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

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ClinicalTrials.gov Identifier: NCT01919697
Recruitment Status : Completed
First Posted : August 9, 2013
Last Update Posted : August 15, 2016
INC Research
Information provided by (Responsible Party):
Synergy Pharmaceuticals Inc.

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

Condition or disease Intervention/treatment Phase
Chronic Idiopathic Constipation Drug: Plecanatide Phase 3

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  (Clinical Trial)
Actual Enrollment : 2370 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label Extension (OLE), Long-term Safety and Tolerability Study of Plecanatide in Patients With Chronic Idiopathic Constipation (CIC)
Study Start Date : August 2013
Primary Completion Date : January 2016
Study Completion Date : March 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Constipation
Drug Information available for: Plecanatide
U.S. FDA Resources

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

Primary Outcome Measures :
  1. Safety and Tolerability [ Time Frame: One year ]
    Safety and tolerability will be evaluated based on the occurrence of treatment-emergent adverse events and assessment of: vital signs, clinical laboratory tests, physical examinations and ECGs.

Secondary Outcome Measures :
  1. Patient-Reported Outcomes [ Time Frame: One year ]
    Patients' assessments of their disease symptoms and severity, continued treatment and quality of life will also be evaluated.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 81 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01919697

  Show 221 Study Locations
Sponsors and Collaborators
Synergy Pharmaceuticals Inc.
INC Research
Principal Investigator: Richard A Krause, MD ClinSearch, LLC

Responsible Party: Synergy Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT01919697     History of Changes
Other Study ID Numbers: SP304203-01
First Posted: August 9, 2013    Key Record Dates
Last Update Posted: August 15, 2016
Last Verified: August 2016

Keywords provided by Synergy Pharmaceuticals Inc.:
Chronic Idiopathic Constipation
CIC study
CIC OLE study
Open label
Open label study
Long term
Long term study
Extension study

Additional relevant MeSH terms:
Signs and Symptoms, Digestive
Signs and Symptoms
Gastrointestinal Agents