Apothekenbasierte, nicht-interventionelle Unbedenklichkeitsprüfung von Hoggar® Night Tabletten/Schmelztabletten unter Alltagsbedingungen (Projekt Alpha)

Study type

• Study topic:
  Disease /health condition

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

  Safety study (incl. comparative)
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cohort

  Other
• Non-interventional study design, other:
  Prospective, multicentric, post-authorisation safety study

Study drug and medical condition

• Medical condition to be studied:
  Sleep disorder
• Additional medical condition(s):
  Fall

Population studied

• Short description of the study population:
  The study focused on elderly patients aged 65 or above to examined the relationship between the risk of falls and the consumption of Hoggar® Night tablets/orodispersible tablets.
• Age groups:
  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)
• Special population of interest:
  Frail population

  Other
• Special population of interest, other:
  Patients with sleep disorders
• Estimated number of subjects:
  2000

Study design details

• Main study objective:
  The primary objective of this study is to investigate a possible causal relationship between falls in patients at ≥ 65 years of age and the intake of Hoggar® Night.
• Outcomes:
  Incidence of falls related to the Hoggar® Night intake.
• Data analysis plan:
  Descriptive statistics: Subgroup analyses (gender, different age groups), absolute and relative frequencies for all data, mean, standard deviation, median, minimum and maximum for selected parameters. Primary/secondary objectives: Negative binomial models to investigate a possible causal relationship between the frequency of falls in patients taking Hoggar® Night and age, gender, dosage form, no. of comorbidities and concomitant medications. OR (incl. 95% CI) for each possible influencing variable. Fall rate of patients analysed descriptively, stratified by gender and age group. Fall rate defined as no. of patients with confirmed falls relative to no. of evaluable patients. Fall rates for all confirmed falls (regardless of the causal relationship with Hoggar® Night) and for the falls with a possible causal relationship with Hoggar® Night. Possible alternative fall causes with absolute and relative frequencies - for all patients as well as for patients ≥ 65 years.