Patients with End Stage Renal Disease (ESRD) undergoing peritoneal dialysis (PD) therapy and experiencing pain on infusion with Extraneal not related to the catheter or volume of dialysis fluid. MedDRA version: 6.1 Level: LLT Classification code 10014646
Conditions
Sponsors
Baxter R&D Europe SCRL
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients who have given written informed consent after the nature of the study has been explained. 2. Patients who are at least 18 years of age. 3. Patients who have been treated with PD with Physioneal 35 or 40 for at least 60 days and Extraneal for at least 30 days before the screening visit. 4. Patients who experience pain on infusion with Extraneal that, based on medical judgement, is not related to the catheter. Such pain is frequently or often associated with a ‘jet’ effect on inflow or with pain on outflow. 5. Patients who experience pain on infusion with Extraneal that, based on medical judgement, is not related to excessive IP volumes of dialysis fluid. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Patients who have received antibiotics for the treatment of an episode of peritonitis within 30 days before to screening visit. Peritonitis being defined as 2 out of 3 of the following criteria: a) Cloudy peritoneal effluent with peritoneal white blood cell (WBC) count > 100 cells/mm3 due predominantly to neutrophils (>50%), (= 1L dialysate after = 2h dwell time). b) Symptoms and signs of peritoneal inflammation (e.g. abdominal pain). c) Demonstration of microorganism or yeast in the peritoneal effluent by culture or Gram’s stain. 2. 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. 3. Patients who are participating in another study that requires Ethics Committee approval. Non-interventional studies are permitted. 4. Patients who have received an investigational product within 30 days preceding the screening visit. 5. 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). 6. 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. 7. Patients who experience persistent pain (= 60 minutes) after IP infusion of dialysis solution (infusion related pain is normally of shorter duration). 8. Patients who are allergic to starch-based polymers. 9. Patients who have glycogen storage disease. 10. Patients who have had abdominal surgery within 30 days preceding the screening visit (V0). 11. Patients who have had abdominal fistulae, tumours, open wounds, herniae or other conditions which compromise the integrity of the abdominal wall, abdominal surface or intra-abdominal cavity within 30 days preceding the screening visit (V0). 12. Patients who have maltose or isomaltose intolerance. 13. Patients who have other serious acute or active conditions that in the investigator's opinion would preclude their participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to evaluate the effect of an icodextrin solution with bicarbonate/lactate buffer (Extraneal Physiological pH) compared to standard Extraneal with lactate buffer on inflow pain in patients treated with peritoneal dialysis (PD).;Secondary Objective: ;Primary end point(s): The primary efficacy variable is: Method of Pain Assessment: Variables Generated Pain Severity Rating Scale: Peak verbal scale pain during infusion * McGill Pain Questionnaire: Weighted pain rating for Affective major class Weighted pain rating for Evaluative major class Weighted pain rating for Miscellaneous major class Weighted pain rating for Sensory major class Weighted pain rating index - Total Number of words chosen Present pain intensity * Peak pain during infusion is defined as the maximum score observed at 1, 3, and 5 minutes during infusion and the end of infusion. | — |
Countries
Germany, Sweden, United Kingdom
Outcome results
None listed