A Long-term Study to Describe the Use of PASCORBIN® 7.5 g in Patients With Vitamin C Deficiency

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02422901
• Other study ID #: 183A12VC
• Status: Recruiting
• 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
• 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.

Related Conditions & MeSH terms

• Acute Disease
• Ascorbic Acid Deficiency
• Chronic Disease
• Scurvy
• Vitamin C Deficiency

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)