Evaluate Analgesic/Sedative Efficacy of Naproxen Sodium and Diphenhydramine

NCT ID: NCT01118273

Last Updated: 2015-06-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 162 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-01-31
• Study Completion Date: 2008-02-29

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

Conditions

Sleep

Study Design

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

Study Groups

Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg

Group Type: EXPERIMENTAL

Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg

Intervention Type: DRUG

Participants received 2 tablets of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.

Naproxen Sodium 440 mg (BAYH6689)

Group Type: ACTIVE_COMPARATOR

Naproxen Sodium 440 mg (BAYH6689)

Intervention Type: DRUG

Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally.

Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg

Group Type: EXPERIMENTAL

Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg

Intervention Type: DRUG

One dose of naproxen sodium 220 mg plus diphenhydramine 50 mg

Naproxen Sodium 220 mg (BAYH6689)

Group Type: ACTIVE_COMPARATOR

Naproxen Sodium 220 mg (BAYH6689)

Intervention Type: DRUG

Participants received 1 tablet of Naproxen Sodium 220 mg and 3 tablets of placebo, single dose, orally.

DPH 50mg

Group Type: ACTIVE_COMPARATOR

DPH 50mg

Intervention Type: DRUG

Participants received 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 2 tablets of placebo, single dose, orally.

Ibuprofen 400 mg / Diphenhydramine citrate 76 mg

Group Type: ACTIVE_COMPARATOR

Ibuprofen 400 mg / Diphenhydramine citrate 76 mg

Intervention Type: DRUG

Participants received 2 tablets of Advil PM (ibuprofen 200 mg and diphenhydramine citrate 38 mg) and 2 tablets of Placebo, single dose, orally.

Interventions

Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg

Participants received 2 tablets of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.

Intervention Type: DRUG

Naproxen Sodium 440 mg (BAYH6689)

Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally.

Intervention Type: DRUG

Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg

One dose of naproxen sodium 220 mg plus diphenhydramine 50 mg

Intervention Type: DRUG

Naproxen Sodium 220 mg (BAYH6689)

Participants received 1 tablet of Naproxen Sodium 220 mg and 3 tablets of placebo, single dose, orally.

Intervention Type: DRUG

DPH 50mg

Participants received 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 2 tablets of placebo, single dose, orally.

Intervention Type: DRUG

Ibuprofen 400 mg / Diphenhydramine citrate 76 mg

Participants received 2 tablets of Advil PM (ibuprofen 200 mg and diphenhydramine citrate 38 mg) and 2 tablets of Placebo, single dose, orally.

Intervention Type: DRUG

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;

• Minimum Eligible Age: 16 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

Salt Lake City, Utah, United States

Countries

United States

Other Identifiers

13053

Identifier Type: -

Identifier Source: org_study_id