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

Bayer

Status and phase: Completed; Phase 3

Conditions: Pain, Postoperative

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT01280591

14837

Details and patient eligibility

About

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.

Enrollment: 712 patients

Sex: All

Ages: 12 to 45 years old

Volunteers: No 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 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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712 participants in 4 patient groups

Naproxen sodium 440 mg / DPH 50 mg (BAY98-7111)

Experimental group

Treatment:

Drug: Naproxen sodium 440 mg / DPH 50 mg (BAY98-7111)

Naproxen sodium 220 mg / DPH 50 mg (BAY98-7111)

Experimental group

Treatment:

Drug: Naproxen sodium 220 mg / DPH 50 mg (BAY98-7111)

Naproxen sodium 440 mg (BAYH6689)

Active Comparator group

Treatment:

Drug: Naproxen sodium 440 mg (BAYH6689)

DPH 50 mg

Active Comparator group

Treatment:

Drug: DPH 50 mg