COMPLETED

Efficacy and Safety of Plecanatide in Children 6 to <18 Years With Irritable Bowel Syndrome With Constipation (IBS-C)

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Conditions

Irritable Bowel Syndrome With Constipation

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The goal of this clinical trial is to learn if plecanatide can improve bowel function and relieve symptoms of irritable bowel syndrome with constipation (IBS-C) in children and adolescents aged 6 to \<18 years. The main questions it aims to answer are: * Does plecanatide increase the number of spontaneous bowel movements (SBMs) compared to placebo? * Is plecanatide safe and well tolerated in this pediatric population? Researchers will compare plecanatide at different doses to a placebo (a look-alike substance with no active drug) to see if plecanatide improves bowel function. Participants will: * Take plecanatide or placebo orally once daily for 4 weeks * Complete daily symptom diaries * Attend clinic visits for assessments and safety checks

Official Title

A Randomized, Double-blind, Placebo-Controlled, Dose Ranging, Parallel-Group Study of the Efficacy and Safety of Plecanatide in Children 6 to <18 Years of Age With Irritable Bowel Syndrome With Constipation (IBS-C)

Quick Facts

Study Start:2018-06-30
Study Completion:2024-11-25
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT03596905

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:6 Years to 18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Locations (Sites)

Bausch Site 178
Saraland, Alabama, 36571
United States
Bausch Site 176
Scottsdale, Arizona, 85258
United States
Bausch Site 160
Corona, California, 92879
United States
Bausch Site 147
Garden Grove, California, 92845
United States
Bausch Site 142
Los Angeles, California, 90036
United States
Bausch Site 143
Ventura, California, 93003
United States
Bausch Site 175
Aurora, Colorado, 80012
United States
Bausch Site 197
Washington D.C., District of Columbia, 20016
United States
Bausch Site 135
Doral, Florida, 33122
United States
Bausch Site 190
Hialeah, Florida, 33012
United States
Bausch Site 150
Miami, Florida, 33126
United States
Bausch Site 130
Miami, Florida, 33134
United States
Bausch Site 165
Miami, Florida, 33136
United States
Bausch Site 110
Tampa, Florida, 33607
United States
Bausch Site 174
Atlanta, Georgia, 30315
United States
Bausch Site 132
Atlanta, Georgia, 30342
United States
Bausch Site 148
Stockbridge, Georgia, 30281
United States
Bausch Site 115
Evansville, Indiana, 47715
United States
Bausch Site 139
Sioux City, Iowa, 51106
United States
Bausch Site 192
Bowling Green, Kentucky, 42101
United States
Bausch Site 172
Covington, Louisiana, 70433
United States
Bausch Site 180
Crowley, Louisiana, 70526
United States
Bausch Site 112
Lafayette, Louisiana, 70508
United States
Bausch Site 220
Omaha, Nebraska, 68134
United States
Bausch Site 145
Akron, Ohio, 44308
United States
Bausch Site 194
Cleveland, Ohio, 44106
United States
Bausch Site 111
Knoxville, Tennessee, 37922
United States
Bausch Site 195
Austin, Texas, 78723
United States
Bausch Site 225
Cedar Park, Texas, 78613
United States
Bausch Site 173
Dallas, Texas, 75243
United States
Bausch Site 193
Houston, Texas, 77030
United States
Bausch Site 170
Houston, Texas, 77087
United States
Bausch Site 140
San Antonio, Texas, 78215
United States
Bausch Site 120
Newport News, Virginia, 23606
United States
Bausch Site 146
Bellevue, Washington, 98007
United States

Collaborators and Investigators

Sponsor: Bausch Health Americas, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2018-06-30
Study Completion Date2024-11-25

Study Record Updates

Study Start Date2018-06-30
Study Completion Date2024-11-25

Terms related to this study

Additional Relevant MeSH Terms

  • Irritable Bowel Syndrome With Constipation