A Long-term Study to Describe the Use of PASCORBIN® 7.5 g in Patients With Vitamin C Deficiency
Information source: Pascoe Pharmazeutische Praeparate GmbH
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Vitamin C Deficiency; Acute Disease; Chronic Disease
Intervention: vitamin C (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: Pascoe Pharmazeutische Praeparate GmbH Official(s) and/or principal investigator(s): Holger Michels, MD & M. Sci., Study Director, Affiliation: Pascoe Pharmazeutische Praeparate GmbH
Overall contact: Bianka B Krick, CRA, Phone: 0049-641-7960963, Email: bianka.krick@pascoe.de
Summary
The aim of this long-term observational study is the documentation of the use of PASCORBIN®
7. 5 g in patients with vitamin C deficiency. Regarding the vitamin C deficiency, the
investigators focus on the acquisition of data of the underlying diseases and the reduction
of symptoms, that are related to oxidative stress and vitamin-C-deficiency. Next to this,
exact assessment of medical tolerance and details of treatment requirements are further
aims. Here the investigators take into account acute and chronic underlying medical
conditions. Further health economic data are collected.
Clinical Details
Official title: A Long-term Observational Study to Describe the Use of PASCORBIN® 7.5 g in Patients With Vitamin C Deficiency
Study design: Time Perspective: Prospective
Primary outcome: change in general and disease-specific symptoms
Secondary outcome: global assessment of efficacy of treatment with PASCORBIN® 7.5 gGlobal assessment of tolerability of treatment with PASCORBIN® 7.5 g number of adverse reactions due to PASCORBIN® 7.5 g epidemiology of the underlying diseases therapy duration dosage scheme
Detailed description:
The observational study began on 01 November 2012 and is scheduled for a period of 10 years
continued (until 01 November 2022). The duration of the observational study for each patient
is not fixed corresponding to the character of a non-interventional study. According to the
underlying disease, characterized either acute or chronic, there are 2 and 3 observations
within the treatment period, respectively. Documentation comprises the course of the
underlying diseases (by tracking of general and diseases-specific symptoms), drug
compatibility (by ADR assessment), concomitant medication or other treatment, health
economic data, details of treatment regimen and standard epidemiological data.
Eligibility
Minimum age: 12 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- patients with vitamin C deficiency
- patients >= 12 years old
Exclusion Criteria:
- an oxalate urolithiasis,
- iron storage disorders (thalassemia, hemochromatosis, sideroblastic anemia) or have
received recently transfused packed red blood cells
- under 12 years of age or
- are pregnant or breastfeeding.
Locations and Contacts
Bianka B Krick, CRA, Phone: 0049-641-7960963, Email: bianka.krick@pascoe.de
multiple medical German Practices of physicians and medical practitioners, Giessen, Hessen 35394, Germany; Recruiting multiple medical practices
Additional Information
Starting date: November 2012
Last updated: April 27, 2015
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