Prucalopride for Dyschezia

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Dyschezia+1 More
Prucalopride - Drug
Eligibility
< 18
All Sexes
What conditions do you have?
Select

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.

Eligible Conditions
  • Dyschezia
  • Constipation

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

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

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 preview

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?
Texas100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%