CompletedPhase 3

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

United States2,370 participantsStarted 2013-08

Plain-language summary

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

Who can participate

Age range18 Years – 81 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Number of Patients With at Least One Treatment-Emergent Adverse Event (TEAE)

Timeframe: From first dose up to 72 weeks

Number of Patients With at Least One Treatment-Emergent Adverse Event (TEAE) Leading to Discontinuation of Plecanatide

Timeframe: From first dose up to 72 weeks

Summary of Vital Signs at >Day 364 - Blood Pressure (Systolic and Diastolic; mmHg)

Timeframe: From first dose up to 72 weeks

Summary of Vital Signs at >Day 364 - Heart Rate (Beats Per Minute)

Timeframe: From first dose up to 72 weeks

Summary of Vital Signs at >Day 364 - Body Temperature (°C)

Timeframe: From first dose up to 72 weeks

Summary of Vital Signs at >Day 364 - Respiration Rate (Breaths Per Minute)

Timeframe: From first dose up to 72 weeks

Summary of ECG Results Shift From Baseline at > Day 364

Timeframe: From first dose up to 72 weeks

Trial details

NCT IDNCT01919697

SponsorBausch Health Americas, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2016-01

Results submitted2018-12-13

View on ClinicalTrials.gov More Chronic Idiopathic Constipation trials

Who can participate

Age range18 Years – 81 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Number of Patients With at Least One Treatment-Emergent Adverse Event (TEAE)

Timeframe: From first dose up to 72 weeks

Number of Patients With at Least One Treatment-Emergent Adverse Event (TEAE) Leading to Discontinuation of Plecanatide

Timeframe: From first dose up to 72 weeks

Summary of Vital Signs at >Day 364 - Blood Pressure (Systolic and Diastolic; mmHg)

Timeframe: From first dose up to 72 weeks

Summary of Vital Signs at >Day 364 - Heart Rate (Beats Per Minute)

Timeframe: From first dose up to 72 weeks

Summary of Vital Signs at >Day 364 - Body Temperature (°C)

Timeframe: From first dose up to 72 weeks

Summary of Vital Signs at >Day 364 - Respiration Rate (Breaths Per Minute)

Timeframe: From first dose up to 72 weeks

Summary of ECG Results Shift From Baseline at > Day 364

Timeframe: From first dose up to 72 weeks