NCT02422901

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

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 5,000 (estimated)
• Sponsor: Pascoe Pharmazeutische Praeparate GmbH · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Vitamin C Deficiency
• Acute Disease
• Chronic Disease

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2012-11-01
• Primary completion: 2022-11-01
• Completion: 2023-12-01
• First posted: 2015-04-22
• Last updated: 2022-04-26

Locations

1 site across 1 country: Germany