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COA-APTIC Cognitive Interview Study of Caregiver and Clinician Assessment of Acute Pain in Infants and Young Children

NCT06164028 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 60

Last updated 2025-09-09

No results posted yet for this study

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).

Conditions

  • Acute Pain

Interventions

OTHER

cognitive interview

Participants will take part in a semi-structured qualitative interview (\~1 hour).

Sponsors & Collaborators

  • Food and Drug Administration (FDA)

    collaborator FED

  • Duke University

    lead OTHER

Principal Investigators

  • Kanecia Zimmerman, MD, MPH · Duke University

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-08-15
Primary Completion
2026-08-31
Completion
2026-08-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06164028 on ClinicalTrials.gov