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Showing 1–13 of 13 matching trials from the live ClinicalTrials.gov search.
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Filters: Intervention: 440 mg naproxen sodium Clear all
Completed Phase 4 Interventional Results available

Evaluate Analgesic/Sedative Efficacy of Naproxen Sodium and Diphenhydramine

NCT01118273
View directory record Official record
Conditions
Sleep
Interventions
Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg, Naproxen Sodium 440 mg (BAYH6689), Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg, Naproxen Sodium 220 mg (BAYH6689), DPH 50mg, Ibuprofen 400 mg / Diphenhydramine citrate 76 mg
Drug
Lead sponsor
Bayer
Industry
Eligibility
16 Years to 45 Years
Enrollment
162 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2008
U.S. locations
1
States / cities
Salt Lake City, Utah
Source: ClinicalTrials.gov public record
Updated Jun 7, 2015 · Synced Sep 27, 2026, 4:55 AM EDT
Completed Phase 4 Interventional Results available

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

NCT04307940
View directory record Official record
Conditions
Pain
Interventions
Naproxen Sodium (Aleve, BAY117031), Hydrocodone/Acetaminophen, Placebo
Drug
Lead sponsor
Bayer
Industry
Eligibility
18 Years to 40 Years
Enrollment
221 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020
U.S. locations
1
States / cities
Salt Lake City, Utah
Source: ClinicalTrials.gov public record
Updated Jul 13, 2022 · Synced Sep 27, 2026, 4:55 AM EDT
Completed Phase 3 Interventional Results available

Efficacy and Safety Study of a Test Naproxen Sodium 220mg Tablet in Postoperative Dental Pain

NCT03566979
View directory record Official record
Conditions
Post-operative Dental Pain
Interventions
Test naproxen sodium tablet, Commercial naproxen sodium tablet, Commercial naproxen sodium liquid gels capsule, Placebo tablet
Drug
Lead sponsor
Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division
Industry
Eligibility
17 Years to 50 Years
Enrollment
501 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2018 – 2019
U.S. locations
1
States / cities
Salt Lake City, Utah
Source: ClinicalTrials.gov public record
Updated Apr 8, 2020 · Synced Sep 27, 2026, 4:55 AM EDT
Completed Phase 4 Interventional Results available

OTC Naproxen and Acetaminophen Anti-Inflammatory Action in Dental Implant Patients

NCT04694300
View directory record Official record
Conditions
Osseointegrated Dental Implantation, Pain, Acute
Interventions
Naproxen, Acetaminophen, Tramadol
Drug
Lead sponsor
Hersh, Elliot V., DMD, MS, PhD
Individual
Eligibility
18 Years to 75 Years
Enrollment
30 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2022
U.S. locations
1
States / cities
Philadelphia, Pennsylvania
Source: ClinicalTrials.gov public record
Updated May 15, 2024 · Synced Sep 27, 2026, 4:55 AM EDT
Completed Phase 2 Interventional Results available

Naproxen Sodium/Acetaminophen Proof of Concept Dosing Study

NCT03879408
View directory record Official record
Conditions
Pain
Interventions
440 mg naproxen sodium with 1000 mg acetaminophen, 220 mg naproxen sodium with 650 mg acetaminophen, 10 mg hydrocodone + 650 mg acetaminophen, 440 mg naproxen sodium, Placebo tablet
Drug
Lead sponsor
Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division
Industry
Eligibility
17 Years to 50 Years
Enrollment
290 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019
U.S. locations
1
States / cities
Salt Lake City, Utah
Source: ClinicalTrials.gov public record
Updated Dec 4, 2022 · Synced Sep 27, 2026, 4:55 AM EDT
Completed Phase 3 Interventional Results available

Evaluate Analgesic/Sedative Efficacy of Naproxen Sodium and Diphenhydramine in Patients With Postsurgical Dental Pain

NCT01280591
View directory record Official record
Conditions
Pain, Postoperative
Interventions
Naproxen sodium 440 mg / DPH 50 mg (BAY98-7111), Naproxen sodium 220 mg / DPH 50 mg (BAY98-7111), Naproxen sodium 440 mg (BAYH6689), DPH 50 mg
Drug
Lead sponsor
Bayer
Industry
Eligibility
12 Years to 45 Years
Enrollment
712 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2010 – 2011
U.S. locations
2
States / cities
Austin, Texas • Salt Lake City, Utah
Source: ClinicalTrials.gov public record
Updated Jun 7, 2015 · Synced Sep 27, 2026, 4:55 AM EDT
Completed Phase 4 Interventional Results available

A Study to Assess Menstrual Cramp Pain Associated With Primary Dysmenorrhea

NCT03448536
View directory record Official record
Conditions
Dysmenorrhea
Interventions
Naproxen Sodium, (Aleve, BAY117031), Acetaminophen (Tylenol Extra Strength)
Drug
Lead sponsor
Bayer
Industry
Eligibility
15 Years to 35 Years · Female only
Enrollment
201 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2018
U.S. locations
8
States / cities
Chandler, Arizona • Scottsdale, Arizona • Pinellas Park, Florida + 5 more
Source: ClinicalTrials.gov public record
Updated Oct 27, 2019 · Synced Sep 27, 2026, 4:55 AM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

Naproxen Sodium ER Pharmacokinetic Study

NCT00818415
View directory record Official record
Conditions
Pain
Interventions
Naproxen sodium ER (BAYH6689), Commercial Naproxen (Aleve, BAYH6689)
Drug
Lead sponsor
Bayer
Industry
Eligibility
18 Years to 55 Years
Enrollment
32 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2008
U.S. locations
1
States / cities
Austin, Texas
Source: ClinicalTrials.gov public record
Updated May 18, 2014 · Synced Sep 27, 2026, 4:55 AM EDT
Completed Phase 3 Interventional Accepts healthy volunteers Results available

Evaluate Analgesic / Sedative Efficacy of Naproxen Sodium and Diphenhydramine in Patients With Postsurgical Dental Pain

NCT01495858
View directory record Official record
Conditions
Pain, Postoperative
Interventions
Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111), Naproxen Sodium 440 mg (BAYH6689), DPH 50 mg
Drug
Lead sponsor
Bayer
Industry
Eligibility
12 Years and older
Enrollment
267 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2011 – 2012
U.S. locations
2
States / cities
Austin, Texas • Salt Lake City, Utah
Source: ClinicalTrials.gov public record
Updated Jun 7, 2015 · Synced Sep 27, 2026, 4:55 AM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

Single/Multiple Dose Bioavailability Trial

NCT00751556
View directory record Official record
Conditions
Healthy
Interventions
Naproxen Sodium 660mg, Commercial Aleve 220 mg
Drug
Lead sponsor
Bayer
Industry
Eligibility
18 Years to 55 Years
Enrollment
32 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2008
U.S. locations
1
States / cities
Little Rock, Arkansas
Source: ClinicalTrials.gov public record
Updated Apr 20, 2014 · Synced Sep 27, 2026, 4:55 AM EDT
Completed Phase 3 Interventional Accepts healthy volunteers Results available

Safety Trial of Naproxen Sodium/ Diphenhydramine

NCT01365052
View directory record Official record
Conditions
Pain
Interventions
Naproxen sodium 440 mg/DPH 50 mg (BAY98-7111), Placebo
Drug
Lead sponsor
Bayer
Industry
Eligibility
12 Years and older
Enrollment
326 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2011
U.S. locations
19
States / cities
Chandler, Arizona • Mesa, Arizona • Peoria, Arizona + 16 more
Source: ClinicalTrials.gov public record
Updated Jun 7, 2015 · Synced Sep 27, 2026, 4:55 AM EDT
Completed Phase 4 Interventional Results available

A Trial to Compare the Duration of Analgesic Efficacy and Safety of Naproxen Sodium Tablets and Ibuprofen Tablets in Postsurgical Dental Pain

NCT03404206
View directory record Official record
Conditions
Pain, Postoperative
Interventions
Naproxen Sodium (Aleve, BAY117031), Ibuprofen (Advil), Placebo
Drug
Lead sponsor
Bayer
Industry
Eligibility
16 Years to 40 Years
Enrollment
387 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2018
U.S. locations
1
States / cities
Salt Lake City, Utah
Source: ClinicalTrials.gov public record
Updated Jul 17, 2019 · Synced Sep 27, 2026, 4:55 AM EDT
Completed Phase 2 Interventional Results available

A Pilot Study Assessing the Treatment Responsiveness of a Novel Osteoarthritis Stiffness Scale

NCT03570554
View directory record Official record
Conditions
Osteoarthritis, Knee
Interventions
Naproxen Sodium (Aleve, BAY117031), Acetaminophen ER, Celecoxib, Placebo
Drug
Lead sponsor
Bayer
Industry
Eligibility
40 Years to 80 Years
Enrollment
41 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2018 – 2019
U.S. locations
5
States / cities
Chandler, Arizona • Pinellas Park, Florida • Chicago, Illinois + 2 more
Source: ClinicalTrials.gov public record
Updated Jun 18, 2020 · Synced Sep 27, 2026, 4:55 AM EDT