Evaluate Analgesic/Sedative Efficacy of Naproxen Sodium and Diphenhydramine in Patients With Postsurgical Dental Pain

NCT ID: NCT01280591

Last Updated: 2015-06-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 712 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-10-31
• Study Completion Date: 2011-02-28

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.

Conditions

Pain, Postoperative

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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

Group Type: EXPERIMENTAL

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

Intervention Type: DRUG

Participants received two Naproxen sodium 220 mg / DPH (Diphenhydramine hydrochloride) 25 mg tablets orally, single dose

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

Group Type: EXPERIMENTAL

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

Intervention Type: DRUG

Participants received one Naproxen sodium 220 mg / DPH 50 mg tablet and one matching placebo capsule orally, single dose

Naproxen sodium 440 mg (BAYH6689)

Group Type: ACTIVE_COMPARATOR

Naproxen sodium 440 mg (BAYH6689)

Intervention Type: DRUG

Participants received two Naproxen sodium 220 mg tablets orally, single dose

DPH 50 mg

Group Type: ACTIVE_COMPARATOR

DPH 50 mg

Intervention Type: DRUG

Participants received two DPH (Diphenhydramine hydrochloride) 25mg tablets orally, single dose

Interventions

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

Participants received two Naproxen sodium 220 mg / DPH (Diphenhydramine hydrochloride) 25 mg tablets orally, single dose

Intervention Type: DRUG

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

Participants received one Naproxen sodium 220 mg / DPH 50 mg tablet and one matching placebo capsule orally, single dose

Intervention Type: DRUG

Naproxen sodium 440 mg (BAYH6689)

Participants received two Naproxen sodium 220 mg tablets orally, single dose

Intervention Type: DRUG

DPH 50 mg

Participants received two DPH (Diphenhydramine hydrochloride) 25mg tablets orally, single dose

Intervention Type: DRUG

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

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bayer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

Austin, Texas, United States

Salt Lake City, Utah, United States

Countries

United States

References

Cooper S, Laurora I, Wang Y, Venkataraman P, An R, Roth T. Efficacy and tolerability studies evaluating a sleep aid and analgesic combination of naproxen sodium and diphenhydramine in the dental impaction pain model in subjects with induced transient insomnia. Int J Clin Pract. 2015 Oct;69(10):1149-58. doi: 10.1111/ijcp.12669. Epub 2015 May 21.

Reference Type: DERIVED

PMID: 25996289 (View on PubMed)

Other Identifiers

14837

Identifier Type: -

Identifier Source: org_study_id