Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Medication Optimisation for Reducing Events in a Private Practice Setting (MORE)
This study is currently recruiting participants.
Verified by Awenydd GmbH, October 2008
Sponsored by: Awenydd GmbH
Information provided by: Awenydd GmbH
ClinicalTrials.gov Identifier: NCT00653653
  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
Pharmacogenetic Analysis to Reduce Events.

U.S. FDA Resources
Study Type: Observational
Study Design: Cohort, 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.

Further study details as provided by Awenydd GmbH:

Primary Outcome Measures:
  • Reduction of reported events in the time frame. [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Reduction of total costs associated per patient in the time frame. [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Biospecimen Retention:   None Retained

Biospecimen Description:

Estimated Enrollment: 500
Study Start Date: August 2008
Groups/Cohorts
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Community sample.

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00653653

Contacts
Contact: Lee S Griffith, Ph.D. +49 170-3828071 ls.griffith@awenydd.de
Contact: André Gessner, MD Ph.D. 09131-8522580

Locations
Germany, BW
Awenydd Gmbh Recruiting
Freiburg, BW, Germany, 79108
Contact: Lee S Griffith, PhD     +49 170-3828071     ls.griffith@awenydd.de    
Contact: Peter Kischkewitz     +49-761-51589 ext 0     p.kischkewitz@awenydd.de    
Principal Investigator: Lee S Griffith, Ph.D.            
Sponsors and Collaborators
Awenydd GmbH
Investigators
Study Director: Lee S Griffith, Ph.D. Awenydd GmbH
Principal Investigator: André Gessner, MD Ph.D. University of Erlangen
  More Information

Responsible Party: awenydd Gene Diagnostic ( Dr. LS Griffith )
Study ID Numbers: AW_SH_08
Study First Received: April 2, 2008
Last Updated: October 1, 2008
ClinicalTrials.gov Identifier: NCT00653653  
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 January 16, 2009