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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 g

Global 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

Page last updated: August 20, 2015

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