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

This study has been completed.
Sponsor:
Information provided by:
Baxter Healthcare Corporation
ClinicalTrials.gov Identifier:
NCT00214695
First received: September 8, 2005
Last updated: November 20, 2006
Last verified: November 2006
  Purpose

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.


Condition Intervention
End Stage Renal Disease
Drug: Experimental Peritoneal Dialysis Solution

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Subjective Evaluation of Inflow Pain Associated With the Use of an Experimental Solution for Peritoneal Dialysis

Resource links provided by NLM:


Further study details as provided by Baxter Healthcare Corporation:

Estimated Enrollment: 20
Study Start Date: May 2005
Estimated Study Completion Date: July 2006
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00214695

Locations
Sweden
Huddinge Sjukhus, Njurmed kliniken K 56
Huddinge, Sweden, 141 86
Sponsors and Collaborators
Baxter Healthcare Corporation
Investigators
Study Director: Charlene Stubbs Baxter Healthcare Corporation
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00214695     History of Changes
Other Study ID Numbers: PRO-RENAL-REG-064
Study First Received: September 8, 2005
Last Updated: November 20, 2006
Health Authority: Sweden: Medical Products Agency
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Dialysis Solutions
Pharmaceutical Solutions
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 21, 2014