17 results
Run-in phase I: To confirm the safety and tolerability of BIBF 1120 up to a dose level of 200 mg b.i.d added to a standard dose of cisplatin/gemcitabine in first line NSCLC patients with squamous cell histology. Pharmacokinetics of BIBF 1120 and…
The primary objective is to assess whether there is a clinical relevant effectiveness of NSAID compared to Paracetamol over a period consistent with the Dutch guidelines for general practitioners in new consulters with knee OA in general practice.…
To investigate the postoperative pain, compliance, satisfaction in the three different groups of postoperative analgesia and a possible interaction.
To evaluate the safety and efficacy in terms of progression-free survival (PFS) and overall survival (OS) of nintedanib + pemetrexed / cisplatin followed by nintedanib versus placebo + pemetrexed / cisplatin followed by placebo as first line…
The main objective of the trial will be to assess safety and tolerability of combined treatmentwith nintedanib and pirfenidone.A secondary objective is to assess the exposure based on PK trough concentration values tonintedanib either given alone or…
Primary Objective:What is the effectiveness of immediate opioid pain medication (followed by step-down) versus step-up pain medication within the treatment according general practitioners* clinical guideline in patients with (sub)acute sciatica,…
Primary: To assess PFS of lung cancer patients with an FGFR1 gene amplified in their tumor cells upon treatment with BIBF1120.Secondary: To assess response rate, duration of response, overall survival and safety.
The objective of the trial is to assess the efficacy and safety of nintedanib in the treatment ofSSc with ILD at a dose of 150 mg bid compared to placebo.
The primary objective is to explore the efficacy of nintedanib (as measured by progression free survival) as second line therapy for patients with either differentiated or medullary thyroid cancer progressing after first line therapy.
The objectives are to assess the efficacy, safety and effect on quality of life of Nintedanib compared to chemotherapy in women with relapsed, advanced or metastatic clear cell cancer of the ovary of endometrium.
Hypothesis #1 efficacyWe hypothesize that a quick onset and a good adjustability of analgesia can be achieved with inhaled ketamine.Hypothesis #2 safetyInhalation of nebulized ketamine might lead to a fast onset of analgesia, with limited adverse…
The objective of this Phase III study is to evaluate the efficacy and safety of nintedanib in patients with mCRC after failure of previous treatment with standard chemotherapy and biological agents.
The objective of the current study is to compare three different strategies of pain management in patients presenting to an emergency department and to a general practice with acute musculoskeletal syndromes (defined as musculoskeletal complaints…
Primary Safety Objective * Proportion of patients who complete 24 weeks of combination treatment on pirfenidone at a dose of 1602*2403 mg/d and nintedanib at a dose of 200*300 mg/d Secondary Safety Objective * Proportion of patients who discontinue…
Based on the identified gaps in the evidence underlying the clinical guidelines on non-specific low back pain of the Dutch College of GPs and the recent findings of the Australian PACE study the objectives of the present study are: 1. What is the…
The main objective of the study is to evaluate dose-exposure and safety of nintedanib in children and adolescents with fibrosing ILD. Additional efficacy and safety endpoints will be collected to explore potential long-term effects.Please see…
This clinical trial is an open-label extension trial of the main study SENSCISTM (1199.214) and 1199-0340 to further evaluate the safety of long term treatment with nintedanib in patients with scleroderma related lung fibrosis.Also, in this trial,…