Trial consisting of an 8-week part to evaluate potency, side effects, tolerability and blood levels of prucalopride in children with functional constipation, aged =6 months to <18 years, followed by a 16-week part to assess the side effects and tolerability of prucalopride in comparison to PEG.

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2010-022402-40-BE

Enrollment

210

Registered

2011-02-17

Start date

2011-05-05

Completion date

Unknown

Last updated

2014-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Functional constipation in paediatric subjects MedDRA version: 14.1 Level: PT Classification code 10010774 Term: Constipation System Organ Class: 10017947 - Gastrointestinal disorders

Interventions

Trade Name: Resolor® Product Name: Resolor Product Code: M0001 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Prucalopride CAS Number: 179474818 Current Sponsor code: M0001 Other descrip

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Boys and girls, aged =6 months to =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1. Children with underlying GI abnormalities and causes for defecation disorders such as Hirschsprung’s disease, spina bifida occulta, cystic fibrosis, GI malformations, or significant developmental delays that are associated with musculoskeletal or neurological conditions affecting the GI tract. 2. Children who are breast fed. 3. Subjects suffering from secondary causes of chronic constipation, e.g.: Endocrine disorders, Metabolic disorders, Neurological disorders, Organic disorders, Surgery, Hernia, Autoimmune disorders.

Design outcomes

Primary

Measure	Time frame
Main Objective: 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.;Secondary Objective: 1. Investigation of the individual symptoms defined by the Rome III criteria: bowel frequency, faecal incontinence, retentive posturing or excessive volitional stool retention, defecation pain, stool consistency, occurrence of large diameter stools. In addition use of rescue medication, abdominal pain and toilet training. 2. Pharmacokinetics: sparse blood sampling at single dose and steady state to enable population pharmacokinetic modelling. 3. Safety and tolerability: evaluation of prucalopride treatment up to 24 weeks. Only for older children after acquisition of toileting skills (as standard of care).;Primary end point(s): The proportion of responders, defined as subjects with an average spontaneous‡ defecation frequency of =3 times/week AND an average number of = 1 episode of faecal incontinence/2 weeks# (as calculated over week 5 to 8 of the double-blind treatment phase). ‡A spontaneous bowel movement (SBM) is defined as a non-laxative induced BM, i.e. not preceded within a period of 24 hours by the intake of a laxative agent or by the use of an enema. #Faecal incontinence will only be taken into account in children after acquisition of toileting skills.;Timepoint(s) of evaluation of this end point: According to the study design, primary endpoint will be evaluated on double-blind placebo controlled data; safety up to 24 weeks will make use of double-blind and open-label data.The first two weeks of the double-blind treatment phase will not be used for the primary efficacy analysis because of a possible effect of the use of an enema or oral laxative agent during run-in to remove the impaction. For evaluation of dose adjustment week 3 and 4 will be used. At the week 4 visit a possible dose adjustment might occur, the endpoint will therefore be determined from week	—

Measure

Time frame

Main Objective: 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.;Secondary Objective: 1. Investigation of the individual symptoms defined by the Rome III criteria: bowel frequency, faecal incontinence, retentive posturing or excessive volitional stool retention, defecation pain, stool consistency, occurrence of large diameter stools. In addition use of rescue medication, abdominal pain and toilet training*. 2. Pharmacokinetics: sparse blood sampling at single dose and steady state to enable population pharmacokinetic modelling. 3. Safety and tolerability: evaluation of prucalopride treatment up to 24 weeks. *Only for older children after acquisition of toileting skills (as standard of care).;Primary end point(s): The proportion of responders, defined as subjects with an average spontaneous‡ defecation frequency of =3 times/week AND an average number of = 1 episode of faecal incontinence/2 weeks# (as calculated over week 5 to 8 of the double-blind treatment phase). ‡A spontaneous bowel movement (SBM) is defined as a non-laxative induced BM, i.e. not preceded within a period of 24 hours by the intake of a laxative agent or by the use of an enema. #Faecal incontinence will only be taken into account in children after acquisition of toileting skills.;Timepoint(s) of evaluation of this end point: According to the study design, primary endpoint will be evaluated on double-blind placebo controlled data; safety up to 24 weeks will make use of double-blind and open-label data.The first two weeks of the double-blind treatment phase will not be used for the primary efficacy analysis because of a possible effect of the use of an enema or oral laxative agent during run-in to remove the impaction. For evaluation of dose adjustment week 3 and 4 will be used. At the week 4 visit a possible dose adjustment might occur, the endpoint will therefore be determined from week

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Secondary

Measure	Time frame
Secondary end point(s): Secondary endpoints following individual Rome III3 criteria: • The proportion of subjects with an average spontaneous defecation frequency of =3 times/week • Number of faecal incontinence episodes/week • Weekly frequency of retentive posturing or excessive volitional stool retention • Frequency of defecation pain (6-point scale; only in subjects of 3 years or older) • Stool consistency/week (4-point scale for children wearing diapers or 7-point Bristol scale for children without diapers ) • Weekly number of large stools Other secondary endpoints: • Time to first SBM • Number of SBMs/week, BMs/week and change from baseline • Amount of rescue medication used/week • Abdominal pain score/week (6-points scale; only in subjects of 3 years or older) • Global assessment of severity of constipation • Global assessment of efficacy of treatment • Weekly frequency of toilet training (only for subjects after acquisition of toileting skills);Timepoint(s) of evaluation of this end point: Diary secondary endpoints are evaluated on a weekly basis. Global assessments are done at every visit.	—

Measure

Time frame

Secondary end point(s): Secondary endpoints following individual Rome III3 criteria: • The proportion of subjects with an average spontaneous defecation frequency of =3 times/week • Number of faecal incontinence episodes/week • Weekly frequency of retentive posturing or excessive volitional stool retention • Frequency of defecation pain (6-point scale; only in subjects of 3 years or older) • Stool consistency/week (4-point scale for children wearing diapers or 7-point Bristol scale for children without diapers ) • Weekly number of large stools Other secondary endpoints: • Time to first SBM • Number of SBMs/week, BMs/week and change from baseline • Amount of rescue medication used/week • Abdominal pain score/week (6-points scale; only in subjects of 3 years or older) • Global assessment of severity of constipation • Global assessment of efficacy of treatment • Weekly frequency of toilet training (only for subjects after acquisition of toileting skills);Timepoint(s) of evaluation of this end point: Diary secondary endpoints are evaluated on a weekly basis. Global assessments are done at every visit.

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Countries

Belgium, Germany, Hungary, Italy, Poland, United Kingdom

Contacts

Public ContactShire-Movetis Clinical Trials

Shire-Movetis NV

Shire-Movetis.clinicaltrials@shire.com+3214404390

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026