Evaluation of Prucalopride in Male Subjects With Chronic Constipation.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Shire
ClinicalTrials.gov Identifier:
NCT01147926
First received: June 17, 2010
Last updated: August 29, 2014
Last verified: August 2014
Results First Received: August 29, 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: Male Subjects With Chronic Constipation
Interventions: Drug: placebo
Drug: prucalopride

  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
No text entered.

Reporting Groups
  Description
PLACEBO Once daily orally matching placebo
PRUCALOPRIDE 2 mg once daily orally for subjects >18 to <65 years; 1 mg once daily orally for subjects >65 years, and in case of insufficient response, increase to 2 mg once daily orally at week 2 or week 4

Participant Flow:   Overall Study
    PLACEBO     PRUCALOPRIDE  
STARTED     187     187  
COMPLETED     160     158  
NOT COMPLETED     27     29  
Subject Withdrew Consent                 9                 10  
Adverse Event                 7                 6  
Subject Non-Compliant                 5                 4  
Principal investigator left hospital                 1                 3  
Selection criteria not met                 3                 1  
Lost to Follow-up                 0                 2  
Sponsor's Decision                 0                 1  
Lack of Efficacy                 1                 0  
Too busy, no time for study                 1                 0  
Went on holiday                 0                 1  
Colonoscopy result                 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.
The Safety Population included all subjects randomized into the study and who took at least 1 dose of investigational product (n = 370).

Reporting Groups
  Description
PLACEBO Once daily orally matching placebo
PRUCALOPRIDE 2 mg once daily orally for subjects >18 to <65 years; 1 mg once daily orally for subjects >65 years, and in case of insufficient response, increase to 2 mg once daily orally at week 2 or week 4
Total Total of all reporting groups

Baseline Measures
    PLACEBO     PRUCALOPRIDE     Total  
Number of Participants  
[units: participants]
  186     184     370  
Age  
[units: Years]
Mean ± Standard Deviation
  58.5  ± 16.28     58.4  ± 17.57     58.5  ± 16.91  
Age, Customized  
[units: Participants]
     
< 65     115     104     219  
>= 65 to <75     39     43     82  
>= 75     32     37     69  
Gender  
[units: Participants]
     
Female     0     0     0  
Male     186     184     370  
Region of Enrollment  
[units: Participants]
     
BELGIUM     10     10     20  
BULGARIA     9     9     18  
CZECH REPUBLIC     15     14     29  
DENMARK     21     19     40  
FRANCE     20     21     41  
GERMANY     11     10     21  
NETHERLANDS     5     5     10  
POLAND     28     26     54  
ROMANIA     57     56     113  
UNITED KINGDOM     10     14     24  



  Outcome Measures
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1.  Primary:   The Percentage of Subjects With an Average of ≥3 Spontaneous Complete Bowel Movements (SCBM) Per Week   [ Time Frame: Over 12 week treatment period ]

2.  Secondary:   Percentage of Subjects With an Average Weekly Frequency of at Least 3 SCBM Per Week and an Increase of ≥ 1 SCBM Per Week for ≥ 75% of the 12-week Treatment Period and ≥ 75% of the Last Third of the 12-week Treatment Period   [ Time Frame: Over 12 week treatment period ]

3.  Secondary:   Percentage of Subjects With an Increase of at Least 1 SCBM Per Week   [ Time Frame: Over 12 week treatment period ]

4.  Secondary:   SCBM Per Week   [ Time Frame: Over 12 week treatment period ]

5.  Secondary:   Percent SBM With a Consistency of Normal and Hard/Very Hard   [ Time Frame: Over 12 week treatment period ]

6.  Secondary:   Percent SCBM With No Straining and Severe/Very Severe Straining   [ Time Frame: Over 12 week treatment period ]

7.  Secondary:   Percent SBM With Sensation of Complete Evacuation   [ Time Frame: Over 12 week treatment period ]

8.  Secondary:   Time to First SCBM After Investigational Product Intake on Day 1   [ Time Frame: Day 1 ]

9.  Secondary:   Bisacodyl Tablets Taken Per Week   [ Time Frame: Over 12 week treatment period ]

10.  Secondary:   Days With Rescue Medication Taken Per Week   [ Time Frame: Over 12 week treatment period ]

11.  Secondary:   Percent of Subjects With an Improvement of ≥ 1 Point on the Patient Assessment of Constipation – Symptom (PAC-SYM) Questionnaire Total Score at Final On Treatment Assessment   [ Time Frame: Over 12 week treatment period ]

12.  Secondary:   Percent of Subjects With an Improvement of ≥ 1 Point on the Patient Assessment of Constipation - Quality of Life (PAC-QOL) Total Score at Final On Treatment Assessment   [ Time Frame: Over 12 week treatment period ]

13.  Secondary:   Percent of Subjects on the Subject Global Evaluation on Severity of Constipation Score Rating Constipation as Severe to Very Severe at Final On-Treatment Assessment   [ Time Frame: Over 12 week treatment period ]

14.  Secondary:   Percent of Subjects on the Subject Global Evaluation on Efficacy of Treatment Score Rating Treatment as Quite a Bit to Extremely Effective at Final On-Treatment Assessment   [ Time Frame: Over 12 week 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
phone: +1 866 842 5335


No publications provided


Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT01147926     History of Changes
Other Study ID Numbers: SPD555-302, M0001-C302, 2009-015719-42
Study First Received: June 17, 2010
Results First Received: August 29, 2014
Last Updated: August 29, 2014
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products
Bulgaria: Bulgarian Drug Agency
Czech Republic: State Institute for Drug Control
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
Romania: National Medicines Agency
United Kingdom: Medicines and Healthcare Products Regulatory Agency