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 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 20536
• Study Type: interventional
• Target: 221
• Locations: 1 country
• Sites: 1

Brief 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

Pain

Keywords

Postsurgical Dental Pain

Outcome Measures

Primary Outcomes (1)

• Sum of Pain Intensity Difference Over 12 Hours (SPID 0-12)

  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 duration (in hours) since the preceding time point and then summing these values over the specific time period. SPID over 12 hours ranges from -120 to 120. A higher value indicates a better pain reduction.

  Up to 12 hours postdose

Secondary Outcomes (8)

• Total Pain Relief Over 12 Hours (TOTPAR 0-12)

  Up to 12 hours postdose

• Total Pain Relief Over 6 Hours (TOTPAR 0-6)

  Up to 6 hours postdose

• Sum of Pain Intensity Difference Over 6 Hours (SPID 0-6)

  Up to 6 hours postdose

• Number of Participants Required or Did Not Reqiure Rescue Pain Medication

  Up to 12 hours postdose

• Amount of Rescue Medication

  Up to 12 hours postdose

Study Arms (3)

Naproxen sodium

EXPERIMENTAL

After completion of the surgical teeth extractions, qualified participants will be randomized into one of three treatments with a 2:2:1 ratio. (Naproxen sodium=2, Hydrocodone/Acetaminophen=2, Placebo=1)

Drug: Naproxen Sodium (Aleve, BAY117031)

Hydrocodone/Acetaminophen

ACTIVE COMPARATOR

After completion of the surgical teeth extractions, qualified participants will be randomized into one of three treatments with a 2:2:1 ratio. (Naproxen sodium=2, Hydrocodone/Acetaminophen=2, Placebo=1)

Drug: Hydrocodone/Acetaminophen

Placebo

PLACEBO COMPARATOR

After completion of the surgical teeth extractions, qualified participants will be randomized into one of three treatments with a 2:2:1 ratio. (Naproxen sodium=2, Hydrocodone/Acetaminophen=2, Placebo=1)

Drug: Placebo

Interventions

Naproxen Sodium (Aleve, BAY117031) DRUG

220 mg per tablet, two tablets (440 mg), intake a single dose orally.

Naproxen sodium

Hydrocodone/Acetaminophen DRUG

5/325 mg per tablet, two tablets (10/650 mg), intake a single dose orally.

Hydrocodone/Acetaminophen

Placebo DRUG

two tablets, intake a single dose orally.

Placebo

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy, ambulatory, male or female volunteers 18 to 40 years of age;
• Subjects will undergo surgical extraction of three or four third molars, two of which must be mandibular molars. Maxillary third molars may be removed regardless of impaction level. The mandibular extractions must have a trauma rating of mild or moderate and meet one of the following scenarios:
• two full bony impactions
• two partial bony impactions
• one full bony impaction in combination with one partial bony impaction Supernumerary teeth present may also be removed at the discretion of the oral surgeon;
• Have not consumed alcoholic beverages, or foods and beverages containing caffeine (examples; coffee, tea, chocolate, and colas) after midnight prior to surgery and agree not to consume any of these foods or beverages throughout their stay at the study site;
• Use of only short-acting local anesthetic (e.g., mepivacaine or lidocaine) preoperatively, with or without a vasoconstrictor and nitrous oxide at the discretion of the Investigator;
• Have moderate to severe postoperative pain on the Categorical Pain Intensity Scale (a score of at least 2 on a 4 point scale) and a score of ≥ 5 on the 0-10 pain intensity NRS within 4.5 hours postsurgery;
• Ability to understand and follow study-related instructions;
• Be willing and able to participate in all scheduled visits, treatment plan, and trial procedures according to the clinical protocol;

You may not qualify if:

• History of hypersensitivity to naproxen sodium, hydrocodone/acetaminophen, ibuprofen, 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 (including hypertension), hepatic, psychiatric, neurologic diseases, or malignancies within the last 5 years;
• Subjects with the following medical conditions may be eligible at the discretion of the investigator: ADHD on a stable dose regimen of methylphenidate/(dextro)amphetamine for at least 6 months; subjects with hypothyroidism on a stable dose of synthetic thyroid hormone for at least 6 months;
• Have received any form of treatment in the form of medication for depression in the past 6 months or any form of psychotropic agent (including selective serotonin uptake inhibitors \[SSRI\] but excluding ADHD medications described above) within the last 6 months;
• Use of any OTC or prescription medications with which the administration of naproxen, hydrocodone/acetaminophen, acetaminophen, ibuprofen, any other NSAID, (e.g., tramadol) or if a medication is contraindicated;
• Females who are planning to become pregnant, pregnant or lactating;
• Habituation to analgesic drugs including opioids (i.e., routine use of oral analgesics 5 or more times per week for greater than 3 weeks within the past 2 years);
• Alcoholism or drug abuse within 2 years prior to the Screening Visit or routine consumption of 3 or more alcohol containing beverages per day; Alcohol containing beverages are defined as one beer (5%), one glass of wine (11%) and one shot (40%) hard liquor;
• Surgeon's trauma rating of severe following surgery;
• Unwilling or unable to comply with all requirements outlined in the protocol;

Sponsors & Collaborators

• Bayer: lead

Study Sites (1)

JBR Clinical Research

Salt Lake City, Utah, 84107, United States

Location

Related Publications (1)

• Cooper SA, Desjardins PJ, Bertoch T, Paredes-Diaz A, Troullos E, Tajaddini A, Centofanti R, An R, Morella D. Analgesic efficacy of naproxen sodium versus hydrocodone/acetaminophen in acute postsurgical dental pain: a randomized, double-blind, placebo-controlled trial. Postgrad Med. 2022 Jun;134(5):463-470. doi: 10.1080/00325481.2021.2008180. Epub 2021 Dec 8.

  PMID: 34878953 DERIVED

Related Links

• Click here to find results for studies related to Bayer products

MeSH Terms

Conditions

Pain

Interventions

Naproxen; oxycodone-acetaminophen

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

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: March 5, 2020
• First Posted: March 13, 2020
• Study Start: March 12, 2020
• Primary Completion: October 2, 2020
• Study Completion: October 5, 2020
• Last Updated: July 14, 2022
• Results First Posted: October 7, 2021

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)