NCT04101318|CompletedResults
Investigation of a New Stoma Product for People With a Stoma
CP288
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CP288
Sponsor study identifier
interventional
79
1 country
1
Study Start
January 22, 2020
Actual (reported)Primary Completion
July 17, 2020
Actual (reported)Study Completion
July 17, 2020
Actual (reported)The CP288 study is an investigation of a non-Conformité Européene marked stoma product which will be conducted in the UK, Italy, Netherlands, Germany, and Norway. The study will enroll up to 100 subjects. The study is a randomized, open-label, comparative study.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 17, 2020
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 6, 2019
Actual (reported)September 24, 2019
Actual (reported)January 22, 2020
Actual (reported)July 17, 2020
Actual (reported)July 17, 2020
Actual (reported)September 21, 2023
Actual (reported)Max Itching Within a Week at Steady State
Participant were asked to rate their itching around the ostomy on a scale of 0-10 with 0= no itch ad 10= worst possible peristomal skin itch. The primary outcome measure was done on the Intended to Treat population. Steady state period of the treatment period began after three weeks of product use.
Within a week at steady state
Percentage of Participants With Varying Frequency of Itching Skin in the Past 14 Days by End of Treatment
past 14 days by end of treatment
Max Pain Within a Week at Steady State
Within one week at steady state
Percentage of Participants With Varying Frequency of Pain in the Past 14 Days by End of Treatment
past 14 days by end of treatment
Max Burning Within a Week at Steady State
Within one week at steady state
Percentage of Participants With Varying Frequency of Burning in the Past 14 Days by End of Treatment
past 14 days by end of treatment
Participants first received the non-Conformité Européene marked investigational product for 42±3 days. Then there was a cross-over and the participants received one of the five Conformité Européene marked comparators products, which they used the following 42±3 days.
Participants first received one of the five Conformité Européene marked comparators products for 42±3 days. Then there was a cross-over and the participants received the non-Conformité Européene marked investigational products, which they used the following 42±3 days.
New Baseplate is not named at this point
The Conformité Européene marked competitor products are considered Standard of Care or products considered to be part of Standard of Care in coming years.
Ragene Saetre
Larvik, 3256, Norway
Nazarena Mazzarro, MD
Coloplast A/S
79 participants (actual enrollment reported by the registry).
First Submitted
September 6, 2019
First Posted
September 24, 2019
Study Start
January 22, 2020
Actual (reported)Preliminary Evaluation of CASTLE Barrier North American Prototype
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
July 17, 2020
Actual (reported)Study Completion
July 17, 2020
Actual (reported)Last Updated
September 21, 2023
Results First Posted
September 21, 2023
Record last verified: 2022-11
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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