Clinical trial NCT01118273: Evaluate Analgesic/Sedative Efficacy of Naproxen Sodium and Diphenhydramine
Official title: A Double-Blind, Randomized, Pilot Study Assessing the Analgesic and Hypnotic Effect of Naproxen Sodium and Diphenhydramine Combination in Dental Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Sleep
Keywords: Naproxen sodium
Diphenhydramine
Drugs, Investigational
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2010-05-06
Enrollment: 162
Sex: ALL
Minimum age (years): 16
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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


Eligibility 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;

Primary outcomes:
measure: Total Sleep Time Measured by Actigraphy
timeFrame: Up to 10 hours
Secondary outcomes:
measure: Wake After Sleep Onset (WASO) Measured by Actigraphy
timeFrame: Up to 10 hours
measure: Sleep Latency Measured by Actigraphy
timeFrame: Up to 10 hours
measure: Global Assessment of Study Medication as a Sleep-aid
timeFrame: Up to 10 hours
measure: Karolinska Sleep Diary - Sleep Quality
timeFrame: Up to 10 hours
measure: Karolinska Sleep Diary - Calmness of Sleep
timeFrame: Up to 10 hours
measure: Karolinska Sleep Diary - Easiness to Fall Asleep
timeFrame: Up to 10 hours
measure: Karolinska Sleep Diary - Premature Awakening
timeFrame: Up to 10 hours
measure: Karolinska Sleep Diary - Ease of Awakening
timeFrame: Up to 10 hours
measure: Karolinska Sleep Diary - Well Rested
timeFrame: Up to 10 hours
measure: Karolinska Sleep Diary - Sufficient Sleep
timeFrame: Up to 10 hours
measure: Total Sleep Time by Subject Assessment
timeFrame: Up to 10 hours
measure: Sleep Quality Index
timeFrame: Up to 10 hours
measure: Overall Rating of Severity in Categorical Pain Rating Scale Score
timeFrame: Up to 10 hours
measure: Change From Baseline in Categorical Pain Rating Scale Score
timeFrame: Baseline and up to 10 hours
measure: Overall Rating of Severity in Visual Analog Scale (VAS) Score
timeFrame: At 10 hours
measure: Change From Baseline in Visual Analog Scale (VAS) Score
timeFrame: Baseline and up to 10 hours
measure: Overall Rating of Pain Relief
timeFrame: Up to 10 hours
measure: Time to Rescue Medication
timeFrame: Up to 10 hours
measure: Cumulative Proportion of Participants Taking Rescue Medication by Hour
timeFrame: Up to 10 hours
measure: Global Assessment of Study Medication as a Pain Reliever
timeFrame: Up to 10 hours
measure: Number of Times Participants Took Rescue Medication
timeFrame: Up to 10 hours
measure: Total Wake Time Measured by Actigraphy
timeFrame: Up to 10 hours
measure: Sleep Efficiency Measured by Actigraphy
timeFrame: Up to 10 hours
measure: Activity Mean Measured by Actigraphy
timeFrame: Up to 10 hours
measure: Wake Episode Measured by Actigraphy
timeFrame: Up to 10 hours
Other outcomes:
Locations:
city: Salt Lake City
country: United States
state: Utah
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: