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

Bayer0 sites712 target enrollmentOctober 2010

InterventionsNaproxen sodium 440 mg / DPH 50 mg (BAY98-7111)Naproxen sodium 220 mg / DPH 50 mg (BAY98-7111)Naproxen sodium 440 mg (BAYH6689)DPH 50 mg

DrugsNaproxen sodium 440 mg / DPH 50 mg (BAY98-7111)Naproxen sodium 220 mg / DPH 50 mg (BAY98-7111)Naproxen sodium 440 mg (BAYH6689)DPH 50 mg

Overview

Phase: Phase 3
Intervention: Naproxen sodium 440 mg / DPH 50 mg (BAY98-7111)
Conditions: Pain, Postoperative
Sponsor: Bayer
Enrollment: 712
Primary Endpoint: Wake Time After Sleep Onset (WASO) Measured by Actigraphy
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

October 2010

End Date

February 2011

Last Updated

10 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Bayer

Responsible Party

Sponsor

Eligibility 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

Arms & Interventions

Naproxen sodium 440 mg / DPH 50 mg (BAY98-7111)

Intervention: Naproxen sodium 440 mg / DPH 50 mg (BAY98-7111)

Naproxen sodium 220 mg / DPH 50 mg (BAY98-7111)

Intervention: Naproxen sodium 220 mg / DPH 50 mg (BAY98-7111)

Naproxen sodium 440 mg (BAYH6689)

Intervention: Naproxen sodium 440 mg (BAYH6689)

DPH 50 mg

Intervention: DPH 50 mg

Outcomes

Primary Outcomes

Wake Time After Sleep Onset (WASO) Measured by Actigraphy

Time Frame: Up to 10 hours

WASO was defined as Total wake time (in minutes) after sleep onset during the 10 hours in-bed period as measured by actigraphy. Actigraphy is a non-intrusive tool that measures an individual's movement during sleep. Actigraphy was used to obtain data in discriminating between sleep and wake states in the subjects.

Sleep Latency Measured by Actigraphy

Time Frame: Up to 10 hours

Sleep latency was defined as the time to sleep onset from the time of dosing as measured by actigraphy. Actigraphy is a non-intrusive tool that measures an individual's movement during sleep. Actigraphy was used to obtain data in discriminating between sleep and wake states in the subjects.

Secondary Outcomes

Karolinska Sleep Diary - Ease of Awakening(Up to 10 hours)
Karolinska Sleep Diary - Sleep Quality(Up to 10 hours)
Karolinska Sleep Diary - Calmness of Sleep(Up to 10 hours)
Karolinska Sleep Diary - Premature Awakening(Up to 10 hours)
Total Sleep Time Measured by Actigraphy(Up to 10 hours)
Sleep Efficiency Measured by Actigraphy(Up to 10 hours)
Karolinska Sleep Diary - Easiness to Fall Asleep(Up to 10 hours)
Overall Rating of Pain Relief(Up to 10 hours)
Global Assessment of Investigational Product as a Sleep Aid(Up to 10 hours)
Karolinska Sleep Diary - Sufficient Sleep(Up to 10 hours)
Subjective Sleep Questionnaire - Quality of Your Sleep Last Night(Up to 10 hours)
Subjective Sleep Questionnaire - Number of Minutes You Think That You Were Awake From the Time You Fell Asleep Until the Time You Got Out of Bed(Up to 10 hours)
Time to Rescue Medication(Up to 10 hours)
Karolinska Sleep Diary - Well Rested(Up to 10 hours)
Subjective Sleep Questionnaire - Time to Fall Asleep Last Night(Up to 10 hours)
Global Assessment of Investigational Product as a Pain Reliever(Up to 10 hours)
Subjective Sleep Questionnaire - Refreshing Nature of Your Sleep Last Night(Up to 10 hours)
Change From Baseline in Pain Intensity(Baseline and up to 10 hours)
Cumulative Proportion of Subjects Taking Rescue Medication by Hour(Up to 10 hours)