Evaluate Analgesic/Sedative Efficacy of Naproxen Sodium and Diphenhydramine (MORPHEUS)

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT01118273
First received: April 15, 2010
Last updated: May 28, 2013
Last verified: May 2013
  Purpose

The objectives of the study are to evaluate the analgesic and hypnotic efficacy of naproxen sodium and diphenhydramine combination when compared to naproxen sodium, diphenhydramine, and an ibuprofen and diphenhydramine combination


Condition Intervention Phase
Sleep
Drug: Naproxen (BAYH6689), diphenhydramine
Drug: Naproxen (BAYH6689)
Drug: Diphenhydramine
Drug: Ibuprofen + diphenhydramine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Double-Blind, Randomized, Pilot Study Assessing the Analgesic and Hypnotic Effect of Naproxen Sodium and Diphenhydramine Combination in Dental Pain

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Total Sleep Time by Actigraph [ Time Frame: 10 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Wake after sleep onset measured by Actigraph [ Time Frame: Over 8 hours ] [ Designated as safety issue: No ]
  • Sleep latency measured by Actigraph [ Time Frame: 8 hours ] [ Designated as safety issue: No ]
  • Subjective sleep variables, Karolinsa Sleep Diary, Total sleep time by subject assessment, global assessment of study medication as sleep aid [ Time Frame: 8 hours ] [ Designated as safety issue: No ]
  • Overall Rating of severity and change in baseline severity as measured by Categorical Pain Intensity and visual analog scale [ Time Frame: 8 hours ] [ Designated as safety issue: No ]

Enrollment: 162
Study Start Date: January 2008
Study Completion Date: February 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 Drug: Naproxen (BAYH6689), diphenhydramine
One dose of naproxen sodium 440 mg plus diphenhydramine 50 mg
Active Comparator: Arm 2 Drug: Naproxen (BAYH6689)
One dose of naproxen sodium 440 mg
Experimental: Arm 3 Drug: Naproxen (BAYH6689), diphenhydramine
One dose of naproxen sodium 220 mg plus diphenhydramine 50 mg
Active Comparator: Arm 4 Drug: Diphenhydramine
One dose of diphenhydramine 50 mg
Active Comparator: Arm 5 Drug: Naproxen (BAYH6689)
One dose of naproxen sodium 220 mg
Active Comparator: Arm 6 Drug: Ibuprofen + diphenhydramine
One dose of Advil PM (ibuprofen 200 mg + diphenhydramine 50 mg)

  Eligibility

Ages Eligible for Study:   16 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Healthy, ambulatory, male and female volunteers between 16-45 years of age;
  • Scheduled to undergo surgical removal of 1 to 3 impacted third molars, one of which must be at least a partial bony mandibular impaction;
  • 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 by 2030 h +/- 15 minutes 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 antiinflammatory drugs (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 negative 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;
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01118273

Locations
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: Medical affairs Therapeutic Area Head, Bayer Consumer Care Inc.
ClinicalTrials.gov Identifier: NCT01118273     History of Changes
Other Study ID Numbers: 13053
Study First Received: April 15, 2010
Last Updated: May 28, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Bayer:
Naproxen sodium
Diphenhydramine
Drugs, Investigational

Additional relevant MeSH terms:
Analgesics
Naproxen
Ibuprofen
Diphenhydramine
Promethazine
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Antirheumatic Agents
Gout Suppressants
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antiemetics
Autonomic Agents
Gastrointestinal Agents
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Hypnotics and Sedatives
Central Nervous System Depressants
Anti-Allergic Agents
Anesthetics, Local

ClinicalTrials.gov processed this record on April 14, 2014