Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Medication Optimisation for Reducing Events in a Private Practice Setting (MORE)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2009 by Awenydd GmbH.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Awenydd GmbH
ClinicalTrials.gov Identifier:
NCT00653653
First received: April 2, 2008
Last updated: April 7, 2009
Last verified: April 2009
  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.

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.

Resource links provided by NLM:


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 ]

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
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Germany
Awenydd Gmbh
Köln, NRW, Germany, 50829
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-Nürnberg
  More Information

Publications:
Chialda, L; Griffith, LS; Heinig, A; Pahl, A. Prospective use of CYP pharmacogenetics and medication analysis to facilitate improved therapy - a pilot study. Personalized Medicine (2008) 5(1): 37-35

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 November 25, 2014