Multi-national, Safety and Performance Study of New Ostomy Product Compared to Standard Care

This study has been terminated.
Information provided by (Responsible Party):
Coloplast A/S Identifier:
First received: June 24, 2011
Last updated: March 3, 2015
Last verified: March 2015
Results First Received: March 3, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Leakage
Skin Condition
Interventions: Device: New ostomy base plate (SS)
Device: Standard Care base plate

  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
A total of 33 subjects were enrolled in the trial. Of these, 6 discontinued during the New ostomy base plate run-in period prior to period 1 and were excluded from the Intention-To-Treat analysis set (no performance data obtained). 27 subjects comprised the intention-to-treat population.

Reporting Groups
Standard Care - New Ostomy Base Plate Subjects first test Standard Care then New ostomy base plate.
New Ostomy Base Plate - Standard Care Subjects first test New ostomy base plate then Standard Care.

Participant Flow for 2 periods

Period 1:   Period 1
    Standard Care - New Ostomy Base Plate     New Ostomy Base Plate - Standard Care  
STARTED     16 [1]   11  
COMPLETED     12     6  
NOT COMPLETED     4     5  
Adverse Event                 1                 2  
Lack of Efficacy                 0                 1  
E.g. study termination                 3                 1  
Withdrawal by Subject                 0                 1  
[1] One subject (who discontinued due to an adverse event) actually used New ostomy base plate.

Period 2:   Period 2
    Standard Care - New Ostomy Base Plate     New Ostomy Base Plate - Standard Care  
STARTED     11 [1]   6  
COMPLETED     5     4  
NOT COMPLETED     6     2  
Adverse Event                 1                 0  
Withdrawal by Subject                 3                 0  
E.g. study termination                 2                 2  
[1] One subject discontinued during run-in and did not start period 2.

  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.
No text entered.

Reporting Groups
Intention-to-treat Analysis Set No text entered.

Baseline Measures
    Intention-to-treat Analysis Set  
Number of Participants  
[units: participants]
[units: years]
Mean (Standard Deviation)
  54.9  (12.8)  
[units: participants]
Female     14  
Male     13  
Region of Enrollment  
[units: participants]
France     6  
Denmark     19  
Iceland     1  
Germany     1  

  Outcome Measures

1.  Primary:   Degree of Output Under the Base Plate (Leakage).   [ Time Frame: Each test product was assessed for 2 weeks. ]

  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
Early termination leading to small number of subjects analyzed.

  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 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.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.

Results Point of Contact:  
Name/Title: Tonny Karlsmark
Organization: Bispebjerg Hospital

No publications provided

Responsible Party: Coloplast A/S Identifier: NCT01517178     History of Changes
Other Study ID Numbers: CP215OC
Study First Received: June 24, 2011
Results First Received: March 3, 2015
Last Updated: March 3, 2015
Health Authority: Denmark: Ethics Committee
Denmark: Danish Medicines Agency
Germany: Federal Institute for Drugs and Medical Devices
Germany: Ethics Commission
France: Agence Nationale de Sécurité du Médicament et des produits de santé
Iceland:The National Bioethics Committee
Iceland: Icelandic Medicines Control Agency
France: Committee for the Protection of Personnes