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Safety of Anthroposophic Medicinal Products


- candidate number29576
- NTR NumberNTR7628
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR24-sep-2018
- Secondary IDsNW2018-57 METC Brabant
- Public TitleSafety of Anthroposophic Medicinal Products
- Scientific TitleSafety of Anthroposophic Medicinal Products in Manufacturers' Pharmacovigilance Database
- ACRONYM
- hypothesisThe reporting rate of adverse drug reactions upon use of anthroposophic medicinal products, as well as the reporting rate of serious adverse drug reactions, is low as retrieved from pharmacovigilance databases of German manufacturers.
- Healt Condition(s) or Problem(s) studiedSafety, Drug, Anthroposophic Medicinal Products
- Inclusion criteria- Only those Adverse Drug Reactions (ADRs) that are reported in humans
- All valid and suspected ADR reports (including those related to off-label use) filed in the period from 1 January 2010 to 31 December 2017, independent from the ADR reporting duty to the European Medicines Agency
- Non-serious and serious ADRs
- ADRs from Anthroposophic Medicinal Products (AMPs) sold in Germany
- ADRs from post-marketing surveillance and clinical/safety trials
- ADRs that are assessed by the responsible person within the company (causal relationship with respect to drug administration is described)
- Spontaneous reports by consumers/patients, health professionals
- Literature cases
- Exclusion criteria- ADRs from AMPs sold in countries other than Germany
- ADRs for which the causality is assessed by the company as excluded or unlikely/remote
- ADRs from medicinal products with active ingredients which are not prepared according to the Anthroposophic Pharmaceutica Codex (APC)
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- Type[default]
- Studytype[default]
- planned startdate 1-nov-2018
- planned closingdate31-dec-2019
- Target number of participants0
- InterventionsAnthroposophic medicinal products
- Primary outcomeThe frequency of reported ADRs relative to the total sales volume of AMPs.
- Secondary outcomeThe relative frequency of ADRs to subgroups of AMPs, properties of ADRs such as the seriousness, classification according to system organ class (MedDRA), labelling, outcome, type of report, type of reporter and causality as well as characteristics of ADRs to AMP such as the origin of starting materials, dilution of active ingredients (non-diluted versus D1-D3 versus D4 versus composition of dilutions), route of administration (parenteral versus local, versus oral) and indications.
- TimepointsADRs from electronic pharmacovigilance database of AMP manufacturers in Germany as reported to and evaluated by the company in the last eight years (2010C2017).
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESProf. dr. Erik Baars
- CONTACT for SCIENTIFIC QUERIESDr. Harald Hamre
- Sponsor/Initiator Louis Bolk Institute, Institute for Applied Epistemology and Medical Methodology (IFAEMM)
- Funding
(Source(s) of Monetary or Material Support)
European Scientific Cooperative on Anthroposophic Medicinal Products. E04
- Publications
- Brief summaryPharmacovigilance is the pharmacological science of the surveillance of drug safety. Manufacturers of medicinal products, including AMPs, are obliged to collect, detect, monitor and assess the side-effects that occur with their medicinal products through their pharmacovigilance database. Safety data collected and analysed include the number of reported Adverse Drugs Reactions (ADRs) that may occur when AMPs are used by patients. The aim of the study is to investigate the safety status of AMPs through a systematic evaluation of reported ADRs from 2010C2017 as identified in the pharmacovigilance databases of German AMP manufacturers. The results of the systematic evaluation will be published in peer-reviewed scientific journals.
- Main changes (audit trail)Non WMO study
- RECORD24-sep-2018 - 30-nov-2018


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