Medication Optimisation for Reducing Events in a Private Practice Setting (MORE)
Recruitment status was Active, not recruiting
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Purpose
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.
| Condition |
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Pharmacogenetic Analysis to Reduce Events. |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Observational Study of the Pharmaco-Economic and Medical Effects of Optimising Medication Using Pharmacokinetic Pharmacogenomics and Medication Interaction Analysis in Private Practice. |
- Reduction of reported events in the time frame. [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
- Reduction of total costs associated per patient in the time frame. [ Time Frame: 3 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 500 |
| Study Start Date: | August 2008 |
| Estimated Study Completion Date: | October 2009 |
| Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
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Group A
Recruited patients will be prospectively observed as one cohort with genotyping/medication interaction analysis after 3 months, followed up by a further 3 month observational period.
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Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Community sample.
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
Contacts and Locations| Germany | |
| Awenydd Gmbh | |
| Köln, NRW, Germany, 50829 | |
| Study Director: | Lee S Griffith, Ph.D. | Awenydd GmbH |
| Principal Investigator: | André Gessner, MD Ph.D. | University of Erlangen-Nürnberg |
More Information
Publications:
| Responsible Party: | Dr. LS Griffith, awenydd Gene Diagnostic |
| ClinicalTrials.gov Identifier: | NCT00653653 History of Changes |
| Other Study ID Numbers: | AW_SH_08 |
| Study First Received: | April 2, 2008 |
| Last Updated: | April 7, 2009 |
| Health Authority: | Germany: Federal Ministry of Education and Research |
Keywords provided by Awenydd GmbH:
|
pharmacogenetics pharmacoeconomics adverse events drug metabolism |
ClinicalTrials.gov processed this record on May 22, 2013