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A randomized, double blind, placebo-controlled, double-dummy study to assess microneedle delivery in comparison to subcutaneous injection of adalimumab in healthy volunteers

1) To evaluate the pain, acceptability and local tolerability of intradermal microneedle injection compared to subcutaneous injection in healthy volunteers.2) To evaluate the safety, pharmacokinetics, pharmacodynamics, and immunogenicity of…

A first-in-human, randomized, dose-Escalation, double-blind, placebo-controlled study to assess safety, tolerability and pharmacokinetics of APX001 administered by intravenous infusion to healthy subjects.

The study will be performed in 4 parts, Parts A, B, C and D. The purpose of the study is to investigate to what extent APX001 is tolerated.It will also be investigated how quickly and to what extent APX001 is absorbed and eliminated from the body (…

Ziverel for PPI-refractory reflux symptoms: efficacy and mechanisms of action in humans

To assess the effect of Ziverel on esophageal sensitivity to acid, mucosal barrier function and reflux symptoms in patients with PPI-refractory reflux symptoms.

A phase 2, randomized, vehicle-controlled, double-blind study to explore the efficacy, pharmacodynamics and safety of topical ionic contra-viral therapy (ICVT) comprised of digoxin and furosemide in HPV-induced genital lesions of immunocompromised and immunocompetent patients.

Primary Objective• To explore the pharmacodynamics of the ionic contra-viral therapy CLS003 in immunocompromised and immunocompetent patients with benign and premalignant HPV-induced genital lesions.• To evaluate clinical efficacy of CLS003 compared…

Hit hard and early. The effect of high dose methylprednisolon on nailfold capillary changes and biomarkers in early SSc: a 12-week randomised double-blind placebo-controlled trial.

Objective 1: analyze the effect of short-term treatment with high dose glucocorticoids on vasculopathic abnormalities as measured by NCM in patients with very early SSc.Objective 2: investigate the effects of glucocorticoids on signs and symptoms of…

Randomized, double-blind (for clazosentan), placebo- and moxifloxacin-controlled, 3-way cross-over Phase 1 study to assess the effect of two intravenous doses of clazosentan on the QTc interval duration in healthy subjects

This study aims at investigating potential relevant QT effects of clazosentan at supra therapeutic doses in healthy male and female subjects using a concentration/response analysis approach in compliance with the ICH E14 guidance [FDA 2017].Primary…

Comparing Methotrexate monotherapy with methotrexate Plus LEflunomide combination ThErapy in Psoriatic Arthritis: A pragmatic randomized placebo-controlled double-blind clinical trial.

To compare the effectiveness of MTX monotherapy with MTX and LEF combination therapy in cDMARD-naïve psoriatic arthritis patients.

A Randomised, Double-Blind, Placebo-Controlled Trial of the Safety and Efficacy of Topical Alicaforsen Enema in Subjects with Active, Chronic, Antibiotic Refractory Primary Idiopathic Pouchitis

Primary Objective : To determine the effect of alicaforsen enema on endoscopic healing and symptoms associated with pouchitis in those subjects with active antibiotic refractory pouchitis Secondary Objectives : 1. To determine the ability of…

A double blind (sponsor open) placebo-controlled, stratified, parallel group study to evaluate the efficacy and safety of repeat doses of GSK3772847 in participants with moderate to severe asthma with allergic fungal airway disease (AFAD) (207972)

Primary:To evaluate the efficacy of 3 doses of GSK3772847 (administered every 4 weeks) compared with placebo in moderate to severe asthma participants with allergic fungal airway disease (AFAD) who are currently on Standard of Care (SoC) Secondary:…

A randomized, double-blind, placebo-controlled multiple ascending dose study to assess safety, pharmacokinetics and pharmacodynamics of oral HTL18318 in healthy young adult and elderly subjects.

1. To evaluate the safety and tolerability of ascending multiple oral doses of HTL18318 in healthy adult male and female subjects.2. To evaluate the pharmacokinetics of ascending multiple oral doses of HTL18318 in healthy adult male and female…

Imagery Rescripting with or without preceding Cognitive Restructuring: a randomized clinical trial

This research project examines whether there are differences in effects between application of ImRs preceeded by CR and ImRs as a stand-alone treatment technique on the so-called encapsulated beliefs, cognitive beliefs based on the aversive…

Efficacy and safety of bumetanide oral liquid formulation in children aged from 2 to less than 7 years old with Autism Spectrum Disorder.
A 6-month randomised, double-blind, placebo controlled multicentre parallel group study to evaluate efficacy and safety of bumetanide 0.5mg twice a day followed by an open label active 6-month treatment period with bumetanide (0.5mg twice a day) and a 6 weeks discontinuation period after treatment stop.

The primary objective is to demonstrate the superiority of bumetanide (0.5mg BID) oral liquid formulation compared to placebo in the improvement of ASD core symptoms after 6 months of treatment in ASD children aged from 2 to less than 7 years old.

A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED PARALLEL GROUP STUDY TO ASSESS THE EFFICACY AND SAFETY OF INDUCTION THERAPY WITH LYC-30937-EC IN SUBJECTS WITH ACTIVE ULCERATIVE COLITIS

The primary objective will be to assess the efficacy of LYC-30937-EC in inducing remission compared with placebo in subjects with active UC over a treatment duration of 8 weeks.The secondary objectives will be to evaluate the safety and tolerability…

Ghrelin treatment of comatose patients after cardiac arrest:
A phase 2 clinical trial to estimate safety and efficacy of ghrelin to promote cerebral recovery

Primary objective: We aim to measure safety and efficacy of intravenous treatment with acyl-ghrelin to promote cerebral recovery in comatose patients after cardiac arrest. Safety will be monitored throughout hospitalization and during follow-up…

Multiple dose escalation study in a multicenter, randomized, single-blind, parallel-group,
placebo-controlled design to investigate safety, tolerability, pharmacokinetics, and
pharmacodynamics of BAY 1213790 administered subcutaneously in healthy male subjects.

The purpose of this study is to investigate how safe the new compound BAY 1213790 is and how well it is tolerated when it is administered as an injection under the skin to healthy male volunteers. BAY 1213790 has been administered to humans before.…

A randomised controlled trial of oral S-ketamine as add-on medication for patients with treatment-resistant major depressive disorder

The proposed study aims to examine the antidepressant efficacy of oral S-ketamine augmentation in patients with TRD treated with regular antidepressants in a double-blind randomised controlled trial. Secondary questions involve the effects of oral S…

Exploring the early healing potential of a novel thermosensitive hyaluronic acid gel with octenidine preservation system as an adjunct to non-surgical periodontal treatment: a split-mouth blinded pilot study with proteomic analysis

This pilot study aims to assess the feasibility, safety and preliminary efficacy of a novel thermosensitive hyaluronic acid gel with an octenidine preservative system as an adjunct to standard non-surgical periodontal treatment. The use of a blinded…

The influence of female sex hormones on the subjective and cognitive response to cannabis

Primary Objective: To assess the acute subjective drug effects (good/bad drug effect, drug liking/wanting, anxiety), cognition (attention, working memory, information processing speed, verbal memory, verbal fluency, motor inhibition), and…