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12-Week Study of Plecanatide for CIC (The CIC3 Study)

Primary Purpose

Chronic Idiopathic Constipation

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Plecanatide
Placebo
Bisacodyl
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 CIC, Constipation, Chronic Constipation, Synergy, Plecanatide

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Male or female aged 18-80, inclusive
  • Meets modified Rome III criteria for functional chronic idiopathic constipation for at least 3 months with symptom onset for at least 6 months
  • Completed a colonoscopy in accordance with AGA colon cancer screening guidelines (5 years), with no clinically significant findings
  • Willing to maintain a stable diet during 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 pre-treatment assessment
  • Active peptic ulcer disease, diabetes or hypertension 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, stroke or MI within 60 days of screening
  • Participated in a previous plecanatide clinical trial

Sites / Locations

  • Synergy Research Site
  • Synergy Research Site
  • Synergy Research Site
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Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Other

Arm Label

Plecanatide 3.0 mg

Plecanatide 6.0 mg

Placebo

Bisacodyl

Arm Description

Plecanatide tablets 3.0 mg QD for 12 weeks

Plecanatide tablets 6.0 mg QD for 12 weeks

Matching placebo tablets QD for 12 weeks

Rescue medication

Outcomes

Primary Outcome Measures

Number of Durable Overall CSBM Responders , Mean Replacement Approach
A durable overall CSBM responder was defined as a weekly CSBM responder for at least 9 of the 12 treatment weeks, included at least 3 of the last 4 weeks. A CSBM weekly responder was defined as a patient who has ≥ 3 Complete Spontaneous Bowel Movements (CSBMs) per week and an increase from baseline of ≥1 CSBM for that week. A CSBM was a bowel movement that occurred in the absence of laxative use within 24 hours and was associated with the feeling of complete evacuation.

Secondary Outcome Measures

Change From Baseline in CSBMs (CSBMS/Week) Over 12-week Treatment Period, Mean Replacement Approach
A Complete Spontaneous Bowel Movement (CSBM) was a Bowel Movement (BM) that occurred in the absence of laxative use within 24 hours of the BM and the patient reported a feeling of complete evacuation. A weekly responder had 3 or more CSBMs and an increase of at least one CSBM from baseline in the same week.
Change From Baseline in SBM (SBMs/Week) Over 12-week Treatment Period, Mean Replacement Approach
The change from baseline in the number of Spontaneous Bowel Movement (SBM) over the 12-week Treatment Period was assessed. Baseline was the mean number of SBMs recorded during the 2-week baseline diary assessment period prior to the first dose of study drug. The weekly SBM totals were derived from the daily diary entries reported during the Treatment Period in the BM and Symptom Diary.
Change From Baseline in Stool Consistency Score Over the 12-week Treatment Period, Mean Replacement Approach
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 Score Over 12-Week Treatment Period, Mean Replacement Approach
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 weekly average straining score was derived from the straining scores reported during the Treatment Period in the Daily Symptom Diary. The severity of straining during bowel movements was assessed on a 5-point Likert scale where 0 = none, 1 = mild, 2 = moderate, 3 = severe, and 4 = very severe.

Full Information

First Posted
November 5, 2013
Last Updated
December 16, 2019
Sponsor
Bausch Health Americas, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01982240
Brief Title
12-Week Study of Plecanatide for CIC (The CIC3 Study)
Official Title
A Randomized, 12-Week, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of Plecanatide (3.0 and 6.0 mg) in Patients With Chronic Idiopathic Constipation (The CIC3 Study)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
November 2013 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
June 2015 (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
The purpose of this study is to confirm that the investigational medication, plecanatide, is safe and effective in treating chronic idiopathic constipation.
Detailed Description
This is a randomized, 12-week, double-blind, placebo-controlled, study in approximately 1350 adult male and female patients with CIC comparing 2 doses of plecanatide to placebo. The study will be conducted at approximately 180 clinical study sites in the United States (US) and Canada. The primary objective of the study is to evaluate the efficacy and safety of 3.0 and 6.0 mg of plecanatide administered once daily (QD) for 12 weeks in a population of patients with CIC. The study population will include only patients without other causes of constipation or other chronic conditions that could interfere with study assessments. Patients may not take laxatives (with the exception of the study-provided rescue medication, bisacodyl 5mg tablets), or a number of prohibited drugs that are known to cause constipation or diarrhea, during study participation. There are 6 scheduled study visits, including the screening and follow-up visits. The planned duration of participation in this study will be 112 days and up to 155 days, with washout and all visit windows considered.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Idiopathic Constipation
Keywords
CIC, Constipation, Chronic Constipation, Synergy, Plecanatide

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1394 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Plecanatide 3.0 mg
Arm Type
Active Comparator
Arm Description
Plecanatide tablets 3.0 mg QD for 12 weeks
Arm Title
Plecanatide 6.0 mg
Arm Type
Active Comparator
Arm Description
Plecanatide tablets 6.0 mg QD for 12 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Matching placebo tablets QD for 12 weeks
Arm Title
Bisacodyl
Arm Type
Other
Arm Description
Rescue medication
Intervention Type
Drug
Intervention Name(s)
Plecanatide
Other Intervention Name(s)
Trulance
Intervention Description
Plecanatide tablets QD for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Trulance placebo
Intervention Description
Matching placebo tablets QD for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Bisacodyl
Other Intervention Name(s)
Dulcolax
Intervention Description
Rescue medication
Primary Outcome Measure Information:
Title
Number of Durable Overall CSBM Responders , Mean Replacement Approach
Description
A durable overall CSBM responder was defined as a weekly CSBM responder for at least 9 of the 12 treatment weeks, included at least 3 of the last 4 weeks. A CSBM weekly responder was defined as a patient who has ≥ 3 Complete Spontaneous Bowel Movements (CSBMs) per week and an increase from baseline of ≥1 CSBM for that week. A CSBM was a bowel movement that occurred in the absence of laxative use within 24 hours and was associated with the feeling of complete evacuation.
Time Frame
12-week Treatment Period
Secondary Outcome Measure Information:
Title
Change From Baseline in CSBMs (CSBMS/Week) Over 12-week Treatment Period, Mean Replacement Approach
Description
A Complete Spontaneous Bowel Movement (CSBM) was a Bowel Movement (BM) that occurred in the absence of laxative use within 24 hours of the BM and the patient reported a feeling of complete evacuation. A weekly responder had 3 or more CSBMs and an increase of at least one CSBM from baseline in the same week.
Time Frame
12-Week Treatment Period
Title
Change From Baseline in SBM (SBMs/Week) Over 12-week Treatment Period, Mean Replacement Approach
Description
The change from baseline in the number of Spontaneous Bowel Movement (SBM) over the 12-week Treatment Period was assessed. Baseline was the mean number of SBMs recorded during the 2-week baseline diary assessment period prior to the first dose of study drug. The weekly SBM totals were derived from the daily diary entries reported during the Treatment Period in the BM and Symptom Diary.
Time Frame
12-Week Treatment Period
Title
Change From Baseline in Stool Consistency Score Over the 12-week Treatment Period, Mean Replacement Approach
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 Score Over 12-Week Treatment Period, Mean Replacement Approach
Description
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 weekly average straining score was derived from the straining scores reported during the Treatment Period in the Daily Symptom Diary. The severity of straining during bowel movements was assessed on a 5-point Likert scale where 0 = none, 1 = mild, 2 = moderate, 3 = severe, and 4 = very severe.
Time Frame
12-Week Treatment Period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female aged 18-80, inclusive Meets modified Rome III criteria for functional chronic idiopathic constipation for at least 3 months with symptom onset for at least 6 months Completed a colonoscopy in accordance with AGA colon cancer screening guidelines (5 years), with no clinically significant findings Willing to maintain a stable diet during 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 pre-treatment assessment Active peptic ulcer disease, diabetes or hypertension 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, stroke or MI within 60 days of screening Participated in a previous plecanatide clinical trial
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mary Beth Layton
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
35242
Country
United States
Facility Name
Synergy Research Site
City
Dothan
State/Province
Alabama
ZIP/Postal Code
36305
Country
United States
Facility Name
Synergy Research Site
City
Gulf Shores
State/Province
Alabama
ZIP/Postal Code
36542
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
Mobile
State/Province
Alabama
ZIP/Postal Code
36695
Country
United States
Facility Name
Synergy Research Site
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85206
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
Phoenix
State/Province
Arizona
ZIP/Postal Code
85023
Country
United States
Facility Name
Synergy Research Site
City
Tempe
State/Province
Arizona
ZIP/Postal Code
85283
Country
United States
Facility Name
Synergy Research Site
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
Synergy Research Site
City
Hot Springs
State/Province
Arkansas
ZIP/Postal Code
71913
Country
United States
Facility Name
Synergy Research Site
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72211
Country
United States
Facility Name
Synergy Research Site
City
North Little Rock
State/Province
Arkansas
ZIP/Postal Code
72117
Country
United States
Facility Name
Synergy Research Site
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
Synergy Research Site
City
Anaheim
State/Province
California
ZIP/Postal Code
92804
Country
United States
Facility Name
Synergy Research Site
City
Carlsbad
State/Province
California
ZIP/Postal Code
92008
Country
United States
Facility Name
Synergy Research Site
City
Cerritos
State/Province
California
ZIP/Postal Code
90703
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
Encinitas
State/Province
California
ZIP/Postal Code
92024
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
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
Facility Name
Synergy Research Site
City
Fresno
State/Province
California
ZIP/Postal Code
93726
Country
United States
Facility Name
Synergy Research Site
City
Hawaiian Gardens
State/Province
California
ZIP/Postal Code
90716
Country
United States
Facility Name
Synergy Research Site
City
Lancaster
State/Province
California
ZIP/Postal Code
93534
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
90015
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
Los Angeles
State/Province
California
ZIP/Postal Code
90067
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
Murrieta
State/Province
California
ZIP/Postal Code
92562
Country
United States
Facility Name
Synergy Research Site
City
North Hollywood
State/Province
California
ZIP/Postal Code
91606
Country
United States
Facility Name
Synergy Research Site
City
Oceanside
State/Province
California
ZIP/Postal Code
92054
Country
United States
Facility Name
Synergy Research Site
City
Oxnard
State/Province
California
ZIP/Postal Code
93030
Country
United States
Facility Name
Synergy Research Site
City
Pasadena
State/Province
California
ZIP/Postal Code
91105
Country
United States
Facility Name
Synergy Research Site
City
Poway
State/Province
California
ZIP/Postal Code
92064
Country
United States
Facility Name
Synergy Research Site
City
Sacramento
State/Province
California
ZIP/Postal Code
95816
Country
United States
Facility Name
Synergy Research Site
City
San Diego
State/Province
California
ZIP/Postal Code
92101
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 Diego
State/Province
California
ZIP/Postal Code
92108
Country
United States
Facility Name
Synergy Research Site
City
San Diego
State/Province
California
ZIP/Postal Code
92114
Country
United States
Facility Name
Synergy Research Site
City
Thousand Oaks
State/Province
California
ZIP/Postal Code
91360
Country
United States
Facility Name
Synergy Research Site
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80907
Country
United States
Facility Name
Synergy Research Site
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80909
Country
United States
Facility Name
Synergy Research Site
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Facility Name
Synergy Research Site
City
Denver
State/Province
Colorado
ZIP/Postal Code
80220
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
Littleton
State/Province
Colorado
ZIP/Postal Code
80120
Country
United States
Facility Name
Synergy Research Site
City
Bristol
State/Province
Connecticut
ZIP/Postal Code
06010
Country
United States
Facility Name
Synergy Research Site
City
Danbury
State/Province
Connecticut
ZIP/Postal Code
06810
Country
United States
Facility Name
Synergy Research Site
City
Waterbury
State/Province
Connecticut
ZIP/Postal Code
06708
Country
United States
Facility Name
Synergy Research Site
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33426
Country
United States
Facility Name
Synergy Research Site
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33759
Country
United States
Facility Name
Synergy Research Site
City
DeLand
State/Province
Florida
ZIP/Postal Code
32720
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
33308
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
Jupiter
State/Province
Florida
ZIP/Postal Code
33458
Country
United States
Facility Name
Synergy Research Site
City
Lakeland
State/Province
Florida
ZIP/Postal Code
33805
Country
United States
Facility Name
Synergy Research Site
City
Lynn Haven
State/Province
Florida
ZIP/Postal Code
32444
Country
United States
Facility Name
Synergy Research Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33130
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
33174
Country
United States
Facility Name
Synergy Research Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33185
Country
United States
Facility Name
Synergy Research Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33186
Country
United States
Facility Name
Synergy Research Site
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
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
Port Orange
State/Province
Florida
ZIP/Postal Code
32129
Country
United States
Facility Name
Synergy Research Site
City
Tampa
State/Province
Florida
ZIP/Postal Code
33604
Country
United States
Facility Name
Synergy Research Site
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
Synergy Research Site
City
Tampa
State/Province
Florida
ZIP/Postal Code
33617
Country
United States
Facility Name
Synergy Research Site
City
Athens
State/Province
Georgia
ZIP/Postal Code
30606
Country
United States
Facility Name
Synergy Research Site
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Facility Name
Synergy Research Site
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30032
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
Johns Creek
State/Province
Georgia
ZIP/Postal Code
30097
Country
United States
Facility Name
Synergy Research Site
City
Oakwood
State/Province
Georgia
ZIP/Postal Code
30566
Country
United States
Facility Name
Synergy Research Site
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31406
Country
United States
Facility Name
Synergy Research Site
City
Smyrna
State/Province
Georgia
ZIP/Postal Code
30082
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
Clive
State/Province
Iowa
ZIP/Postal Code
50325
Country
United States
Facility Name
Synergy Research Site
City
Augusta
State/Province
Kansas
ZIP/Postal Code
67010
Country
United States
Facility Name
Synergy Research Site
City
Newton
State/Province
Kansas
ZIP/Postal Code
67114
Country
United States
Facility Name
Synergy Research Site
City
Shawnee Mission
State/Province
Kansas
ZIP/Postal Code
66218
Country
United States
Facility Name
Synergy Research Site
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67205
Country
United States
Facility Name
Synergy Research Site
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67207
Country
United States
Facility Name
Synergy Research Site
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40503
Country
United States
Facility Name
Synergy Research Site
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40504
Country
United States
Facility Name
Synergy Research Site
City
Bastrop
State/Province
Louisiana
ZIP/Postal Code
71220
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
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Facility Name
Synergy Research Site
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70115
Country
United States
Facility Name
Synergy Research Site
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70119
Country
United States
Facility Name
Synergy Research Site
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71103
Country
United States
Facility Name
Synergy Research Site
City
Chevy Chase
State/Province
Maryland
ZIP/Postal Code
20815
Country
United States
Facility Name
Synergy Research Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02131
Country
United States
Facility Name
Synergy Research Site
City
Brockton
State/Province
Massachusetts
ZIP/Postal Code
02302
Country
United States
Facility Name
Synergy Research Site
City
New Bedford
State/Province
Massachusetts
ZIP/Postal Code
02740
Country
United States
Facility Name
Synergy Research Site
City
Chesterfield
State/Province
Michigan
ZIP/Postal Code
48047
Country
United States
Facility Name
Synergy Research Site
City
Flint
State/Province
Michigan
ZIP/Postal Code
48504
Country
United States
Facility Name
Synergy Research Site
City
Rochester
State/Province
Michigan
ZIP/Postal Code
48307
Country
United States
Facility Name
Synergy Research Site
City
Saginaw
State/Province
Michigan
ZIP/Postal Code
48604
Country
United States
Facility Name
Synergy Research Site
City
Southfield
State/Province
Michigan
ZIP/Postal Code
48034
Country
United States
Facility Name
Synergy Research Site
City
Biloxi
State/Province
Mississippi
ZIP/Postal Code
39531
Country
United States
Facility Name
Synergy Research Site
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39202
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
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Facility Name
Synergy Research Site
City
Henderson
State/Province
Nevada
ZIP/Postal Code
89014
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
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89121
Country
United States
Facility Name
Synergy Research Site
City
Reno
State/Province
Nevada
ZIP/Postal Code
89511
Country
United States
Facility Name
Synergy Research Site
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
Synergy Research Site
City
Lodi
State/Province
New Jersey
ZIP/Postal Code
07644
Country
United States
Facility Name
Synergy Research Site
City
Ocean City
State/Province
New Jersey
ZIP/Postal Code
07712
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
Brooklyn
State/Province
New York
ZIP/Postal Code
11206
Country
United States
Facility Name
Synergy Research Site
City
Great Neck
State/Province
New York
ZIP/Postal Code
11023
Country
United States
Facility Name
Synergy Research Site
City
North Massapequa
State/Province
New York
ZIP/Postal Code
11758
Country
United States
Facility Name
Synergy Research Site
City
Cary
State/Province
North Carolina
ZIP/Postal Code
27518
Country
United States
Facility Name
Synergy Research Site
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Synergy Research Site
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28210
Country
United States
Facility Name
Synergy Research Site
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28277
Country
United States
Facility Name
Synergy Research Site
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27403
Country
United States
Facility Name
Synergy Research Site
City
Kinston
State/Province
North Carolina
ZIP/Postal Code
28501
Country
United States
Facility Name
Synergy Research Site
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
Synergy Research Site
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
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
Fargo
State/Province
North Dakota
ZIP/Postal Code
58103
Country
United States
Facility Name
Synergy Research Site
City
Beavercreek
State/Province
Ohio
ZIP/Postal Code
45432
Country
United States
Facility Name
Synergy Research Site
City
Centerville
State/Province
Ohio
ZIP/Postal Code
45459
Country
United States
Facility Name
Synergy Research Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45246
Country
United States
Facility Name
Synergy Research Site
City
Hilliard
State/Province
Ohio
ZIP/Postal Code
43026
Country
United States
Facility Name
Synergy Research Site
City
Huber Heights
State/Province
Ohio
ZIP/Postal Code
45424
Country
United States
Facility Name
Synergy Research Site
City
Maumee
State/Province
Ohio
ZIP/Postal Code
43537
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
Oakwood
State/Province
Ohio
ZIP/Postal Code
45419
Country
United States
Facility Name
Synergy Research Site
City
Stow
State/Province
Ohio
ZIP/Postal Code
44224
Country
United States
Facility Name
Synergy Research Site
City
Norman
State/Province
Oklahoma
ZIP/Postal Code
73071
Country
United States
Facility Name
Synergy Research Site
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73102
Country
United States
Facility Name
Synergy Research Site
City
Limerick
State/Province
Pennsylvania
ZIP/Postal Code
19468
Country
United States
Facility Name
Synergy Research Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19152
Country
United States
Facility Name
Synergy Research Site
City
Smithfield
State/Province
Pennsylvania
ZIP/Postal Code
15478
Country
United States
Facility Name
Synergy Research Site
City
Yardley
State/Province
Pennsylvania
ZIP/Postal Code
19067
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
Charleston
State/Province
South Carolina
ZIP/Postal Code
28406
Country
United States
Facility Name
Synergy Research Site
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29204
Country
United States
Facility Name
Synergy Research Site
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37421
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
Nashville
State/Province
Tennessee
ZIP/Postal Code
37205
Country
United States
Facility Name
Synergy Research Site
City
New Tazewell
State/Province
Tennessee
ZIP/Postal Code
37825
Country
United States
Facility Name
Synergy Research Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78745
Country
United States
Facility Name
Synergy Research Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
Synergy Research Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75234
Country
United States
Facility Name
Synergy Research Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77043
Country
United States
Facility Name
Synergy Research Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77062
Country
United States
Facility Name
Synergy Research Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77070
Country
United States
Facility Name
Synergy Research Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77090
Country
United States
Facility Name
Synergy Research Site
City
Killeen
State/Province
Texas
ZIP/Postal Code
76543
Country
United States
Facility Name
Synergy Research Site
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States
Facility Name
Synergy Research Site
City
San Angelo
State/Province
Texas
ZIP/Postal Code
76904
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
78258
Country
United States
Facility Name
Synergy Research Site
City
Sugar Land
State/Province
Texas
ZIP/Postal Code
77479
Country
United States
Facility Name
Synergy Research Site
City
Logan
State/Province
Utah
ZIP/Postal Code
84341
Country
United States
Facility Name
Synergy Research Site
City
Saint George
State/Province
Utah
ZIP/Postal Code
84790
Country
United States
Facility Name
Synergy Research Site
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84124
Country
United States
Facility Name
Synergy Research Site
City
Christiansburg
State/Province
Virginia
ZIP/Postal Code
24073
Country
United States
Facility Name
Synergy Research Site
City
Henrico
State/Province
Virginia
ZIP/Postal Code
23233
Country
United States
Facility Name
Synergy Research Site
City
Lynchburg
State/Province
Virginia
ZIP/Postal Code
24502
Country
United States
Facility Name
Synergy Research Site
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
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
23294
Country
United States
Facility Name
Synergy Research Site
City
Virginia Beach
State/Province
Virginia
ZIP/Postal Code
23455
Country
United States
Facility Name
Synergy Research Site
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Facility Name
Synergy Research Site
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
Synergy Research Site
City
Wauwatosa
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Synergy Research Site
City
Kelowna
State/Province
British Columbia
ZIP/Postal Code
V1Y 1Z9
Country
Canada
Facility Name
Synergy Research Site
City
Bridgewater
State/Province
Nova Scotia
ZIP/Postal Code
B4V 3N2
Country
Canada
Facility Name
Synergy Research Site
City
Brampton
State/Province
Ontario
ZIP/Postal Code
L6T 0G1
Country
Canada
Facility Name
Synergy Research Site
City
Cambridge
State/Province
Ontario
ZIP/Postal Code
N1S 2M6
Country
Canada
Facility Name
Synergy Research Site
City
London
State/Province
Ontario
ZIP/Postal Code
N5Y 5K7
Country
Canada
Facility Name
Synergy Research Site
City
Oshawa
State/Province
Ontario
ZIP/Postal Code
L1H 1B9
Country
Canada
Facility Name
Synergy Research Site
City
Sudbury
State/Province
Ontario
ZIP/Postal Code
P3E 1H5
Country
Canada
Facility Name
Synergy Research Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M3H 5S4
Country
Canada
Facility Name
Synergy Research Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M9W 4L6
Country
Canada
Facility Name
Synergy Research Site
City
Mirabel
State/Province
Quebec
ZIP/Postal Code
J7J 2K8
Country
Canada
Facility Name
Synergy Research Site
City
Pointe-Claire
State/Province
Quebec
ZIP/Postal Code
H9R 4S3
Country
Canada
Facility Name
Synergy Research Site
City
St-Romuald
State/Province
Quebec
ZIP/Postal Code
G6W 5M6
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
35086735
Citation
Moshiree B, Schoenfeld P, Franklin H, Rezaie A. The Effect of Acid Suppression Therapy on the Safety and Efficacy of Plecanatide: Analysis of Randomized Phase III Trials. Clin Ther. 2022 Jan;44(1):98-110.e1. doi: 10.1016/j.clinthera.2021.11.009. Epub 2022 Jan 25.
Results Reference
derived
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
PubMed Identifier
28169285
Citation
Miner PB Jr, Koltun WD, Wiener GJ, De La Portilla M, Prieto B, Shailubhai K, Layton MB, Barrow L, Magnus L, Griffin PH. A Randomized Phase III Clinical Trial of Plecanatide, a Uroguanylin Analog, in Patients With Chronic Idiopathic Constipation. Am J Gastroenterol. 2017 Apr;112(4):613-621. doi: 10.1038/ajg.2016.611. Epub 2017 Feb 7.
Results Reference
derived

Learn more about this trial

12-Week Study of Plecanatide for CIC (The CIC3 Study)

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