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

January 20, 2011
November 19, 2012
October 2010
January 2011   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01280591 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Evaluate Analgesic/Sedative Efficacy of Naproxen Sodium and Diphenhydramine in Patients With Postsurgical Dental Pain
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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Pain, Postoperative
  • Drug: BAY98-7111
    Naproxen sodium 220 mg/DPH 25 mg tablet combination
  • Drug: BAY98-7111
    Naproxen sodium 220 mg/DPH 50 mg tablet combination
  • Drug: Placebo
  • Drug: Naproxen Sodium (Aleve, BAYH6689)
  • Drug: Diphenhydramine
  • Experimental: BAY98-7111 [440mg]
    Two Naproxen sodium 220 mg/DPH (Diphenhydramine) 25 mg tablets
    Intervention: Drug: BAY98-7111
  • Experimental: BAY98-7111 [220mg] + Placebo
    One Naproxen sodium 220 mg/DPH 50 mg tablet and one matching placebo capsule
    Interventions:
    • Drug: BAY98-7111
    • Drug: Placebo
  • Active Comparator: Naproxen Sodium
    Two Naproxen sodium 220 mg tablets
    Intervention: Drug: Naproxen Sodium (Aleve, BAYH6689)
  • Active Comparator: Diphenhydramine
    Two DPH 25 mg tablets
    Intervention: Drug: Diphenhydramine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
733
February 2011
January 2011   (final data collection date for primary outcome measure)

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
Both
12 Years to 45 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01280591
14837
No
Head Clinical and Medical Affairs, Bayer Healthcare LLC, Consumer Care
Bayer
Not Provided
Study Director: Bayer Study Director Bayer
Bayer
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP