38 results
Primary ObjectiveTo assess the effect of ABT-981 on OA knee pain using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) at Week 16 and synovitis/effusion volume of the index knee using quantitative measures and semi-…
The principal aims of the study are to assess: 1. The effectiveness of a 5 day treatment course in arresting/ resolving episodic knee arthralgia/ flaring knee pain.2. The relative effectiveness of a low dose (1200 mg/day) of lipid formulated…
Primary Objective:The purpose of this study is to investigate the clinical efficacy of xylomethazoline, combined with dilating the nasal passage way with a polyvinyl-alcohol nasal dilator in the prevention of iatrogenic epistaxis during nasotracheal…
PrimaryThe primary objective is to evaluate the effect of ABT-981 on pain using the Australian/Canadian Osteoarthritis Hand Index (AUSCAN NR3.1) pain subdomain score, in subjects with erosive hand OA at Week 16.Secundary* Evaluate the safety and…
The primary objective is to compare change in weekly average daily pain score (ADPS) from baseline to Week 13 in subjects receiving either dose of DS-5565 versus placebo. Weekly ADPS is based on daily pain scores reported by the subject that best…
In patients with primary biliary cirrhosis (PBC) taking UDCA, to assess the effects of INT-747 on: Primary: - Alkaline phosphatase (AP) levels - SafetySecondary: - Hepatocellular injury and liver function - Disease-specific and general health…
A clinical research study to find out if Xolair is safe and has beneficial effects in adolescents (12 years old and above) and adults with cystic fibrosis (CF) and ABPA. All patients entering the study will be taking oral corticosteroids (steroid…
To assess the efficacy of bosentan in neonates with persistent pulmonary hypertension of the newborn (PPHN) who are in need of continued inhaled nitric oxide (iNO) after at least 4 hours of continuous iNO treatment and to evaluate the…
Part 1:- To assess tolerability, safety and PK of escalating single Intravenous (IV) doses of NI-0101 in healthy volunteers with the aim of covering a wide range of plasma concentrations up to those theoretically reflecting a potential therapeutic…
The purpose of this study is to show that the incidence of new thrombotic events during an additional 6 or 12 months of treatment with rivaroxaban is lower when compared to placebo and that the likely advantage of an extended effect is not offset by…
The objective of this study is to evaluate the efficacy and safety of adalimumab 80 mg loading dose followed by 40 mg dose given every other week (eow) subcutaneously (SC) starting at Week 1 compared with placebo in subjects with inactive non-…
The primary objective of this study is to determine the clinical safety and efficacy of adalimumab compared to placebo in subjects with moderate to severe HS after 12 weeks of treatment. A secondary objective is to evaluate safety and explore…
The general aim of the present study is to investigate, in a longitudinal-experimental design, the effects of melatonin treatment and light therapy in children on sleep, health, and various psychosocial, behavioural, and cognitive outcomes. A second…
Primary Study Objective:To assess the efficacy and safety of the co-administration of low-dose pegvisomant (40 mg, administered via subcutaneous injection given once a week) and long-acting somatostatin analogs (administered once monthly) on the…
The primary objectives of this study are to compare the percentage of subjects achieving SVR12 (HCV RNA < lower limit of quantification [LLOQ] 12 weeks following treatment) of 12 weeks of treatment with ABT-450/r/ABT-267 and ABT-333 co-…
The objective is to evaluate the efficacy and safety of risankizumab versus placebo during induction therapy in subjects with moderately to severely active CD.
The objective is to evaluate the efficacy and safety of risankizumab versus placebo during induction therapy in subjects with moderately to severely active CD.
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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…
The primary objective of this study is to assess the efficacy of MEDI4736 treatment compared with placebo in terms of overall survival (OS) and progression free survival (PFS; (per RECIST 1.1 as assessed by the investigator).