A Subjective Evaluation of Inflow Pain Associated With the Use of an Experimental Solution for Pe⦠(NCT00214695) | Clinical Trial Compass
CompletedNot Applicable
A Subjective Evaluation of Inflow Pain Associated With the Use of an Experimental Solution for Peritoneal Dialysis
Sweden20 participantsStarted 2005-05
Plain-language summary
The purpose of this study is to evaluate the inflow pain using an experimental peritoneal dialysis solution compared to a current solution for the management of end stage renal disease (ESRD) in peritoneal dialysis (PD) patients.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Patients who have given written informed consent after the nature of the study has been explained.
* Patients who are at least 18 years of age.
* Patients who have been treated with PD using specific solutions for at least 30 days before the screening visit.
* Patients who experience pain on infusion based on medical judgement.
Exclusion Criteria:
* Patients who have received antibiotics for the treatment of an episode of peritonitis within 30 days before to screening visit.
* Patients who have had acute or chronic exit-site or tunnel infection in the past 14 days, counted from the last day of infection to the screening visit.
* Patients who are participating in another study that requires Ethics Committee approval. Non-interventional studies are permitted.
* Patients who have received an investigational product within 30 days preceding the screening visit.
* Patients who are pregnant or lactating. (NB: Female patients of childbearing potential must have a negative urine or serum pregnancy test at the time of the screening and will be required to use a medically acceptable means of contraception during their participation in this study).
* Patients who have a significant psychiatric disorder or mental disability that could interfere with his/her ability to provide informed consent and/or comply with protocol procedures.