Chronic Disease Clinical Trial
Official title:
A Long-term Observational Study to Describe the Use of PASCORBIN® 7.5 g in Patients With Vitamin C Deficiency
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 |
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.
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. |
Country | Name | City | State |
---|---|---|---|
Germany | multiple medical German Practices of physicians and medical practitioners | Giessen | Hessen |
Lead Sponsor | Collaborator |
---|---|
Pascoe Pharmazeutische Praeparate GmbH |
Germany,
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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