Trials / Completed
CompletedNCT04307940
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 Randomized, Double-Blind, Placebo-Controlled Trial to Compare the Analgesic Efficacy and Safety of Naproxen Sodium Tablets and Hydrocodone/Acetaminophen Tablets in Postsurgical Dental Pain
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 221 (actual)
- Sponsor
- Bayer · Industry
- Sex
- All
- Age
- 18 Years – 40 Years
- Healthy volunteers
- Not accepted
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Naproxen Sodium (Aleve, BAY117031) | 220 mg per tablet, two tablets (440 mg), intake a single dose orally. |
| DRUG | Hydrocodone/Acetaminophen | 5/325 mg per tablet, two tablets (10/650 mg), intake a single dose orally. |
| DRUG | Placebo | two tablets, intake a single dose orally. |
Timeline
- Start date
- 2020-03-12
- Primary completion
- 2020-10-02
- Completion
- 2020-10-05
- First posted
- 2020-03-13
- Last updated
- 2022-07-14
- Results posted
- 2021-10-07
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04307940. Inclusion in this directory is not an endorsement.