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NCT04132336 · ClinicalTrials.gov registry record · Phase 2
Study to Find Out the Optimal Dose of Caffeine in the Combination Tablet of Naproxen Sodium and Caffeine in Patients Experiencing Moderate to Severe Pain After Having Wisdom Teeth Removed
A Phase 2 study, sponsored by Bayer.
- Completed
- Registry status
- Phase 2
- Development phase
- 193
- Enrollment target
NCT04132336 is a Phase 2 study that has completed, run by Bayer. The registered enrollment target is 193 participants.
The verdict
NCT04132336, a Phase 2 study, has completed, sponsored by Bayer.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 193 participants
- Enrollment target
Study Summary
The researchers in this study wanted to find out the optimal dose of Caffeine in the combination tablet of Naproxen Sodium and Caffeine that works in patients experiencing moderate to severe pain after having wisdom teeth removed. In the US, Naproxen has been marketed since 1976, and Naproxen Sodium has been approved for over-the-counter (OTC) use since 1994 for the temporary relief of minor aches and pains. Caffeine, which is generally consumed as coffee, tea or cocoa, has been shown to enhance the effectiveness of various pain relievers, and therefore is accepted as an additive to painkillers like aspirin and acetaminophen. Patients participating in this study underwent a surgery to remove 3 or 4 wisdom teeth. If the pain severity after the surgery met the study requirement, patients would receive oral tablet(s) of Naproxen Sodium and Caffeine, or Naproxen Sodium, or Caffeine, or placebo (drug with no active ingredient). Patients could also receive additional pain medication when needed. Researchers would also learn if the patients have any medical problems during the study.
Interventions
- DRUG Placebo
- DRUG Caffeine
- DRUG Naproxen sodium/Caffeine (BAY2880376)
- DRUG Naproxen sodium (Aleve)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 193 participants |
| Start Date | 2019-11-12 |
| Est. Completion | 2020-03-03 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04132336
The ClinicalTrials.gov registry entry for NCT04132336 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 193 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bayer, which has 591 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT04132336 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04132336 about?
NCT04132336 is a clinical study titled "Study to Find Out the Optimal Dose of Caffeine in the Combination Tablet of Naproxen Sodium and Caffeine in Patients Experiencing Moderate to Severe Pain After Having Wisdom Teeth Removed". The researchers in this study wanted to find out the optimal dose of Caffeine in the combination tablet of Naproxen Sodium and Caffeine that works in patients experiencing moderate to severe pain after having wisdom teeth removed. In the US, Naproxen has been marketed since 1976, and Naproxen Sodium...
What is the current status of trial NCT04132336?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 193 participants. The study started on 2019-11-12. Estimated completion is 2020-03-03.
What interventions are being tested in trial NCT04132336?
The interventions under investigation include: Placebo (DRUG), Caffeine (DRUG), Naproxen sodium/Caffeine (BAY2880376) (DRUG), Naproxen sodium (Aleve) (DRUG).
Who is sponsoring clinical trial NCT04132336?
This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.
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