A Clinical Investigation of New Ostomy Appliances

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Coloplast A/S
ClinicalTrials.gov Identifier:
NCT01523756
First received: January 10, 2012
Last updated: January 28, 2014
Last verified: January 2014
Results First Received: November 21, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Open Label
Condition: Leakage
Interventions: Device: test product 1: new ostomy base plate with Coloplast as manufacturer
Device: test product 2: new ostomy base plate with Coloplast as manufacturer

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The subjects were recruited through the Coloplast database.

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
Own Product (Baseline) - Test Product 1 - Test Product 2

own product (baseline) - test product 1 - test product 2

test product 1 = New ostomy base plate. Due to company confidentiality the product is just called test product 1

Own Product (Baseline) - Test Product 2 - Test Product 1

own product (baseline) - test product 2 - test product 1

test product 2 = New ostomy base plate. Due to company confidentiality the product is just called test product 2


Participant Flow for 3 periods

Period 1:   Baseline Period
    Own Product (Baseline) - Test Product 1 - Test Product 2     Own Product (Baseline) - Test Product 2 - Test Product 1  
STARTED     11     9  
COMPLETED     11     8  
NOT COMPLETED     0     1  
Adverse Event                 0                 1  

Period 2:   Test Period 1
    Own Product (Baseline) - Test Product 1 - Test Product 2     Own Product (Baseline) - Test Product 2 - Test Product 1  
STARTED     11     8  
COMPLETED     10     8  
NOT COMPLETED     1     0  
Adverse Event                 1                 0  

Period 3:   Test Period 2
    Own Product (Baseline) - Test Product 1 - Test Product 2     Own Product (Baseline) - Test Product 2 - Test Product 1  
STARTED     10     8  
COMPLETED     10     7  
NOT COMPLETED     0     1  
Withdrawal by Subject                 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.
No text entered.

Reporting Groups
  Description
Overall Study No text entered.

Baseline Measures
    Overall Study  
Number of Participants  
[units: participants]
  20  
Age  
[units: years]
Mean ± Standard Deviation
  64  ± 10.8  
Gender  
[units: participants]
 
Female     12  
Male     8  



  Outcome Measures

1.  Primary:   Leakage Under the Base Plate Using a 24-point Scale   [ Time Frame: Each product will be tested 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
No text entered.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Marianne Raff
Organization: Coloplast A7S
phone: +45 4911 2562
e-mail: dkmr@oloplast.com


No publications provided


Responsible Party: Coloplast A/S
ClinicalTrials.gov Identifier: NCT01523756     History of Changes
Other Study ID Numbers: CP226
Study First Received: January 10, 2012
Results First Received: November 21, 2013
Last Updated: January 28, 2014
Health Authority: Denmark: Danish Medicines Agency
Denmark: National Ethical Committee for the Capital Region of Denmark