Open-label Extension (OLE) Study of Plecanatide for Chronic Idiopathic Constipation (CIC)

An Open-Label Extension (OLE), Long-term Safety and Tolerability Study of Plecanatide in Patients With Chronic Idiopathic Constipation (CIC)

This is a multi-center, open-label, 52-week safety and tolerability study of plecanatide in patients with Chronic Idiopathic Constipation (CIC).

Study Overview

• Status: Completed
• Conditions: Chronic Idiopathic Constipation
• Intervention / Treatment: Drug: Plecanatide

Detailed Description

This is an open-label extension study of plecanatide in the treatment of patients with CIC who previously completed Synergy Protocols SP304-20210 and SP304203-00 (The CIC3 Study).

The planned duration of each patient's study participation is up to 411 days, including up to 33 days of screening, 8 study visits over 52 weeks of treatment and a follow-up visit 2 weeks after the last dose of study drug.

• Study Type: Interventional
• Enrollment (Actual): 2370
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Kelowna, British Columbia, Canada, V1Y 1Z9
      • Synergy Research Site
  • Nova Scotia
    • Bridgewater, Nova Scotia, Canada, B4V 3N2
      • Synergy Research Site
  • Ontario
    • Cambridge, Ontario, Canada, N1S 2M6
      • Synergy Research Site
    • Sudbury, Ontario, Canada, P3A 1Y8
      • Synergy Research Site
    • Toronto, Ontario, Canada, M3J 2C5
      • Synergy Research Site
    • Toronto, Ontario, Canada, M9W 4L6
      • Synergy Research Site
  • Quebec
    • Mirabel, Quebec, Canada, J7J 2K8
      • Synergy Research Site
    • Pointe-Claire, Quebec, Canada, H9R 4S3
      • Synergy Research Site
    • St-Romuald, Quebec, Canada, G6W 5M6
      • Synergy Research Site
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35242
      • Synergy Research Site
    • Dothan, Alabama, United States, 36305
      • Synergy Research Site
    • Gulf Shores, Alabama, United States, 36542
      • Synergy Research Site
    • Huntsville, Alabama, United States, 35801
      • Synergy Research Site
  • Arizona
    • Chandler, Arizona, United States, 85224
      • Synergy Research Site
    • Phoenix, Arizona, United States, 85018
      • Synergy Research Site
    • Tempe, Arizona, United States, 85283
      • Synergy Research Site
    • Tucson, Arizona, United States, 85704
      • Synergy Research Site
    • Tucson, Arizona, United States, 85712
      • Synergy Research Site
    • Tucson, Arizona, United States, 85716
      • Synergy Research Site
  • Arkansas
    • Little Rock, Arkansas, United States, 72211
      • Synergy Research Site
    • North Little Rock, Arkansas, United States, 72117
      • Synergy Research Site
  • California
    • Anaheim, California, United States, 92801
      • Synergy Research Site
    • Anaheim, California, United States, 92804
      • Synergy Research Site
    • Artesia, California, United States, 90701
      • Synergy Research Site
    • Carlsbad, California, United States, 92008
      • Synergy Research Site
    • Cerritos, California, United States, 90703
      • Synergy Research Site
    • Chula Vista, California, United States, 91910
      • Synergy Research Site
    • Corona, California, United States, 92879
      • Synergy Research Site
    • Encinitas, California, United States, 92024
      • Synergy Research Site
    • Fountain Valley, California, United States, 92708
      • Synergy Research Site
    • Fresno, California, United States, 93726
      • Synergy Research Site
    • Hawaiian Gardens, California, United States, 90716
      • Synergy Research Site
    • La Mirada, California, United States, 90638
      • Synergy Research Site
    • Laguna Hills, California, United States, 92653
      • Synergy Research Site
    • Lancaster, California, United States, 93534
      • Synergy Research Site
    • Long Beach, California, United States, 90806
      • Synergy Research Site
    • Los Angeles, California, United States, 90045
      • Synergy Research Site
    • Los Angeles, California, United States, 90015
      • Synergy Research Site
    • Mission Hills, California, United States, 91345
      • Synergy Research Site
    • North Hollywood, California, United States, 91606
      • Synergy Research Site
    • Orange, California, United States, 92868
      • Synergy Research Site
    • Pasadena, California, United States, 91105
      • Synergy Research Site
    • Sacramento, California, United States, 95821
      • Synergy Research Site
    • San Diego, California, United States, 92103
      • Synergy Research Site
    • San Diego, California, United States, 92108
      • Synergy Research Site
    • San Diego, California, United States, 92114
      • Synergy Research Site
    • Thousand Oaks, California, United States, 91360
      • Synergy Research Site
  • Colorado
    • Colorado Springs, Colorado, United States, 80904
      • Synergy Research Site
    • Colorado Springs, Colorado, United States, 80907
      • Synergy Research Site
    • Colorado Springs, Colorado, United States, 80909
      • Synergy Research Site
    • Denver, Colorado, United States, 80246
      • Synergy Research Site
    • Denver, Colorado, United States, 80218
      • Synergy Research Site
    • Denver, Colorado, United States, 80220
      • Synergy Research Site
    • Littleton, Colorado, United States, 80128
      • Synergy Research Site
  • Connecticut
    • Bristol, Connecticut, United States, 06010
      • Synergy Research Site
    • Waterbury, Connecticut, United States, 06708
      • Synergy Research Site
  • Florida
    • Boynton Beach, Florida, United States, 33426
      • Synergy Research Site
    • Brandon, Florida, United States, 33511
      • Synergy Research Site
    • Clearwater, Florida, United States, 33756
      • Synergy Research Site
    • Clearwater, Florida, United States, 33759
      • Synergy Research Site
    • Cutler Bay, Florida, United States, 33189
      • Synergy Research Site
    • DeLand, Florida, United States, 32720
      • Synergy Research Site
    • Fort Lauderdale, Florida, United States, 33306
      • Synergy Research Site
    • Hialeah, Florida, United States, 33012
      • Synergy Research Site
    • Hialeah, Florida, United States, 33013
      • Synergy Research Site
    • Hialeah, Florida, United States, 33016
      • Synergy Research Site
    • Homestead, Florida, United States, 33030
      • Synergy Research Site
    • Jupiter, Florida, United States, 33458
      • Synergy Research Site
    • Lakeland, Florida, United States, 33805
      • Synergy Research Site
    • Miami, Florida, United States, 33015
      • Synergy Research Site
    • Miami, Florida, United States, 33032
      • Synergy Research Site
    • Miami, Florida, United States, 33122
      • Synergy Research Site
    • Miami, Florida, United States, 33125
      • Synergy Research Site
    • Miami, Florida, United States, 33126
      • Synergy Research Site
    • Miami, Florida, United States, 33142
      • Synergy Research Site
    • Miami, Florida, United States, 33144
      • Synergy Research Site
    • Miami, Florida, United States, 33155
      • Synergy Research Site
    • Miami, Florida, United States, 33165
      • Synergy Research Site
    • Miami, Florida, United States, 33173
      • Synergy Research Site
    • Miami, Florida, United States, 33175
      • Synergy Research Site
    • Miami, Florida, United States, 33176
      • Synergy Research Site
    • Miami, Florida, United States, 33130
      • Synergy Research Site
    • Miami, Florida, United States, 33174
      • Synergy Research Site
    • Miami, Florida, United States, 33186
      • Synergy Research Site
    • Miami Lakes, Florida, United States, 33016
      • Synergy Research Site
    • Miami Springs, Florida, United States, 33166
      • Synergy Research Site
    • Orlando, Florida, United States, 32806
      • Synergy Research Site
    • Orlando, Florida, United States, 32807
      • Synergy Research Site
    • Orlando, Florida, United States, 32801
      • Synergy Research Site
    • Pembroke Pines, Florida, United States, 33026
      • Synergy Research Site
    • Port Orange, Florida, United States, 32129
      • Synergy Research Site
    • Saint Petersburg, Florida, United States, 33709
      • Synergy Research Site
    • Tamarac, Florida, United States, 33319
      • Synergy Research Site
    • Tampa, Florida, United States, 33607
      • Synergy Research Site
    • Tampa, Florida, United States, 33606
      • Synergy Research Site
    • West Palm Beach, Florida, United States, 33409
      • Synergy Research Site
  • Georgia
    • Athens, Georgia, United States, 30606
      • Synergy Research Site
    • Atlanta, Georgia, United States, 30342
      • Synergy Research Site
    • Decatur, Georgia, United States, 30033
      • Synergy Research Site
    • Decatur, Georgia, United States, 30032
      • Synergy Research Site
    • Oakwood, Georgia, United States, 30566
      • Synergy Research Site
    • Sandy Springs, Georgia, United States, 30328
      • Synergy Research Site
    • Savannah, Georgia, United States, 31406
      • Synergy Research Site
    • Smyrna, Georgia, United States, 30082
      • Synergy Research Site
    • Snellville, Georgia, United States, 30078
      • Synergy Research Site
  • Idaho
    • Blackfoot, Idaho, United States, 83221
      • Synergy Research Site
  • Illinois
    • Chicago, Illinois, United States, 60602
      • Synergy Research Site
  • Indiana
    • Brownsburg, Indiana, United States, 46112
      • Synergy Research Site
  • Iowa
    • Clive, Iowa, United States, 50325
      • Synergy Research Site
  • Kansas
    • Augusta, Kansas, United States, 67010
      • Synergy Research Site
    • Newton, Kansas, United States, 67114
      • Synergy Research Site
    • Shawnee Mission, Kansas, United States, 66218
      • Synergy Research Site
    • Wichita, Kansas, United States, 67205
      • Synergy Research Site
    • Wichita, Kansas, United States, 67207
      • Synergy Research Site
  • Kentucky
    • Lexington, Kentucky, United States, 40503
      • Synergy Research Site
    • Owensboro, Kentucky, United States, 42303
      • Synergy Research Site
  • Louisiana
    • Bastrop, Louisiana, United States, 71220
      • Synergy Research Site
    • Marrero, Louisiana, United States, 70072
      • Synergy Research Site
    • Metairie, Louisiana, United States, 70006
      • Synergy Research Site
    • New Orleans, Louisiana, United States, 70115
      • Synergy Research Site
    • New Orleans, Louisiana, United States, 70119
      • Synergy Research Site
    • Shreveport, Louisiana, United States, 71103
      • Synergy Research Site
  • Maryland
    • Chevy Chase, Maryland, United States, 20815
      • Synergy Research Site
  • Massachusetts
    • Boston, Massachusetts, United States, 02131
      • Synergy Research Site
    • New Bedford, Massachusetts, United States, 02740
      • Synergy Research Site
  • Michigan
    • Chesterfield, Michigan, United States, 48047
      • Synergy Research Site
    • Flint, Michigan, United States, 48504
      • Synergy Research Site
    • Rochester, Michigan, United States, 48307
      • Synergy Research Site
    • Saginaw, Michigan, United States, 48604
      • Synergy Research Site
    • Southfield, Michigan, United States, 48034
      • Synergy Research Site
  • Mississippi
    • Biloxi, Mississippi, United States, 39531
      • Synergy Research Site
    • Jackson, Mississippi, United States, 39202
      • Synergy Research Site
  • Missouri
    • Saint Louis, Missouri, United States, 63128
      • Synergy Research Site
  • Nebraska
    • Grand Island, Nebraska, United States, 68803
      • Synergy Research Site
    • Omaha, Nebraska, United States, 68114
      • Synergy Research Site
  • Nevada
    • Henderson, Nevada, United States, 89014
      • Synergy Research Site
    • Las Vegas, Nevada, United States, 89103
      • Synergy Research Site
    • Las Vegas, Nevada, United States, 89119
      • Synergy Research Site
    • Las Vegas, Nevada, United States, 89121
      • Synergy Research Site
    • Reno, Nevada, United States, 89511
      • Synergy Research Site
  • New Jersey
    • Elizabeth, New Jersey, United States, 07202
      • Synergy Research Site
    • Lodi, New Jersey, United States, 07644
      • Synergy Research Site
    • Marlton, New Jersey, United States, 08053
      • Synergy Research Site
  • New Mexico
    • Albuquerque, New Mexico, United States, 87109
      • Synergy Research Site
    • Albuquerque, New Mexico, United States, 87108
      • Synergy Research Site
  • New York
    • Brooklyn, New York, United States, 11206
      • Synergy Research Site
    • Great Neck, New York, United States, 11023
      • Synergy Research Site
    • New York, New York, United States, 10016
      • Synergy Research Site
    • Poughkeepsie, New York, United States, 12601
      • Synergy Research Site
  • North Carolina
    • Cary, North Carolina, United States, 27518
      • Synergy Research Site
    • Chapel Hill, North Carolina, United States, 27599
      • Synergy Research Site
    • Charlotte, North Carolina, United States, 28210
      • Synergy Research Site
    • Charlotte, North Carolina, United States, 28277
      • Synergy Research Site
    • Greensboro, North Carolina, United States, 27403
      • Synergy Research Site
    • Kinston, North Carolina, United States, 28501
      • Synergy Research Site
    • Raleigh, North Carolina, United States, 27612
      • Synergy Research Site
    • Wilmington, North Carolina, United States, 28401
      • Synergy Research Site
    • Winston-Salem, North Carolina, United States, 27103
      • Synergy Research Site
  • North Dakota
    • Fargo, North Dakota, United States, 58103
      • Synergy Research Site
  • Ohio
    • Beavercreek, Ohio, United States, 45432
      • Synergy Research Site
    • Centerville, Ohio, United States, 45459
      • Synergy Research Site
    • Cincinnati, Ohio, United States, 45224
      • Synergy Research Site
    • Cincinnati, Ohio, United States, 45246
      • Synergy Research Site
    • Cleveland, Ohio, United States, 44122
      • Synergy Research Site
    • Huber Heights, Ohio, United States, 45424
      • Synergy Research Site
    • Maumee, Ohio, United States, 43537
      • Synergy Research Site
    • Mentor, Ohio, United States, 44060
      • Synergy Research Site
    • Oakwood, Ohio, United States, 45419
      • Synergy Research Site
    • Stow, Ohio, United States, 44224
      • Synergy Research Site
  • Oklahoma
    • Norman, Oklahoma, United States, 73071
      • Synergy Research Site
    • Oklahoma City, Oklahoma, United States, 73104
      • Synergy Research Site
    • Oklahoma City, Oklahoma, United States, 73102
      • Synergy Research Site
  • Pennsylvania
    • Levittown, Pennsylvania, United States, 19056
      • Synergy Research Site
    • Limerick, Pennsylvania, United States, 19468
      • Synergy Research Site
    • Philadelphia, Pennsylvania, United States, 19152
      • Synergy Research Site
    • Pittsburgh, Pennsylvania, United States, 15206
      • Synergy Research Site
    • Yardley, Pennsylvania, United States, 19067
      • Synergy Research Site
  • South Carolina
    • Anderson, South Carolina, United States, 29621
      • Synergy Research Site
    • Charleston, South Carolina, United States, 29406
      • Synergy Research Site
    • Columbia, South Carolina, United States, 29203
      • Synergy Research Site
  • Tennessee
    • Chattanooga, Tennessee, United States, 37421
      • Synergy Research Site
    • Franklin, Tennessee, United States, 37064
      • Synergy Research Site
    • Jackson, Tennessee, United States, 38305
      • Synergy Research Site
    • Knoxville, Tennessee, United States, 37912
      • Synergy Research Site
    • Memphis, Tennessee, United States, 38119
      • Synergy Research Site
    • Nashville, Tennessee, United States, 37211
      • Synergy Research Site
    • New Tazewell, Tennessee, United States, 37825
      • Synergy Research Site
  • Texas
    • Arlington, Texas, United States, 76012
      • Synergy Research Site
    • Austin, Texas, United States, 78731
      • Synergy Research Site
    • Austin, Texas, United States, 78745
      • Synergy Research Site
    • Channelview, Texas, United States, 77530
      • Synergy Research Site
    • Dallas, Texas, United States, 75230
      • Synergy Research Site
    • Dallas, Texas, United States, 75234
      • Synergy Research Site
    • Houston, Texas, United States, 77062
      • Synergy Research Site
    • Houston, Texas, United States, 77034
      • Synergy Research Site
    • Houston, Texas, United States, 77043
      • Synergy Research Site
    • Houston, Texas, United States, 77070
      • Synergy Research Site
    • Houston, Texas, United States, 77090
      • Synergy Research Site
    • Houston, Texas, United States, 77099
      • Synergy Research Site
    • Humble, Texas, United States, 77338
      • Synergy Research Site
    • Katy, Texas, United States, 77450
      • Synergy Research Site
    • Plano, Texas, United States, 75093
      • Synergy Research Site
    • San Antonio, Texas, United States, 78215
      • Synergy Research Site
    • San Antonio, Texas, United States, 78209
      • Synergy Research Site
    • Sugar Land, Texas, United States, 77479
      • Synergy Research Site
  • Utah
    • Logan, Utah, United States, 84341
      • Synergy Research Site
    • Saint George, Utah, United States, 84790
      • Synergy Research Site
    • Salt Lake City, Utah, United States, 84124
      • Synergy Research Site
    • West Jordan, Utah, United States, 84088
      • Synergy Research Site
  • Virginia
    • Christiansburg, Virginia, United States, 24073
      • Synergy Research Site
    • Henrico, Virginia, United States, 23233
      • Synergy Research Site
    • Lynchburg, Virginia, United States, 24502
      • Synergy Research Site
    • Newport News, Virginia, United States, 23606
      • Synergy Research Site
    • Norfolk, Virginia, United States, 23507
      • Synergy Research Site
    • Norfolk, Virginia, United States, 23502
      • Synergy Research Site
    • Richmond, Virginia, United States, 23294
      • Synergy Research Site
  • Washington
    • Richland, Washington, United States, 99352
      • Synergy Research Site
    • Seattle, Washington, United States, 98105
      • Synergy Research Site
    • Tacoma, Washington, United States, 98405
      • Synergy Research Site
  • Wisconsin
    • Wauwatosa, Wisconsin, United States, 53226
      • Synergy Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 81 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patient completed a previous double-blind plecanatide study and was compliant with the study requirements.
• Patient is in good health without unstable acute illness or exacerbation of an unstable chronic illness or chronic disease that may affect study assessments, particularly if there has been a significant change to health status since the previous plecanatide study.

Exclusion Criteria:

• Patient has had major surgery including laparoscopic procedures requiring general anesthesia within 60 days of Day 1.
• Patient has a medical history of hepatitis B, hepatitis C or human immunodeficiency virus (HIV) infection.
• Patient has taken a protocol-prohibited drug without the appropriate washout period.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Plecanatide 3.0 mg; Plecanatide 3.0 mg, one tablet by mouth daily for 52 weeks	Drug: Plecanatide
Experimental: Plecanatide 6.0 mg; Plecanatide 6.0 mg, one tablet by mouth daily for 52 weeks	Drug: Plecanatide

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Patients With at Least One Treatment-Emergent Adverse Event (TEAE)	All clinically significant findings upon Physical Examinations of the Safety Population during the treatment period were reported as TEAEs. Safety was evaluated based on number of patients who experienced at least one TEAE.	From first dose up to 72 weeks
Number of Patients With at Least One Treatment-Emergent Adverse Event (TEAE) Leading to Discontinuation of Plecanatide	Tolerability was evaluated based on number of patients who experienced at least one TEAE leading to discontinuation of the study drug	From first dose up to 72 weeks
Summary of Vital Signs at >Day 364 - Blood Pressure (Systolic and Diastolic; mmHg)	The vital signs included in the assessments were blood pressure (systolic and diastolic; mmHg), heart rate (beats per minute), body temperature (°C) and respiration rate (breaths per minute).	From first dose up to 72 weeks
Summary of Vital Signs at >Day 364 - Heart Rate (Beats Per Minute)	The vital signs included in the assessments were blood pressure (systolic and diastolic; mmHg), heart rate (beats per minute), body temperature (°C) and respiration rate (breaths per minute).	From first dose up to 72 weeks
Summary of Vital Signs at >Day 364 - Body Temperature (°C)	The vital signs included in the assessments were blood pressure (systolic and diastolic; mmHg), heart rate (beats per minute), body temperature (°C) and respiration rate (breaths per minute).	From first dose up to 72 weeks
Summary of Vital Signs at >Day 364 - Respiration Rate (Breaths Per Minute)	The vital signs included in the assessments were blood pressure (systolic and diastolic; mmHg), heart rate (beats per minute), body temperature (°C) and respiration rate (breaths per minute).	From first dose up to 72 weeks
Summary of ECG Results Shift From Baseline at > Day 364	Baseline was defined as the last non-missing value collected prior to first dose of study drug)	From first dose up to 72 weeks
Summary of Treatment-Emergent Laboratory Abnormalities With At Least a 1-grade Shift From Baseline	Baseline was defined as the last non-missing value collected prior to first dose of study drug within a given entry into the study. The Common Terminology Criteria for Adverse Events (CTCAE), Grades 1 through 5 were used for descriptions of severity for each Adverse Event (AE): Grade 1 - Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated; Grade 2 - Moderate; minimal, local or noninvasive intervention indicated; limiting age appropriate instrumental Activities of Daily Living (ADL); Grade 3 - Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL; Grade 4 - Life-threatening consequences; urgent intervention indicated; Grade 5 - Death related to AE.	From first dose up to 72 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Summary of Patient Patient Global Assessment (PGA) for Constipation Severity at > Day 364	Constipation severity was measured using a 5-point score: 1=None, 2=Mild, 3=Moderate, 4=Severe, 5=Very severe Baseline was defined as the last non-missing value collected prior to first dose of study drug within a given entry into the study.	Form first dose up to 72 weeks
Summary of Patient Global Assessment (PGA) for Constipation - Change From Baseline to > Day 364	Change of Constipation measured using a 7-point score: 1=Very Much Improved, 2=Much Improved, 3=Minimally Improved, 4=No change, 5=Minimally Worse, 6=Much Worse, 7=Very Much Worse Baseline is defined as the last non-missing value collected prior to first dose of study drug within a given entry into the study.	From first dose up to 72 weeks
Summary of Patient Global Assessment (PGA) for Treatment Satisfaction at > Day 364	Baseline was defined as the last non-missing value collected prior to first dose of study drug within a given entry into the study. Treatment Satisfaction was measured using a 5-point score: 1=Not At All Satisfied, 2=A Little Satisfied, 3=Moderately Satisfied, 4=Quite Satisfied, 5=Very Satisfied.	From first dose up to 72 weeks
Summary of Patient Global Assessment (PGA) for Treatment Continuation at End of Treatment	Treatment continuation was measured using 5-point score: 1=Not At All Likely, 2=A Little Likely, 3=Moderately Likely, 4=Quite Likely, 5=Very Likely	From first dose up to 72 weeks

Collaborators and Investigators

• Sponsor: Bausch Health Americas, Inc.
• Collaborators: Syneos Health
• Investigators: Principal Investigator: Richard A Krause, MD, ClinSearch, LLC

Publications and helpful links

General Publications

• Barish CF, Griffin P. Safety and tolerability of plecanatide in patients with chronic idiopathic constipation: long-term evidence from an open-label study. Curr Med Res Opin. 2018 Apr;34(4):751-755. doi: 10.1080/03007995.2018.1430024. Epub 2018 Feb 2.

Study record dates

Study Major Dates

• Study Start: August 1, 2013
• Primary Completion (Actual): January 1, 2016
• Study Completion (Actual): March 1, 2016

Study Registration Dates

• First Submitted: August 7, 2013
• First Submitted That Met QC Criteria: August 7, 2013
• First Posted (Estimate): August 9, 2013

Study Record Updates

• Last Update Posted (Actual): July 2, 2019
• Last Update Submitted That Met QC Criteria: June 11, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: Constipation; CIC; Synergy; Extension; Chronic; Open label; Idiopathic; Extension study; Chronic Idiopathic Constipation; Plecantaide; CIC study; CIC OLE; CIC OLE study; OLE; OLE CIC; OLE CIC3; Open label study; Long term; Long term study
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Constipation; Molecular Mechanisms of Pharmacological Action; Gastrointestinal Agents; Guanylyl Cyclase C Agonists; Enzyme Activators; Plecanatide
• Other Study ID Numbers: SP304203-01