Clinical Trials Related to Allegra D-12 Hour (Fexofenadine / Pseudoephedrine)
Topical Treatment of Under Eye Dark Circles and Swelling [Recruiting]
This study examines topical treatment of under eye circles and swelling.
Cocktail Approach for Cytochrome P450 and P-glycoprotein Activity Assessment Using Dried Blood Spot [Recruiting]
Phenotyping is an approach largely used for the evaluation of the activity of cytochromes
and transporters in vivo. It consists of the administration of probe substances metabolised
by a specific cytochrome or transported by P-glycoprotein (P-gp) for example, followed by
the determination of a metabolic ratio or the evaluation of the plasmatic or urinary
concentrations of the probe substances. The administration of a cocktail containing several
probe substances allows the simultaneous evaluation of the activity of several cytochromes
and P-gp in a single test.
The aim of this project is the validation of a phenotyping cocktail of low dose probe drugs
for the assessment of cytochrome P450 and P-gp activities by simple capillary blood sampling
and dried blood spot (DBS) analysis. The cocktail consists of caffeine, bupropion,
flurbiprofen, omeprazole, dextromethorphan, midazolam and fexofenadine for the simultaneous
phenotyping of CYP1A2, CYP2B6, CYP2C9, CAP2C19, CYP2D6, CYP3A4 and P-gp, respectively.
The modulation of the activity of cytochromes or P-gp will be evaluated by the
administration of inhibitors (fluvoxamine, voriconazole, quinidine) or inducer (rifampicin)
of the metabolic pathways or the P-gp mediated transport.
Efficacy, Safety and Pharmacokinetics of SPK-843 in the Treatment of Pulmonary Mycosis [Recruiting]
Recruitment of at least 10 adult patients (men and women) among individuals affected and
admitted to the hospitals identified for the clinical study. All patients shall be between
18 and 75 years of age, with confirmed diagnosis of cryptococcosis or aspergillosis . During
therapy (14 days) and examination (28 days), the patients will be subject to 7 doctor's
visits (day 1,3,7,10,14,21, and 28).
Panitumumab After Resection of Liver Metastases From Colorectal Cancer in KRAS Wild-type Patients [Recruiting]
Up to 50% of patients with colorectal cancer (CRC) develop liver metastasis during the
course of their disease. In 30-40% of patients metastasis is confined to the liver. In these
patients R0-resection of metastases may contribute to marked improvement of overall
survival. Primary resection of liver metastasis is possible in about 15-20% of patients
(Scheele 2005, Petrelli 2005). Recent studies indicate that perioperative chemotherapy may
improve survival after resection of liver metastases (Portier 2007, Nordlinger 2007).
Nevertheless, there is evidence that 70-80% of patients have recurrent disease after
resection of liver metastasis. Stratification for the risk of recurrence may be performed
using the FONG-score (Fong 1999).
This study is designed to investigate the efficacy of postoperative chemotherapy combined
with an anti-EGFR treatment using panitumumab.
The majority of patients present to the surgeon after chemotherapeutic pretreatment with
various not necessarily standardized regimens. Also postoperative therapy after resection of
liver metastasis is not a clearly defined standard of care in Germany.
Based on the study by Nordlinger et al. an oxaliplatin-based regimen is chosen for
postoperative therapy (Nordlinger 2008). For reasons of practicability mFOLFOX6 was selected
as the chemotherapy backbone for additive treatment (Allegra 2010).
Also, there is evidence that the combination of FOLFOX with panitumumab is associated with
enhanced antitumor activity (Douillard et al. ESMO 2009). The experimental treatment arm
will therefore evaluate the combination of FOLFOX plus panitumumab. Since in colorectal
cancer monoclonal antibodies directed against the EGFR are not active in KRAS mutant
patients, the experimental arm including panitumumab will only be performed in KRAS
wild-type patients (Amado 2008).
The planned study aims to assess the efficacy of postoperative therapy with FOLFOX plus
panitumumab followed by maintenance with panitumumab for 3 months in KRAS wild-type
patients, compared to the historical data for standard FOLFOX chemotherapy alone, which are
verified by a randomised control group without the antibody. (Figure 1: Study Design).
The study will allow preoperative treatment with regimens such as FOLFIRI, XELIRI, FOLFOX or
XELOX +/-bevacizumab or +/- cetuximab. However, only those patients will be considered
eligible who did not progress during preoperative therapy.
After surgery, a treatment-free interval of at least 4 weeks, but no longer than 8 weeks
will be granted.
KRAS-wild-type patients (60% of all pts) will then be randomized in a 2: 1 ratio to an
experimental arm with FOLFOX + panitumumab or to a reference arm with FOLFOX alone.
Combination treatment will be performed for a duration of 3 months, after which patients in
the experimental arm will receive maintenance therapy with panitumumab for further 3 months.
In the reference arm, treatment will, however, be ended after 3 months.
Changes in Dopamine Levels Before and After Weight Restoration in People With Anorexia Nervosa [Recruiting]
This study will use positron emission tomography imaging to investigate changes in dopamine
systems in people with anorexia nervosa before and after weight restoration.