Trial Outcomes & Findings for Safety and Performance Investigation of a New 1-piece Ostomy Product Compared to Standard of Care 1-piece in Subjects With Ileostomy (NCT NCT01994863)

NCT ID: NCT01994863

Last Updated: 2015-03-11

Results Overview

The percentage of baseplates with no leakage/seeping under the baseplate was measured. Leakage/seeping under the baseplate was assessed after each baseplate change.

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 23 participants
• Primary outcome timeframe: 14+/-3 days per product
• Results posted on: 2015-03-11

Participant Flow

"Not completed" includes those who did not complete the entire period (those that did not try all products within the period) and then continued to next period, if relevant.

Participant milestones

Measure	First Coloplast Test Product; Then Standard Care (See Below) The subjects are randomised to test Coloplast Test product first and thereafter test Standard Care. Standard Care is a collection of three different already marketed 1-piece flat ostomy appliances. These are Coloplast Sensura 1-piece; Hollister: Moderma 1-piece and B.Braun Flexima 1-piece. The three Standard Care products were tested in a 1:1:1 randomisation. Coloplast Test product: Coloplast test product is a newly developed 1-piece ostomy appliance Standard Care: Standard care consists of three already marketed 1-piece ostomy products Coloplast SenSura Hollister Moderma/Moderma Flex B.Braun Flexima/Softima	First Standard Care (See Below); Then Coloplast Test Product The subjects are randomised to test Standard care first and thereafter test Coloplast test product. Standard Care is a collection of three different already marketed 1-piece flat ostomy appliances. These are Coloplast Sensura 1-piece; Hollister: Moderma 1-piece and B.Braun Flexima 1-piece. The three Standard Care products were tested in a 1:1:1 randomisation. Coloplast Test product: Coloplast test product is a newly developed 1-piece ostomy appliance Standard Care: Standard care consists of three already marketed 1-piece ostomy products Coloplast SenSura Hollister Moderma/Moderma Flex B.Braun Flexima/Softima
Period 1 STARTED	11	12
Period 1 COMPLETED	4	9
Period 1 NOT COMPLETED	7	3
Period 2 STARTED	8	9
Period 2 COMPLETED	7	5
Period 2 NOT COMPLETED	1	4

Reasons for withdrawal

Measure	First Coloplast Test Product; Then Standard Care (See Below) The subjects are randomised to test Coloplast Test product first and thereafter test Standard Care. Standard Care is a collection of three different already marketed 1-piece flat ostomy appliances. These are Coloplast Sensura 1-piece; Hollister: Moderma 1-piece and B.Braun Flexima 1-piece. The three Standard Care products were tested in a 1:1:1 randomisation. Coloplast Test product: Coloplast test product is a newly developed 1-piece ostomy appliance Standard Care: Standard care consists of three already marketed 1-piece ostomy products Coloplast SenSura Hollister Moderma/Moderma Flex B.Braun Flexima/Softima	First Standard Care (See Below); Then Coloplast Test Product The subjects are randomised to test Standard care first and thereafter test Coloplast test product. Standard Care is a collection of three different already marketed 1-piece flat ostomy appliances. These are Coloplast Sensura 1-piece; Hollister: Moderma 1-piece and B.Braun Flexima 1-piece. The three Standard Care products were tested in a 1:1:1 randomisation. Coloplast Test product: Coloplast test product is a newly developed 1-piece ostomy appliance Standard Care: Standard care consists of three already marketed 1-piece ostomy products Coloplast SenSura Hollister Moderma/Moderma Flex B.Braun Flexima/Softima
Period 1 Adverse Event	4	0
Period 1 Withdrawal by Subject	1	0
Period 1 Trial stopped by sponsor	1	3
Period 1 Lack of Efficacy	1	0
Period 2 Adverse Event	0	1
Period 2 Lack of Efficacy	0	2
Period 2 Withdrawal by Subject	1	1

Baseline Characteristics

Safety and Performance Investigation of a New 1-piece Ostomy Product Compared to Standard of Care 1-piece in Subjects With Ileostomy

Baseline characteristics by cohort

Measure	All Subjects n=23 Participants
Age, Continuous	57.2 years STANDARD_DEVIATION 12.9 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants
Region of Enrollment Netherlands	17 participants n=5 Participants
Region of Enrollment France	6 participants n=5 Participants

PRIMARY outcome

Timeframe: 14+/-3 days per product

Population: Intention-to-treat population

The percentage of baseplates with no leakage/seeping under the baseplate was measured. Leakage/seeping under the baseplate was assessed after each baseplate change.

Outcome measures

Measure	Coloplast Test Product n=145 Baseplates	Standard Care n=180 Baseplates
Leakage	50 percentage of baseplates with no leakage	77 percentage of baseplates with no leakage

Adverse Events

Coloplast Test Product

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Standard Care

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Coloplast Test Product n=20 participants at risk	Standard Care n=20 participants at risk
Skin and subcutaneous tissue disorders Peristomal skin problem/pain/itching	40.0% 8/20 • Number of events 9	30.0% 6/20 • Number of events 6

Additional Information

Director Clinical Affairs

Coloplast A/S

Email: dkdac@coloplast.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: GT60