Trial record 1 of 1 for:    NCT02706483
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Long Term Safety Study of Plecanatide (IBS-C)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02706483
Recruitment Status : Completed
First Posted : March 11, 2016
Last Update Posted : October 5, 2017
Information provided by (Responsible Party):
Synergy Pharmaceuticals Inc.

Brief Summary:
Multi-center, open-label, long-term safety study

Condition or disease Intervention/treatment Phase
Irritable Bowel Syndrome Drug: Plecanatide Phase 3

Detailed Description:

This is a phase 3, multicenter, open-label, long-term safety and tolerability study of 6 mg daily dose of plecanatide administered orally. Patients who are Study Completers or Eligible Screen Failures whose eligibility is confirmed at the end of their participation in the double-blind plecanatide studies SP304203-04 or SP304203-05 will be enrolled.

Beginning on Day 1, patients will take one (1) plecanatide 6.0 mg tablet in the clinic and thereafter every morning with approximately 240 mL (8 ounces) of liquid, with or without meals.

Safety and tolerability assessments and patients' self-assessment of disease severity will be performed according to the Schedule of Assessments.

Patients who discontinue early from the study will undergo an Early Withdrawal (EW) visit within 5 days after stopping study drug.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1500 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label, Long Term Safety and Tolerability Study of Plecanatide in Patients With Irritable Bowel Syndrome With Constipation (IBS-C)
Study Start Date : January 2016
Actual Primary Completion Date : May 2017
Actual Study Completion Date : June 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Plecanatide

Arm Intervention/treatment
Experimental: Plecanatide
Plecanatide 6.0 mg tablets
Drug: Plecanatide

Primary Outcome Measures :
  1. Number of participants with treatment related adverse events. [ Time Frame: up to 53 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

Patients with documented diagnosis of IBS-C who:

  • Completed plecanatide study SP304203-04 or SP304203-05, were compliant with the previous study's requirements, and did not experience any Serious Adverse Event (SAE) deemed related to study drug during the course of the previous study, OR
  • Failed screening in study SP304203-04 or SP304203-05 due to diary noncompliance (an exclusion in the core study) or due to an administrative reason and is allowed to enter this study by notification from Sponsor or delegate.

Key Exclusion Criteria:

  • Patient is unwilling or unable to: participate in the study for the required duration, understand and sign the informed consent form (ICF) and undergo all protocol related tests and procedures throughout the study.
  • Female patient of childbearing potential with a positive urine pregnancy test on Day 1.
  • Male and female patients of childbearing potential who do not agree to continue to use the method of birth control used in the core double-blind plecanatide study for the duration of this clinical trial.
  • Patient has experienced a significant negative change in health status during the course of participation in the core double-blind plecanatide study or after completion of the study.
  • In the opinion of the Investigator or Medical Monitor, it is not in the patient's best interest to participate in the study. The reason(s) for the patient's exclusion must be specified.

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 identifier (NCT number): NCT02706483

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Sponsors and Collaborators
Synergy Pharmaceuticals Inc.

Responsible Party: Synergy Pharmaceuticals Inc. Identifier: NCT02706483     History of Changes
Other Study ID Numbers: SP304203-06
First Posted: March 11, 2016    Key Record Dates
Last Update Posted: October 5, 2017
Last Verified: October 2017

Additional relevant MeSH terms:
Irritable Bowel Syndrome
Pathologic Processes
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastrointestinal Agents