Trial Outcomes & Findings for Investigation of a New 1-piece Convex Ostomy Product (NCT NCT02043782)

NCT ID: NCT02043782

Last Updated: 2016-05-04

Results Overview

The degree of leakage is investigated on a 32-point scale (including 0 for no leakage). O represents no leakage and 32 represents the worst leakage.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 38 participants
• Primary outcome timeframe: 14 +/- 3 days
• Results posted on: 2016-05-04

Participant Flow

Participant milestones

Measure	Test - Competitor - Own The subjects were randomized into six possible treatment groups: The order of test products for this group was: Coloplast test product Competitor soft convex product Own product Coloplast Test: Newly developed 1-piece convex ostomy product Own product: The subject's own product was used as baseline performance in this investigation. The products are commercially available on the market, and are products manufactured by manufactures who produce convex ostomy products, i.e. Coloplast, Convatec, Dansac, B. Braun, Hollister and more. Competitor soft convex: A commercially available soft convex product	Competitor - Own - Test The subjects were randomized into six possible treatment groups: The order of test products for this group was: Competitor soft convex product Own product Coloplast test product Coloplast Test: Newly developed 1-piece convex ostomy product Own product: The subject´s own product was used as baseline performance in this investigation. The products are commercially available on the market, and are products manufactured by manufactures who produce convex ostomy products, i.e. Coloplast, Convatec, Dansac, B. Braun, Hollister and more. Competitor soft convex: A commercially available soft convex product	Own - Test - Competitor The subjects were randomized into six possible treatment groups: The order of test products for this group was: Own product Coloplast test product Competitor soft convex product Coloplast Test: Newly developed 1-piece convex ostomy product Own product: The subject´s own product was used as baseline performance in this investigation. The products are commercially available on the market, and are products manufactured by manufactures who produce convex ostomy products, i.e. Coloplast, Convatec, Dansac, B. Braun, Hollister and more. Competitor soft convex: A commercially available soft convex product	Competitor - Test - Own The subjects were randomized into six possible treatment groups: The order of test products for this group was: Competitor soft convex product Coloplast test product Own product Coloplast Test: Newly developed 1-piece convex ostomy product Own product: The subject´s own product was used as baseline performance in this investigation. The products are commercially available on the market, and are products manufactured by manufactures who produce convex ostomy products, i.e. Coloplast, Convatec, Dansac, B. Braun, Hollister and more. Competitor soft convex: A commercially available soft convex product	Own - Competitor - Test The subjects were randomized into six possible treatment groups: The order of test products for this group was: Own product Competitor soft convex product Coloplast test product Coloplast Test: Newly developed 1-piece convex ostomy product Own product: The subject´s own product was used as baseline performance in this investigation. The products are commercially available on the market, and are products manufactured by manufactures who produce convex ostomy products, i.e. Coloplast, Convatec, Dansac, B. Braun, Hollister and more. Competitor soft convex: A commercially available soft convex product	Test - Own - Competitor The subjects were randomized into six possible treatment groups: The order of test products for this group was: Coloplast test product Own product Competitor soft convex product Coloplast Test: Newly developed 1-piece convex ostomy product Own product: The subject´s own product was used as baseline performance in this investigation. The products are commercially available on the market, and are products manufactured by manufactures who produce convex ostomy products, i.e. Coloplast, Convatec, Dansac, B. Braun, Hollister and more. Competitor soft convex: A commercially available soft convex product
Period 1 STARTED	7	6	7	6	6	6
Period 1 COMPLETED	7	6	6	6	6	6
Period 1 NOT COMPLETED	0	0	1	0	0	0
Period 2 STARTED	7	6	6	6	6	6
Period 2 COMPLETED	7	6	6	6	6	6
Period 2 NOT COMPLETED	0	0	0	0	0	0
Period 3 STARTED	7	6	6	6	6	6
Period 3 COMPLETED	7	6	6	6	6	6
Period 3 NOT COMPLETED	0	0	0	0	0	0

Reasons for withdrawal

Measure	Test - Competitor - Own The subjects were randomized into six possible treatment groups: The order of test products for this group was: Coloplast test product Competitor soft convex product Own product Coloplast Test: Newly developed 1-piece convex ostomy product Own product: The subject's own product was used as baseline performance in this investigation. The products are commercially available on the market, and are products manufactured by manufactures who produce convex ostomy products, i.e. Coloplast, Convatec, Dansac, B. Braun, Hollister and more. Competitor soft convex: A commercially available soft convex product	Competitor - Own - Test The subjects were randomized into six possible treatment groups: The order of test products for this group was: Competitor soft convex product Own product Coloplast test product Coloplast Test: Newly developed 1-piece convex ostomy product Own product: The subject´s own product was used as baseline performance in this investigation. The products are commercially available on the market, and are products manufactured by manufactures who produce convex ostomy products, i.e. Coloplast, Convatec, Dansac, B. Braun, Hollister and more. Competitor soft convex: A commercially available soft convex product	Own - Test - Competitor The subjects were randomized into six possible treatment groups: The order of test products for this group was: Own product Coloplast test product Competitor soft convex product Coloplast Test: Newly developed 1-piece convex ostomy product Own product: The subject´s own product was used as baseline performance in this investigation. The products are commercially available on the market, and are products manufactured by manufactures who produce convex ostomy products, i.e. Coloplast, Convatec, Dansac, B. Braun, Hollister and more. Competitor soft convex: A commercially available soft convex product	Competitor - Test - Own The subjects were randomized into six possible treatment groups: The order of test products for this group was: Competitor soft convex product Coloplast test product Own product Coloplast Test: Newly developed 1-piece convex ostomy product Own product: The subject´s own product was used as baseline performance in this investigation. The products are commercially available on the market, and are products manufactured by manufactures who produce convex ostomy products, i.e. Coloplast, Convatec, Dansac, B. Braun, Hollister and more. Competitor soft convex: A commercially available soft convex product	Own - Competitor - Test The subjects were randomized into six possible treatment groups: The order of test products for this group was: Own product Competitor soft convex product Coloplast test product Coloplast Test: Newly developed 1-piece convex ostomy product Own product: The subject´s own product was used as baseline performance in this investigation. The products are commercially available on the market, and are products manufactured by manufactures who produce convex ostomy products, i.e. Coloplast, Convatec, Dansac, B. Braun, Hollister and more. Competitor soft convex: A commercially available soft convex product	Test - Own - Competitor The subjects were randomized into six possible treatment groups: The order of test products for this group was: Coloplast test product Own product Competitor soft convex product Coloplast Test: Newly developed 1-piece convex ostomy product Own product: The subject´s own product was used as baseline performance in this investigation. The products are commercially available on the market, and are products manufactured by manufactures who produce convex ostomy products, i.e. Coloplast, Convatec, Dansac, B. Braun, Hollister and more. Competitor soft convex: A commercially available soft convex product
Period 1 Adverse Event	0	0	1	0	0	0

Baseline Characteristics

Investigation of a New 1-piece Convex Ostomy Product

Baseline characteristics by cohort

Measure	All Subjects n=38 Participants Pooled data from all arms.
Age, Continuous	62.3 years STANDARD_DEVIATION 13.6 • n=5 Participants
Sex: Female, Male Female	21 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants
Region of Enrollment Denmark	38 participants n=5 Participants

PRIMARY outcome

Timeframe: 14 +/- 3 days

The degree of leakage is investigated on a 32-point scale (including 0 for no leakage). O represents no leakage and 32 represents the worst leakage.

Outcome measures

Measure	Coloplast Test Product n=552 Baseplates Subjects testing Coloplast test product	Own Product n=759 Baseplates Subjects testing own product	Competitor Soft Convex n=612 Baseplates Subjects testing Competitor Soft Convex
Degree of Leakage	2.6 units on a scale Standard Deviation 4.8	4.8 units on a scale Standard Deviation 5.7	2.5 units on a scale Standard Deviation 4.3

Adverse Events

Coloplast Test Product

Serious events: 1 serious events

Other events: 22 other events

Deaths: 0 deaths

Own Product

Serious events: 1 serious events

Other events: 12 other events

Deaths: 0 deaths

Competitor Soft Convex

Serious events: 0 serious events

Other events: 23 other events

Deaths: 0 deaths

Serious adverse events

Measure	Coloplast Test Product n=37 participants at risk Adverse events reported by subjects testing Coloplast test product	Own Product n=38 participants at risk Adverse events reported by subjects testing own product	Competitor Soft Convex n=37 participants at risk Adverse events reported by subjects testing Competitor soft convex
Renal and urinary disorders Cystitis	2.7% 1/37 • Number of events 1 • The AE were reported throughout the investigation, up to 5 months.	2.6% 1/38 • Number of events 1 • The AE were reported throughout the investigation, up to 5 months.	0.00% 0/37 • The AE were reported throughout the investigation, up to 5 months.

Other adverse events

Measure	Coloplast Test Product n=37 participants at risk Adverse events reported by subjects testing Coloplast test product	Own Product n=38 participants at risk Adverse events reported by subjects testing own product	Competitor Soft Convex n=37 participants at risk Adverse events reported by subjects testing Competitor soft convex
Skin and subcutaneous tissue disorders Peristomal skin irritation/ broken skin/ stomal bleeding	54.1% 20/37 • Number of events 26 • The AE were reported throughout the investigation, up to 5 months.	13.2% 5/38 • Number of events 8 • The AE were reported throughout the investigation, up to 5 months.	56.8% 21/37 • Number of events 32 • The AE were reported throughout the investigation, up to 5 months.
Infections and infestations Influenza/ cold/ sore throat, Pneumonia, vomiting, infected wounds	8.1% 3/37 • Number of events 3 • The AE were reported throughout the investigation, up to 5 months.	10.5% 4/38 • Number of events 4 • The AE were reported throughout the investigation, up to 5 months.	8.1% 3/37 • Number of events 3 • The AE were reported throughout the investigation, up to 5 months.
Gastrointestinal disorders control of fistula, pain after control of fistula, constipation, sub ileus	0.00% 0/37 • The AE were reported throughout the investigation, up to 5 months.	5.3% 2/38 • Number of events 3 • The AE were reported throughout the investigation, up to 5 months.	2.7% 1/37 • Number of events 1 • The AE were reported throughout the investigation, up to 5 months.
Nervous system disorders headache, pain in right hand	5.4% 2/37 • Number of events 2 • The AE were reported throughout the investigation, up to 5 months.	0.00% 0/38 • The AE were reported throughout the investigation, up to 5 months.	0.00% 0/37 • The AE were reported throughout the investigation, up to 5 months.
Immune system disorders Herpes Zoster	2.7% 1/37 • Number of events 1 • The AE were reported throughout the investigation, up to 5 months.	0.00% 0/38 • The AE were reported throughout the investigation, up to 5 months.	0.00% 0/37 • The AE were reported throughout the investigation, up to 5 months.
Surgical and medical procedures Cataract	0.00% 0/37 • The AE were reported throughout the investigation, up to 5 months.	2.6% 1/38 • Number of events 1 • The AE were reported throughout the investigation, up to 5 months.	0.00% 0/37 • The AE were reported throughout the investigation, up to 5 months.
Social circumstances Gash on the riight Tibia (tipped on bike)	0.00% 0/37 • The AE were reported throughout the investigation, up to 5 months.	0.00% 0/38 • The AE were reported throughout the investigation, up to 5 months.	2.7% 1/37 • Number of events 1 • The AE were reported throughout the investigation, up to 5 months.
Skin and subcutaneous tissue disorders	2.7% 1/37 • Number of events 1 • The AE were reported throughout the investigation, up to 5 months.	0.00% 0/38 • The AE were reported throughout the investigation, up to 5 months.	0.00% 0/37 • The AE were reported throughout the investigation, up to 5 months.

Additional Information

Medical Director

Coloplast A/S

Phone: +45 4911 1395

Email: dkbir@coloplast.com

Results disclosure agreements

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