Evaluate Efficacy and Safety of Extended Release (ER) Naproxen Sodium

NCT01389284 | Completed Phase 3 Results

• 2 other identifiers: 151422014-005272-28
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

The objective is to evaluate pain relief of the extended release naproxen sodium 660 mg tablet compared to commercial naproxen sodium 220 mg tablet over 24 hours in patients with postsurgical dental pain.

Conditions

Pain, Postoperative

Keywords

Naproxen Sodium,; dental pain

Outcome Measures

Primary Outcomes (1)

• Summed, Time-weighted Pain Intensity Difference From 0 to 24 Hours Postdose (SPID0-24)

  SPID0-24 was calculated by multiplying the pain intensity difference score at each post-dose timepoint by the duration (in hours) since the preceding timepoint and then summing these values over 0 to 24 hours. Pain intensity was measured at baseline, 0.25, 0.5, 0.75, 1, 2, 3, 4, 5, 6, 8, 12, 16, 20 and 24 hours using the 4-point categorical pain intensity scale: 0 = none, 1 = mild, 2 = moderate, 3 = severe. SPID0-24 can vary from -24 to 72. The positive SPID value indicates improvement of pain relief. The higher the SPID value, the more improvement of pain relief.

  From 0 to 24 hours post-dose

Secondary Outcomes (8)

• Summed, Time-weighted Pain Intensity Differences (SPID)

  0-6, 0-8, 0-12, 0-16 and 16-24 hours postdose

• Summed, Time-weighted Total Pain Relief Scores (TOTPARs)

  0-6, 0-8, 0-12, 0-16, 0-24, and 16-24 hours postdose

• Pain Intensity Differences (PIDs) by Time From Initial Dose

  At 0, 0.25, 0.5, 0.75, 1, 2, 3, 4 ,5 ,6, 8, 12, 16, 20 and 24 hours postdose

• Pain Relief From Initial Dose

  At 0.25, 0.5, 0.75, 1, 2, 3, 4 ,5 ,6, 8, 12, 16, 20 and 24 hours postdose

• Median Time to First Intake of Rescue Medication

  Up to 24 hours postdose

Study Arms (3)

Naproxen Sodium ER (BAYH6689)

EXPERIMENTAL

1 naproxen sodium extended release (ER) 660 mg tablet and 1 naproxen sodium immediate release (IR) 220 mg placebo tablet initially followed by 1 naproxen sodium IR 220 mg matching placebo tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg matching placebo tablet at hour 16 (± 15 min)

Drug: Naproxen Sodium ER (BAYH6689); Drug: Naproxen Sodium IR Placebo

Naproxen Sodium IR (Aleve, BAYH6689)

ACTIVE COMPARATOR

1 naproxen sodium ER 660 mg matching placebo tablet and 1 naproxen sodium IR 220 mg tablet initially followed by 1 naproxen sodium IR 220 mg tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg tablet eight hours at hour 16 (± 15 min)

Drug: Naproxen Sodium IR (Aleve, BAYH6689); Drug: Naproxen Sodium ER Placebo

Placebo

PLACEBO COMPARATOR

1 naproxen sodium ER 660 mg matching placebo tablet and 1 naproxen sodium IR 220 mg matching placebo tablet initially followed by 1 naproxen sodium IR 220 mg matching placebo tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg matching placebo tablet at hour 16 (± 15 min)

Drug: Naproxen Sodium ER Placebo; Drug: Naproxen Sodium IR Placebo

Interventions

Naproxen Sodium ER (BAYH6689) DRUG

660 mg Naproxen Sodium extended release tablet, orally administered once daily for 24 hours

Naproxen Sodium ER (BAYH6689)

Naproxen Sodium IR (Aleve, BAYH6689) DRUG

220 mg Naproxen Sodium instant release tablet, orally administered 3 times daily (TID) for 24 hours

Naproxen Sodium IR (Aleve, BAYH6689)

Naproxen Sodium ER Placebo DRUG

Matching placebo of 660 mg Naproxen Sodium ER for 24 hours

Naproxen Sodium IR (Aleve, BAYH6689); Placebo

Naproxen Sodium IR Placebo DRUG

Matching placebo of 220 mg Naproxen Sodium IR (Aleve) for 24 hours

Naproxen Sodium ER (BAYH6689); Placebo

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy, ambulatory, male and female volunteers 15 years of age and above
• Scheduled to undergo surgical removal of up to two impacted third molars, one of which must be mandibular full or partial bony impaction and the other a maxillary impaction
• Female subjects of childbearing potential must be using a medically acceptable form of birth control for at least 1 month prior to screening (3 months on oral contraceptives), e.g., oral or patch contraceptives, intrauterine device, NuvaRing, Depo-Provera, or double-barrier and have a negative pregnancy test at Screening and prior to surgery
• Have not taken any form of medication or herbal supplements (ie, St. Johns Wort) within 5 days of admission (except for oral contraceptives, prophylactic antibiotics, or other routine medications to treat benign conditions, such as antibiotics to treat acne) and agree not to take any medication (other than that provided to them) throughout the study
• Have not consumed alcoholic beverages, or foods and beverages containing xanthines (examples, coffee, tea, chocolate, and colas) after midnight prior to surgery and agree not to consume any of these foods or beverages throughout the evaluation period
• Use of only short-acting local anesthetic (e.g., mepivacaine or lidocaine) preoperatively, with or without vasoconstrictor and nitrous oxide
• 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 ≥ 50 mm on the 100 mm Visual Analog Scale (VAS) within 4 hours postsurgery, but no later than 1330 hours +/- 15 minutes
• Understand the pain rating scales (as judged by the study coordinator)
• Be willing and able to participate in all scheduled visits, treatment plan, tests and other trial procedures according to the protocol
• Provide a personally signed and dated informed consent form (ICF) indicating that the subject has been informed of all pertinent aspects of the trial, (subjects \< 18 years of age must sign a written assent and have parental or guardian consent)

You may not qualify if:

• History of hypersensitivity to naproxen sodium, acetaminophen, Non Steroidal Anti-inflammatory Drugs (NSAIDS), aspirin, hydrocodone, similar pharmacological agents 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), chronic sinusitis or nasal structural abnormalities causing greater than 50 percent obstruction (polyposis nasi, marked septal deviation) that can interfere with the conduct of the study in the judgment of the investigator
• Current or past history of gastrointestinal bleeding or other bleeding disorder(s)
• Acute illness or local infection prior to surgery that can interfere with the conduct of the study in the judgment of the investigator
• Use of any Over-the-Counter (OTC) or prescription medications with which the administration of naproxen, acetaminophen, ibuprofen or any other NSAIDs, Lortab, is contraindicated or use of any medications within 5 days of surgery (except oral contraceptives, prophylactic antibiotics or medications to treat benign conditions such as antibiotics to treat acne)
• Females who are pregnant or lactating
• Habituation to analgesic drugs (i.e., routine use of oral analgesics 5 or more times per week for greater than 3 weeks)
• Alcoholism or drug abuse within 2 years prior to the Screening Visit or routine consumption of 3 or more alcohol containing beverages per day
• Positive urine, alcohol or nicotine test on day of surgery
• Smokers or using nicotine replacement therapies including transdermal patches, spray, lozenges or gum

Sponsors & Collaborators

• Bayer: lead

Study Sites (1)

Unknown Facility

Austin, Texas, 78744, United States

Location

Related Publications (1)

• Laurora I, An R. Efficacy of single-dose, extended-release naproxen sodium 660 mg in postsurgical dental pain: two double-blind, randomized, placebo-controlled trials. Curr Med Res Opin. 2016;32(2):331-42. doi: 10.1185/03007995.2015.1123680. Epub 2015 Dec 15.

  PMID: 26588111 DERIVED

Related Links

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

MeSH Terms

Conditions

Pain, Postoperative; Toothache

Interventions

Naproxen

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Tooth Diseases; Stomatognathic Diseases; Facial Pain

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Head Medical Affairs
• Organization: Bayer HealthCare LLC, Consumer Care

clinical-trials-contact@bayerhealthcare.com

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2011
• First Posted: July 8, 2011
• Study Start: June 1, 2011
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: August 25, 2015
• Results First Posted: May 7, 2013

Record last verified: 2015-08

Locations

US (1)