Evaluate Analgesic/Sedative Efficacy of Naproxen Sodium and Diphenhydramine

Bayer

Status and phase: Completed; Phase 4

Conditions: Sleep

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT01118273

13053

Details and patient eligibility

About

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

Enrollment: 162 patients

Sex: All

Ages: 16 to 45 years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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162 participants in 6 patient groups

Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg

Experimental group

Treatment:

Drug: Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg

Naproxen Sodium 440 mg (BAYH6689)

Active Comparator group

Treatment:

Drug: Naproxen Sodium 440 mg (BAYH6689)

Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg

Experimental group

Treatment:

Drug: Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg

Naproxen Sodium 220 mg (BAYH6689)

Active Comparator group

Treatment:

Drug: Naproxen Sodium 220 mg (BAYH6689)

DPH 50mg

Active Comparator group

Treatment:

Drug: DPH 50mg

Ibuprofen 400 mg / Diphenhydramine citrate 76 mg

Active Comparator group

Treatment:

Drug: Ibuprofen 400 mg / Diphenhydramine citrate 76 mg