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Prucalopride for Constipation
Study Summary
This trial is testing a medicine called prucalopride to see if it can help children and teenagers with functional constipation have more regular bowel movements. There are two parts to the trial, and participants will be randomly assigned to one of three groups: a low dose of prucalopride, a high dose of prucalopride, or a placebo (a pill with no medicine in it). The trial will last for 48 weeks total, and participants will be seen at the clinic several times throughout the trial.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2012 Phase 4 trial • 364 Patients • NCT01424228Trial Design
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Who is running the clinical trial?
Media Library
- Group 1: Part B: Low Dose Group
- Group 2: Part B: High Dose Group
- Group 3: Part A: High Dose Group
- Group 4: Part A: Placebo
- Group 5: Part A: Low Dose Group
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Where are the different sites where people can participate in this research?
"Currently, there are 36 trial sites for this study. They are situated in Boston, Philadelphia, Orange and other locations. Minimizing travel is important, so please enroll at the location nearest you."
Do we have any historical context for the use of Prucalopride?
"University Hospitals first conducted research on prucalopride in 2011 and, since then, 18310 similar studies have completed. At the moment, 3 more trials are ongoing with a considerable amount of these taking place in Boston, Massachusetts."
Are there any severe dangers associated with taking Prucalopride?
"Prucalopride has been studied in Phase 3 trials, meaning that there is some data supporting its efficacy and multiple rounds of data supporting its safety. Our team at Power estimates the safety of Prucalopride to be a 3 on a scale from 1 to 3."
How many people are included in this clinical trial?
"The pharmaceutical company Takeda is sponsoring a clinical trial that requires 255 eligible patients. The study will take place at various hospitals, like Massachusetts General in Boston and Children's Hospital of Philadelphia."
Based on the inclusion criteria, may I join this research project?
"This clinical trial is investigating a potential new medication for the treatment of dyschezia. To participate in this study, patients must be between 6 months and 17 years old. A total of 255 candidates will be enrolled in this trial."
Would patients above the age of 35 be interested in enrolling in this clinical trial?
"This particular clinical study is only for paediatric patients that fall between the ages of 6 months to 17 years old. In contrast, there are 25 other trials targeting a similar age group and 62 studies looking at senior citizens."
Are patients still being enrolled in this research project?
"Yes, this study is still looking for participants. The information on clinicaltrials.gov shows that the trial was originally posted on August 2nd, 2021 and was last updated November 16th, 2022."
Who else is applying?
What state do they live in?
What portion of applicants met pre-screening criteria?
What site did they apply to?
How many prior treatments have patients received?
How responsive is this trial?
Typically responds via
Most responsive sites:
- Children's Hospital of Philadelphia: < 48 hours
Average response time
- < 2 Days
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