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Completed

NCT Number: NCT01919697

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

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

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Key information

Conditions

Chronic Idiopathic Constipation Bronchial Diseases Bronchiolitis Bronchiolitis Obliterans Bronchiolitis Obliterans Syndrome Bronchitis Constipation Graft vs Host Disease Immune System Diseases Lung Diseases Lung Diseases, Obstructive Organizing Pneumonia Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year–81 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Synergy Research Site, Kelowna, British Columbia, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Plecanatide

Drug

Primary outcomes

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

    Time frame: From first dose up to 72 weeks

    All clinically significant findings upon Physical Examinations of the Safety Population during the treatment period were reported as TEAEs. Safety was evaluated based on number of patients who experienced at least one TEAE.

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

    Time frame: From first dose up to 72 weeks

    Tolerability was evaluated based on number of patients who experienced at least one TEAE leading to discontinuation of the study drug

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

    Time frame: From first dose up to 72 weeks

    The vital signs included in the assessments were blood pressure (systolic and diastolic; mmHg), heart rate (beats per minute), body temperature (°C) and respiration rate (breaths per minute).

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

    Time frame: From first dose up to 72 weeks

    The vital signs included in the assessments were blood pressure (systolic and diastolic; mmHg), heart rate (beats per minute), body temperature (°C) and respiration rate (breaths per minute).

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

    Time frame: From first dose up to 72 weeks

    The vital signs included in the assessments were blood pressure (systolic and diastolic; mmHg), heart rate (beats per minute), body temperature (°C) and respiration rate (breaths per minute).

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

    Time frame: From first dose up to 72 weeks

    The vital signs included in the assessments were blood pressure (systolic and diastolic; mmHg), heart rate (beats per minute), body temperature (°C) and respiration rate (breaths per minute).

  7. Summary of ECG Results Shift From Baseline at > Day 364

    Time frame: From first dose up to 72 weeks

    Baseline was defined as the last non-missing value collected prior to first dose of study drug)

  8. Summary of Treatment-Emergent Laboratory Abnormalities With At Least a 1-grade Shift From Baseline

    Time frame: From first dose up to 72 weeks

    Baseline was defined as the last non-missing value collected prior to first dose of study drug within a given entry into the study. The Common Terminology Criteria for Adverse Events (CTCAE), Grades 1 through 5 were used for descriptions of severity for each Adverse Event (AE): Grade 1 - Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated; Grade 2 - Moderate; minimal, local or noninvasive intervention indicated; limiting age appropriate instrumental Activities of Daily Living (ADL); Grade 3 - Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL; Grade 4 - Life-threatening consequences; urgent intervention indicated; Grade 5 - Death related to AE.

Secondary outcomes

  1. Summary of Patient Patient Global Assessment (PGA) for Constipation Severity at > Day 364

    Time frame: Form first dose up to 72 weeks

    Constipation severity was measured using a 5-point score: 1=None, 2=Mild, 3=Moderate, 4=Severe, 5=Very severe Baseline was defined as the last non-missing value collected prior to first dose of study drug within a given entry into the study.

  2. Summary of Patient Global Assessment (PGA) for Constipation - Change From Baseline to > Day 364

    Time frame: From first dose up to 72 weeks

    Change of Constipation measured using a 7-point score: 1=Very Much Improved, 2=Much Improved, 3=Minimally Improved, 4=No change, 5=Minimally Worse, 6=Much Worse, 7=Very Much Worse Baseline is defined as the last non-missing value collected prior to first dose of study drug within a given entry into the study.

  3. Summary of Patient Global Assessment (PGA) for Treatment Satisfaction at > Day 364

    Time frame: From first dose up to 72 weeks

    Baseline was defined as the last non-missing value collected prior to first dose of study drug within a given entry into the study. Treatment Satisfaction was measured using a 5-point score: 1=Not At All Satisfied, 2=A Little Satisfied, 3=Moderately Satisfied, 4=Quite Satisfied, 5=Very Satisfied.

  4. Summary of Patient Global Assessment (PGA) for Treatment Continuation at End of Treatment

    Time frame: From first dose up to 72 weeks

    Treatment continuation was measured using 5-point score: 1=Not At All Likely, 2=A Little Likely, 3=Moderately Likely, 4=Quite Likely, 5=Very Likely

Sponsors and collaborators

Lead sponsor

Bausch Health Americas, Inc.

Industry

Collaborators

  • Syneos Health

Registry information

Official study title

An Open-Label Extension (OLE), Long-term Safety and Tolerability Study of Plecanatide in Patients With Chronic Idiopathic Constipation (CIC)

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Aug 9, 2013
Registry last updated
Jul 2, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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