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NCT04226404 · ClinicalTrials.gov registry record · NA

CSD190501: A Study to Determine Subject Puffing Patterns of an Electronic Nicotine Delivery System in an Ambulatory Setting

A NA study, sponsored by RAI Services Company.

Completed
Registry status
NA
Development phase
75
Enrollment target

NCT04226404: Completed NA study, sponsored by RAI Services Company.

NCT04226404 is a NA study that has completed, run by RAI Services Company. The registered enrollment target is 75 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04226404, a NA study, has completed, sponsored by RAI Services Company.

COMPLETED
Registry status
NA
Development phase
75 participants
Enrollment target

Study Summary

This study will be a single-center, controlled, open-label, parallel study to evaluate the puffing patterns of healthy adult consumers of tobacco products switching from a usual brand (UB) Electronic Nicotine Delivery Systems (ENDS) product to an ENDS Investigational Product (IP) product with 4.8% nicotine over a three-week ambulatory period. This study will be conducted in support of a Premarket Tobacco Product Application (PMTA) ENDS submission to the US Food and Drug Administration (FDA) Center for Tobacco Products (CTP).

Primary Outcome

Arithmetic Mean puff duration

Interventions

  • OTHER CSD1905-11
  • OTHER CSD1905-12
  • OTHER CSD1905-13
  • OTHER CSD1905-14
  • OTHER CSD1905-15

Trial Details

FieldValue
Enrollment Target 75 participants
Start Date 2020-01-14
Est. Completion 2020-02-27
Phase NA
RAI Services Company

42 total trials

What the finished NCT04226404 record still lists

NCT04226404 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 75 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower).

The record links to 0 conditions, and to 5 interventions - of which CSD1905-11 is the first listed.

NCT04226404 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04226404 about?

NCT04226404 is a clinical study titled "CSD190501: A Study to Determine Subject Puffing Patterns of an Electronic Nicotine Delivery System in an Ambulatory Setting". This study will be a single-center, controlled, open-label, parallel study to evaluate the puffing patterns of healthy adult consumers of tobacco products switching from a usual brand (UB) Electronic Nicotine Delivery Systems (ENDS) product to an ENDS Investigational Product (IP) product with 4.8% n...

What is the current status of trial NCT04226404?

This trial is currently completed. It is a NA study. The enrollment target is 75 participants. The study started on 2020-01-14. Estimated completion is 2020-02-27.

What interventions are being tested in trial NCT04226404?

The interventions under investigation include: CSD1905-11 (OTHER), CSD1905-12 (OTHER), CSD1905-13 (OTHER), CSD1905-14 (OTHER), CSD1905-15 (OTHER).

Who is sponsoring clinical trial NCT04226404?

This trial is sponsored by RAI Services Company, which has 42 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04226404's enrollment target sits among peer trials

75 1069th of 2000 higher than 919 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA 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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Source: ClinicalTrials.gov NCT04226404, the US trial registry maintained by the National Library of Medicine. NCT04226404 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.