An observational study in Vitamin C Deficiency, Acute Disease and Chronic Disease, sponsored by Pascoe Pharmazeutische Praeparate GmbH. Status unknown at 1 site in Germany. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2022-04-26.
Sponsored by Pascoe Pharmazeutische Praeparate GmbH · Observational
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.
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.
57 studies on the registry are indexed under Acute Disease; 12 are open to participants now.
This study's planned enrollment of 5,000 is above the median of 900 across 22 observational studies indexed under Acute Disease.
Browse Acute Disease studies →Pascoe Pharmazeutische Praeparate GmbH is the lead sponsor of 15 studies on the registry; 1 is open to participants now.
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Patients with a vitamin C deficiency due to acute or chronic underlying diseases
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Patients with vitamin C deficiency due to a acute underlying disease treated with Pascorbin® 7.5 g
Drug: vitamin C
Patients with vitamin C deficiency due to a chronic underlying disease treated with Pascorbin® 7.5 g
Drug: vitamin C
According to the character of an observational study no intervention other than the administration of Pascorbin® 7.5g (which is administered routinely in these cases) is provided.
Also known as: Pascorbin® 7.5g
change in general and disease-specific symptoms
The main aim was to measure the success of the treatment with Pascorbin® 7.5 g by the documentation of the change in general and disease-specific symptoms. The symptoms are measured by a score: 0 = not present, 1 = slightly, 2 = moderate and 3 = strong The change of the symptoms is measured in change groups: * number of patients with improved symptoms * number of patients with unchanged symptoms * number of patients with worsened symptoms
Time frame: therapy duration, an expected average of 3 weeks (for acute diseases) or 12 weeks (for chronic diseases)
global assessment of efficacy of treatment with PASCORBIN® 7.5 g
Global assessment of efficacy is measured by a score: * Very good efficacy (complete regression of symptoms) * Good efficacy (symptoms was much improved) * Moderate efficacy (symptoms was slightly improved) * No efficacy (symptoms remained unchanged) * No efficacy (symptoms worsened)
Time frame: therapy duration, an expected average of 3 weeks (for acute diseases) or 12 weeks (for chronic diseases)
Global assessment of tolerability of treatment with PASCORBIN® 7.5 g
Global assessment of tolerability is measured by a score: * Very good tolerability (no side effects) * Poor tolerability (side effects occurred)
Time frame: on last visit, an expected average of 3 weeks (for acute diseases) or 12 weeks (for chronic diseases)
number of adverse reactions due to PASCORBIN® 7.5 g
number of adverse reactions due to PASCORBIN® 7.5 g
Time frame: on last visit, an expected average of 3 weeks (for acute diseases) or 12 weeks (for chronic diseases)
epidemiology of the underlying diseases
number of patients with different underlying diseases due to vitamin C deficiency
Time frame: on visit 1 (begin of the study) week 1
therapy duration
measured in weeks or months
Time frame: time period between first and last infusion an expected average of 3 weeks (for acute diseases) or 12 weeks (for chronic diseases)
dosage scheme
number of infusions within the therapy duration
Time frame: therapy duration, an expected average of 3 weeks (for acute diseases) or 12 weeks (for chronic diseases)
Plan to share: No — All data are anonymous. Patient data list only will be sent to regulatory authorities.
The record gives a start of Nov 2012, a primary completion of Nov 2022 and a completion of Dec 2023. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
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Pascoe Pharmazeutische Praeparate GmbH