Current partner codePEPTIDESDE
NCT02706483·Phase 3·INTERVENTIONAL

Long Term Safety Study of Plecanatide

Status

Completed

Phase

Phase 3

Enrollment

2,272

Locations

204

Results

Posted

Publications

1

Study summary

What the protocol is testing.

Multi-center, open-label, long-term safety study

Full 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.

Interventions

Treatment arms and agents.

DRUG

Plecanatide

Timeline

From registration to results.

  1. First posted

    Mar 11, 2016

  2. Study start

    Jan 2016

  3. Primary completion

    May 2017

  4. Study completion

    Jun 2017

  5. Results posted

    Aug 18, 2020

  6. Registry updated

    Aug 18, 2020

Outcomes

What the study measures.

Primary outcomes

Number of Participants With Treatment Related Adverse Events.

Time frame · up to 53 weeks

Number of participants with adverse events with evidence to suggest a causal relationship between treatment and study drug.

Secondary outcomes

Not reported in the indexed record.

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
85 Years
Sex
ALL
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.

Study locations

204 registered sites.

United States. Showing up to 24 locations stored in the fast local snapshot.

Synergy Research Site

Athens, Alabama, United States

Synergy Research Site

Birmingham, Alabama, United States

Synergy Research Site

Dothan, Alabama, United States

Synergy Research Site

Foley, Alabama, United States

Synergy Research Site

Guntersville, Alabama, United States

Synergy Research Site

Huntsville, Alabama, United States

Synergy Research Site

Saraland, Alabama, United States

Synergy Research Site

Chandler, Arizona, United States

Synergy Research Site

Phoenix, Arizona, United States

Synergy Research Site

Surprise, Arizona, United States

Synergy Research Site

Tucson, Arizona, United States

Synergy Research Site

Conway, Arkansas, United States

Synergy Research Site

Glendale, Arkansas, United States

Synergy Research Site

Little Rock, Arkansas, United States

Synergy Research Site

Artesia, California, United States

Synergy Research Site

Canoga Park, California, United States

Synergy Research Site

Carmichael, California, United States

Synergy Research Site

Chula Vista, California, United States

Synergy Research Site

Corona, California, United States

Synergy Research Site

Costa Mesa, California, United States

Synergy Research Site

El Cajon, California, United States

Synergy Research Site

Encino, California, United States

Synergy Research Site

Foothill Ranch, California, United States

Synergy Research Site

Fountain Valley, California, United States

Related trials

More studies on Plecanatide.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.