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The effect of a single gift antibiotics before ERCP to prevent post-ERCP pancreatitis.
A study protocol for a single centre, double blinded randomized controlled study.

This study aims to further reduce the incidence of a post-ERCP pancreatitis by administrating a single gift antibiotics after the procedure.

A randomized, double-blind, placebo-controlled single and multiple ascending dose study to test the safety, tolerability, pharmacokinetics and pharmacodynamics of NT-0167 in healthy volunteers

Primary:- To evaluate the safety and tolerability of NT-0167 in healthy volunteersSecondary:- To evaluate the pharmacokinetic (PK) profile of NT-0167 in healthy volunteers after the administration of single ascending (SAD) and multiple ascending…

A Randomized, Double-Blind, Vehicle-Controlled, Phase I Study to Evaluate the Safety and Tolerability of Topically Applied INM-755 Cream on Epidermal Wounds in Healthy Volunteers

Primary Objective• To evaluate the local safety and tolerability of INM-755 cream following repeated once-daily topical applications for 14 consecutive days on wounded skin of healthy volunteers. Secondary Objectives• To evaluate the systemic safety…

A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study of EDP-938 Administered Orally for the Treatment of Acute Upper Respiratory Tract Infection with Respiratory Syncytial Virus in Ambulatory Adult Subjects (RSVP)

Primary Objective• To evaluate the effect of EDP-938 on the progression of RSV infection by assessment of clinical symptomsSecondary Objectives• To evaluate the antiviral efficacy of EDP-938• To evaluate the pharmacokinetics (PK) of EDP-938• To…

BACILLUS CALMETTE-GUÉRIN VACCINATION TO PREVENT SERIOUS RESPIRATORY TRACT INFECTION AND COVID-19 IN VULNERABLE ELDERLY -* AN ADAPTIVE RANDOMIZED CONTROLLED TRIAL

To determine the impact of BCG vaccination on the incidence of clinically relevant respiratory infections or COVID-19 in vulnerablel older adults.

A phase 3, randomized, double-blind trial to evaluate the safety and immunogenicity of a 20-valent pneumococcal conjugate vaccine given as a series of 2 infant doses and 1 toddler dose in healthy infants

Primary Safety Objective: To describe the safety profile of 20vPnC

Defining long-term macrolide maintenance therapy in COPD: a single center randomized controlled trial:

The primary objectives of this study are:· To assess the time to first exacerbation of COPD, measured from the time of randomization The secondary objectives of this study are:· To evaluate the improvement of quality of life by Saint George*s…

A Randomized, Double-blind, Placebo-controlled, Sequential group, Dose-escalation Study to Evaluate the Safety and Pharmacokinetics of Single and Repeat Doses of Ceftibuten Administered Orally for 10 days in Healthy Adult Volunteers

The purpose of this study is to investigate how safe ceftibuten is and how well it is tolerated when it is administered at higher dose levels than those currently available on the market (daily doses up to 400 mg). It will also be investigated how…

CV019-010: A Randomized, Double-Blinded, Placebo-Controlled, Study to Evaluate the Safety and Tolerability of BMS-986259 in Stabilized Patients Hospitalized for Acute Decompensated Heart Failure

The purpose of this study is to evaluate the effectiveness of the BMS-986259 study drug on blood pressure events in stable participants diagnosed with heart failure admitted to the hospital with Acute Decompensated Heart Failure (ADHF).

A trial to assess the injection site pain experience of excipient solutions relevant for subcutaneous injection

The primary objective is to assess, in healthy subjects with a body mass index (BMI) greater than or equal to 25.0 kg/m2, the injection site pain experience of 9 excipient solutions (Trial Products 4 to 12), intended to be used in future…

A phase 3, randomized, double-blind trial of nivolumab in combination with intravesical BCG versus standard of care BCG alone in participants with high-risk non-muscle invasive bladder cancer that is persistent or recurrent after treatment with BCG

Primary objectiveTo compare the event free survival per pathological review committee (PRC) of nivolumab plus BCG vs BCG alone in all randomized ParticipantsEFS, defined as the time from randomization until any of the following events: recurrence (…

Randomized, Blinded, 2 stage, 2-way Crossover Bioequivalence Study of Mentholatum 10% w/w Ibuprofen Gel and Ibuleve 10% w/w Ibuprofen Gel Administered as a Single Application of 125 mg in Healthy Subjects

This study will compare the study compound Mentholatum 10% w/w Ibuprofen Gel to a similar product, which is already on the market in UK called Ibuleve Maximum Strength Gel. The purpose of the study is to compare these two gels in how quickly and to…

A Phase IIB, Randomized, Double blinded, Placebo controlled, Parallel
group Study to Evaluate the Efficacy and Safety of MEDI6570 in
Participants with a Prior Myocardial Infarction, Persistent Inflammation,
and Elevated N terminal Prohormone Brain Natriuretic Peptide

primaryTo evaluate the effect of MEDI6570 on non-calcified coronary atherosclerotic plaques compared with placebosecundaryTo evaluate the effect of MEDI6570 on a surrogate biomarker of HF compared with placeboTo evaluate the effect of MEDI6570 on…

ARISE - A Randomized, Double-Blind, Placebo-Controlled, Active Comparator, Multicenter Study to Validate Patient-Reported Outcome Instruments in Adult Subjects with Newly Diagnosed Nontuberculous Mycobacterial (NTM) Lung Infection Caused by Mycobacterium avium Complex (MAC)

Primary ObjectiveTo generate evidence demonstrating the domain specification (via modern psychometric methods), reliability, validity, and responsiveness (within-subject meaningful change) of the patient-reported outcome (PRO) endpoints Secondary…

IM011-127 A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety, Efficacy, and Biomarker Response of BMS-986165 in Subjects with Moderate to Severe Ulcerative Colitis

Study IM011-127 is a Phase 2 randomized, double-blind, placebo-controlled, multicenter clinical study designed to assess the safety and tolerability, efficacy and biomarker response of BMS-986165 12 mg BID in subjects with moderate to severe…

A Phase 2, Long-Term Extension (LTE) Study with Elsubrutinib and Upadacitinib Given Alone or in Combination (ABBV-599) in Subjects with Moderately to Severely Active Systemic Lupus Erythematosus Who Have Completed the M19-130 Phase 2 Randomized Controlled Trial (RCT)

To evaluate the long-term safety and tolerability of elsubrutinib and upadacitinib given alone or as the ABBV-599 (elsubrutinib/upadacitinib) combination in SLE subjects who have completed the M19-130 Phase 2 study.

A double-blind, placebo-controlled, randomized, single and multiple ascending dose study of the safety and tolerability, and pharmacokinetics (including food effect, pH effect and Japanese bridging study) of BMS-986337 following oral administration in healthy participants

The purpose of this study is to investigate how safe the new compound BMS-986337 is and how well it is tolerated when it is administered as single or multiple doses to healthy volunteers. BMS-986337 has not been administered to humans before. It has…

A Phase 3, Double blind, Randomized, Multicenter, Parallel Group, Placebo controlled Sequential Dose Titration Study to Evaluate Efficacy, Safety and Pharmacokinetics of Mirabegron in Pediatric Subjects from 5 to < 18 Years of Age with Overactive Bladder

ObjectivesPrimary* To evaluate the efficacy of mirabegron in children (5 to < 18 years of age) with OABSecondary* To evaluate the efficacy of mirabegron in children (5 to < 18 years of age) with OAB* To evaluate the safety and…

Randomized, double-blind, placebo-controlled crossover study to validate finger tapping tasks for the quantification of levodopa/carbidopa effects in Parkinson*s Disease patients.

Primary ObjectivesAssess whether the finger tapping task endpoints:• Differentiate between ON and OFF states in PD patients• Correlate with the MDS-UPDRS part III total score• Differentiate between placebo and levodopa/carbidopa treatmentSecondary…

COUNTER-COVID - Oral imatinib to prevent pulmonary vascular leak in Covid19 * a randomized, double-blind, placebo controlled, clinical trial in patients with severe Covid19 disease

To test whether treatment with oral imatinib reduce disease burden and consumption of medical resources.