Trials / Completed
CompletedNCT00753298
A Randomized, Fully-blinded Parallel Groups Study of Catheter Materials Used for Clean Intermittent Catheterisation
A Multi-centre, Double-blind, Randomized, Parallel Groups Study Comparing PVC and Polyolefin-based Elastomer (POBE) as Catheter Materials, Outcomes Will be Measured by Subject Perception.
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 195 (actual)
- Sponsor
- Wellspect HealthCare · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The study is designed as a randomized, double-blind, parallel-group, multi centre study comparing perception and tolerability of investigational product and comparator. In the randomized part of the study the subjects will be given either LoFric Primo (POBE) or the comparator LoFric Primo (PVC) for use over 4 weeks. The hypothesis is that subject perception and satisfaction of POBE is equal to or better than for PVC.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | LoFric Primo (POBE) single-use urinary catheter | LoFric Primo (POBE) single-use urinary catheter |
| DEVICE | LoFric Primo (PVC) single-use urinary catheter | LoFric Primo (PVC) single-use urinary catheter |
Timeline
- Start date
- 2007-01-01
- Primary completion
- 2008-03-01
- Completion
- 2008-03-01
- First posted
- 2008-09-16
- Last updated
- 2021-11-11
- Results posted
- 2009-06-02
Locations
13 sites across 6 countries: Austria, Germany, Italy, Netherlands, Sweden, United Kingdom
Source: ClinicalTrials.gov record NCT00753298. Inclusion in this directory is not an endorsement.