Prucalopride in Pediatric Subjects With Functional Constipation

Functional Constipation Clinical Trial

— FC  

Official title:

Trial Consisting of an 8-week Double-blind Placebo-controlled Part to Evaluate Efficacy, Safety, Tolerability and Pharmacokinetics of Prucalopride in Paediatric Subjects With Functional Constipation, Aged ≥6 Months to <18 Years, Followed by a 16-week Open-label Comparator (PEG) Controlled Part, to Document Safety and Tolerability up to 24 Weeks

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01330381
• Other study ID #: SPD555-303
• Secondary ID: M0001-C3032010-0
• Status: Completed
• Phase: Phase 3
• Start date: April 28, 2011
• Est. completion date: March 1, 2013

Study information

• Verified date: May 2021
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To evaluate the efficacy of prucalopride compared to placebo for the treatment of functional constipation in a paediatric population, aged ≥ 6 months to < 18 years. A 16-week open-label comparator (PEG) controlled part will follow, to document safety and tolerability up to 24 weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 215
• Est. completion date: March 1, 2013
• Est. primary completion date: March 1, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 17 Years

Eligibility

Main Inclusion Criteria:

1. Boys and girls, aged = 6 months and < 18 years.

2. Subjects with a confirmed diagnosis of functional constipation as defined by the Rome III criteria.

Main Exclusion Criteria:

1. Children with underlying GI abnormalities and causes for defecation disorders.

2. Constipation is thought to be drug-induced.

3. Subjects suffering from secondary causes of chronic constipation.

Related Conditions & MeSH terms

• Constipation
• Functional Constipation

Intervention

Drug:
• prucalopride
prucalopride subjects with weight =50kg: 0.04 mg/kg once daily as oral solution of 0.4 mg/ml subjects with weight >50 kg: prucalopride 2 mg tablet once daily
• Placebo
Matching oral solution or oral tablets given once daily
• PEG 4000

Locations

Country	Name	City	State
Netherlands	Academisch Medisch Centrum	Amsterdam

Sponsors (2)

Lead Sponsor	Collaborator
Shire	PRA Health Sciences

Country where clinical trial is conducted

Netherlands, 

References & Publications (1)

Mugie SM, Korczowski B, Bodi P, Green A, Kerstens R, Ausma J, Ruth M, Levine A, Benninga MA. Prucalopride is no more effective than placebo for children with functional constipation. Gastroenterology. 2014 Dec;147(6):1285-95.e1. doi: 10.1053/j.gastro.2014 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent of Responders in the Last Four Weeks of the Double-Blind Treatment Period	Responders are defined as subjects with an average spontaneous defecation frequency is =3 times per week AND the average number of fecal incontinence episodes per 2 weeks is = 1 episode (only for subjects after acquisition of toileting skills).	Last 4 weeks of double-blind treatment period
Secondary	Percent of Subjects With Bowel Frequency of 3 or More Spontaneous Bowel Movements (SBM) Per Week in the Last Four Weeks of the Double-Blind Treatment Period	Spontaneous Bowel Movements defined as a bowel movement that is not preceded within a period of 24 hours by the intake of a laxative agent or by the use of an enema.	Last 4 weeks of double-blind treatment period
Secondary	Percent of Subjects With Fecal Incontinence Episodes of 1 or Less Per 2 Weeks in the Last Four Weeks of the Double-Blind Treatment Period	Fecal incontinence is a lack of control over defecation, leading to involuntary loss of bowel contents (only for subjects after acquisition of toileting skills).	Last 4 weeks of double-blind treatment period
Secondary	Number of Retentive Posturing or Excessive Volitional Stool Retention in the Double-Blind Treatment Period	Purposefully avoiding defecation.	Over the 8 week double blind treatment period
Secondary	Painful Bowel Movements Score in the Double-Blind Treatment Period	Pain was rated on a 6-point scale (0=no hurt, 1=hurts little bit, 2=hurts little more, 3=hurts even more, 4=hurts whole lot, 5=hurts worst) in subjects of 3 years and older. Lower scores represent less pain.	Over the 8 week double blind treatment period
Secondary	Stool Consistency Per SBM Score in Children Without Diapers in the Double-Blind Treatment Period	Measured using the 7-point Bristol scale where 1-2 indicate constipation, 3-4 are ideal stools, and 5-7 tending toward diarrhea.	Over the 8 week double blind treatment period
Secondary	Stool Consistency Per SBM Score in Children With Diapers in the Double-Blind Treatment Period	Measured on a 4-point scale where 1 is constipation, 2-3 is ideal, and 4 is diarrhea.	Over the 8 week double blind treatment period
Secondary	Large Diameter Stools in the Double-Blind Treatment Period	Large diameter stools make defecation more difficult. Small diameter stools are better.	Over the 8 week double blind treatment period
Secondary	Abdominal Pain Score in Double-Blind Treatment Period	Pain was rated on a 6-point scale (0=no hurt, 1=hurts little bit, 2=hurts little more, 3=hurts even more, 4=hurts whole lot, 5=hurts worst) in subjects of 3 years and older. Lower scores represent less pain.	Over the 8 week double blind treatment period
Secondary	Frequency of Toilet Training in the Double-Blind Treatment Period	Only for subjects after acquisition of toileting skills.	Over the 8 week double blind treatment period
Secondary	Number of Rescue Medications Taken in the Double-Blind Treatment Period		Over the 8 week double blind treatment period
Secondary	Time to First SBM in the Double-Blind Treatment Period	After intake of the trial medication on Day 1.	Day 1 onwards
Secondary	Number of SBM Per Week in the Double-Blind Treatment Period		Over the 8 week double blind treatment period
Secondary	Change From Baseline in the Number of SBM Per Week Over the 8 Week Double Blind Treatment Period		Baseline and over the 8 week double blind treatment period
Secondary	Severity of Constipation Over the Past 2 Weeks for the Final On Treatment Assessment in the Double-Blind Treatment Period		2 weeks
Secondary	Severity of Constipation Over the Past 2 Weeks for the Final On Treatment Assessment in the Open-Label Treatment Period		2 weeks
Secondary	Efficacy of Treatment for Final On Treatment Assessment in Double-Blind Treatment Period		Over the 8 week double blind treatment period
Secondary	Efficacy of Treatment for Final On Treatment Assessment in Open-Label Treatment Period		Over the 16 week open label treatment period
Secondary	Convenience of Treatment for Final On Treatment Assessment in Open-Label Treatment Period		Over the 16 week open label treatment period