Prucalopride in Pediatric Subjects With Functional Constipation (FC)

This study has been completed.
Sponsor:
Collaborator:
PRA International
Information provided by (Responsible Party):
Shire
ClinicalTrials.gov Identifier:
NCT01330381
First received: April 4, 2011
Last updated: June 10, 2014
Last verified: January 2014

April 4, 2011
June 10, 2014
April 2011
March 2013   (final data collection date for primary outcome measure)
Percent of Responders in the Last Four Weeks of the Double-Blind Treatment Period [ Time Frame: Last 4 weeks of double-blind treatment period ] [ Designated as safety issue: No ]
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).
Efficacy [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
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. Efficacy is evaluated by the proportion of responders in the prucalopride vs. placebo arm. A subject is defined as a responder when the average spontaneous defecation frequency is ≥3 times/week AND the average number of faecal incontinence episodes per 2 weeks is ≤ 1 episode (as calculated over week 5 to 8 of the double-blind treatment phase).
Complete list of historical versions of study NCT01330381 on ClinicalTrials.gov Archive Site
  • 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 [ Time Frame: Last 4 weeks of double-blind treatment period ] [ Designated as safety issue: No ]
    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.
  • 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 [ Time Frame: Last 4 weeks of double-blind treatment period ] [ Designated as safety issue: No ]
    Fecal incontinence is a lack of control over defecation, leading to involuntary loss of bowel contents (only for subjects after acquisition of toileting skills).
  • Number of Retentive Posturing or Excessive Volitional Stool Retention in the Double-Blind Treatment Period [ Time Frame: Over the 8 week double blind treatment period ] [ Designated as safety issue: No ]
    Purposefully avoiding defecation.
  • Painful Bowel Movements Score in the Double-Blind Treatment Period [ Time Frame: Over the 8 week double blind treatment period ] [ Designated as safety issue: No ]
    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.
  • Stool Consistency Per SBM Score in Children Without Diapers in the Double-Blind Treatment Period [ Time Frame: Over the 8 week double blind treatment period ] [ Designated as safety issue: No ]
    Measured using the 7-point Bristol scale where 1-2 indicate constipation, 3-4 are ideal stools, and 5-7 tending toward diarrhea.
  • Stool Consistency Per SBM Score in Children With Diapers in the Double-Blind Treatment Period [ Time Frame: Over the 8 week double blind treatment period ] [ Designated as safety issue: No ]
    Measured on a 4-point scale where 1 is constipation, 2-3 is ideal, and 4 is diarrhea.
  • Large Diameter Stools in the Double-Blind Treatment Period [ Time Frame: Over the 8 week double blind treatment period ] [ Designated as safety issue: No ]
    Large diameter stools make defecation more difficult. Small diameter stools are better.
  • Abdominal Pain Score in Double-Blind Treatment Period [ Time Frame: Over the 8 week double blind treatment period ] [ Designated as safety issue: No ]
    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.
  • Frequency of Toilet Training in the Double-Blind Treatment Period [ Time Frame: Over the 8 week double blind treatment period ] [ Designated as safety issue: No ]
    Only for subjects after acquisition of toileting skills.
  • Number of Rescue Medications Taken in the Double-Blind Treatment Period [ Time Frame: Over the 8 week double blind treatment period ] [ Designated as safety issue: No ]
  • Time to First SBM in the Double-Blind Treatment Period [ Time Frame: Day 1 onwards ] [ Designated as safety issue: No ]
    After intake of the trial medication on Day 1.
  • Number of SBM Per Week in the Double-Blind Treatment Period [ Time Frame: Over the 8 week double blind treatment period ] [ Designated as safety issue: No ]
  • Change From Baseline in the Number of SBM Per Week Over the 8 Week Double Blind Treatment Period [ Time Frame: Baseline and over the 8 week double blind treatment period ] [ Designated as safety issue: No ]
  • Severity of Constipation Over the Past 2 Weeks for the Final On Treatment Assessment in the Double-Blind Treatment Period [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • Severity of Constipation Over the Past 2 Weeks for the Final On Treatment Assessment in the Open-Label Treatment Period [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • Efficacy of Treatment for Final On Treatment Assessment in Double-Blind Treatment Period [ Time Frame: Over the 8 week double blind treatment period ] [ Designated as safety issue: No ]
  • Efficacy of Treatment for Final On Treatment Assessment in Open-Label Treatment Period [ Time Frame: Over the 16 week open label treatment period ] [ Designated as safety issue: No ]
  • Convenience of Treatment for Final On Treatment Assessment in Open-Label Treatment Period [ Time Frame: Over the 16 week open label treatment period ] [ Designated as safety issue: No ]
  • individual symptoms defined by the Rome III criteria [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
    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* (*only for children after acquisition of toileting skills (as standard of care))
  • Pharmacokinetics [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Pharmacokinetics: sparse blood sampling at single dose and steady state to enable population pharmacokinetic modelling.
  • Safety and tolerability [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

    Safety and tolerability: evaluation of prucalopride treatment:

    Blood samples for biochemistry/haematology and urine samples for urinalysis will be taken at visit 1, visit 6 and visit 8.

    All non-related and trial medication related AEs, will be recorded from signing the ICF onwards till the last trial-related visit.

Not Provided
Not Provided
 
Prucalopride in Pediatric Subjects With Functional Constipation
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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Functional Constipation
  • 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
  • Drug: Placebo
    Matching oral solution or oral tablets given once daily
  • Drug: PEG 4000
  • Experimental: prucalopride
    drug
    Intervention: Drug: prucalopride
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
  • Active Comparator: PEG 4000
    4-20g administered as an oral solution once daily
    Intervention: Drug: PEG 4000
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
215
March 2013
March 2013   (final data collection date for primary outcome measure)

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.
Both
6 Months to 17 Years
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT01330381
SPD555-303, M0001-C303, 2010-022402-40
Yes
Shire
Shire
PRA International
Not Provided
Shire
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP