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A Randomized, Double-Blind, Double-Dummy, Parallel-Group Study To Evaluate The Efficacy And Safety Of Ocrelizumab In Comparison To Interferon Beta-1a (Rebif®) In Patients With Relapsing Multiple Sclerosis

The primary objective of this study is to assess whether the efficacy of ocrelizumab given as two dose regimens of 600 mg (given as 300 mg infusions on days 1 and 15 and 600 mg infusion in the following cycles) or 400 mg (given as 200 mg infusions…

A phase IIb, Double Blind, Randomized, placebo- controlled, Double-Dummy, Dose Rangining Study To Evaluate the Clinical Efficacy and Safety of Induction and Maintenance therapy with BMS- 945429 in subjects with Moderate to Severe Crohn's Disease.

Objectives1.3.1 Primary ObjectiveCompare the efficacy of BMS-945429 versus placebo for induction of clinical remission (defined by an absolute Crohn*s Disease Activity Index [CDAI] score < 150) at Week 8 (IP-57).1.3.2 Secondary Objectives•…

Efficacy, safety, and tolerability of oral cebranopadol versus morphine sulfate PR in subjects with chronic moderate to severe pain related to cancer.

The primary objective is to evaluate the efficacy of orally administered cebranopadol in comparison with morphine sulfate PR in subjects suffering from chronic moderate to severe pain related to cancer.The secondary objective is to compare the…

The ORANGE II PLUS - Trial: An international multicentre randomized controlled trial of open versus laparoscopic liver surgery (hemihepatectomy and postero-superior liver segment resection).

Hypotheses: - For patients undergoing a laparoscopic left or right hemihepatectomy (with or without the need for one additional hepatic wedge resection or metastasectomy), time to functional recovery is reduced by 2 days in comparison with patients…

PRotective Ventilation with Higher versus Lower PEEP during General Anesthesia for Surgery in OBESE Patients - The PROBESE Randomized Controlled Trial

To compare a ventilation strategy using higher levels of PEEP with recruitment maneuvers with one using lower levels of PEEP without recruitment maneuvers in obese patients at an intermediate-to-high risk for PPCs.We hypothesize that an intra-…

A Combined Phase 2/3, Double-Blind, Randomized, Placebo-Controlled, Induction and Maintenance Study Evaluating the Safety and Efficacy of GS-5745 in Subjects with Moderately to Severely Active Ulcerative Colitis

Cohort 1:A data monitoring committee (DMC) will evaluate all available safety data from the study. The first 2 meetings for safety surveillance will occur after 50 and 100 subjects complete or discontinue from the Blinded Induction Phase from Cohort…

A PHASE I STUDY, TO DETERMINE THE SAFETY, TOLERABILITY, PHARMACOKINETICS AND FOOD EFFECT OF SINGLE AND MULTIPLE DOSES OF ORALLY ADMINISTERED HM71224 IN HEALTHY, ADULT MALE VOLUNTEERS

Primary:To evaluate the safety and tolerability, and if possible to determine the maximum tolerated dose (MTD) of HM71224 after single and multiple ascending dose administration in healthy subjects.Secondary: To determine the pharmacokinetics (PK)…

*Efficacy and safety of intratympanic dexamethasone compared to intratympanic gentamicin in patients with proven unilateral Ménière*s disease*; a randomised, double-blind, controlled non-inferiority trial

To compare the effect of IT dexamethasone versus IT gentamicin on number and severity vertigo attacks.To compare the effects of IT dexamethasone with IT gentamicin on hearing function, functional level scale and aural fullness.

Safety, Tolerability and Efficacy Study of ESBA1008 versus LUCENTIS® for the Treatment of Exudative Age-Related Macular Degeneration

To assess the safety, tolerability and the effects of treatment on ocular outcomes following a single intravitreal administration of ESBA1008 compared to Lucentis in patients with exudative AMD

A randomized, double-blind, placebo-controlled, multicenter Phase II trial investigating two doses of EMD 525797 in subjects with asymptomatic or mildly symptomatic metastatic castrate-resistant prostate cancer (mCRPC).

The main objective of this study is to investigate of the drug EMD 525797 is better then no treatment with subjects with metastasized asymptomatic or mild symptomatic mCRPC. The efficacy and safety of the drug EMD 525797 is evaluated.Primary…

A randomized, double-blind, placebo-controlled, multi-center study to assess the safety and efficacy of different oral doses of BAY 94-8862 in subjects with type 2 diabetes mellitus and the clinical diagnosis of diabetic nephropathy

Primary objective of the study is•To investigate the change of Urinary Albumin-to-Creatinine ratio (UCAR) after 90 days treatment Secondary objectives of the study are•To assess safety and tolerability of these doses by assessing the effects on…

Can HDL Infusions Significantly Quicken Atherosclerosis Regression?
A phase II, Multi-center, double-blind, ascending dose, placebo-controlled, dose-finding trial of CER-001 or placebo in subjects with acute coronary syndrome.

To assess the impact of six IV infusions of 3, 6, or 12 mg/kg of CER-001 or placebo, given at weekly intervals, on atherosclerotic plaque volume, as measured by coronary IVUS.

A SINGLE AND MULTIPLE ASCENDING DOSE TRIAL INVESTIGATING THE SAFETY, TOLERABILITY, PHARMACOKINETICS AND PHARMACODYNAMICS OF ORALLY ADMINISTERED SP-35454 IN HEALTHY POSTMENOPAUSAL WOMEN

The objectives of the trial are:1. To investigate the tolerability and safety of SP-35454 following single and multiple dose oral administration.2. To investigate the single and multiple dose pharmacokinetics of SP-35454 and its metabolite SP-…

Valvuloplasty as alternative to Toupet fundoplication for the minimal invasive treatment of gastroesophageal reflux disease: a randomized controlled trial

This monocenter randomized controlled trial aims to compare postoperative outcomes of a laparoscopic valvuloplasty with a Toupet fundoplication in patients with GERD with a maximum hiatal hernia of 3cm. In addition, an economic evaluation of the new…

A first-in-human, randomized, double-blind, placebo-controlled, single ascending dose and multiple ascending dose study to investigate the safety, tolerablility, pharmacokinetics (including food and gender effect), and pharmacodynamics of LNP1955 in healthy subjects.

The purpose of the study is to investigate to what extent LNP1955 is tolerated and safe.It will also be investigated how quickly and to what extent LNP1955 is absorbed and eliminated from the body (this is called pharmacokinetics). Further, the…

A RANDOMIZED DOUBLE-BLIND TRIAL, USING A SINGLE-BLIND RUN-IN TO ASSESS WITHDRAWAL SYMPTOMS AFTER PROLONGED TREATMENT WITH CANNABIDIOL (GWP42003-P)

The purpose of the study is to investigate to what extent GWP42003-P might lead to withdrawal effects after several weeks of dosing. Withdrawal effects are the signs and symptoms that can occur upon the abrupt discontinuation of some medications or…

PROSPECTIVE, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED PHASE III STUDY EVALUATING EFFICACY AND SAFETY OF OCTAGAM 10% IN PATIENTS WITH DERMATOMYOSITIS

Primary Objective:The primary objective of this study is to provide confirmatory data on the beneficial effect of 2.0 g/kg of Octagam 10% given every 4 weeks compared with placebo in subjects with active DM based on the percentage of responders at…

Targeting fear memory by disrupting the process of reconsolidation: A new intervention for panic disorder.

Our aim is to test whether disrupting the process of fear memory reconsolidation is an effective as well as efficient intervention for patients with panic disorder. A secondary aim is to test whether the expected reduction in panic attacks and…

A randomised, controlled, double-blind, parallel group, multi-country study to investigate the effects of an infant formula containing partially hydrolysed proteins on growth, safety, and tolerance in healthy term infants

To investigate the effects of a partially hydrolysed protein based infant formula (pHPformula) in healthy term infants until 17 weeks of age on growth, blood parameters, safety,and gastro intestinal tolerance compared to standard infant formula.…

An Open-label, 2 x 2 Factorial, Randomized Controlled, Clinical Trial to Evaluate the Safety of Apixaban vs. Vitamin K Antagonist and Aspirin vs. Aspirin Placebo in Patients with Atrial Fibrillation and Acute Coronary Syndrome and/or Percutaneous Coronary Intervention.

Dual Primary Objectives:* To determine if apixaban is noninferior to VKA (INR target range 2.0-3.0) on the combined endpoint of ISTHmajor or clinically relevant non-major bleeding in patients with NVAF who develop ACS or undergo PCI withplanned…