A long-term observational study to describe the use of PASCORBIN® 7.5 g in patients with vitamin C deficiency. (Long-term OBS PASCORB® 7.5 g)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/27336
• EU PAS number:
  EUPAS3658
• Study ID:
  27336
• Official title and acronym:
  A long-term observational study to describe the use of PASCORBIN® 7.5 g in patients with vitamin C deficiency. (Long-term OBS PASCORB® 7.5 g)
• DARWIN EU® study:
  No
• Study countries:
  Germany
• Study description:
  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, we focus on the aquisition of data of the underlying diseases and the reduction of disease. Next to this, exact assessment of medical tolerance and details of treatment requirements ae further aims. Here we take into account acute and chronic underlying medical conditions are taken into account.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. There are 2 (for acute conditions) or 3 observation times (for chronic conditions) are provided.
• Study status:
  Ongoing

Research institutions and networks

Institutions

Pascoe pharmazeutische Präparate

pyhsicians and alternative practitioners Germany

Study timelines

Date when funding contract was signed

Actual: 22/11/2012

Study start date

Planned: 01/11/2012

Actual: 05/11/2012

Data analysis start date

Planned: 01/11/2022

Date of final study report

Planned: 01/11/2023

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Pascoe pharmazeutische Präparate GmbH

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable