Study identification

EU PAS number

EUPAS31817

Study ID

34160

Official title and acronym

Retrospektive Ärztebefragung zu Vorkommen und Ursachen von Stürzen bei älteren Patienten unter besonderer Betrachtung von Antihistaminika der ersten Generation als mögliche Sturzursache (Echo)

DARWIN EU® study

No

Study countries

Germany

Study description

The Echo project is a retrospective survey of physicians on the incidence and causes of falls in older patients, with a special focus on first-generation antihistamines as a possible cause of falls. The background to this question is that in patients at ≥ 65 years of age an increased fall rate in connection with the intake of antihistamines of the first generation with sedative effect is discussed as a possible risk. No valid data are currently available to confirm or refute this risk. 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 antihistamines of the first generation with sedative effect. Secondary objectives are the investigation of a possible causal relationship of falls after the intake of antihistamines of the first generation with sedative effect for the subgroups < 65 years, 65-84 years and ≥ 85 years, the determination of the fall rate of patients ≥ 65 years as well as for the subgroups < 65 years, 65-84 years and ≥ 85 years, and the identification of causes for falls in patients ≥ 65 years. To answer this question, the design of a retrospective non-interventional post-authorisation safety study (according to § 63f German Drug Law) in the form of a cross-sectional study (medical chart review) is chosen. The survey will be conducted among at least 500 resident physicians, of which approx. 426 (~85%) are general practitioners/internists with no specialisation (≙ family doctors) and approx. 74 (~15%) are neurologists. Data collection is planned for October 2019 to December 2019. Data evaluation by means of descriptive statistics and study completion are planned for January 2020.

Study status

Finalised
Research institutions and networks

Institutions

Resident physicians (family doctors and neurologists) Germany

Contact details

Friederike Klein

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Data analysis start date

Planned:
Actual:

Date of final study report

Planned:
Actual:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

STADA Arzneimittel AG
Regulatory

Was the study required by a regulatory body?

No

Is the study required by a Risk Management Plan (RMP)?

Not applicable