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Evaluate Analgesic/Sedative Efficacy of Naproxen Sodium and Diphenhydramine

Information source: Bayer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Sleep

Intervention: Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg (Drug); Naproxen Sodium 440 mg (BAYH6689) (Drug); Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg (Drug); Naproxen Sodium 220 mg (BAYH6689) (Drug); DPH 50mg (Drug); Ibuprofen 400 mg / Diphenhydramine citrate 76 mg (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Bayer

Official(s) and/or principal investigator(s):
Bayer Study Director, Study Director, Affiliation: Bayer


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

Clinical Details

Official title: A Double-Blind, Randomized, Pilot Study Assessing the Analgesic and Hypnotic Effect of Naproxen Sodium and Diphenhydramine Combination in Dental Pain

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Primary outcome: Total Sleep Time Measured by Actigraphy

Secondary outcome:

Wake After Sleep Onset (WASO) Measured by Actigraphy

Sleep Latency Measured by Actigraphy

Global Assessment of Study Medication as a Sleep-aid

Karolinska Sleep Diary - Sleep Quality

Karolinska Sleep Diary - Calmness of Sleep

Karolinska Sleep Diary - Easiness to Fall Asleep

Karolinska Sleep Diary - Premature Awakening

Karolinska Sleep Diary - Ease of Awakening

Karolinska Sleep Diary - Well Rested

Karolinska Sleep Diary - Sufficient Sleep

Total Sleep Time by Subject Assessment

Sleep Quality Index

Overall Rating of Severity in Categorical Pain Rating Scale Score

Change From Baseline in Categorical Pain Rating Scale Score

Overall Rating of Severity in Visual Analog Scale (VAS) Score

Change From Baseline in Visual Analog Scale (VAS) Score

Overall Rating of Pain Relief

Time to Rescue Medication

Cumulative Proportion of Participants Taking Rescue Medication by Hour

Global Assessment of Study Medication as a Pain Reliever

Number of Times Participants Took Rescue Medication

Total Wake Time Measured by Actigraphy

Sleep Efficiency Measured by Actigraphy

Activity Mean Measured by Actigraphy

Wake Episode Measured by Actigraphy


Minimum age: 16 Years. Maximum age: 45 Years. Gender(s): Both.


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;

Locations and Contacts

Salt Lake City, Utah 84124, United States
Additional Information

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Starting date: January 2008
Last updated: May 13, 2015

Page last updated: August 23, 2015

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