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

Bayer

Status and phase

Completed

Phase 3

Conditions

Pain, Postoperative

Treatments

Drug: Naproxen Sodium 440 mg (BAYH6689)

Drug: Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)

Drug: DPH 50 mg

Study type

Interventional

Funder types

Industry

Identifiers

NCT01495858

15881

Details and patient eligibility

About

The objective of the study is to evaluate the efficacy and safety of a single oral dose of naproxen sodium 440 mg in combination with DPH (diphenhydramine) 25 mg in subjects with postsurgical dental pain and phase advanced sleep.

Enrollment

267 patients

Sex

All

Ages

12+ years old

Volunteers

Accepts Healthy Volunteers

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 non-childbearing potential must be amenorrheic for at least 2 years or had a hysterectomy and/or bilateral oophorectomy.

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