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Diagnosing Adverse Drug Reactions Registry (DART)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2015 by Renaissance RX.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01970709
First Posted: October 28, 2013
Last Update Posted: March 19, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Syntactx
Information provided by (Responsible Party):
Renaissance RX
  Purpose
This multicenter Registry is to assess whether the use of pharmacogenomic data results in a meaningful change in a subject's drug or dose regimen. In addition, the Registry will evaluate the relationship between adverse drug reactions (ADR) and genotype and assess resource utilization (emergency department visits and hospitalizations) associated with ADR.

Condition
Genetics of Drug Metabolism

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Target Follow-Up Duration: 60 Days
Official Title: DART Registry: Diagnosing Adverse Drug Reactions Registry

Resource links provided by NLM:


Further study details as provided by Renaissance RX:

Primary Outcome Measures:
  • Occurrence of meaningful change in drug regimen [ Time Frame: 60 days ]

    The primary endpoint of the study is the binary occurrence of meaningful change in drug regimen, defined in each subject when:

    • A genotype known to affect a drug the subject is taking is identified, and
    • The subject's treating physician makes at least one drug regimen change in concordance with the PharmD recommendations.


Secondary Outcome Measures:
  • Change in the regimen of drugs controlled by genes of interest over the 12 months prior to enrollment and change in the regimen of drugs controlled by genes of interest over the 60 days following receipt of pharmacogenetic test results. [ Time Frame: 60 days ]
  • Number of ADR per month over the 12 months prior to enrollment and number of ADR per month over the 60 days following receipt of pharmacogenomic test results. [ Time Frame: 60 days ]
  • Frequency of genome-based PharmD recommendations to alter drug or dose. [ Time Frame: 60 days ]
  • Emergency department visits and hospitalizations [ Time Frame: 60 days ]
    Emergency department visits over the 12 months prior to enrollment, emergency department visits over the 60 days following receipt of test results, hospitalizations over the 12 months prior to enrollment, and hospitalizations over the 60 days following receipt of test results.


Biospecimen Retention:   Samples With DNA
Buccal swab

Estimated Enrollment: 250000
Study Start Date: November 2013
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Male and female subjects over the age of 18, taking three or more medications, two of which are metabolized by the CYP450 pathway.
Criteria

Inclusion Criteria:

  • Subject has care coordinated at the treating physician's outpatient clinic;
  • Subject has provided written informed consent;
  • Subject is taking at least three (3) regularly scheduled medications, excluding as needed (PRN) medications, over the counter medications and nutritional supplements; two (2) of which are known to be affected by genetic allelic variation.
  • Subject's treating physician has a clinical suspicion that the subject is experiencing adverse signs or symptoms related to a prescribed medication or is not achieving the intended effect from the medication.

Exclusion Criteria:

  • Subject has a history of chronic renal dysfunction, Chronic Kidney Disease Stage 4 or 5;
  • Subject has a history of abnormal hepatic function within the last 2 years (INR >1.2 not attributable to anticoagulant medications, AST (aspartate aminotransferase) or ALT (alanine aminotransferase) >1.5x normal, or suspected cirrhosis);
  • Subject has a history of malabsorption (short gut syndrome);
  • Subject has a history of any gastric or small bowel surgery;
  • Subject is currently hospitalized;
  • Subject is currently being treated with intravenous medication;
  • Subject underwent prior pharmacogenomic testing with results reported within the last 12 months.

Subjects may be eligible within 60 days from the date of pharmacogenomic testing.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01970709


  Show 49 Study Locations
Sponsors and Collaborators
Renaissance RX
Syntactx
  More Information

Publications:

Responsible Party: Renaissance RX
ClinicalTrials.gov Identifier: NCT01970709     History of Changes
Other Study ID Numbers: 2013-101
First Submitted: October 22, 2013
First Posted: October 28, 2013
Last Update Posted: March 19, 2015
Last Verified: March 2015

Keywords provided by Renaissance RX:
Adverse Drug Reactions
Emergency Department Visits
Hospitalizations
Pharmacogenomic

Additional relevant MeSH terms:
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders