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

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ClinicalTrials.gov Identifier: NCT00653653
Recruitment Status : Unknown
Verified April 2009 by Awenydd GmbH.
Recruitment status was:  Active, not recruiting
First Posted : April 7, 2008
Last Update Posted : April 8, 2009
Sponsor:
Information provided by:
Awenydd GmbH

Tracking Information
First Submitted Date April 2, 2008
First Posted Date April 7, 2008
Last Update Posted Date April 8, 2009
Study Start Date August 2008
Estimated Primary Completion Date June 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 4, 2008)
Reduction of reported events in the time frame. [ Time Frame: 3 months ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: April 4, 2008)
Reduction of total costs associated per patient in the time frame. [ Time Frame: 3 months ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Medication Optimisation for Reducing Events in a Private Practice Setting
Official Title Observational Study of the Pharmaco-Economic and Medical Effects of Optimising Medication Using Pharmacokinetic Pharmacogenomics and Medication Interaction Analysis in Private Practice.
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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Community sample.
Condition Pharmacogenetic Analysis to Reduce Events.
Intervention Not Provided
Study 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.
Publications * Chialda L, Griffith LS, Heinig A, Pahl A. Prospective use of CYP pharmacogenetics and medication analysis to facilitate improved therapy - a pilot study. Per Med. 2008 Jan;5(1):37-45. doi: 10.2217/17410541.5.1.37.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: April 4, 2008)
500
Original Estimated Enrollment Same as current
Estimated Study Completion Date October 2009
Estimated Primary Completion Date June 2009   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Germany
Removed Location Countries  
 
Administrative Information
NCT Number NCT00653653
Other Study ID Numbers AW_SH_08
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Dr. LS Griffith, awenydd Gene Diagnostic
Study Sponsor Awenydd GmbH
Collaborators Not Provided
Investigators
Study Director: Lee S Griffith, Ph.D. Awenydd GmbH
Principal Investigator: André Gessner, MD Ph.D. University of Erlangen-Nürnberg
PRS Account Awenydd GmbH
Verification Date April 2009