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Nitric Oxide during Cardio Pulmonary Bypass during surgery for congenital heart defects: A Randomised Controlled Trial.

Primary objective of this trial is to investigate in a double blind randomized controlled trial in children undergoing open heart surgery if NO exposure during CPB reduces the postoperative duration of invasive mechanical ventilation (defined as…

A Phase 2 Study to Investigate the Safety and Efficacy of ABBV-105 and Upadacitinib Given Alone or in Combination (ABBV-599 Combination) in Subjects with Moderately to Severely Active Systemic Lupus Erythematosus

The main objective of this study is to evaluate the safety and efficacy of ABBV-105, upadacitinib, and ABBV-599 versus placebo for the treatment of signs and symptoms of SLE in participants with moderately to severely active SLE and to define doses…

Satisfaction study of split doses botulinum toxin with double frequency

This study has been transitioned to CTIS with ID 2025-520915-14-00 check the CTIS register for the current data. Primary objectiveTo investigate the client*s satisfaction over time for the treatment of glabellar frown lines (GFL), horizontal…

A multicentre randomized, double-blind, placebo-controlled Phase 2 study to evaluate the safety, tolerability, efficacy, dose-response, pharmacokinetics and pharmacodynamics of repeat dosing of an anti-LAG3 cell depleting monoclonal antibody (GSK2831781) in patients with active ulcerative colitis

Primary:- To evaluate the safety and tolerability of repeat doses of GSK2831781 during the Induction Phase.- To characterise the efficacy dose-response of GSK2831781 during the Induction Phase.Secondary:- To evaluate the safety and tolerability of…

A 24-week multi-center, double-blind, placebo controlled dose-range finding study to investigate the efficacy and safety of oral QBW251 in COPD patients on triple inhaled therapy (LABA/LAMA/ICS)

The purpose of this study is to support the dose selection for the future development program of QBW251 by evaluating efficacy and safety of different QBW251 doses in patients with Chronic Obstructive pulmonary disease (COPD) with chronic bronchitis…

The role of dopamine and oxytocin in individual and social performance monitoring

The aim of this study is to improve our understanding of the mechanisms underlying altered social performance monitoring from a pharmacological perspective by directly comparing the effects of dopamine and oxytocin on individual and social…

A Phase 2 Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of DCR-PHXC Solution for Injection (subcutaneous use) in Patients with Primary Hyperoxaluria

Primary:To assess the efficacy of DCR-PHXC in reducing urinary oxalate burden in patients with PH (types 1 and 2)Key Secondary:To assess the efficacy of DCR-PHXC in reducing urinary oxalate burden over time in patients with PHSecondary:1. To…

A double blind, randomised, placebo-controlled trial to evaluate the dose-exposure and safety of nintedanib per os on top of standard of care for 24 weeks, followed by open label treatment with nintedanib of variable duration, in children and adolescents (6 to 17 year-old) with clinically significant fibrosing Interstitial Lung Disease.

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…

Multicenter, randomized, active comparator-controlled, double-blind, double-dummy, parallel group, dose-finding Phase 2 study to compare the safety of the oral FXIa inhibitor BAY 2433334 to apixaban in patients with atrial fibrillation

To evaluate that the oral FXIa inhibitor BAY 2433334 when compared to apixaban leads to a lower incidence of bleeding in participants with AF

A randomized, double-blind, placebo controlled, single center study to assess the efficacy and pharmacodynamics of Gladskin eczema cream BID in patients with mild to moderate atopic dermatitis.

Primary ObjectiveTo assess the efficacy of Gladskin Eczema Cream BID in patients with mild to moderate AD as assessed by EASI ScoreSecondary Objectives* To assess the pharmacodynamic effects of Gladskin Eczema Cream on the skin-microbiome, with…

A single dose, randomised, double-blind parallel group study to compare the pharmacokinetics and pharmacodynamics of PB006 with Tysabri® in healthy subjects

The sponsor is developing a compound (PB006) similar to Tysabri® (natalizumab, hereafter referred to as Tysabri). As part of medical-scientific studies to confirm the similarity of the two compounds, the Sponsor wants to compare PB006 with EU-…

A randomized, double-blind, two-way cross-over study to determine the effects of levetiracetam on corticospinal excitability in patients with treatment-controlled epilepsy, as measured by single and paired pulse TMS-EMG and TMS-EEG

- To evaluate effects of levetiracetam 2000 mg on single and paired pulse TMS-EMG and TMS-EEG in patients with epilepsy treated with mono-therapy levetiracetam, when compared to placebo (levetiracetam trough concentrations). - To evaluatethe effects…

A phase 1a/1b/2 study to assess the safety, tolerability and pharmacokinetics of OTL78, a PSMA-targeted fluorescent agent, for the intraoperative imaging of prostate cancer

Part A: healthy volunteers (n=up to 15)Primary/safety objective: - To assess the safety, tolerability and pharmacokinetics of a single IV dosage of OTL78 Secondary objective: - To assess the pharmacodynamics of OTL78 by measuring the temporal…

A randomized, double-blinded, placebo-controlled, single and multiple ascending dose study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of BMS-986259 in healthy participants

The purpose of this study is to investigate how safe the new compound BMS-986259 is and how well it is tolerated when it is administered as single or multiple doses to healthy volunteers. BMS-986259 has not been administered to humans before. It has…

The PaPa Trial: Paracetamol as an adjunct to intrapartum Remifentanil/PCA. An RCT of multimodal pain management during labor.

Primary objective: to research if Paracetamol reduces Remifentanil use when added to Remifentanil/PCA pain management during labour. Patients: Women in labour, using Remifantanil as pain management Intervention: Paracetamol intravenous (1 gram,…

Randomized, double blind, multicenter extension to CZPL389A2203 dose-ranging study to assess the shortterm and long-term safety and efficacy of oral ZPL389 with concomitant or intermittent use of TCS and/or TCI in adult patients with atopic dermatitis (ZEST Extension)

The purpose of this study is to assess short-term and the long-term safety and efficacy of oral ZPL389 (30 mg once daily (o.d.) and 50 mg o.d.) when used concomitantly or intermittently with topical corticosteroid (TCS) and/or topical calcineurin…

A Phase 3b Multicenter, Randomized, Double-Blind, Double-Dummy, Active Controlled
Study Comparing the Safety and Efficacy of Upadacitinib to Dupilumab in Adult Subjects with Moderate to Severe Atopic Dermatitis.

The objective of this study is to evaluate the efficacy and safety of upadacitinib versus dupilumab for the treatment of adult subjects with moderate to severe atopic dermatitis who are candidates for systemic therapy.

Phase 4 Double-blinded, Randomized, Active Comparator-controlled
Clinical Trial to Study the Efficacy, Safety, and Pharmacokinetics of Sugammadex (MK-
8616) for Reversal of Neuromuscular Blockade in Pediatric Participants Aged Birth to <2
Years

The current trial aims to demonstrate that sugammadex is generally safe and effective for reversing both moderate and deep block after rocuronium or vecuronium induced NMB in term neonates and young children.

A prospective, multicenter, randomised, double-blind, placebo-controlled, parallel groups, phase 3 study to compare the efficacy and safety of masitinib in combination with Riluzole versus placebo in combination with Riluzole in the treatment of patients suffering from Amyotrophic Lateral Sclerosis (ALS)

The objective is to evaluate the efficacy and safety of two doses of masitinib (4.5 mg/kg/day and 6.0 mg/kg/day) versus matching placebo in patients diagnosed with ALS treated with Riluzole (50 mg bid).The primary objective is to demonstrate…

A phase 1, randomized, double-blind, placebo-controlled, single-dose escalation, multiple-dose
escalation, and food effect study of RPT193 in healthy subjects and patients with moderate to severe
atopic dermatitis

The purpose of this study is to investigate how safe the new compound RPT193 is when it is administered to healthy subjects. RPT193 has not been administered to humans before. It has been previously tested in the laboratory and on animals. RPT193…