Trial Outcomes & Findings for Clinical Investigation of Filter Improvement for New Filter to Ostomy Bags (NCT NCT01272869)

Results Overview

Data will not be recorded at specific time points due to individual changing patterns (1-2 bags per day). Study subjects will fill out the Case Report Form (CRF) by themselves when changing bag. The subject is asked in the CRF among others the reason for changing bag (e.g. ballooning). Subjects will change bag according to their normal routine or when deemed appropriate. They are advised to change bag if it is filled with air and the air cannot be released through the filter within a specified time period.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

20 participants

Primary outcome timeframe

Daily or at every change of bag in a period of a maximum of 28 days

Results posted on

2012-12-31

Participant Flow

The subjects were recruited from a user data base in Denmark.

20 subjects were enrolled and randomized in the study.

Participant milestones

Participant milestones
Measure	Sensura First; Then Morfeus The reference product is the SenSura product which is already commercially available	Morfeus First; Then Sensura The test product with the Morfeus filter is the test product with the proposed new filter.
Period 1 (14 Days) STARTED	10	10
Period 1 (14 Days) COMPLETED	10	10
Period 1 (14 Days) NOT COMPLETED	0	0
Period 2 (14 Days) STARTED	10	10
Period 2 (14 Days) COMPLETED	9	10
Period 2 (14 Days) NOT COMPLETED	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Sensura First; Then Morfeus The reference product is the SenSura product which is already commercially available	Morfeus First; Then Sensura The test product with the Morfeus filter is the test product with the proposed new filter.
Period 2 (14 Days) Adverse Event	1	0

Baseline Characteristics

Clinical Investigation of Filter Improvement for New Filter to Ostomy Bags

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sensura n=10 Participants The reference product is the SenSura product which is already commercially available	Morfeus n=10 Participants The test product is the product with the proposed new filter (Morfeus)	Total n=20 Participants Total of all reporting groups
Age Continuous	59 years STANDARD_DEVIATION 13 • n=5 Participants	61 years STANDARD_DEVIATION 10 • n=7 Participants	60 years STANDARD_DEVIATION 11 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	1 Participants n=7 Participants	7 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	9 Participants n=7 Participants	13 Participants n=5 Participants

PRIMARY outcome

Timeframe: Daily or at every change of bag in a period of a maximum of 28 days

Population: Intention to treat (ITT)

Data will not be recorded at specific time points due to individual changing patterns (1-2 bags per day). Study subjects will fill out the Case Report Form (CRF) by themselves when changing bag. The subject is asked in the CRF among others the reason for changing bag (e.g. ballooning). Subjects will change bag according to their normal routine or when deemed appropriate. They are advised to change bag if it is filled with air and the air cannot be released through the filter within a specified time period.

Outcome measures

Outcome measures
Measure	Sensura n=156 Bags SenSura is the reference product and the product is already commercially available	Morfeus n=146 Bags The test product is the product with the proposed new filter (Morfeus)
Frequency of Ballooning in the Morfeus and the Sensura Filter Test Period.	55 percentage bags with ballooning	26 percentage bags with ballooning

Adverse Events

Sensura

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Morfeus

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Sensura n=20 participants at risk The reference product is the SenSura product which is already commercially available	Morfeus n=20 participants at risk The test product is the product with the proposed new filter (Morfeus)
Musculoskeletal and connective tissue disorders Abscess in the buttock	5.0% 1/20 • Number of events 1	0.00% 0/20

Other adverse events

Other adverse events
Measure	Sensura n=20 participants at risk The reference product is the SenSura product which is already commercially available	Morfeus n=20 participants at risk The test product is the product with the proposed new filter (Morfeus)
Skin and subcutaneous tissue disorders Pristomal skin redness	10.0% 2/20 • Number of events 2	0.00% 0/20
Nervous system disorders Sleep disruption	5.0% 1/20 • Number of events 1	0.00% 0/20

Additional Information

Director Medical Affairs

Coloplast A/S

Phone: 4549111111

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place