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

Primary Purpose

Chronic Idiopathic 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 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 American Gastroenterological Association (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 Bowel Movements (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 myocardial infarction (MI) within 60 days of screening
  • Participated in a previous plecanatide clinical trial

Sites / Locations

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

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Experimental

Arm Label

Plecanatide 3.0 mg

Placebo

Plecanatide 6.0 mg

Arm Description

Plecanatide tablets 3.0 mg QD for 12 weeks

Matching placebo tablets QD for 12 weeks

Plecanatide tablets 6.0 mg QD for 12 weeks

Outcomes

Primary Outcome Measures

Number of Durable Overall CSBM Responders, Mean Replacement Approach
The primary efficacy endpoint was measured by the number of durable overall CSBM responders over the 12-week Treatment Period. A durable overall CSBM responder was defined as a weekly CSBM responder for at least 9 of the 12 treatment weeks, including 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 the 12-week Treatment Period , Mean Replacement Approach
The change from baseline in the number of Complete Spontaneous Bowel Movements (CSBMs) over the 12-week Treatment Period was analyzed. Baseline was the mean number of CSBMs recorded during the 2-week baseline diary assessment period prior to the first dose of study drug. 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.
Change From Baseline in SBMs (SBMs/Week) Over the 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 analyzed. 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.
Change From Baseline in Average Weekly SBM Stool Consistency Over the 12-week Treatment Period, Mean Replacement Approach
The change from baseline in the stool consistency score (i.e. BSFS) over the 12-week Treatment Period was analyzed. Baseline was the mean BSFS score recorded during the 2-week baseline diary assessment period prior to the first dose of study drug. The weekly mean BSFS score per patient was derived from the BSFS entries reported during the Treatment Period in the Daily Symptom Diary. 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 Average Weekly Straining Score Over the 12-week Treatment Period, Mean Replacement Approach
The change from baseline in the straining score over the 12-week Treatment Period was analyzed. 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
April 22, 2014
Last Updated
May 23, 2019
Sponsor
Bausch Health Americas, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02122471
Brief Title
12-Week Study of Plecanatide for CIC (The National CIC3 Study)
Acronym
CIC
Official Title
A National, 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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
July 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 national, 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. 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
1410 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Plecanatide 3.0 mg
Arm Type
Experimental
Arm Description
Plecanatide tablets 3.0 mg QD for 12 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Matching placebo tablets QD for 12 weeks
Arm Title
Plecanatide 6.0 mg
Arm Type
Experimental
Arm Description
Plecanatide tablets 6.0 mg QD for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Plecanatide
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Number of Durable Overall CSBM Responders, Mean Replacement Approach
Description
The primary efficacy endpoint was measured by the number of durable overall CSBM responders over the 12-week Treatment Period. A durable overall CSBM responder was defined as a weekly CSBM responder for at least 9 of the 12 treatment weeks, including 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 the 12-week Treatment Period , Mean Replacement Approach
Description
The change from baseline in the number of Complete Spontaneous Bowel Movements (CSBMs) over the 12-week Treatment Period was analyzed. Baseline was the mean number of CSBMs recorded during the 2-week baseline diary assessment period prior to the first dose of study drug. 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
Baseline and 12 weeks
Title
Change From Baseline in SBMs (SBMs/Week) Over the 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 analyzed. 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.
Time Frame
Baseline and 12 weeks
Title
Change From Baseline in Average Weekly SBM Stool Consistency Over the 12-week Treatment Period, Mean Replacement Approach
Description
The change from baseline in the stool consistency score (i.e. BSFS) over the 12-week Treatment Period was analyzed. Baseline was the mean BSFS score recorded during the 2-week baseline diary assessment period prior to the first dose of study drug. The weekly mean BSFS score per patient was derived from the BSFS entries reported during the Treatment Period in the Daily Symptom Diary. 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
Baseline and 12 weeks
Title
Change From Baseline in Average Weekly Straining Score Over the 12-week Treatment Period, Mean Replacement Approach
Description
The change from baseline in the straining score over the 12-week Treatment Period was analyzed. 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
Baseline and 12 weeks

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 American Gastroenterological Association (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 Bowel Movements (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 myocardial infarction (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
Anniston
State/Province
Alabama
ZIP/Postal Code
36207
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
Chandler
State/Province
Arizona
ZIP/Postal Code
85224
Country
United States
Facility Name
Synergy Research Site
City
Goodyear
State/Province
Arizona
ZIP/Postal Code
85395
Country
United States
Facility Name
Synergy Research Site
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85704
Country
United States
Facility Name
Synergy Research Site
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85710
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
Tucson
State/Province
Arizona
ZIP/Postal Code
85715
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
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
Synergy Research Site
City
Artesia
State/Province
California
ZIP/Postal Code
90701
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
Corona
State/Province
California
ZIP/Postal Code
92879
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
Garden Grove
State/Province
California
ZIP/Postal Code
92843
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
Glendale
State/Province
California
ZIP/Postal Code
91204
Country
United States
Facility Name
Synergy Research Site
City
La Mirada
State/Province
California
ZIP/Postal Code
90638
Country
United States
Facility Name
Synergy Research Site
City
Laguna Hills
State/Province
California
ZIP/Postal Code
92653
Country
United States
Facility Name
Synergy Research Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90017
Country
United States
Facility Name
Synergy Research Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90036
Country
United States
Facility Name
Synergy Research Site
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
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
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Synergy Research Site
City
Sacramento
State/Province
California
ZIP/Postal Code
95821
Country
United States
Facility Name
Synergy Research Site
City
Sacramento
State/Province
California
ZIP/Postal Code
95831
Country
United States
Facility Name
Synergy Research Site
City
San Bernardino
State/Province
California
ZIP/Postal Code
92408
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
Upland
State/Province
California
ZIP/Postal Code
91786
Country
United States
Facility Name
Synergy Research Site
City
Ventura
State/Province
California
ZIP/Postal Code
93003
Country
United States
Facility Name
Synergy Research Site
City
Denver
State/Province
Colorado
ZIP/Postal Code
80209
Country
United States
Facility Name
Synergy Research Site
City
Littleton
State/Province
Colorado
ZIP/Postal Code
80128
Country
United States
Facility Name
Synergy Research Site
City
Stamford
State/Province
Connecticut
ZIP/Postal Code
06905
Country
United States
Facility Name
Synergy Research Site
City
Aventura
State/Province
Florida
ZIP/Postal Code
33180
Country
United States
Facility Name
Synergy Research Site
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33472
Country
United States
Facility Name
Synergy Research Site
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34208
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
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
33312
Country
United States
Facility Name
Synergy Research Site
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32607
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
Hialeah
State/Province
Florida
ZIP/Postal Code
33106
Country
United States
Facility Name
Synergy Research Site
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33024
Country
United States
Facility Name
Synergy Research Site
City
Homestead
State/Province
Florida
ZIP/Postal Code
33030
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
Jacksonville
State/Province
Florida
ZIP/Postal Code
32277
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 Springs
State/Province
Florida
ZIP/Postal Code
33166
Country
United States
Facility Name
Synergy Research Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33014
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
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
33125
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
33142
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
33157
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
33175
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
33185
Country
United States
Facility Name
Synergy Research Site
City
New Port Richey
State/Province
Florida
ZIP/Postal Code
34653
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
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
33026
Country
United States
Facility Name
Synergy Research Site
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33028
Country
United States
Facility Name
Synergy Research Site
City
Plant City
State/Province
Florida
ZIP/Postal Code
33563
Country
United States
Facility Name
Synergy Research Site
City
Plantation
State/Province
Florida
ZIP/Postal Code
33324
Country
United States
Facility Name
Synergy Research Site
City
Saint Cloud
State/Province
Florida
ZIP/Postal Code
34769
Country
United States
Facility Name
Synergy Research Site
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33709
Country
United States
Facility Name
Synergy Research Site
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34242
Country
United States
Facility Name
Synergy Research Site
City
Seminole
State/Province
Florida
ZIP/Postal Code
33777
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
33607
Country
United States
Facility Name
Synergy Research Site
City
Tampa
State/Province
Florida
ZIP/Postal Code
33614
Country
United States
Facility Name
Synergy Research Site
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33409
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
Savannah
State/Province
Georgia
ZIP/Postal Code
31406
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
Chicago
State/Province
Illinois
ZIP/Postal Code
60602
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
Evansville
State/Province
Indiana
ZIP/Postal Code
47714
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
Monroe
State/Province
Louisiana
ZIP/Postal Code
71201
Country
United States
Facility Name
Synergy Research Site
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71105
Country
United States
Facility Name
Synergy Research Site
City
Columbia
State/Province
Maryland
ZIP/Postal Code
21045
Country
United States
Facility Name
Synergy Research Site
City
Watertown
State/Province
Massachusetts
ZIP/Postal Code
02472
Country
United States
Facility Name
Synergy Research Site
City
Buckley
State/Province
Michigan
ZIP/Postal Code
49620
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
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
89103
Country
United States
Facility Name
Synergy Research Site
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89106
Country
United States
Facility Name
Synergy Research Site
City
Stateline
State/Province
Nevada
ZIP/Postal Code
89449
Country
United States
Facility Name
Synergy Research Site
City
Newington
State/Province
New Hampshire
ZIP/Postal Code
03801
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
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102
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
Elmsford
State/Province
New York
ZIP/Postal Code
10523
Country
United States
Facility Name
Synergy Research Site
City
New Hyde Park
State/Province
New York
ZIP/Postal Code
11040
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
New York
State/Province
New York
ZIP/Postal Code
10018
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
Concord
State/Province
North Carolina
ZIP/Postal Code
28025
Country
United States
Facility Name
Synergy Research Site
City
Hickory
State/Province
North Carolina
ZIP/Postal Code
28601
Country
United States
Facility Name
Synergy Research Site
City
Hickory
State/Province
North Carolina
ZIP/Postal Code
28602
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
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27609
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
Cleveland
State/Province
Ohio
ZIP/Postal Code
44122
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
Kettering
State/Province
Ohio
ZIP/Postal Code
45429
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
Sylvania
State/Province
Ohio
ZIP/Postal Code
43560
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
73103
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
Jenkintown
State/Province
Pennsylvania
ZIP/Postal Code
19046
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
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15206
Country
United States
Facility Name
Synergy Research Site
City
Upper Saint Clair
State/Province
Pennsylvania
ZIP/Postal Code
15241
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
Moncks Corner
State/Province
South Carolina
ZIP/Postal Code
29461
Country
United States
Facility Name
Synergy Research Site
City
Bristol
State/Province
Tennessee
ZIP/Postal Code
37620
Country
United States
Facility Name
Synergy Research Site
City
Franklin
State/Province
Tennessee
ZIP/Postal Code
37064
Country
United States
Facility Name
Synergy Research Site
City
Jefferson City
State/Province
Tennessee
ZIP/Postal Code
37760
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
37919
Country
United States
Facility Name
Synergy Research Site
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37938
Country
United States
Facility Name
Synergy Research Site
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
Synergy Research Site
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37211
Country
United States
Facility Name
Synergy Research Site
City
Arlington
State/Province
Texas
ZIP/Postal Code
76012
Country
United States
Facility Name
Synergy Research Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
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
78735
Country
United States
Facility Name
Synergy Research Site
City
Carrollton
State/Province
Texas
ZIP/Postal Code
75007
Country
United States
Facility Name
Synergy Research Site
City
Carrollton
State/Province
Texas
ZIP/Postal Code
75010
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
Gonzales
State/Province
Texas
ZIP/Postal Code
78629
Country
United States
Facility Name
Synergy Research Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77015
Country
United States
Facility Name
Synergy Research Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77025
Country
United States
Facility Name
Synergy Research Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77054
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
Pharr
State/Province
Texas
ZIP/Postal Code
78577
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
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States
Facility Name
Synergy Research Site
City
Plano
State/Province
Texas
ZIP/Postal Code
75903
Country
United States
Facility Name
Synergy Research Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78205
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
Draper
State/Province
Utah
ZIP/Postal Code
84020
Country
United States
Facility Name
Synergy Research Site
City
Newport News
State/Province
Virginia
ZIP/Postal Code
23606
Country
United States
Facility Name
Synergy Research Site
City
Sterling
State/Province
Virginia
ZIP/Postal Code
20166
Country
United States
Facility Name
Synergy Research Site
City
Richland
State/Province
Washington
ZIP/Postal Code
99352
Country
United States

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
29147135
Citation
DeMicco M, Barrow L, Hickey B, Shailubhai K, Griffin P. Randomized clinical trial: efficacy and safety of plecanatide in the treatment of chronic idiopathic constipation. Therap Adv Gastroenterol. 2017 Nov;10(11):837-851. doi: 10.1177/1756283X17734697. Epub 2017 Oct 25.
Results Reference
derived

Learn more about this trial

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

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