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Randomized controlled trial of escitalopram versus placebo for patients with irritable bowel syndrome and panic disorder.

PRIMARY OBJECTIVE· 1. To study the effect of escitalopram versus placebo in the treatment of abdominal pain, in IBS patients with panic disorder.SECONDARY OBJECTIVES· 2.1. To assess the effect of escitalopram on gastrointestinal and psychiatric…

Study to investigate the association between the response to a cholinergic challenge with galantamine and the clinical response to subsequent treatment with galantamine in patients with mild to moderate Alzheimer's Disease

We propose to conduct a study in patients with mild to moderate AD where a cholinergic challenge is given in a placebo-controlled, cross-over fashion, prior to onset of treatment with a CEI. Patients will be followed over a period of 6 months to…

A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Phase 3 Study of Denosumab as Adjuvant Treatment for Women with Early-Stage Breast Cancer at High Risk of Recurrence

The purpose of this research study is to evaluate how safe and effective Denosumab is, compared with placebo, in delaying the time it takes for cancer to spread to the bones in subjects with early-stage breast cancer at high risk of recurrence.The…

A multicentre, international, randomised, parallel group, double blind study to evaluate Cardiovascular safety of linagliptin versus glimepiride in patients with type 2 diabetes mellitus at high cardiovascular risk. The CAROLINA Trial.

CAROLINA studyThe aim of the present study is to investigate the long*term impact on CV morbidity and mortality and relevant efficacy parameters (HbA1c, fasting plasma glucose, treatment sustainability) of treatment with linagliptin in a relevant…

Caphosol, a therapeutic option in cancer therapy induced mucositis in children.

Main objective: To assess the effect of Caphosol on the number of days of mucositis > grade ISecondary objective: to assess the effect of Caphosol on duration and degree of mucositis and pain, a possible influence on the occurrence of…

A Phase III Randomized, Double-blind Study of the Safety and Efficacy of GSK1349572 50 mg Once Daily Versus Raltegravir 400 mg Twice Daily, Both Administered with an Investigator-selected Background Regimen Over 48 Weeks in HIV-1 Infected, Integrase Inhibitor-Naïve, Antiretroviral Therapy-Experienced Adults.

Primary: Antiviral efficacy after 48 weeks of treatment. Secundary: Antiviral efficacy after 24 weeks, safety and tolerability, resistance development, PK, incidence of HIV-associated conditions, gender-, race-, and/or HIV-1 subtype on response to…

A Phase 3 Extension, Multicenter, Double-blind, Parallel-Group, Long-term Safety and Tolerability Trial of Bapineuzumab (AAB-001, ELN115727) in Subjects With Alzheimer Disease Who Are Apolipoprotein E E4 Noncarriers and Participated in Study 3133K1-3000-WW

Primary objectives: To evaluate the long-term safety and tolerability of IV administered bapineuzumab in subjects with AD.Secundary objectives: Efficacy. To explore the long-term efficacy of IV administered bapineuzumab in subjects with AD, using…

Randomized, Double-Blind, Phase 3 Trial to Compare the Efficacy of Ipilimumab vs
Placebo in Asymptomatic or Minimally Symptomatic Patients with Metastatic
Chemotherapy-Naïve Castration Resistant Prostate Cancer

The objective of this study is to compare the overall survival of patients with prostate cancer who are no longer responding to hormone therapy (castration resistant) and who have not yet received chemotherapy live longer (overall survival) when…

A Randomized, Double-Blind, Phase 3 Study of Docetaxel and Ramucirumab versus Docetaxel and Placebo in the Treatment of Stage IV Non-Small Cell Lung Cancer Following Disease Progression after One Prior Platinum-Based Therapy

The primary objective of this study is to compare the overall survival (OS) of ramucirumab DP administered in combination with docetaxel versus docetaxel with placebo as therapy for patients with Stage IV non-small cell lung cancer (NSCLC) who have…

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo Controlled, Trial of AMG 479 or Placebo in Combination with Gemcitabine as First-line Therapy for Metastatic Adenocarcinoma of the Pancreas

The primary objective of the study is to determine if the treatment of AMG 479 at 12 mg/kg and/or 20 mg/kg in combination with gemcitabine improves overall survival as compared with placebo in combination with gemcitabine in subjects with metastatic…

A Randomized, Double-Blind, Active-Controlled, Multicenter Study of Patients with Primary Hypercholesterolemia and High Cardiovascular Risk Who Are Not Adequately Controlled with Atorvastatin 10 mg: A Comparison of the Efficacy and Safety of Switching to Coadministration Ezetimibe and Atorvastatin Versus Doubling the Dose of Atorvastatin or Switching to Rosuvastatin

Primary ObjectivesIn patients with primary hypercholesterolemia and high cardiovascular risk with LDL-C >=100 mg/dL (2.59 mmol/L) and <=160 mg/dL (4.14 mmol/L), to evaluate:1)at the end of Phase I, the additional LDL-C percentage…

A Phase 3, Randomized, Double-Blind, Multicenter Trial Comparing Orteronel (TAK 700) Plus Prednisone With Placebo Plus Prednisone in Patients With Metastatic Castration-Resistant Prostate Cancer That Has Progressed During or Following Docetaxel-based Therapy

Primary Objective:• To determine if orteronel plus prednisone improves overall survival (OS)Key Secondary Objectives: • To determine if orteronel plus prednisone improves radiographic progression-free survival (rPFS)• To determine if orteronel plus…

A phase Ib double-blind, placebo-controlled, randomized, dose-escalating trial to investigate the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of repeated subcutaneous injections of MT203 in patients with mild to moderate rheumatoind arthritis (RA) on treatment with methotrexate.

Primary objective: Safety and tolerability of repeated subcutaneous injections of MT203 in patients with mild to moderate RA.Secondary objectives: Pharmacokinetics, pharmacodynamics, including explorative biomarker assessments and efficacy of…

The value of Autologous Tenocyte Implantation in patients with chronic Achilles tendinopathy: a double-blind randomised clinical trial

This study is designed to compare the treatment of 2 groups: autologous tenocytes injection in combination with exercises versus saline injection in combination with exercises.

Effects of high protein intake in obese children

To assess the effects of a 4-week high protein diet on body composition in obese children. Secondary outcomes are whole-body protein turnover, gluconeogenesis, energy expenditure, markers of the metabolic syndrome, appetite sensations,…

A Phase 3, Randomized, Double-Blind, Multicenter Trial Comparing Orteronel (TAK-700) Plus Prednisone With Placebo Plus Prednisone in Patients With Chemotherapy-Naïve Metastatic Castration-Resistant Prostate Cancer

To determine if orteronel plus prednisone improves radiographic progression-freesurvival (rPFS)To determine if orteronel plus prednisone improves overall survival (OS)

A MR30365/07 dose-ascending, cohort group, single-blind pilot phase followed by a randomised, double-blind, placebo controlled parallel group study to compare the effect of intravenous MR30365/07 and intravenous fentanyl on respiration and analgesic responses, in healthy volunteers.

The aim of the main study is to compare the effects of MR30365/07 and fentanyl on ventilation and analgesic responses to noxious electrical and heat stimulation in healthy volunteers, by performing pharmacokinetic / pharmacodynamics (PK/PD) modeling…

PREVAIL: A Multinational Phase 3, Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of Oral MDV3100 in Chemotherapy-Naïve Patients with Progressive Metastatic Prostate Cancer Who Have Failed Androgen Deprivation Therapy

The purpose of this study is to evaluate the efficacy and safety of MDV3100, a novel potent androgen-receptor antagonist without known agonist activity, in asymptomatic or mildly symptomatic patients with progressive metastatic prostate cancer who…

Phase III Randomized Double-Blind Trial of Bepanthen® Cream Versus Cetomacrogol Cream in the Prevention of Papulopustular eruption in Patients Receiving Epidermal Growth Factor Receptor Inhibitors (EGFRI): BeCet

To assess the preemptive effect of Bepanthen® on decreasing the incidence of specific >= grade 2 dermatological side effects of interest in respect of compliance to EGFRI agents, HRQoL and the adherence during the 6-week skin treatment period…

Randomized placebo-controlled multicenter exploratory Phase IIA study to assess the safety and efficacy of PEG-liposomal prednisolone sodium phosphate (Nanocort) in subjects with active ulcerative colitis.

The primary objective is to evaluate the safety of PEG-liposomal prednisolone sodium phosphate (Nanocort) The secondary objectives of this study are:To explore the efficacy of PEG-liposomal prednisolone sodium phosphate (Nanocort) To evaluate the…