bowel movement in the same week) for at least 6 of the 12 treatment weeks.
Time Frame
12 weeks
Title
Number of Abdominal Pain Responders for at Least 6 of 12 Treatment Weeks
Description
An Abdominal Pain Intensity Responder was a patient who had a decrease of 30 % from baseline for abdominal pain intensity. Baseline is the mean of non-missing abdominal pain scores recorded during the 2-week baseline diary assessment period prior to the first dose of study drug.
Time Frame
12 Weeks
Title
Number of Stool Frequency Responder for at Least 6 of the 12 Treatment Weeks
Description
A Stool Frequency Responder was a patient who experienced an increase of at least one CSBM (complete spontaneous bowel movement) per week from baseline. Baseline was the mean number of CSBMs recorded during the 2-week baseline diary assessment period prior to the first dose of study drug.
Time Frame
12 Weeks
Secondary Outcome Measure Information:
Title
Number of Sustained Efficacy Responders
Description
A Sustained Efficacy Responder was a patient who was an Overall Responder who also was a Weekly Responder, i.e., decreased of 30% from baseline for abdominal pain intensity and increased of at least one CSBM (complete spontaneous bowel movement) in the same week for at least 2 of the 4 weeks in month 3 of the Treatment Period.
Time Frame
12 Weeks
Title
Change From Baseline in Stool Consistency
Description
Change from baseline in stool consistency based upon the Bristol Stool Form Scale (BSFS). Baseline was the mean BSFS score recorded during the 2-week baseline diary assessment period prior to the first dose of study drug. BSFS Rating 1 to 7: Separate hard lumps, like nuts (hard 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
Baseline and 12-Week
Title
Change From Baseline in Straining
Description
Change from baseline in Straining Score over the 12-week treatment period. Baseline was the mean of non-missing straining scores recorded during the 2-week baseline diary assessment period prior to the first dose of study drug. The severity of straining during a bowel movement was measured using an 11-point scale (0-10 rating; 0 = no straining; 10 = worst straining).
Time Frame
Baseline and 12-Week
Title
Change From Baseline in CSBMs (CSBMs/Week)Complete Spontaneous Bowel Movement
Description
Change from baseline over the 12-week Treatment Period in CSBM (Complete Spontaneous Bowel Movement) Frequency Rate (CSBMs/Week). Baseline was the mean number of CSBMs recorded during the 2-week baseline diary assessment period prior to the first dose of study drug.
Time Frame
Baseline and 12-Week
Title
Number of Patients With a SBM Within 24 Hours After First Dose of Study Medication
Description
A responder was any patient with a SBM within 24 hours after the first dose of study drug.
Time Frame
Up to 24 hours after the first dose of study drug
Title
Change From Baseline in Abdominal Pain
Description
Change from baseline in abdominal pain as measured with an 11-point (0-10) Numerical Rating Scale from 0 (None) to 10 (Worst Possible). Baseline was the mean of the non-missing abdominal pain scores recorded during the 2-week baseline diary assessment period prior to the first dose of study drug. The average daily abdominal pain score was the average of the non-missing worst daily abdominal pain scores (on a 0 to 10 scale) in the given week.
Time Frame
Baseline and 12-Week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: • Adult patients between the ages of 18 and 85 years (inclusive) with a diagnosis of IBS based on ROME III diagnostic criteria and meeting criteria for diagnosis of the constipation predominant subtype - IBS-C Exclusion Criteria: Refusal or inability to sign informed consent for the trial Refusal or inability to complete daily Episodic (real-time) BM / RM calls, End of Day daily Calls, and/or complete electronic questionnaires BMI ≥ 40 or < 18 Women of child bearing potential who refuse to use an acceptable method of birth control for the duration of the trial Women who are pregnant or lactating Diagnosis of IBS-D or IBS-M Organic or obstructive disease of the small or large intestine Use of laxatives other than the study-supplied rescue medication (Dulcolax®, bisacodyl) Use of a prohibited concomitant medication within the time frame prior to screening outlined in the study protocol for that medication Unstable medical illness Bilirubin > 3X ULN in the absence of a conjugation defect Any laboratory value > 3X ULN unless discussed and approved by the study Medical Monitor
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul F.C. Eng, PhD
Organizational Affiliation
Synergy Pharmaceuticals Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Synergy Research Site
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States
Facility Name
Synergy Research Site
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35216
Country
United States
Facility Name
Synergy Research Site
City
Guntersville
State/Province
Alabama
ZIP/Postal Code
35976
Country
United States
Facility Name
Synergy Research Site
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
Synergy Research Site
City
Saraland
State/Province
Alabama
ZIP/Postal Code
36571
Country
United States
Facility Name
Synergy Research Site
City
Glendale
State/Province
Arizona
ZIP/Postal Code
85301
Country
United States
Facility Name
Synergy Research Site
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85018
Country
United States
Facility Name
Synergy Research Site
City
Surprise
State/Province
Arizona
ZIP/Postal Code
85374
Country
United States
Facility Name
Synergy Research Site
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85745
Country
United States
Facility Name
Synergy Research Site
City
Conway
State/Province
Arkansas
ZIP/Postal Code
72034
Country
United States
Facility Name
Synergy Research Site
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Synergy Research Site
City
Canoga Park
State/Province
California
ZIP/Postal Code
91303
Country
United States
Facility Name
Synergy Research Site
City
Carmichael
State/Province
California
ZIP/Postal Code
95608
Country
United States
Facility Name
Synergy Research Site
City
Chino
State/Province
California
ZIP/Postal Code
91710
Country
United States
Facility Name
Synergy Research Site
City
Chula Vista
State/Province
California
ZIP/Postal Code
91910
Country
United States
Facility Name
Synergy Research Site
City
El Cajon
State/Province
California
ZIP/Postal Code
92020
Country
United States
Facility Name
Synergy Research Site
City
Encino
State/Province
California
ZIP/Postal Code
91436
Country
United States
Facility Name
Synergy Research Site
City
Foothill Ranch
State/Province
California
ZIP/Postal Code
92610
Country
United States
Facility Name
Synergy Research Site
City
Garden Grove
State/Province
California
ZIP/Postal Code
92844
Country
United States
Facility Name
Synergy Research Site
City
Huntington Beach
State/Province
California
ZIP/Postal Code
92647
Country
United States
Facility Name
Synergy Research Site
City
Irvine
State/Province
California
ZIP/Postal Code
92614
Country
United States
Facility Name
Synergy Research Site
City
Lomita
State/Province
California
ZIP/Postal Code
90717
Country
United States
Facility Name
Synergy Research Site
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Facility Name
Synergy Research Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90045
Country
United States
Facility Name
Synergy Research Site
City
Mission Hills
State/Province
California
ZIP/Postal Code
91345
Country
United States
Facility Name
Synergy Research Site
City
Montclair
State/Province
California
ZIP/Postal Code
91763
Country
United States
Facility Name
Synergy Research Site
City
Northridge
State/Province
California
ZIP/Postal Code
91324
Country
United States
Facility Name
Synergy Research Site
City
Norwalk
State/Province
California
ZIP/Postal Code
90650
Country
United States
Facility Name
Synergy Research Site
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
Facility Name
Synergy Research Site
City
Orangevale
State/Province
California
ZIP/Postal Code
95662
Country
United States
Facility Name
Synergy Research Site
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Synergy Research Site
City
Placentia
State/Province
California
ZIP/Postal Code
92870
Country
United States
Facility Name
Synergy Research Site
City
Riverside
State/Province
California
ZIP/Postal Code
92501
Country
United States
Facility Name
Synergy Research Site
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Synergy Research Site
City
San Marino
State/Province
California
ZIP/Postal Code
91108
Country
United States
Facility Name
Synergy Research Site
City
Santa Ana
State/Province
California
Country
United States
Facility Name
Synergy Research Site
City
Sherman Oaks
State/Province
California
ZIP/Postal Code
91403
Country
United States
Facility Name
Synergy Research Site
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80920
Country
United States
Facility Name
Synergy Research Site
City
Denver
State/Province
Colorado
ZIP/Postal Code
80246
Country
United States
Facility Name
Synergy Research Site
City
Hamden
State/Province
Connecticut
ZIP/Postal Code
06517
Country
United States
Facility Name
Synergy Research Site
City
Atlantis
State/Province
Florida
ZIP/Postal Code
33462
Country
United States
Facility Name
Synergy Research Site
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33428
Country
United States
Facility Name
Synergy Research Site
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34201
Country
United States
Facility Name
Synergy Research Site
City
Brandon
State/Province
Florida
ZIP/Postal Code
33511
Country
United States
Facility Name
Synergy Research Site
City
Brooksville
State/Province
Florida
ZIP/Postal Code
34601
Country
United States
Facility Name
Synergy Research Site
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33756
Country
United States
Facility Name
Synergy Research Site
City
Cutler Bay
State/Province
Florida
ZIP/Postal Code
33189
Country
United States
Facility Name
Synergy Research Site
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33306
Country
United States
Facility Name
Synergy Research Site
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33312
Country
United States
Facility Name
Synergy Research Site
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33012
Country
United States
Facility Name
Synergy Research Site
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33013
Country
United States
Facility Name
Synergy Research Site
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Facility Name
Synergy Research Site.
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Facility Name
Synergy Research Site
City
Lauderdale Lakes
State/Province
Florida
ZIP/Postal Code
33319
Country
United States
Facility Name
Synergy Research Site
City
Maitland
State/Province
Florida
ZIP/Postal Code
32751
Country
United States
Facility Name
Synergy Research Site
City
Miami Lakes
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Facility Name
Synergy Research Site
City
Miami Lakes
State/Province
Florida
ZIP/Postal Code
33173
Country
United States
Facility Name
Synergy Research Site
City
Miami Springs
State/Province
Florida
ZIP/Postal Code
33166
Country
United States
Facility Name
Synergy Research Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33015
Country
United States
Facility Name
Synergy Research Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Facility Name
Synergy Research Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33032
Country
United States
Facility Name
Synergy Research Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33122
Country
United States
Facility Name
Synergy Research Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33126
Country
United States
Facility Name
Synergy Research Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Synergy Research Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33144
Country
United States
Facility Name
Synergy Research Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States
Facility Name
Synergy Research Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33165
Country
United States
Facility Name
Synergy Research Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33173
Country
United States
Facility Name
Synergy Research Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Facility Name
Synergy Research Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33183
Country
United States
Facility Name
Synergy Research Site
City
Naples
State/Province
Florida
ZIP/Postal Code
34102
Country
United States
Facility Name
Synergy Research Site
City
North Miami Beach
State/Province
Florida
ZIP/Postal Code
33162
Country
United States
Facility Name
Synergy Research Site
City
Orange Park
State/Province
Florida
ZIP/Postal Code
32073
Country
United States
Facility Name
Synergy Research Site.
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Synergy Research Site
City
Orlando
State/Province
Florida
ZIP/Postal Code
32807
Country
United States
Facility Name
Synergy Research Site
City
Ormond Beach
State/Province
Florida
ZIP/Postal Code
32174
Country
United States
Facility Name
Synergy Research Site
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33024
Country
United States
Facility Name
Synergy Research Site
City
Pinellas Park
State/Province
Florida
ZIP/Postal Code
33782
Country
United States
Facility Name
Synergy Research Site
City
Port Orange
State/Province
Florida
ZIP/Postal Code
32127
Country
United States
Facility Name
Synergy Research Site
City
Tamarac
State/Province
Florida
ZIP/Postal Code
33319
Country
United States
Facility Name
Synergy Research Site
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Facility Name
Synergy Research Site
City
Tampa
State/Province
Florida
ZIP/Postal Code
33634
Country
United States
Facility Name
Synergy Research Site
City
Williston
State/Province
Florida
ZIP/Postal Code
32696
Country
United States
Facility Name
Synergy Research Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Synergy Research Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Synergy Research Site
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
Facility Name
Synergy Research Site
City
Lilburn
State/Province
Georgia
ZIP/Postal Code
30047
Country
United States
Facility Name
Synergy Research Site
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Synergy Research Site
City
Snellville
State/Province
Georgia
ZIP/Postal Code
30078
Country
United States
Facility Name
Synergy Research Site
City
Blackfoot
State/Province
Idaho
ZIP/Postal Code
83221
Country
United States
Facility Name
Synergy Research Site
City
Boise
State/Province
Idaho
ZIP/Postal Code
83709
Country
United States
Facility Name
Synergy Research Site
City
Meridian
State/Province
Idaho
ZIP/Postal Code
83646
Country
United States
Facility Name
Synergy Research Site
City
Blue Island
State/Province
Illinois
ZIP/Postal Code
60406
Country
United States
Facility Name
Synergy Research Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60602
Country
United States
Facility Name
Synergy Research Site
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States
Facility Name
Synergy Research Site
City
Hoffman Estates
State/Province
Illinois
ZIP/Postal Code
60169
Country
United States
Facility Name
Synergy Research Site
City
Morton
State/Province
Illinois
ZIP/Postal Code
61550
Country
United States
Facility Name
Synergy Research Site
City
Oak Lawn
State/Province
Illinois
ZIP/Postal Code
60453
Country
United States
Facility Name
Synergy Research Site
City
Schaumburg
State/Province
Illinois
ZIP/Postal Code
60194
Country
United States
Facility Name
Synergy Research Site
City
Brownsburg
State/Province
Indiana
ZIP/Postal Code
46112
Country
United States
Facility Name
Synergy Research Site
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46237
Country
United States
Facility Name
Synergy Research Site
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67203
Country
United States
Facility Name
Synergy Research Site
City
Madisonville
State/Province
Kentucky
ZIP/Postal Code
42431
Country
United States
Facility Name
Synergy Research Site
City
Owensboro
State/Province
Kentucky
ZIP/Postal Code
42303
Country
United States
Facility Name
Synergy Research Site
City
Marrero
State/Province
Louisiana
ZIP/Postal Code
70072
Country
United States
Facility Name
Synergy Research Site
City
Annapolis
State/Province
Maryland
ZIP/Postal Code
21401
Country
United States
Facility Name
Synergy Research Site
City
Catonsville
State/Province
Maryland
ZIP/Postal Code
21228
Country
United States
Facility Name
Synergy Research Site
City
Oxon Hill
State/Province
Maryland
ZIP/Postal Code
20745
Country
United States
Facility Name
Synergy Research Site
City
Towson
State/Province
Maryland
ZIP/Postal Code
21204
Country
United States
Facility Name
Synergy Research Site
City
Marlborough
State/Province
Massachusetts
ZIP/Postal Code
01752
Country
United States
Facility Name
Synergy Research Site
City
Quincy
State/Province
Massachusetts
ZIP/Postal Code
02169
Country
United States
Facility Name
Synergy Research Site
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49009
Country
United States
Facility Name
Synergy Research Site
City
Port Gibson
State/Province
Mississippi
ZIP/Postal Code
39150
Country
United States
Facility Name
Synergy Research Site
City
Chesterfield
State/Province
Missouri
ZIP/Postal Code
63005
Country
United States
Facility Name
Synergy Research Site
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63128
Country
United States
Facility Name
Synergy Research Site
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Synergy Research Site
City
Missoula
State/Province
Montana
ZIP/Postal Code
59808
Country
United States
Facility Name
Synergy Research Site
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Facility Name
Synergy Research Site
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89119
Country
United States
Facility Name
Synergy Research Site
City
Blackwood
State/Province
New Jersey
ZIP/Postal Code
08012
Country
United States
Facility Name
Synergy Research Site
City
Egg Harbor Township
State/Province
New Jersey
ZIP/Postal Code
08234
Country
United States
Facility Name
Synergy Research Site
City
Vineland
State/Province
New Jersey
ZIP/Postal Code
08360
Country
United States
Facility Name
Synergy Research Site
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87109
Country
United States
Facility Name
Synergy Research Site
City
Hopewell Junction
State/Province
New York
ZIP/Postal Code
12533
Country
United States
Facility Name
Synergy Research Site
City
Kew Gardens
State/Province
New York
ZIP/Postal Code
11415
Country
United States
Facility Name
Synergy Research Site
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Synergy Research Site
City
Poughkeepsie
State/Province
New York
ZIP/Postal Code
12601
Country
United States
Facility Name
Synergy Research Site
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27514
Country
United States
Facility Name
Synergy Research Site
City
Fayetteville
State/Province
North Carolina
ZIP/Postal Code
28304
Country
United States
Facility Name
Synergy Research Site
City
High Point
State/Province
North Carolina
ZIP/Postal Code
27262
Country
United States
Facility Name
Synergy Research Site
City
Jacksonville
State/Province
North Carolina
ZIP/Postal Code
28546
Country
United States
Facility Name
Synergy Research Site
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27609
Country
United States
Facility Name
Synergy Research Site
City
Salisbury
State/Province
North Carolina
ZIP/Postal Code
28144
Country
United States
Facility Name
Synergy Research Site
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Synergy Research Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45224
Country
United States
Facility Name
Synergy Research Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
Facility Name
Synergy Research Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45249
Country
United States
Facility Name
Synergy Research Site
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43214
Country
United States
Facility Name
Synergy Research Site
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45419
Country
United States
Facility Name
Synergy Research Site
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45439
Country
United States
Facility Name
Synergy Research Site
City
Franklin
State/Province
Ohio
ZIP/Postal Code
45005
Country
United States
Facility Name
Synergy Research Site
City
Kettering
State/Province
Ohio
ZIP/Postal Code
45429
Country
United States
Facility Name
Synergy Research Site
City
Mentor
State/Province
Ohio
ZIP/Postal Code
44060
Country
United States
Facility Name
Synergy Research Site
City
Middleburg Heights
State/Province
Ohio
ZIP/Postal Code
44130
Country
United States
Facility Name
Synergy Research Site
City
Wadsworth
State/Province
Ohio
ZIP/Postal Code
44203
Country
United States
Facility Name
Synergy Research Site
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Synergy Research Site
City
Doylestown
State/Province
Pennsylvania
ZIP/Postal Code
18901
Country
United States
Facility Name
Synergy Research Site
City
Lansdale
State/Province
Pennsylvania
ZIP/Postal Code
19446
Country
United States
Facility Name
Synergy Research Site
City
Levittown
State/Province
Pennsylvania
ZIP/Postal Code
19056
Country
United States
Facility Name
Synergy Research Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States
Facility Name
Synergy Research Site
City
Anderson
State/Province
South Carolina
ZIP/Postal Code
29621
Country
United States
Facility Name
Synergy Research Site
City
Greer
State/Province
South Carolina
ZIP/Postal Code
29651
Country
United States
Facility Name
Synergy Research Site
City
Mount Pleasant
State/Province
South Carolina
ZIP/Postal Code
29464
Country
United States
Facility Name
Synergy Research Site
City
Fayetteville
State/Province
Tennessee
ZIP/Postal Code
37334
Country
United States
Facility Name
Synergy Research Site
City
Franklin
State/Province
Tennessee
ZIP/Postal Code
37067
Country
United States
Facility Name
Synergy Research Site
City
Hermitage
State/Province
Tennessee
ZIP/Postal Code
37076
Country
United States
Facility Name
Synergy Research Site
City
Jackson
State/Province
Tennessee
ZIP/Postal Code
38305
Country
United States
Facility Name
Synergy Research Site
City
Kingsport
State/Province
Tennessee
ZIP/Postal Code
37660
Country
United States
Facility Name
Synergy Research Site
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37909
Country
United States
Facility Name
Synergy Research Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Facility Name
Synergy Research Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78758
Country
United States
Facility Name
Synergy Research Site
City
Baytown
State/Province
Texas
ZIP/Postal Code
77521
Country
United States
Facility Name
Synergy Research Site
City
Beaumont
State/Province
Texas
ZIP/Postal Code
77701
Country
United States
Facility Name
Synergy Research Site
City
Channelview
State/Province
Texas
ZIP/Postal Code
77530
Country
United States
Facility Name
Synergy Research Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75224
Country
United States
Facility Name
Synergy Research Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Synergy Research Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75254
Country
United States
Facility Name
Synergy Research Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77008
Country
United States
Facility Name
Synergy Research Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77081
Country
United States
Facility Name
Synergy Research Site
City
Humble
State/Province
Texas
ZIP/Postal Code
77338
Country
United States
Facility Name
Synergy Research Site
City
Lampasas
State/Province
Texas
ZIP/Postal Code
76550
Country
United States
Facility Name
Synergy Research Site
City
McKinney
State/Province
Texas
ZIP/Postal Code
75070
Country
United States
Facility Name
Synergy Research Site
City
Missouri City
State/Province
Texas
ZIP/Postal Code
77459
Country
United States
Facility Name
Synergy Research Site
City
Plano
State/Province
Texas
ZIP/Postal Code
75024
Country
United States
Facility Name
Synergy Research Site
City
Plano
State/Province
Texas
ZIP/Postal Code
75075
Country
United States
Facility Name
Synergy Research Site
City
Port Arthur
State/Province
Texas
ZIP/Postal Code
77640
Country
United States
Facility Name
Synergy Research Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78209
Country
United States
Facility Name
Synergy Research Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States
Facility Name
Synergy Research Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Synergy Research Site
City
Sugar Land
State/Province
Texas
ZIP/Postal Code
77478
Country
United States
Facility Name
Synergy Research Site
City
Orem
State/Province
Utah
ZIP/Postal Code
84058
Country
United States
Facility Name
Synergy Research Site
City
West Valley City
State/Province
Utah
ZIP/Postal Code
84120
Country
United States
Facility Name
Synergy Research Site
City
Chesapeake
State/Province
Virginia
ZIP/Postal Code
23320
Country
United States
Facility Name
Synergy Research Site
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Facility Name
Synergy Research Site
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Facility Name
Synergy Research Site
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23220
Country
United States
Facility Name
Synergy Research Site
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23235
Country
United States
Facility Name
Synergy Research Site
City
Spokane
State/Province
Washington
ZIP/Postal Code
99202
Country
United States
Facility Name
Synergy Research Site
City
Vancouver
State/Province
Washington
ZIP/Postal Code
98664
Country
United States
Facility Name
Synergy Research Site
City
Kingwood
State/Province
West Virginia
ZIP/Postal Code
26537
Country
United States
Facility Name
Synergy Research Site
City
La Crosse
State/Province
Wisconsin
ZIP/Postal Code
54601
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
32660770
Citation
Menees SB, Franklin H, Chey WD. Evaluation of Plecanatide for the Treatment of Chronic Idiopathic Constipation and Irritable Bowel Syndrome With Constipation in Patients 65 Years or Older. Clin Ther. 2020 Jul;42(7):1406-1414.e4. doi: 10.1016/j.clinthera.2020.05.012. Epub 2020 Jul 10.
Results Reference
derived

Learn more about this trial

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

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