Diagnosing Adverse Drug Reactions Registry (DART)

March 18, 2015 updated by: Renaissance RX

DART Registry: Diagnosing Adverse Drug Reactions Registry

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
250000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35235
        • Edwards Lake Medical Center
    • Arizona
      • Glendale, Arizona, United States, 85308
        • Gerald Harris MD
      • Peoria, Arizona, United States, 85381
        • Holland Center for Family Health
      • Phoenix, Arizona, United States, 85032
        • AZ Pain Center
    • California
      • Los Angeles, California, United States, 90048
        • Olga Voroshilovsky
      • Pasadena, California, United States, 91105
        • Institute for Regenerative Medicine and Clinical Research
    • Colorado
      • Boulder, Colorado, United States, 80304
        • Boulder Medical Center
    • Connecticut
      • Avon, Connecticut, United States, 06001
        • Prime Healthcare - Anthony Roselli MD
    • District of Columbia
      • Washington, District of Columbia, United States, 20016
        • Washington Pain Center
    • Florida
      • Doral, Florida, United States, 33126
        • Continental Research Network
      • Miami, Florida, United States, 33144
        • Latin Foundation for Health
      • Stuart, Florida, United States, 34994
        • Primary Care Associates, P.A.
    • Georgia
      • Columbus, Georgia, United States, 31904
        • Roman Medical Group
      • Hampton, Georgia, United States, 30228
        • Wellness Medicine
      • Macon, Georgia, United States, 31201
        • Ocmulgee Physicians
      • Macon, Georgia, United States, 31204
        • Macon Family Health Center Inc.
      • Rome, Georgia, United States, 30161
        • Your Personal Physician
      • Rome, Georgia, United States, 30165
        • Valley Health Care
      • Snellville, Georgia, United States, 30039
        • Dr. B. Abraham PC
      • Statesboro, Georgia, United States, 30458
        • Candler Internal Medicine
    • Illinois
      • Orland Park, Illinois, United States, 60467
        • Primary Health Associates
    • Kentucky
      • Lexington, Kentucky, United States, 40503
        • Women's Care Center
    • Michigan
      • Grandville, Michigan, United States, 49418
        • Healthy Heart Cardiology
      • Southfield, Michigan, United States, 48075
        • Heart Cardiology Consultants
    • New Jersey
      • Elizabeth, New Jersey, United States, 07208
        • Union Square Medical Associates, PC
      • Lyndhurst, New Jersey, United States, 07071
        • United Medical PC
    • New Mexico
      • Alamogordo, New Mexico, United States, 88310
        • Internal Medicine Specialists of Alamogordo, P.C.
      • Albuquerque, New Mexico, United States, 87102
        • Lovelace Rehabilitation Hospital
      • Albuquerque, New Mexico, United States, 87109
        • Sage Neuroscience Center
      • Albuquerque, New Mexico, United States, 87113
        • Geriatrics Associates, PAC
      • Las Cruces, New Mexico, United States, 88005
        • Isabel C Vigil MD
    • North Carolina
      • Charlotte, North Carolina, United States, 28210-0106
        • Larry F Berman MD PC
      • Durham, North Carolina, United States, 27704
        • Lakewood Pediatrics and Family Medicine
      • Gastonia, North Carolina, United States, 28054
        • Carolina Urology Partners
      • Greensboro, North Carolina, United States, 27401
        • Carolina Neurosurgery and Spine Associates
    • Ohio
      • Columbus, Ohio, United States, 43213
        • Comprehensive Pain Center
      • Columbus, Ohio, United States, 43214
        • Knightsbridge Internal Medicine and Cardiology Associates, Inc
      • Columbus, Ohio, United States, 43215
        • Gateway Health and Wellness LLC
      • Mansfield, Ohio, United States, 44907
        • Robert E Barkett Jr MD
      • Marion, Ohio, United States, 43302
        • Midwestern Internal Medicine Associates (MIMA)
      • Reynoldsburg, Ohio, United States, 43068
        • Stonegate Family Health
      • Tallmadge, Ohio, United States, 44278
        • Primary Care Associates - Unity
    • Pennsylvania
      • Easton, Pennsylvania, United States, 18042
        • Easton Cardiovascular Associates
    • South Carolina
      • Greenville, South Carolina, United States, 29601
        • Carolina Center for Advanced Management of Pain
      • Sumter, South Carolina, United States, 29150
        • Colonial Family Practice
      • Sumter, South Carolina, United States, 29150
        • Palmetto Adult Medicine
    • Tennessee
      • Oak Ridge, Tennessee, United States, 37830
        • Parkway Cardiology Associates
    • Texas
      • Fort Worth, Texas, United States, 76107
        • Mark A. Sanders, DO
    • Virginia
      • Emporia, Virginia, United States, 23847
        • Emporia Medical Associates

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
60 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
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
60 days
Frequency of genome-based PharmD recommendations to alter drug or dose.
Time Frame: 60 days
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.
60 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Renaissance RX

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Syntactx

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2013

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 22, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 22, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 28, 2013

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 19, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 18, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2013-101

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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