COA-APTIC Cognitive Interview Study of Caregiver and Clinician Assessment of Acute Pain in Infants and Young Children
NCT06164028
This study is recruiting at 1 US site in 1 state, according to its ClinicalTrials.gov record last updated .
Summary
Evaluate the content validity and comprehensibility of a caregiver observer-reported outcome assessment and clinician-reported assessments for acute pain in children aged 0 to <2 years. The primary objective of the Qualitative Protocol in the UH3 phase study is to establish or create reliable Clinical Outcome Assessments (COAs) and endpoints that can assess acute pain during clinical trials of pain therapeutics specifically designed for infants and young children (0 - <2 years).
Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov
Conditions studied
- Acute Pain
Eligibility basics and study details
- Study type
- Observational
- Phase
- Not applicable
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Sponsor
- Duke University
- Last updated on ClinicalTrials.gov
- September 9, 2025
These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.
US recruiting sites
North Carolina · 1
- Duke Clinical Research Institute · Durham, NC
Source: ClinicalTrials.gov, data processed . Recruiting US sites filtered by distance and site status; summaries shortened.