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

Condition(s) targeted: Pain, Postoperative

Intervention: Naproxen sodium 440 mg / DPH 50 mg (BAY98-7111) (Drug); Naproxen sodium 220 mg / DPH 50 mg (BAY98-7111) (Drug); Naproxen sodium 440 mg (BAYH6689) (Drug); DPH 50 mg (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Bayer

Official(s) and/or principal investigator(s):
Bayer Study Director, Study Director, Affiliation: Bayer

The objective of the study is to evaluate the efficacy and safety of a single oral dose of two dose combinations of naproxen sodium and diphenhydramine (DPH) to demonstrate that naproxen sodium/DPH combination provides added clinical benefit to sleep improvement than either single ingredient alone in subjects with post-surgical dental pain and phase advanced sleep.

Official title: A Multicenter, Randomized, Double-Blind, Parallel Group Trial Assessing the Efficacy of Naproxen Sodium and Diphenhydramine Combination in Postsurgical Dental Pain With Phase Advanced Sleep

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Primary outcome:

Wake Time After Sleep Onset (WASO) Measured by Actigraphy

Sleep Latency Measured by Actigraphy

Secondary outcome:

Total Sleep Time Measured by Actigraphy

Sleep Efficiency Measured by Actigraphy

Global Assessment of Investigational Product as a Sleep Aid

Karolinska Sleep Diary - Sleep Quality

Karolinska Sleep Diary - Calmness of Sleep

Karolinska Sleep Diary - Easiness to Fall Asleep

Karolinska Sleep Diary - Premature Awakening

Karolinska Sleep Diary - Ease of Awakening

Karolinska Sleep Diary - Well Rested

Karolinska Sleep Diary - Sufficient Sleep

Subjective Sleep Questionnaire - Quality of Your Sleep Last Night

Subjective Sleep Questionnaire - Refreshing Nature of Your Sleep Last Night

Subjective Sleep Questionnaire - Time to Fall Asleep Last Night

Subjective Sleep Questionnaire - Number of Minutes You Think That You Were Awake From the Time You Fell Asleep Until the Time You Got Out of Bed

Change From Baseline in Pain Intensity

Overall Rating of Pain Relief

Time to Rescue Medication

Cumulative Proportion of Subjects Taking Rescue Medication by Hour

Global Assessment of Investigational Product as a Pain Reliever

Minimum age: 12 Years. Maximum age: 45 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Healthy, ambulatory, male and female volunteers ages 12 and older

- Scheduled to undergo surgical removal of a minimum of two third molars of which at

least one has to be a mandibular third molar. The mandibular extraction(s) required by each subject must meet one of the following scenarios:

- one full bony impaction

- two partial bony impactions

- one full bony impaction and one partial bony impaction

- one full bony impaction and one soft tissue impaction

- one full bony impaction and one erupted third molar. Two full bony mandibular

impactions are not allowed. Maxillary third molars may be removed regardless of impaction level.

- Have moderate to severe postoperative pain on the Categorical Pain Rating Scale and a

score of ≥ 50 mm on the 100-mm visual analog Pain Severity Rating Scale between 1600 hour and 1830 hour on the day of surgery

- 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, Depo-Provera, or double-barrier and have a negative pregnancy test at Screening and prior to surgery. Female subjects of nonchildbearing potential must be amenorrheic for at least 2 years or had a hysterectomy and/or bilateral oophorectomy

- Provide a personally signed and dated informed consent 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, diphenhydramine, nonsteroidal

anti-inflammatory drug (NSAIDS), tramadol, aspirin or any other antihistamine and similar pharmacological agents or components of the 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 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

- Chronic use of antihistamines defined as using 5 or more times a week for 2 or more

consecutive weeks during the past 3 months

- Positive alcohol breathalyzer test and positive urine drug test prior to surgery

- Females who are pregnant or lactating

- Chronic or severe sleep problems that do not respond to / Over the Counter (OTC)

medication and requires a prescription hypnotic or sedative

- Habitually spends less than 6. 5 hours in bed

Austin, Texas 78744, United States

Salt Lake City, Utah 84124, United States

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Starting date: October 2010
Last updated: May 13, 2015