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Coloplast DialogueStudy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Coloplast A/S
ClinicalTrials.gov Identifier:
NCT00626821
First received: February 21, 2008
Last updated: February 9, 2012
Last verified: January 2012
Results First Received: October 6, 2011  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Stoma
Intervention: Device: SenSura

  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
SenSura Test of SenSura for 6-8 weeks

Participant Flow:   Overall Study
    SenSura  
STARTED     3017  
Quality of Life     2672 [1]
COMPLETED     2796  
NOT COMPLETED     221  
Adverse Event                 44  
Protocol Violation                 33  
Withdrawal by Subject                 10  
Physician Decision                 9  
Product dysfunction                 21  
other/unknown reason                 104  
[1] Attended both visit 1 and visit 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
  Description
SenSura Test of SenSura for 6-8 weeks

Baseline Measures
    SenSura  
Number of Participants  
[units: participants]
  3017  
Age  
[units: years]
Mean ± Standard Deviation
  63.2  ± 14.3  
Gender [1]
[units: participants]
 
Female     1541  
Male     1474  
[1] Gender is unknown for 2 participants



  Outcome Measures

1.  Primary:   Quality of Life (Scale 0(Worst)-100(Best))   [ Time Frame: 6-8 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
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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 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: Helle Aaes Senior Scientific Manager
Organization: Coloplast
phone: +45 49112949
e-mail: dkheaa@coloplast.com


No publications provided


Responsible Party: Coloplast A/S
ClinicalTrials.gov Identifier: NCT00626821     History of Changes
Other Study ID Numbers: DK175OS
Study First Received: February 21, 2008
Results First Received: October 6, 2011
Last Updated: February 9, 2012
Health Authority: Denmark: Danish Dataprotection Agency
Denmark: Ethics Committee
United States: Institutional Review Board
Slovakia: Ethics Committee
The Netherlands: Ethics Committee
Australia: Ethics Committee
Iceland: Ethics Committee
Poland: Ethics Committee
Spain: Ethics Committee
Japan: Ethics Committee