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

History of Changes

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
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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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.
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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 ]

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Serious Adverse Events

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Other Adverse Events

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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:

	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.
	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.
	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

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

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