5 results
The purpose of the study is to collect long-term data of safety, tolerability, and efficacy to support the submission of marketing authorisation of one-month dosing regimen of degarelix for treatment of prostate cancer.Primary Objective:•To evaluate…
To compare prostate-specific antigen (PSA) progression-free survival (PFS) failure rates during long-term treatment with 3-monthly subcutaneous (s.c.) injections of degarelix or goserelin in prostate cancer patients (PSA PFS failure is defined as…
Primary Objective - To evaluate the time to PSA >4 ng/mL during the first cycle of IAD after the end of an induction period with degarelix (7 monthly treatments) in prostate cancer patientsSecondary Objectives - To evaluate the time to PSA .4…
This study aims to assess the Pharmacokinetic (PK)-parameters and safety of treatment with BR-003 in humans. BR-003 is a pliable, ring-shaped, biocompatible hydrogel that contains bupivacaine, a well-known and approved local anaesthetic. Attached to…
Primary Objective: Proof of safety and tolerability of home parenteral nutrition (HPN) with an Omega-3 fatty acid enriched MCT/LCT lipid emulsion in adult patients with chronic intestinal failure (CIF) in need of long-term HPNSecondary Objectives:…