NCT04132336

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 Randomized, Double-Blind, Single-Dose, Parallel, Placebo-Controlled Trial to Determine the Dose of Caffeine in a Fixed Dose Combination Tablet of Naproxen Sodium and Caffeine to Effectively Alleviate Postsurgical Dental Pain

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 193 (actual)
• Sponsor: Bayer · Industry
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pain, Postoperative

Interventions

Type	Name	Description
DRUG	Naproxen sodium/Caffeine (BAY2880376)	Tablet, oral, single dose
DRUG	Naproxen sodium (Aleve)	Tablet, oral, single dose
DRUG	Caffeine	Tablet, oral, single dose
DRUG	Placebo	Tablet, oral, single dose

Timeline

• Start date: 2019-11-12
• Primary completion: 2020-03-02
• Completion: 2020-03-03
• First posted: 2019-10-18
• Last updated: 2021-09-01
• Results posted: 2021-06-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study