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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

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

Brief 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 Summary: 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.
Sponsor: Pascoe Pharmazeutische Praeparate GmbH

Current Primary Outcome: change in general and disease-specific symptoms [ Time Frame: therapy duration, an expected average of 3 weeks (for acute diseases) or 12 weeks (for chronic diseases) ]

Original Primary Outcome: change in general and disease-specific symptoms [ Time Frame: therapy duration, an expected average of 3 weeks (for acute diseases) or 12 weeks (for chronic diseases) ]

Current Secondary Outcome:

• global assessment of efficacy of treatment with PASCORBIN® 7.5 g [ Time Frame: therapy duration, an expected average of 3 weeks (for acute diseases) or 12 weeks (for chronic diseases) ]

  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)
• Global assessment of tolerability of treatment with PASCORBIN® 7.5 g [ Time Frame: on last visit, an expected average of 3 weeks (for acute diseases) or 12 weeks (for chronic diseases) ]

  Global assessment of tolerability is measured by a score:

  • Very good tolerability (no side effects)
  • Poor tolerability (side effects occurred)
• number of adverse reactions due to PASCORBIN® 7.5 g [ Time Frame: on last visit, an expected average of 3 weeks (for acute diseases) or 12 weeks (for chronic diseases) ]
• epidemiology of the underlying diseases [ Time Frame: on visit 1 (begin of the study) week 1 ]
  number of patients with different underlying diseases due to vitamin C deficiency
• therapy duration [ Time Frame: time period between first and last infusion an expected average of 3 weeks (for acute diseases) or 12 weeks (for chronic diseases) ]
  measured in weeks or months
• dosage scheme [ Time Frame: therapy duration, an expected average of 3 weeks (for acute diseases) or 12 weeks (for chronic diseases) ]
  number of infusions within the therapy duration

Original Secondary Outcome:

• global assessment of efficacy of treatment with PASCORBIN® 7.5 g [ Time Frame: therapy duration, an expected average of 3 weeks (for acute diseases) or 12 weeks (for chronic diseases) ]

  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)
• Global assessment of tolerability of treatment with PASCORBIN® 7.5 g [ Time Frame: on last visit, an expected average of 3 weeks (for acute diseases) or 12 weeks (for chronic diseases) ]

  Global assessment of tolerability is measured by a score:

  • Very good tolerability (no side effects)
  • Poor tolerability (side effects occurred)
• number of adverse reactions due to PASCORBIN® 7.5 g [ Time Frame: on last visit, an expected average of 3 weeks (for acute diseases) or 12 weeks (for chronic diseases) ]
• epidemiology of the underlying diseases [ Time Frame: on visit 1 (begin of the study) week 1 ]
  number of patients with different undelying diseases due to vitamin C defciency
• therapy duration [ Time Frame: time period between first and last infusion an expected average of 3 weeks (for acute diseases) or 12 weeks (for chronic diseases) ]
  measured in weeks or months
• dosage scheme [ Time Frame: therapy duration, an expected average of 3 weeks (for acute diseases) or 12 weeks (for chronic diseases) ]
  number of infusions within the therapy duration

Information By: Pascoe Pharmazeutische Praeparate GmbH

Dates:
Date Received: March 24, 2015
Date Started: November 2012
Date Completion: December 2023
Last Updated: April 5, 2017
Last Verified: April 2017