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

This study has been completed.
Information provided by:
ClinicalTrials.gov Identifier:
First received: December 16, 2011
Last updated: May 8, 2013
Last verified: May 2013

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.

Condition Intervention Phase
Pain, Postoperative
Drug: BAY98-7111
Drug: Naproxen Sodium (Aleve, BAYH-6689)
Drug: Diphenhydramine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-Blind, Parallel Group Trial Assessing the Efficacy and Safety of Naproxen Sodium and Diphenhydramine Combination in Postsurgical Dental Pain With Phase Advanced Sleep

Resource links provided by NLM:

Further study details as provided by Bayer:

Primary Outcome Measures:
  • Wake time after sleep onset (WASO) measured by actigraphy [ Time Frame: 10 hours ] [ Designated as safety issue: No ]
  • Sleep latency measured by actigraphy [ Time Frame: 10 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Total sleep time by Actigraphy [ Time Frame: 10 hours ] [ Designated as safety issue: No ]
  • Sleep efficiency as determined by patient questionnaire [ Time Frame: 10 hours ] [ Designated as safety issue: No ]
  • Change in pain intensity score [ Time Frame: From baseline to 10 hours ] [ Designated as safety issue: No ]
  • Adverse events [ Time Frame: Throughout the treatment period ] [ Designated as safety issue: Yes ]
  • Vital Signs [ Time Frame: Screening Visit, Day 1, Day 2 ] [ Designated as safety issue: Yes ]
    Vital signs included blood pressure (diastolic and systolic), pulse rate, and respiration rate.

Enrollment: 267
Study Start Date: December 2011
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
One dose Naproxen sodium 220 mg plus diphenhydramine 25 mg tablet and one Naproxen sodium 220 mg tablet
Drug: BAY98-7111
BAY98-7111 contains Naproxen sodium 220 mg and diphenhydramine 25 mg
Drug: Naproxen Sodium (Aleve, BAYH-6689)
Active Comparator: Arm 2
Two naproxen sodium 220 mg tablets
Drug: Naproxen Sodium (Aleve, BAYH-6689)
Active Comparator: Arm 3
Two diphenhydramine 25 mg tablets
Drug: Diphenhydramine


Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01495858

United States, Texas
Austin, Texas, United States, 78744
United States, Utah
Salt Lake City, Utah, United States, 84106
Sponsors and Collaborators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Head Clinical and Medical Affairs, Bayer Consumer Care Inc.
ClinicalTrials.gov Identifier: NCT01495858     History of Changes
Other Study ID Numbers: 15881
Study First Received: December 16, 2011
Last Updated: May 8, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Bayer:
Naproxen sodium

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Tooth Diseases
Stomatognathic Diseases
Facial Pain
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Gout Suppressants
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents
Autonomic Agents
Gastrointestinal Agents

ClinicalTrials.gov processed this record on April 16, 2014