Clinical trial NCT01389284: Evaluate Efficacy and Safety of Extended Release (ER) Naproxen Sodium
Official title: A Randomized, Double-Blind, Placebo Controlled Trial to Assess the Analgesic Efficacy and Safety of Extended Release Naproxen Sodium Tablets in Postsurgical Dental Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pain, Postoperative
Keywords: Naproxen Sodium,
dental pain
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2011-07-08
Enrollment: 300
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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

Primary outcomes:
measure: Summed, Time-weighted Pain Intensity Difference From 0 to 24 Hours Postdose (SPID0-24)
timeFrame: From 0 to 24 hours post-dose
Secondary outcomes:
measure: Summed, Time-weighted Pain Intensity Differences (SPID)
timeFrame: 0-6, 0-8, 0-12, 0-16 and 16-24 hours postdose
measure: Summed, Time-weighted Total Pain Relief Scores (TOTPARs)
timeFrame: 0-6, 0-8, 0-12, 0-16, 0-24, and 16-24 hours postdose
measure: Pain Intensity Differences (PIDs) by Time From Initial Dose
timeFrame: At 0, 0.25, 0.5, 0.75, 1, 2, 3, 4 ,5 ,6, 8, 12, 16, 20 and 24 hours postdose
measure: Pain Relief From Initial Dose
timeFrame: At 0.25, 0.5, 0.75, 1, 2, 3, 4 ,5 ,6, 8, 12, 16, 20 and 24 hours postdose
measure: Median Time to First Intake of Rescue Medication
timeFrame: Up to 24 hours postdose
measure: Cumulative Percentage of Participants Who Took Rescue Medication
timeFrame: At 0.25, 0.5, 0.75, 1, 2, 3, 4 ,5 ,6, 8, 12, 16, 20 and 24 hours postdose
measure: Number of Times the Participants Took Rescue Medication Over the 24-hour Period
timeFrame: 24 hours postdose
measure: Global Assessment of the Investigational Product as a Pain Reliever
timeFrame: 24 hours postdose or immediately before the first intake of rescue medication
Other outcomes:
Locations:
city: Austin
country: United States
state: Texas
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
citation: 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.