Test Catheter Pilot Study in Healthy Volunteers (Test catheter)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Coloplast A/S
ClinicalTrials.gov Identifier:
NCT00832078
First received: January 26, 2009
Last updated: August 2, 2012
Last verified: August 2012
Results First Received: January 9, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Crossover Assignment;   Masking: Single Blind (Subject);   Primary Purpose: Treatment
Condition: Healthy
Interventions: Device: SpeediCath Compact Male
Device: Speedicath

  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
28 participants enrolled in study. 2 were excluded before randomization as they did not comply with inclusion criteria. One was excluded from study (ITT) as participants dropped out before having any data recorded.

Reporting Groups
  Description
Group A Test day 1: first SCCM then SC; Test day 2: first SC then SCCM; this gives 4 catherizations per participant
Group B Test day 1 first SC then SCCM; Test day 2 first SCCM then SC; this gives 4 catherizations per participant

Participant Flow for 4 periods

Period 1:   Test Day 1- 1 Period
    Group A     Group B  
STARTED     13     12  
COMPLETED     13     12  
NOT COMPLETED     0     0  

Period 2:   Test Day 1-2 Period
    Group A     Group B  
STARTED     13     12  
COMPLETED     13     10  
NOT COMPLETED     0     2  
Lack of Efficacy                 0                 2  

Period 3:   Test Day 2 - 1 Period
    Group A     Group B  
STARTED     13     10  
COMPLETED     13     10  
NOT COMPLETED     0     0  

Period 4:   Test Day 2 - 2 Period
    Group A     Group B  
STARTED     13     10  
COMPLETED     12     10  
NOT COMPLETED     1     0  
Lack of Efficacy                 1                 0  



  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
Entire Study Population No text entered.

Baseline Measures
    Entire Study Population  
Number of Participants  
[units: participants]
  25  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     25  
>=65 years     0  
Age  
[units: years]
Mean ± Standard Deviation
  27.3  ± 10.4  
Gender  
[units: participants]
 
Female     0  
Male     25  
Region of Enrollment  
[units: participants]
 
Denmark     25  



  Outcome Measures

1.  Primary:   Discomfort   [ Time Frame: After each catheterisation ]

2.  Secondary:   Handling   [ Time Frame: After each catheterisation ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

3.  Secondary:   Preference   [ Time Frame: At study termination ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

4.  Secondary:   Haematuria   [ Time Frame: After each catheterisation ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes


  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:  
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: Scientific Manager
Organization: Coloplast
phone: +4549113557
e-mail: dkkg@coloplast.com


No publications provided


Responsible Party: Coloplast A/S
ClinicalTrials.gov Identifier: NCT00832078     History of Changes
Other Study ID Numbers: DK058CC
Study First Received: January 26, 2009
Results First Received: January 9, 2012
Last Updated: August 2, 2012
Health Authority: Denmark: Danish Medicines Agency
Denmark: Ethics Committee