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Prucalopride in Pediatric Subjects With Functional Constipation (FC)

This study has been completed.
Sponsor:
Collaborator:
PRA Health Sciences
Information provided by (Responsible Party):
Shire
ClinicalTrials.gov Identifier:
NCT01330381
First received: April 4, 2011
Last updated: April 13, 2015
Last verified: January 2014
Results First Received: January 7, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Functional Constipation
Interventions: Drug: prucalopride
Drug: Placebo
Drug: PEG 4000

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Subjects who completed the 8 week double blind treatment period and wished to continue were re-randomized after the double-blind treatment period to the 16 week open-label treatment period. Out of 215 subjects randomized in the study, 213 subjects received treatment and 2 subjects withdrew consent before treatment.

Reporting Groups
  Description
Prucalopride Subjects with weight ≤50 kg received 0.04 mg/kg prucalopride once daily as oral solution of 0.4 mg/mL. Subjects with weight >50 kg received prucalopride 2 mg oral tablet once daily.
Placebo

Subjects with weight ≤50 kg received placebo matching to prucalopride oral solution.

Subjects with weight >50 kg received placebo matching prucalopride oral tablet.

PEG 4000 (Polyethylene Glycol) Subjects received PEG 4000 oral solution at a dose of 4 gram to 20 gram once daily.

Participant Flow for 2 periods

Period 1:   Double-blind Treatment Period (8 Weeks)
    Prucalopride   Placebo   PEG 4000 (Polyethylene Glycol)
STARTED   107   108   0 
Received Treatment   106   107   0 
COMPLETED   96   101   0 
NOT COMPLETED   11   7   0 
Withdrawal by Subject                5                4                0 
Non-compliance                2                1                0 
Adverse Event                1                1                0 
Lost to Follow-up                1                0                0 
Did not fulfill inclusion/exclusion                1                0                0 
Lack of Efficacy                1                1                0 

Period 2:   Open-label Treatment Period (16 Weeks)
    Prucalopride   Placebo   PEG 4000 (Polyethylene Glycol)
STARTED   98   0   99 
COMPLETED   88   0   81 
NOT COMPLETED   10   0   18 
Withdrawal by Subject                7                0                16 
Adverse Event                2                0                0 
Sponsor's decision                1                0                1 
Non-compliance                0                0                1 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Safety Set was used for baseline characteristics. The Safety Set includes all subjects who were randomized and received at least 1 dose of investigational product. One randomized subject in each group did not receive investigational product and therefore were not included in the Safety Set.

Reporting Groups
  Description
Prucalopride Subjects with weight ≤50 kg received 0.04 mg/kg prucalopride once daily as oral solution of 0.4 mg/mL. Subjects with weight >50 kg received prucalopride 2 mg oral tablet once daily.
Placebo Subjects with weight ≤50 kg received placebo matching to prucalopride oral solution. Subjects with weight >50 kg received placebo matching to prucalopride oral tablet.
Total Total of all reporting groups

Baseline Measures
   Prucalopride   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 106   107   213 
Age 
[Units: Participants]
     
<=18 years   106   107   213 
Between 18 and 65 years   0   0   0 
>=65 years   0   0   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 8.3  (4.54)   8.2  (4.69)   8.3  (4.61) 
Gender 
[Units: Participants]
     
Female   60   58   118 
Male   46   49   95 
Region of Enrollment 
[Units: Participants]
     
Hungary   39   35   74 
Netherlands   25   26   51 
Poland   23   23   46 
United Kingdom   10   10   20 
Belgium   4   4   8 
Germany   1   6   7 
France   2   2   4 
Italy   2   1   3 


  Outcome Measures
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1.  Primary:   Percent of Responders in the Last Four Weeks of the Double-Blind Treatment Period   [ Time Frame: Last 4 weeks of double-blind treatment period ]

2.  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   [ Time Frame: Last 4 weeks of double-blind treatment period ]

3.  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   [ Time Frame: Last 4 weeks of double-blind treatment period ]

4.  Secondary:   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 ]

5.  Secondary:   Painful Bowel Movements Score in the Double-Blind Treatment Period   [ Time Frame: Over the 8 week double blind treatment period ]

6.  Secondary:   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 ]

7.  Secondary:   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 ]

8.  Secondary:   Large Diameter Stools in the Double-Blind Treatment Period   [ Time Frame: Over the 8 week double blind treatment period ]

9.  Secondary:   Abdominal Pain Score in Double-Blind Treatment Period   [ Time Frame: Over the 8 week double blind treatment period ]

10.  Secondary:   Frequency of Toilet Training in the Double-Blind Treatment Period   [ Time Frame: Over the 8 week double blind treatment period ]

11.  Secondary:   Number of Rescue Medications Taken in the Double-Blind Treatment Period   [ Time Frame: Over the 8 week double blind treatment period ]

12.  Secondary:   Time to First SBM in the Double-Blind Treatment Period   [ Time Frame: Day 1 onwards ]

13.  Secondary:   Number of SBM Per Week in the Double-Blind Treatment Period   [ Time Frame: Over the 8 week double blind treatment period ]

14.  Secondary:   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 ]

15.  Secondary:   Severity of Constipation Over the Past 2 Weeks for the Final On Treatment Assessment in the Double-Blind Treatment Period   [ Time Frame: 2 weeks ]

16.  Secondary:   Severity of Constipation Over the Past 2 Weeks for the Final On Treatment Assessment in the Open-Label Treatment Period   [ Time Frame: 2 weeks ]

17.  Secondary:   Efficacy of Treatment for Final On Treatment Assessment in Double-Blind Treatment Period   [ Time Frame: Over the 8 week double blind treatment period ]

18.  Secondary:   Efficacy of Treatment for Final On Treatment Assessment in Open-Label Treatment Period   [ Time Frame: Over the 16 week open label treatment period ]

19.  Secondary:   Convenience of Treatment for Final On Treatment Assessment in Open-Label Treatment Period   [ Time Frame: Over the 16 week open label treatment period ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Study Physician
Organization: Shire Development LLC
phone: +1 866 842 5335


Publications of Results:

Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT01330381     History of Changes
Other Study ID Numbers: SPD555-303
M0001-C303 ( Other Identifier: Movetis )
2010-022402-40 ( EudraCT Number )
Study First Received: April 4, 2011
Results First Received: January 7, 2014
Last Updated: April 13, 2015
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Italy: Ministry of Health
Hungary:
United Kingdom: Medicines and Healthcare Products Regulatory Agency