Trial Outcomes & Findings for Investigating the Safety and Performance of a New 2-piece Ostomy Product Compared With SenSura Click 2-piece (NCT NCT01957553)

NCT ID: NCT01957553

Last Updated: 2014-09-08

Results Overview

The subjects were asked which product they preferred (the Test product or SenSura) at the end of the investigation. The preference result shows the percentage of subjects preferring either the Test product or SenSura.

Recruitment status

COMPLETED

Study phase

Target enrollment

130 participants

Primary outcome timeframe

21+1 days

Results posted on

2014-09-08

Participant Flow

The subjects were recruited from Coloplast user data base, from hospital sites and stoma care sites.

130 subjects were randomised, however 3 of these were not exposed to a product and where not included in the safety population. The participant flow below is generated based on the safety population.

Participant milestones

Participant milestones
Measure	Treatment Sequence 1, First Coloplast Test Product, the SenSur Subjects first allocated to Coloplast Test product will after cross-over test SenSura Coloplast test product: Coloplast test product is a newly developed 2-piece ostomy appliance SenSura: SenSura is the commercial available CE-marked SenSura Click 2-piece ostomy appliance from Coloplast A/S	Treatment Seqence 2; First SenSura the Coloplast Test Product Subjects first allocated to SenSura will after cross-over test Coloplast Test product Coloplast test product: Coloplast test product is a newly developed 2-piece ostomy appliance SenSura: SenSura is the commercial available CE-marked SenSura Click 2-piece ostomy appliance from Coloplast A/S
Test Period 1 (21 +- 1 Days) STARTED	61	66
Test Period 1 (21 +- 1 Days) COMPLETED	54	63
Test Period 1 (21 +- 1 Days) NOT COMPLETED	7	3
Test Period 2 (21 +- 1 Days) STARTED	54	63
Test Period 2 (21 +- 1 Days) COMPLETED	51	56
Test Period 2 (21 +- 1 Days) NOT COMPLETED	3	7

Reasons for withdrawal

Reasons for withdrawal
Measure	Treatment Sequence 1, First Coloplast Test Product, the SenSur Subjects first allocated to Coloplast Test product will after cross-over test SenSura Coloplast test product: Coloplast test product is a newly developed 2-piece ostomy appliance SenSura: SenSura is the commercial available CE-marked SenSura Click 2-piece ostomy appliance from Coloplast A/S	Treatment Seqence 2; First SenSura the Coloplast Test Product Subjects first allocated to SenSura will after cross-over test Coloplast Test product Coloplast test product: Coloplast test product is a newly developed 2-piece ostomy appliance SenSura: SenSura is the commercial available CE-marked SenSura Click 2-piece ostomy appliance from Coloplast A/S
Test Period 1 (21 +- 1 Days) Lack of Efficacy	2	3
Test Period 1 (21 +- 1 Days) Adverse Event	2	0
Test Period 1 (21 +- 1 Days) Withdrawal by Subject	2	0
Test Period 1 (21 +- 1 Days) screen failure	1	0
Test Period 2 (21 +- 1 Days) Adverse Event	1	3
Test Period 2 (21 +- 1 Days) Lack of Efficacy	1	2
Test Period 2 (21 +- 1 Days) completed early by mistake	0	1
Test Period 2 (21 +- 1 Days) device deficiency without AE	0	1
Test Period 2 (21 +- 1 Days) Other	1	0

Baseline Characteristics

Investigating the Safety and Performance of a New 2-piece Ostomy Product Compared With SenSura Click 2-piece

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Subjects n=125 Participants baseline data are summarized for all subjects
Age, Continuous	58.4 years STANDARD_DEVIATION 12.7 • n=5 Participants
Sex: Female, Male Female	46 Participants n=5 Participants
Sex: Female, Male Male	79 Participants n=5 Participants

PRIMARY outcome

Timeframe: 21+1 days

Population: The ITT population was constituted by all randomized subjects with valid informed consent who had applied at least one test product and had valid information for the primary endpoint preference, or valid information for at least one product with respect to one of the secondary endpoints., who included all subject who contributed with endpoint data

Outcome measures

Outcome measures
Measure	Coloplast Test Product n=114 Participants	SenSura n=114 Participants
Preference	65 percentage of participants	35 percentage of participants

Adverse Events

Test Product

Serious events: 4 serious events

Other events: 27 other events

Deaths: 0 deaths

SenSura

Serious events: 1 serious events

Other events: 22 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Test Product n=124 participants at risk Safety data for subjects exposed to the test product	SenSura n=120 participants at risk Safety data for subjects exposed to SenSura
Cardiac disorders pain in chest	0.81% 1/124 • Number of events 1 • 42+/- 3 days	0.00% 0/120 • 42+/- 3 days
Gastrointestinal disorders rectal bleeding/inflammtion of the intestine	0.81% 1/124 • Number of events 1 • 42+/- 3 days	0.00% 0/120 • 42+/- 3 days
Musculoskeletal and connective tissue disorders Sclerosing angiomatoid nodlar tranformation	0.81% 1/124 • Number of events 1 • 42+/- 3 days	0.00% 0/120 • 42+/- 3 days
Surgical and medical procedures A cystic lesion in operation area	0.81% 1/124 • Number of events 1 • 42+/- 3 days	0.00% 0/120 • 42+/- 3 days
Respiratory, thoracic and mediastinal disorders COPD	0.00% 0/124 • 42+/- 3 days	0.83% 1/120 • Number of events 1 • 42+/- 3 days
Cardiac disorders Atrial fibrillation	0.81% 1/124 • Number of events 1 • 42+/- 3 days	0.00% 0/120 • 42+/- 3 days

Other adverse events

Other adverse events
Measure	Test Product n=124 participants at risk Safety data for subjects exposed to the test product	SenSura n=120 participants at risk Safety data for subjects exposed to SenSura
Skin and subcutaneous tissue disorders peristomal skin irritation	21.8% 27/124 • Number of events 46 • 42+/- 3 days	18.3% 22/120 • Number of events 35 • 42+/- 3 days

Additional Information

Dr. Birte P.Jakobsen

Coloplast

Phone: +45 4911 1395

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60