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Medication Optimisation for Reducing Events in a Private Practice Setting

Observational Study of the Pharmaco-Economic and Medical Effects of Optimising Medication Using Pharmacokinetic Pharmacogenomics and Medication Interaction Analysis in Private Practice.

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00653653
Acronym
MORE
Enrollment
500
Registered
2008-04-07
Start date
2008-08-31
Completion date
2009-10-31
Last updated
2009-04-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pharmacogenetic Analysis to Reduce Events.

Keywords

pharmacogenetics, pharmacoeconomics, adverse events, drug metabolism

Brief summary

Using a prospective study design of two three month periods (before and after genotyping) in which the patients will self-monitor their health status and possible medical events it is hypothesized that it will be shown that patients having their medication altered to fit their genetic status and/or having their medication altered because of inherent interaction potential will have less recordable events after genotyping and medical analysis than before. It is well known that ADRs (recordable adverse events to medication) are responsible for a large number of deaths and hospitalizations. Furthermore it is well recorded that genotyping of individual cytochrome P450 enzymes (2D6, 2C9, 2C19, among others) is directly related to a metabolic phenotype - fast metabolisers, slow metabolisers, intermediate and normal metabolisers. These differing phenotypes have altered metabolism of many medications and in a number of retrospective clinical trails it has been shown that ADRs and effect can be reduced/bettered through genotyping and alteration of medication.

Interventions

None listed

Sponsors

Awenydd GmbH
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* older than 18 years * not demented * 1 or more documented events in the previous 6 months. * more than one medication * multi-morbid

Exclusion criteria

* demented * life expectancy less than 1 year * heart attack within the last 6 months * Marcumar® Therapy

Design outcomes

Primary

MeasureTime frame
Reduction of reported events in the time frame.3 months

Secondary

MeasureTime frame
Reduction of total costs associated per patient in the time frame.3 months

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026