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.

Eligible Conditions

Dyschezia
Constipation

Treatment Effectiveness

Effectiveness Progress

2 of 3

This is further along than 85% of similar trials

Similar Trials

1

Low FODMAP diet/PEG 3350

1

Capsule

1

TEA

Study Objectives

1 Primary · 5 Secondary · Reporting Duration: 1 to 3 hours post-dose at baseline (Day 0), 14 to 26 hours post-dose at Days 28, 56 and 84

Day 28

Part A: Pharmacokinetic (PK) Plasma Concentrations of Prucalopride Succinate

Pharmacokinetic (PK) Plasma Concentrations of Prucalopride Succinate

Week 12

Part A: Average Change From Baseline in Number of Spontaneous Bowel Movements (SBMs) per Week

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 Participants' Stool Consistency During Week 12

Part A: Average Change From Baseline in Straining During Week 12

Week 52

Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)

Up to Week 12

Part A: Percentage of Participants With Fecal Incontinence per Week

Part A: Percentage of Responders With Increase of Greater Than or Equal to (>=) 1 and >= 3 Spontaneous Bowel Movements (SBMs) Per Week

Trial Safety

Safety Progress

3 of 3

This is further along than 85% of similar trials

Similar Trials

1

Low FODMAP diet/PEG 3350

1

Capsule

2

TEA

Side Effects for

Prucalopride

12%Headache

10%Abdominal pain

7%Nausea

1%Electrocardiogram QT prolonged

1%Abnormal behavior

1%Obstruction gastric

1%Cerebrovascular accident

1%Blood pressure decreased

This histogram enumerates side effects from a completed 2012 Phase 4 trial (NCT01424228) in the Prucalopride ARM group. Side effects include: Headache with 12%, Abdominal pain with 10%, Nausea with 7%, Electrocardiogram QT prolonged with 1%, Abnormal behavior with 1%.

Trial Design

5 Treatment Groups

Part A: Low Dose Group

1 of 5

Part B: Low Dose Group

1 of 5

Part B: High Dose Group

1 of 5

Part A: High Dose Group

1 of 5

Part A: Placebo

1 of 5

Experimental Treatment

Non-Treatment Group

255 Total Participants · 5 Treatment Groups

Primary Treatment: Prucalopride · Has Placebo Group · Phase 3

Part A: Low Dose Group

Drug

Experimental Group · 1 Intervention: Prucalopride · Intervention Types: Drug

Part B: Low Dose Group

Drug

Experimental Group · 1 Intervention: Prucalopride · Intervention Types: Drug

Part B: High Dose Group

Drug

Experimental Group · 1 Intervention: Prucalopride · Intervention Types: Drug

Part A: High Dose Group

Drug

Experimental Group · 1 Intervention: Prucalopride · Intervention Types: Drug

Part A: Placebo

Other

PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Other

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Prucalopride

FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks

Treatment: Varies

Reporting: 1 to 3 hours post-dose at baseline (day 0), 14 to 26 hours post-dose at days 28, 56 and 84

Who is running the clinical trial?

TakedaLead Sponsor

1,108 Previous Clinical Trials

4,042,522 Total Patients Enrolled

Takeda Development Center Americas, Inc.Industry Sponsor

46 Previous Clinical Trials

11,019 Total Patients Enrolled

Study DirectorStudy DirectorTakeda Development Center Americas, Inc.

1,056 Previous Clinical Trials

473,330 Total Patients Enrolled

Eligibility Criteria

Age < 18 · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:

You have ≥ 1 episode of fecal incontinence per week.

You have a minimum age of 3 years, or 6 months to 17 years, inclusive.

You are female and you are sexually active and agree to comply with the applicable contraceptive requirements of the protocol.

You have a history of retentive posturing or excessive volitional stool retention.

About The Reviewer

Michael Gill - B. Sc.

First Published: October 15th, 2021

Last Reviewed: November 29th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

Who else is applying?

What state do they live in?

Texas	100.0%

What portion of applicants met pre-screening criteria?

Met criteria	100.0%

References

2021. "A Study of Prucalopride For Functional Constipation in Children and Teenagers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04759833.

Prucalopride for Dyschezia

Study Summary

Treatment Effectiveness

Effectiveness Progress

Similar Trials

Study Objectives

Trial Safety

Safety Progress

Similar Trials

Side Effects for

Trial Design

5 Treatment Groups

Part A: Low Dose Group

1 of 5

Part B: Low Dose Group

1 of 5

Part B: High Dose Group

1 of 5

Part A: High Dose Group

1 of 5

Part A: Placebo

1 of 5

Trial Logistics

Trial Timeline

Who is running the clinical trial?

Eligibility Criteria

About The Reviewer

Who else is applying?

What state do they live in?

What portion of applicants met pre-screening criteria?

Other Trials to Consider

Low FODMAP Diet/PEG 3350for Irritable Bowel Syndrome

Capsulefor Stool Frequency

TEAfor Constipation-predominant Irritable Bowel Syndrome (IBS-C)

Naloxegol 25 MGfor Dyschezia

72 Μg Linaclotidefor Constipation-predominant Irritable Bowel Syndrome (IBS-C)

Glepaglutidefor Short Bowel Syndrome

Experimentalfor Dyschezia

Polyethylene Glycol 3350for Dyschezia

Psylliumfor Abdominal Pain

TEASfor Dyschezia

Healthy Individualsfor Dyschezia

Low Level Laser Therapyfor Dyschezia

Product Tolerability Armfor Dyschezia

Non-invasive, Surface Electrical Stimulation Device, DS5 Digitimerfor Dyschezia

OMM Treatmentfor Dyschezia

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