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

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT01280591
First received: January 20, 2011
Last updated: November 19, 2012
Last verified: November 2012
  Purpose

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.


Condition Intervention Phase
Pain, Postoperative
Drug: BAY98-7111
Drug: Placebo
Drug: Naproxen Sodium (Aleve, BAYH6689)
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 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 by 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 by Actigraphy [ Time Frame: 10 hours ] [ Designated as safety issue: No ]
  • Subjective sleep variables [ Time Frame: 10 hours ] [ Designated as safety issue: No ]
  • Overall rating of severity and change from baseline [ Time Frame: 10 hours ] [ Designated as safety issue: No ]

Enrollment: 733
Study Start Date: October 2010
Study Completion Date: February 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BAY98-7111 [440mg]
Two Naproxen sodium 220 mg/DPH (Diphenhydramine) 25 mg tablets
Drug: BAY98-7111
Naproxen sodium 220 mg/DPH 25 mg tablet combination
Experimental: BAY98-7111 [220mg] + Placebo
One Naproxen sodium 220 mg/DPH 50 mg tablet and one matching placebo capsule
Drug: BAY98-7111
Naproxen sodium 220 mg/DPH 50 mg tablet combination
Drug: Placebo
Active Comparator: Naproxen Sodium
Two Naproxen sodium 220 mg tablets
Drug: Naproxen Sodium (Aleve, BAYH6689)
Active Comparator: Diphenhydramine
Two DPH 25 mg tablets
Drug: Diphenhydramine

  Eligibility

Ages Eligible for Study:   12 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01280591

Locations
United States, Texas
Austin, Texas, United States, 78744
United States, Utah
Salt Lake City, Utah, United States, 84124
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Head Clinical and Medical Affairs, Bayer Healthcare LLC, Consumer Care
ClinicalTrials.gov Identifier: NCT01280591     History of Changes
Other Study ID Numbers: 14837
Study First Received: January 20, 2011
Last Updated: November 19, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Bayer:
Naproxen sodium
Diphenhydramine

Additional relevant MeSH terms:
Pain, Postoperative
Toothache
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Tooth Diseases
Stomatognathic Diseases
Facial Pain
Naproxen
Diphenhydramine
Promethazine
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
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
Antiemetics
Autonomic Agents
Gastrointestinal Agents

ClinicalTrials.gov processed this record on April 15, 2014