Overview

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

Status:
Completed
Trial end date:
2011-02-01
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Bayer
Treatments:
Diphenhydramine
Naproxen
Promethazine
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