A Subjective Evaluation of Inflow Pain Associated With the Use of an Experimental Solution for Peritoneal Dialysis

End Stage Renal Disease Clinical Trial

Official title:

A Subjective Evaluation of Inflow Pain Associated With the Use of an Experimental Solution for Peritoneal Dialysis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00214695
• Other study ID #: PRO-RENAL-REG-064
• Status: Completed
• Phase: N/A
• First received: September 8, 2005
• Last updated: November 20, 2006
• Start date: May 2005
• Est. completion date: July 2006

Study information

• Verified date: November 2006
• Source: Baxter Healthcare Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products AgencyUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: July 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• End Stage Renal Disease
• Kidney Failure, Chronic

Intervention

Drug:
• Experimental Peritoneal Dialysis Solution

Locations

Country	Name	City	State
Sweden	Huddinge Sjukhus, Njurmed kliniken K 56	Huddinge

Sponsors (1)

Lead Sponsor	Collaborator
Baxter Healthcare Corporation

Country where clinical trial is conducted

Sweden,