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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Synergy Pharmaceuticals Inc.
Sponsor:
Collaborators:
INC Research
Numoda
Information provided by (Responsible Party):
Synergy Pharmaceuticals Inc.
ClinicalTrials.gov Identifier:
NCT01919697
First received: August 7, 2013
Last updated: September 25, 2014
Last verified: September 2014
  Purpose

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


Condition Intervention Phase
Chronic Idiopathic Constipation
Drug: Plecanatide
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: 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)

Resource links provided by NLM:


Further study details as provided by Synergy Pharmaceuticals Inc.:

Primary Outcome Measures:
  • Safety and Tolerability [ Time Frame: One year ] [ Designated as safety issue: No ]
    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:
  • Patient-Reported Outcomes [ Time Frame: One year ] [ Designated as safety issue: No ]
    Patients' assessments of their disease symptoms and severity, continued treatment and quality of life will also be evaluated.


Estimated Enrollment: 1000
Study Start Date: August 2013
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 81 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01919697

Contacts
Contact: Laura Barrow, PharmD 212-297-0020 lbarrow@synergypharma.com

  Show 142 Study Locations
Sponsors and Collaborators
Synergy Pharmaceuticals Inc.
INC Research
Numoda
Investigators
Principal Investigator: Richard A Krause, MD ClinSearch, LLC
  More Information

No publications provided

Responsible Party: Synergy Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT01919697     History of Changes
Other Study ID Numbers: SP304203-01
Study First Received: August 7, 2013
Last Updated: September 25, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Synergy Pharmaceuticals Inc.:
Chronic Idiopathic Constipation
Constipation
Plecantaide
Chronic
Idiopathic
Synergy
CIC
CIC study
CIC OLE
CIC OLE study
OLE
OLE CIC
OLE CIC3
Open label
Open label study
Long term
Long term study
Extension
Extension study

Additional relevant MeSH terms:
Constipation
Signs and Symptoms
Signs and Symptoms, Digestive

ClinicalTrials.gov processed this record on October 23, 2014