Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed Phase 2 study, sponsored by Bayer.
NCT04132336 is a Phase 2 study that has completed, run by Bayer. The registered enrollment target is 193 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (45% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
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 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 |
What the finished NCT04132336 record still lists
NCT04132336 is an interventional study that assigns participants to a tested intervention. The registered 193 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (45% higher).
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT04132336 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04132336's enrollment target sits among peer trials
193 352nd of 2000 higher than 1,649 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT06226220 · 193 participants · NA
Percutaneous Nerve Evaluation Trial Time
- NCT03593759 · 194 participants · Phase 3
Cardiac Sarcoidosis Randomized Trial
- NCT05053152 · 194 participants · Phase 2
Testing the Addition of the Drug Relugolix to the Usual Radiation Therapy for Advanced-Stage Prostate Cancer, The NRG Promethean Study
- NCT05156112 · 194 participants · NA
OSA PAP Treatment for Veterans With SUD and PTSD on Residential Treatment Unit
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI