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NCT04307940 · ClinicalTrials.gov registry record · Phase 4
Study to Collect Information on How Well the Study Drug Naproxen Sodium Tablets Works Compared to Hydrocodone/Acetaminophen Tablets in Order to Relieve Pain in Participants Experiencing Moderate to Severe Pain After Having Their Wisdom Teeth Removed
A Phase 4 study, sponsored by Bayer.
- Completed
- Registry status
- Phase 4
- Development phase
- 221
- Enrollment target
NCT04307940: Completed Phase 4 study, sponsored by Bayer.
NCT04307940 is a Phase 4 study that has completed, run by Bayer. The registered enrollment target is 221 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (57% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04307940, a Phase 4 study, has completed, sponsored by Bayer.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 221 participants
- Enrollment target
Study Summary
With this study researchers want to collect information on how long the pain relief lasts after a fixed dose of naproxen sodium or hydrocodone/acetaminophen or placebo (contains no medication) over 12 hours in subjects experiencing moderate to severe pain after having their wisdom teeth removed. Naproxen Sodium (Aleve®) is a drug that is used for the temporary relief of minor aches and pains. Hydrocodone/Acetaminophen is a combination drug used to relieve moderate to severe pain. It contains an opioid (narcotic) pain reliever (hydrocodone) and a non-opioid pain reliever (acetaminophen).
Primary Outcome
Pain intensity is measured using Numerical Rating Scale (from 0 to 10: 0 = no pain, 10 = worst possible pain). For each post dose time point, pain intensity difference (PID) is derived by subtracting the pain intensity at the post dose time point from the baseline intensity score (baseline score - post-baseline score). A positive difference is indicative of improvement. Sum of Pain Intensity Differences (SPIDs) was calculated by multiplying the PID score at each post-dose time point by the durat
Interventions
- DRUG Placebo
- DRUG Naproxen Sodium (Aleve, BAY117031)
- DRUG Hydrocodone/Acetaminophen
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 221 participants |
| Start Date | 2020-03-12 |
| Est. Completion | 2020-10-05 |
| Phase | Phase 4 |
What the finished NCT04307940 record still lists
NCT04307940 is an interventional study that assigns participants to a tested intervention. The registered 221 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (57% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT04307940 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04307940 about?
NCT04307940 is a clinical study titled "Study to Collect Information on How Well the Study Drug Naproxen Sodium Tablets Works Compared to Hydrocodone/Acetaminophen Tablets in Order to Relieve Pain in Participants Experiencing Moderate to Severe Pain After Having Their Wisdom Teeth Removed". With this study researchers want to collect information on how long the pain relief lasts after a fixed dose of naproxen sodium or hydrocodone/acetaminophen or placebo (contains no medication) over 12 hours in subjects experiencing moderate to severe pain after having their wisdom teeth removed. Nap...
What is the current status of trial NCT04307940?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 221 participants. The study started on 2020-03-12. Estimated completion is 2020-10-05.
What interventions are being tested in trial NCT04307940?
The interventions under investigation include: Placebo (DRUG), Naproxen Sodium (Aleve, BAY117031) (DRUG), Hydrocodone/Acetaminophen (DRUG).
Who is sponsoring clinical trial NCT04307940?
This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04307940's enrollment target sits among peer trials
221 383rd of 2000 higher than 1,616 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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