Recruiting

Observational Study

Sponsor:

University of British Columbia

Code:

NCT00414115

Conditions

Adverse Drug Reaction (ADR)

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Accepted

Study Details

Brief summary:

The purpose of the study is (1) to identify and collect samples from children and adults who take drugs and have adverse drug reactions AND children and adults who take drugs and do not experience any adverse drug effects; (2) to determine if genetic differences between the two groups contribute to causing the adverse drug reactions; and (3) to develop patient specific drug dosing guidelines to prevent future adverse drug reactions. We also wish to compare the use of prescription drugs, medical and hospital services and vital statistics between BC participants who experience adverse drug reactions and those who do not.

Study hypothesis: Genetic differences may contribute to patients' response to drugs and may be responsible for adverse drug reactions.

Conditions

Adverse Drug Reaction (ADR)

Study ID

NCT00414115

Start date

Aug, 2005

Status verified date

Apr, 2026

Completion date

Mar, 2029

Anticipated

Primary completion date

Mar, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Children under 19 years who have taken drugs.
  • Biological parents of children who have had an ADR.
  • Patients/parents who speak and understand English (except in Quebec).
  • Adults (for validation of findings in children)

Study Design

Enrollment

7000 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Determine the role of genetic and clinical factors in adverse drug reactions to develop risk mitigation strategies. [ Time Frame: December 2018 ]

Central Contacts and Locations

Central contacts

Bruce Carleton, PharmD.

604-875-2179bcarleton@popi.ubc.ca

Locations

Children's and Women's Health Centre of British Columbia

Recruiting

Vancouver, British Columbia, Canada, V6H 3V4

Contacts

Principal Investigator:

Bruce Carleton, MD

More Information

Sponsor

University of British Columbia

Last update posted

May 1, 2026

Last verified

Apr, 2026

Keywords

  • Observational controlled study
  • Genomic biomarkers
  • Adverse drug reaction
  • In children OR adults

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of British Columbia on 2026-05-01.