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Serotonin-4 Receptor Agonist

Prucalopride for Constipation

Phase 3
Waitlist Available
Research Sponsored by Takeda
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
>= 1 episode of fecal incontinence per week (only for participants after the acquisition of toileting skills).
History of retentive posturing or excessive volitional stool retention.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 to 3 hours post-dose at baseline (day 0), 14 to 26 hours post-dose at days 28, 56 and 84
Awards & highlights
Pivotal Trial

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.

Who is the study for?
This trial is for children and teenagers aged 6 months to 17 years with functional constipation, which means they have difficulty passing stools not caused by other health issues or medications. They must weigh at least 5.5 kg (12 lbs), be toilet-trained if over 3 years old, and experience less than three bowel movements per week among other specific criteria related to stool characteristics.Check my eligibility
What is being tested?
The study tests prucalopride's effectiveness in improving bowel movements in young patients with functional constipation. It has two parts: the first part randomly assigns participants to a low dose of prucalopride, a higher dose, or a placebo for 12 weeks; the second part continues treatment for another 36 weeks, with placebo group members switching to prucalopride.See study design
What are the potential side effects?
Possible side effects from prucalopride may include abdominal pain, diarrhea, headache, nausea, fatigue and an increase in heart rate. The severity of these side effects can vary between individuals.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 to 3 hours post-dose at baseline (day 0), 14 to 26 hours post-dose at days 28, 56 and 84
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 to 3 hours post-dose at baseline (day 0), 14 to 26 hours post-dose at days 28, 56 and 84 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants With Clinically Significant Changes in Clinical Laboratory Parameters, Electrocardiogram (ECG), Vital Signs and Physical Examination
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
Part A: Average Change From Baseline in Number of Spontaneous Bowel Movements (SBMs) per Week
Secondary outcome measures
Part A: Average Change From Baseline in Participants' Stool Consistency Based on Bristol Stool Form Scale (BSFS) Score During Week 12
Part A: Average Change From Baseline in Straining During Week 12
Part A: Percentage of Participants With Fecal Incontinence per Week
+1 more
Other outcome measures
Part A: Pharmacokinetic (PK) Plasma Concentrations of Prucalopride Succinate

Side effects data

From 2012 Phase 4 trial • 364 Patients • NCT01424228
12%
Headache
10%
Abdominal pain
7%
Nausea
1%
Obstruction gastric
1%
Blood pressure decreased
1%
Electrocardiogram QT prolonged
1%
Cerebrovascular accident
1%
Abnormal behavior
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Prucalopride

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

5Treatment groups
Experimental Treatment
Placebo Group
Group I: Part B: Low Dose GroupExperimental Treatment1 Intervention
Participants weighing < 50 kg will receive a daily dose of 0.04 mg/kg prucalopride oral solution (will draw the required volume from one bottle of 0.4 mg/mL and one bottle of placebo oral solution to account for the daily dose assigned) QD or participants weighing >= 50 kg will receive a single dose of 2 mg prucalopride oral tablet during 36 weeks of treatment period. Volume of the oral solution will be based on the participants BW at the randomization visit.
Group II: Part B: High Dose GroupExperimental Treatment1 Intervention
Participants weighing < 50 kg will receive a daily dose of 0.08 mg/kg prucalopride oral solution (will draw the required volume from two bottle of 0.4 mg/mL to account for the daily dose assigned) QD or participants weighing >= 50 kg will receive two dose of 2 mg prucalopride oral tablet during 36 weeks of treatment period. Volume of the oral solution will be based on the participants BW at the randomization visit.
Group III: Part A: Low Dose GroupExperimental Treatment1 Intervention
Participants weighing less than (<) 50 kilograms (kg) will receive a daily dose of 0.04 milligrams per kilogram (mg/kg) prucalopride oral solution (will draw the required volume from one bottle of 0.4 milligram per milliliter [mg/mL] and one bottle of placebo oral solution to account for the daily dose assigned) once daily (QD) or participants weighing greater than or equal to (>=) 50 kg will receive a single dose of 2 milligram (mg) prucalopride oral tablet during 12 weeks of treatment period. Volume of the oral solution will be based on the participants body weight (BW) at the randomization visit.
Group IV: Part A: High Dose GroupExperimental Treatment1 Intervention
Participants weighing < 50 kg will receive a daily dose of 0.08 mg/kg prucalopride oral solution (will draw the required volume from two bottle of 0.4 mg/mL to account for the daily dose assigned) QD or participants weighing >= 50 kg will receive a two dose of 2 mg prucalopride oral tablet during 12 weeks of treatment period. Volume of the oral solution will be based on the participants BW at the randomization visit.
Group V: Part A: PlaceboPlacebo Group1 Intervention
Participants weighing < 50 kg will draw equal volumes from two bottles of matching placebo oral solution to account for the daily dose assigned or participants weighing >= 50 kg will receive two daily dose of matching placebo oral tablet during 12 weeks of treatment period.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Prucalopride
2013
Completed Phase 4
~5850

Find a Location

Who is running the clinical trial?

TakedaLead Sponsor
1,193 Previous Clinical Trials
4,178,215 Total Patients Enrolled
14 Trials studying Constipation
5,542 Patients Enrolled for Constipation
Takeda Development Center Americas, Inc.Industry Sponsor
56 Previous Clinical Trials
12,037 Total Patients Enrolled
Study DirectorStudy DirectorTakeda Development Center Americas, Inc.
1,191 Previous Clinical Trials
489,989 Total Patients Enrolled
9 Trials studying Constipation
4,868 Patients Enrolled for Constipation

Media Library

Prucalopride (Serotonin-4 Receptor Agonist) Clinical Trial Eligibility Overview. Trial Name: NCT04759833 — Phase 3
Constipation Research Study Groups: Part B: High Dose Group, Part A: High Dose Group, Part B: Low Dose Group, Part A: Placebo, Part A: Low Dose Group
Constipation Clinical Trial 2023: Prucalopride Highlights & Side Effects. Trial Name: NCT04759833 — Phase 3
Prucalopride (Serotonin-4 Receptor Agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04759833 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

Who else is applying?

What state do they live in?
Texas
Pennsylvania
What portion of applicants met pre-screening criteria?
Met criteria
What site did they apply to?
Children's Hospital of Philadelphia
How many prior treatments have patients received?
0

How responsive is this trial?

Average response time
  • < 2 Days
Typically responds via
Email
Most responsive sites:
  1. Children's Hospital of Philadelphia: < 48 hours
~50 spots leftby Feb 2025