51 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 objectives of the study are as follows:*1. To assess the effectiveness of inhaled PA101 delivered via eFlow high efficiency nebulizer for treating chronic cough. Improvements in chronic cough will be assessed by measuring the change from…
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…
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…
Primary objective1. To determine the effect of food on the pharmacokinetics of sildenafil administered as the Lybrido formulation2. To determine whether >90% of the testosterone content is released after maximally 90 seconds after sublingual…
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-…
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…
Primary Objective• To validate the existing demarcation formula (consisting of psychometric and biological markers) which predicts the sensitivity to Lybrido or Lybridos in women with female sexual interest/arousal disorder (FSIAD with or without…
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 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-…
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…
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…
Primary objective:To compare the pharmacokinetics of testosterone and sildenafil citrate following administration of a sublingual solution of testosterone with an encapsulated tablet versus a combination product.Secondary objective:To investigate…
This study will investigate whether oligometastatic triple negative or BRCA1/2 related breast cancer can be treated effectively with a multimodality approach including induction chemotherapy, and whether high dose alkylating chemotherapy can improve…
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…
The aim of this pilot study is to assess if the sildenafil leads to an increase in tumour blood flow in NSCLC.
The primary objective of this study is to compare the progression free survival (PFS) following administration of IPI-504 plus best supportive care versus placebo plus best supportive care in patients with metastatic and/or unresectable…
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…
To investigate the effect of low-dose long acting insulin therapy on nutritional status in adult CF patients without diabetes.
Investigate the effect of adjuvant metformin therapy on insulin need and on glycaemic control in CFRD patients.