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NCT06164028 · ClinicalTrials.gov registry record
COA-APTIC Cognitive Interview Study of Caregiver and Clinician Assessment of Acute Pain in Infants and Young Children
A clinical trial of Acute Pain, sponsored by Duke University.
- Recruiting
- Registry status
- 60
- Enrollment target
- 1
- Study location
NCT06164028: Recruiting study of Acute Pain, sponsored by Duke University.
NCT06164028 is a study of Acute Pain that is actively recruiting participants, run by Duke University. The registered enrollment target is 60 participants, below the 267-participant average among 50 other Acute Pain trials with a reported enrollment target (78% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06164028, a study of Acute Pain, is actively recruiting participants, sponsored by Duke University.
- RECRUITING
- Registry status
- 60 participants
- Enrollment target
- 1
- Study location
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).
Primary Outcome
Understanding (or clarity) of all features of the clinical outcome assessments (ObsRO measure or ClinRO measures) including, but not limited to, its instructions, questions, and response options.
Conditions Studied
Interventions
- OTHER cognitive interview
Study Locations (1)
North Carolina
- Duke Clinical Research Institute - Durham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2023-08-15 |
| Est. Completion | 2026-08-31 |
What NCT06164028 shows while recruiting
NCT06164028 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 267-participant average among 50 other Acute Pain trials with a reported enrollment target (78% lower).
The record links to 1 condition, with Acute Pain appearing as the primary indexed condition, and to 1 intervention - of which cognitive interview is the first listed.
NCT06164028 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT06164028 about?
NCT06164028 is a clinical study titled "COA-APTIC Cognitive Interview Study of Caregiver and Clinician Assessment of Acute Pain in Infants and Young Children". 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 Clini...
What is the current status of trial NCT06164028?
This trial is currently recruiting. The enrollment target is 60 participants. The study started on 2023-08-15. Estimated completion is 2026-08-31.
What conditions does trial NCT06164028 study?
This clinical trial studies the following conditions: Acute Pain.
What interventions are being tested in trial NCT06164028?
The interventions under investigation include: cognitive interview (OTHER).
Who is sponsoring clinical trial NCT06164028?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06164028 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Acute Pain
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06164028's enrollment target sits among peer trials
60 36th of 50 higher than 14 of 50 other Acute Pain trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Acute Pain trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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