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The pharmacokinetics of two generic co-formulations of lopinavir/ritonavir for HIV-infected children: a pilot study of Lopimune vs. the branded product

Primary objective: To determine the pharmacokinetic profile of lopinavir and ritonavir in two differ-ent co-formulations (Lopimune granules and Lopimune tablets) after single-dose in HIV-negative, healthy adult subjects, and to compare this to the…

Problem-Solving Therapy to reduce distress in patients with cancer: a randomized clinical trial and investigation of mechanisms of change

To test the effects of a problem-solving therapy to reduce distress and increase quality of life in patients with cancer. Also to test the mechanisms of change of the therapy.

A Double-Blind, Randomized Phase II Study Evaluating the Efficacy and Safety of Sorafenib Compared to Placebo in Ovarian Epithelial Cancer or Primary Peritoneal Cancer Patients who have achieved a Complete Clinical Response after Standard Platinum/Taxane Containing Chemotherapy

The objective of this phase IIb is to compare the efficacy and safety of sorafenib to placebo of patients with ovarian epithelial or primary peritoneal cancers stage IIIb and IV who have achieved a complete clinical response after standard platinum/…

A prospective, non-controlled, open-label study to assess the safety and effectiveness of Fibrocaps* in subjects undergoing liver resection.

The primary objective of this trial is to investigate the safety of Fibrocaps* in subjects undergoing liver resection.The secondary objective of this study is to investigate the effectiveness of Fibrocaps* on time to achieve haemostasis and volume…

The effect of occlusal splints on sleep and respiratory variables in OSA patients.

To what extend should a possible worsening of the OSA condition, caused by an increase of mouth opening and partial palatinal coverage, be taken into consideration in daily dental practice, when an occlusal splint is placed in the mouth.Amendement:…

Effect of fluticasone proprionate 0.05% cream on narrow band UV-B phototherapy in active vitiligo: a randomised single blinded controlled trial

The objective of this study is to evaluate the difference in clinical effects (onset and degree of repigmentation) of NB-UVB and fluticasone proprionate vs NB-UVB alone.

A 6-month, double-blind, randomized, placebo-controlled, parallel group outpatient trial, investigating the efficacy and safety of Org 50081 in adult patients with chronic primary insomnia.

Primary: To demonstrate the long-term efficacy of treatment with Org 50081, as compared to placebo, on sleep maintenance in patients with chronic primary insomnia as measured by the subjective Total Sleep Time. Primary efficacy endpoint is the…

A PHASE 4, MULTINATIONAL, MULTICENTRE, DOUBLE BLIND, DOUBLE DUMMY, RANDOMIZED, PARALLEL GROUP, CONTROLLED CLINICAL STUDY OF FIXED COMBINATION BECLOMETHASONE DIPROPIONATE 100 µg PLUS FORMOTEROL FUMARATE 6 µg pMDI WITH HFA-134A PROPELLANT (CHF1535, FOSTER®) VERSUS FLUTICASONE 250 µg PLUS SALMETEROL 50 µg DPI (SERETIDE® DISKUS®) AS MAINTENANCE TREATMENT IN CONTROLLED ASTHMATIC PATIENTS

The objective of this study is to obtain information regarding the effectiveness and safety of a product called Foster® for the treatment of asthma. This product is a combination between two well known drugs: formoterol fumarate and beclomethasone…

Prednisolone-induced Impairment of Glucose Metabolism and Beta-cell function and the protective effects of Exenatide: a single-center, randomized, double-blind, placebo-controlled crossover study in healthy volunteers

Primary objective:To assess whether a single day infusion of the GLP-1 RA exenatide, as compared to placebo, reverses GC-induced impairment of glucose metabolism and beta-cell function in healthy males

A randomised, double-blind, placebo- and active comparator-controlled, five parallel groups study to investigate the efficacy and safety of BI 44370 TA (50 mg, 200 mg, and 400 mg) administered orally once during an acute migraine attack of moderate or severe intensity

Supported by the observation from the Phase I studies in healthy volunteers, doses within a range of 50 to 500 mg are safe and well tolerated. This Phase II trial will be performed to:a. obtain proof of concept of BI 44370 TAb. perform dose finding…

A multi-center, randomized, double-blind, placebo and active controlled, parallel group, dose finding study to evaluate the efficacy and safety of LCI699 compared to placebo after 8 weeks treatment in patients with essential hypertension

This study is a proof-of-efficacy, dose finding study of LCI699 in patients with mild-to-moderate uncomplicated essential hypertension in order to assess whether the BP effect, safety and tolerability of LCI699 as compared to those of placebo…

Phase I/II trial of Lenalidomide plus Bortezomib combined with Dexamethasone in elderly patients in 1st relapse or primary refractory after first line therapy for multiple myeloma.

Phase I:-To determine the maximum tolerated dose (MTD) and recommended phase II dose level (RDL) of Bortezomib administered once weekly, and of Lenalidomide administered for 3 weeks when combined with Dexamethasone in a 28-days schedule.Phase II:-To…

Comparative efficacy and safety of two asparaginase preparations in children with previously untreated acute lymphoblastic leukemia (ALL), a phase III clinical trial

This multicentre phase III study is designed to assess the efficacy and safety of recombinant versus E-Coli derived Aaparaginase from Medac, during treatment of children with newly diagnosed ALL according to the DCOG ALL-10 protocol.Futhermore: To…

A partly blinded single center trial studying the effect of daily oral treatment with 30 mg prednisolone during two weeks on metabolic and disease activity parameters in patients with severe chronic atopic dermatitis and in healthy volunteers

Primary objectives:• To explore whether daily oral treatment with 30 mg prednisolone modulates biomarkers for adverse metabolic effects in a similar manner in patients with chronic atopic dermatitis as compared to healthy volunteers.• To determine…

A Multicenter, Randomized, Double-Blind, Double-Dummy, Phase 3 Study of the Safety and Efficacy of Ritonavir-Boosted Elvitegravir (EVG/r) Versus Raltegravir (RAL) Each Administered With a Background Regimen in HIV-1 Infected, Antiretroviral Treatment-Experienced Adults.

To assess non-inferiority of a regimen containing ritonavir-boosted elvitegravir versusraltegravir, each administered with a background regimen in HIV-1 infected,antiretroviral treatment-experienced adult subjects as determined by the proportion…

Rivastigmine for delirium in Intensive Care patients, a double-blind, randomised, placebo-controlled, multi-center add-on trial

To study whether rivastigmine added to treatment with haloperidol shortens the duration of delirium in ICU patients and reduces costs.

A Phase IIIB, multicenter study with a 12-week double-blind, placebo-controlled, randomized period followed by an open-label, extension phase to evaluate the safety and efficacy of certolizumab pegol administered to patients with active rheumatoid arthritis.

Primary Objective:To assess the clinical response rate as measured by American College of Rheumatology 20% (ACR20) response rate at Week 12.Secondary Objective:• To assess:- for all patients at Week 12, and every 8 weeks and at the completion/…

Effect of dietary proteins on blood pressure

The primary objective of the study is to demonstrate a difference in changes in fasting blood pressure and 24-hour ambulatory blood pressure after 4 weeks on a diet with a high protein content or a diet with a high carbohydrate content.Secondary…

Phase I study: determining toxicity and immunity of the p53 synthetic long peptides vaccine combined with Interferon-alfa in patients treated for colorectal cancer

Primary objectives of the study are to assess whether the administration of p53-SLP together with the local administration of IFNα is safe and able to induce a strong (directly ex-vivo detectable) p53-specific CD4+ T-cell response. Secondary…

A multicenter, double-blind, randomized, placebo-controlled, parallel group, event-driven, Phase III study to assess the effects of ACT-064992 on morbidity and mortality in patients with symptomatic pulmonary arterial hypertension

Primary objective• To demonstrate that either dose of ACT-064992 prolongs the time to the first morbidity or mortality event in patients with symptomatic pulmonary arterial hypertension.Secondary objectives• To demonstrate that either dose of ACT-…