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

NCT03404206 | Completed Phase 4 Results FDA Drug

• 2 other identifiers: 197622017-005049-67
• Study Type: interventional
• Target: 387
• Locations: 1 country
• Sites: 1

Brief Summary

To compare the duration of analgesic efficacy as determined by the time to rescue medication of a single oral dose of naproxen sodium 440 mg (2 x 220 mg tablets) relative to ibuprofen 400 mg (2 x 200 mg tablets) and placebo over 24 hours in subjects experiencing moderate to severe post-impaction surgery dental pain. To compare the overall analgesic effect (SPID 0-24) of a single dose of naproxen sodium 440 mg (2 x 220 mg tablets) relative to ibuprofen 400 mg (2 x 200 mg tablets) and placebo. To compare the overall relief from pain (TOTPAR 0-24) of a single dose of naproxen sodium 440 mg (2 x 220 mg tablets) relative to ibuprofen 400 mg (2 x 200 mg tablets) and placebo.

Conditions

Pain, Postoperative

Keywords

Postsurgical pain

Outcome Measures

Primary Outcomes (1)

• Time to First Use of Rescue Medication

  Time to first use of rescue medication was estimated using Kaplan-Meier method. If a subject did not take the rescue medication during the treatment period, (s)he was censored at the time of last assessment.

  Up to 24 hours

Secondary Outcomes (2)

• Sum of Pain Intensity Difference (SPID)

  Up to 24 hours

• Total Pain Relief (TOTPAR)

  Up to 24 hours

Study Arms (3)

Naproxen Sodium (Aleve, BAY117031)

EXPERIMENTAL

Participants received one single dose of 440 mg naproxen sodium tablets (200 mg x 2 tablets, oral) after randomization

Drug: Naproxen Sodium (Aleve, BAY117031)

Ibuprofen (Advil)

ACTIVE COMPARATOR

Participants received one single dose of 400 mg ibuprofen tablets (200 mg x 2 tablets, oral) after randomization

Drug: Ibuprofen (Advil)

Placebo

PLACEBO COMPARATOR

Participants received one single dose of matching placebo tablets (2 tablets, oral) after randomization

Drug: Placebo

Interventions

Naproxen Sodium (Aleve, BAY117031) DRUG

220 mg x 2 tablets, oral, single dose

Naproxen Sodium (Aleve, BAY117031)

Ibuprofen (Advil) DRUG

200 mg x 2 tablets, oral, single dose

Ibuprofen (Advil)

Placebo DRUG

Matching placebo, 2 tablets, oral, single dose

Placebo

Eligibility Criteria

• Age: 16 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Healthy, ambulatory, male or female volunteers 16-40 years of age;
• Body mass index 18.0 to 30.0 kg/m\^2 inclusive;
• Scheduled to undergo surgical removal of at least 2 mandibular partial or full bony impacted third molars. Up to two maxillary third molars may be removed regardless of impaction level. Supernumerary teeth present may also be removed at the discretion of the oral surgeon;
• Mandibular molars must demonstrate modified Demirjian root classification stage D, E, F, G or H;

You may not qualify if:

• History of hypersensitivity to naproxen sodium, ibuprofen, nonsteroidal anti-inflammatory drugs (NSAIDS), aspirin, similar pharmacological agents, local anesthetics, rescue medication or components of the investigational products;
• Evidence or history of clinically significant (in the judgment of the investigator) hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic diseases, or malignancies within the last 5 years;
• Relevant concomitant disease such as asthma (exercise induced asthma is permitted)

Sponsors & Collaborators

• Bayer: lead

Study Sites (1)

Jean Brown Research

Salt Lake City, Utah, 84124, United States

Location

Related Publications (1)

• Cooper SA, Desjardins P, Brain P, Paredes-Diaz A, Troullos E, Centofanti R, An B. Longer analgesic effect with naproxen sodium than ibuprofen in post-surgical dental pain: a randomized, double-blind, placebo-controlled, single-dose trial. Curr Med Res Opin. 2019 Dec;35(12):2149-2158. doi: 10.1080/03007995.2019.1655257. Epub 2019 Aug 27.

  PMID: 31402718 DERIVED

Related Links

• Click here to find results for studies related to Bayer products
• Click here to find information about studies related to Bayer Healthcare products conducted in Europe

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Naproxen; Ibuprofen

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Naphthaleneacetic Acids; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids

Results Point of Contact

• Title: Therapeutic Area Head
• Organization: Bayer

clinical-trials-contact@bayer.com

1-888-8422937

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2018
• First Posted: January 19, 2018
• Study Start: February 12, 2018
• Primary Completion: July 6, 2018
• Study Completion: July 10, 2018
• Last Updated: July 18, 2019
• Results First Posted: July 18, 2019

Record last verified: 2019-06

Locations

US (1)