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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02422901
Other study ID # 183A12VC
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 2012
Est. completion date December 2023

Study information

Verified date April 2022
Source Pascoe Pharmazeutische Praeparate GmbH
Contact Bianka B Krick, CRA
Phone 0049-641-7960963
Email bianka.krick@pascoe.de
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 5000
Est. completion date December 2023
Est. primary completion date November 2022
Accepts healthy volunteers No
Gender All
Age group 12 Years and older
Eligibility 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.

Study Design


Intervention

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.

Locations

Country Name City State
Germany multiple medical German Practices of physicians and medical practitioners Giessen Hessen

Sponsors (1)

Lead Sponsor Collaborator
Pascoe Pharmazeutische Praeparate GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
therapy duration, an expected average of 3 weeks (for acute diseases) or 12 weeks (for chronic diseases)
Secondary 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)
therapy duration, an expected average of 3 weeks (for acute diseases) or 12 weeks (for chronic diseases)
Secondary 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)
on last visit, an expected average of 3 weeks (for acute diseases) or 12 weeks (for chronic diseases)
Secondary number of adverse reactions due to PASCORBIN® 7.5 g number of adverse reactions due to PASCORBIN® 7.5 g on last visit, an expected average of 3 weeks (for acute diseases) or 12 weeks (for chronic diseases)
Secondary epidemiology of the underlying diseases number of patients with different underlying diseases due to vitamin C deficiency on visit 1 (begin of the study) week 1
Secondary therapy duration measured in weeks or months time period between first and last infusion an expected average of 3 weeks (for acute diseases) or 12 weeks (for chronic diseases)
Secondary dosage scheme number of infusions within the therapy duration therapy duration, an expected average of 3 weeks (for acute diseases) or 12 weeks (for chronic diseases)
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