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

Primary Purpose

End Stage Renal Disease

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Experimental Peritoneal Dialysis Solution
Sponsored by
Baxter Healthcare Corporation
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for End Stage Renal Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Huddinge Sjukhus, Njurmed kliniken K 56

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
September 8, 2005
Last Updated
November 20, 2006
Sponsor
Baxter Healthcare Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT00214695
Brief Title
A Subjective Evaluation of Inflow Pain Associated With the Use of an Experimental Solution for Peritoneal Dialysis
Official Title
A Subjective Evaluation of Inflow Pain Associated With the Use of an Experimental Solution for Peritoneal Dialysis
Study Type
Interventional

2. Study Status

Record Verification Date
November 2006
Overall Recruitment Status
Completed
Study Start Date
May 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Baxter Healthcare Corporation

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Renal Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Randomized
Enrollment
20 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Experimental Peritoneal Dialysis Solution

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charlene Stubbs
Organizational Affiliation
Baxter Healthcare Corporation
Official's Role
Study Director
Facility Information:
Facility Name
Huddinge Sjukhus, Njurmed kliniken K 56
City
Huddinge
ZIP/Postal Code
141 86
Country
Sweden

12. IPD Sharing Statement

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

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