Trial Outcomes & Findings for An Explorative Randomized Controlled Investigation Evaluating Newly Developed Ostomy Products (NCT NCT02351817)
NCT ID: NCT02351817
Last Updated: 2016-01-06
Results Overview
Product acceptance was measurement qualitatively by interviews exploring the factors and mechanisms affecting the acceptance. The interview questions were formulated in such a way that was not possible to quantify the number of subjects accepting the test products. There were problems with test product performance and handling and therefore the acceptance of the products was not high. Product preference was secondary endpoint, where the subjects were asked whether they preffered their own product over the test products. This endpoint is the best measure we have for mimiking product acceptance. However, we are aware subjects could accept a product without preferring it over own product and the preferrence result might therefore not be accurate. The result presented below shows how many subjects preferred Test A/Test B over own product
COMPLETED
NA
10 participants
7 days per test period
2016-01-06
Participant Flow
Participant milestones
| Measure |
Baseline - Test A - Test B
First each subject tests baseline product, then Test A and finally Test B.
Baseline product: the subject's usual product
Test A: A newly developed 1-piece, open ostomy appliance for collecting feces
Test B: A newly developed 1-piece, open ostomy appliance for collecting feces
|
Baseline - Test B - Test A
First each subject tests baseline product, then Test B and finally Test A.
Baseline product: the subject's usual product
Test A: A newly developed 1-piece, open ostomy appliance for collecting feces
Test B: A newly developed 1-piece, open ostomy appliance for collecting feces
|
|---|---|---|
|
Baseline Period
STARTED
|
5
|
5
|
|
Baseline Period
COMPLETED
|
5
|
5
|
|
Baseline Period
NOT COMPLETED
|
0
|
0
|
|
Period 1
STARTED
|
5
|
5
|
|
Period 1
COMPLETED
|
4
|
2
|
|
Period 1
NOT COMPLETED
|
1
|
3
|
|
Period 2
STARTED
|
5
|
5
|
|
Period 2
COMPLETED
|
4
|
3
|
|
Period 2
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
| Measure |
Baseline - Test A - Test B
First each subject tests baseline product, then Test A and finally Test B.
Baseline product: the subject's usual product
Test A: A newly developed 1-piece, open ostomy appliance for collecting feces
Test B: A newly developed 1-piece, open ostomy appliance for collecting feces
|
Baseline - Test B - Test A
First each subject tests baseline product, then Test B and finally Test A.
Baseline product: the subject's usual product
Test A: A newly developed 1-piece, open ostomy appliance for collecting feces
Test B: A newly developed 1-piece, open ostomy appliance for collecting feces
|
|---|---|---|
|
Period 1
Adverse Event
|
1
|
2
|
|
Period 1
Lack of Efficacy
|
0
|
1
|
|
Period 2
Adverse Event
|
0
|
2
|
|
Period 2
Protocol Violation
|
1
|
0
|
Baseline Characteristics
An Explorative Randomized Controlled Investigation Evaluating Newly Developed Ostomy Products
Baseline characteristics by cohort
| Measure |
Overall Study Population
n=10 Participants
The investigation is a cross-over investigation therefore baseline data is presented for the overall population
|
|---|---|
|
Age, Continuous
|
57.0 years
STANDARD_DEVIATION 9.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 7 days per test periodPopulation: One subject did not answer the preference question.
Product acceptance was measurement qualitatively by interviews exploring the factors and mechanisms affecting the acceptance. The interview questions were formulated in such a way that was not possible to quantify the number of subjects accepting the test products. There were problems with test product performance and handling and therefore the acceptance of the products was not high. Product preference was secondary endpoint, where the subjects were asked whether they preffered their own product over the test products. This endpoint is the best measure we have for mimiking product acceptance. However, we are aware subjects could accept a product without preferring it over own product and the preferrence result might therefore not be accurate. The result presented below shows how many subjects preferred Test A/Test B over own product
Outcome measures
| Measure |
Test A
n=9 Participants
How many subjects preferred Test A over own product
|
Test B
n=9 Participants
How many subjects preferred Test B over own product
|
|---|---|---|
|
Product Acceptance
|
0 participants
|
1 participants
|
Adverse Events
Baseline
Test A
Test B
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Baseline
n=10 participants at risk
Adverse events reported by subjects testing Own product
|
Test A
n=10 participants at risk
Adverse events reported by subjects testing Test A
|
Test B
n=10 participants at risk
Adverse events reported by subjects testing Test B
|
|---|---|---|---|
|
Infections and infestations
Common Cold with fever
|
10.0%
1/10 • Number of events 1
|
0.00%
0/10
|
0.00%
0/10
|
|
Skin and subcutaneous tissue disorders
Peristomal skin irritation
|
0.00%
0/10
|
20.0%
2/10 • Number of events 2
|
20.0%
2/10 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Pain from peristomal skin
|
0.00%
0/10
|
0.00%
0/10
|
10.0%
1/10 • Number of events 1
|
|
Infections and infestations
Pneumonia
|
0.00%
0/10
|
10.0%
1/10 • Number of events 1
|
0.00%
0/10
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place