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 type

• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Disease epidemiology

  Effectiveness study (incl. comparative)

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Non-interventional observational study

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  ASCORBIC ACID
• Medical condition to be studied:
  Vitamin C deficiency

Population studied

• Age groups:
  Adolescents (12 to < 18 years)

  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Estimated number of subjects:
  5000

Study design details

• Main study objective:
  The main aim was to measure the achievement of the treatment with Pascorbin® 7.5 g done by the documentation of the change in general and disease-specific symptoms.
• Outcomes:
  global assessment of efficacy of treatment with PASCORBIN® 7.5 g, Global assessment of tolerability of treatment with PASCORBIN® 7.5 g, epidemiology of the underlying diseases, dosage scheme and therapy duration
• Data analysis plan:
  For descriptive data:- qualitative and categorical data: absolute and relative frequencies,- quantative data: median, 25% - and 75% quantile, arithmetic mean, standard deviation, variance, minimum, maximum, and number of valid and missing data.Subgroups among 10 Pat. are not evaluated separately.The following statistical tests can be performed on explorative basis: Assessment of effectiveness of the theapy is compared with the corresponding assessment of previous med. using Fisher's Exact test. The change in individual symptoms between visit 1 and the last documented visit during therapy is checked using the Mantel-Haenszel test. For the corresponding change in the total symptom scores during the treatment of one-sample t-test is applied. Performing test statistical comparisons of said parameters between different subgroups is carried out in dependence of the real data. All tests are two-sided. Data-dependent, justified deviations (for example inadequate group size) may occur