Evaluate Analgesic/Sedative Efficacy of Naproxen Sodium and Diphenhydramine

NCT01118273 | Completed Phase 4 Results

• 1 other identifier: 13053
• Study Type: interventional
• Target: 162
• Locations: 1 country
• Sites: 1

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

Keywords

Naproxen sodium; Diphenhydramine; Drugs, Investigational

Outcome Measures

Primary Outcomes (1)

• Total Sleep Time 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. In calculating the total sleep time, subjects who took rescue medication were treated as "awake" from the time the rescue medication was given until the end of the sleep period. In addition, if subjects rescued before sleep onset, their total sleep time was set to zero.

  Up to 10 hours

Secondary Outcomes (25)

• Wake After Sleep Onset (WASO) Measured by Actigraphy

  Up to 10 hours

• Sleep Latency Measured by Actigraphy

  Up to 10 hours

• Global Assessment of Study Medication as a Sleep-aid

  Up to 10 hours

• Karolinska Sleep Diary - Sleep Quality

  Up to 10 hours

• Karolinska Sleep Diary - Calmness of Sleep

  Up to 10 hours

Study Arms (6)

Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg

EXPERIMENTAL

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

Naproxen Sodium 440 mg (BAYH6689)

ACTIVE COMPARATOR

Drug: Naproxen Sodium 440 mg (BAYH6689)

Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg

EXPERIMENTAL

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

Naproxen Sodium 220 mg (BAYH6689)

ACTIVE COMPARATOR

Drug: Naproxen Sodium 220 mg (BAYH6689)

DPH 50mg

ACTIVE COMPARATOR

Drug: DPH 50mg

Ibuprofen 400 mg / Diphenhydramine citrate 76 mg

ACTIVE COMPARATOR

Drug: Ibuprofen 400 mg / Diphenhydramine citrate 76 mg

Interventions

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

Naproxen Sodium 440 mg (BAYH6689) DRUG

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

Naproxen Sodium 440 mg (BAYH6689)

Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg DRUG

One dose of naproxen sodium 220 mg plus diphenhydramine 50 mg

Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg

Naproxen Sodium 220 mg (BAYH6689) DRUG

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

Naproxen Sodium 220 mg (BAYH6689)

DPH 50mg DRUG

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

DPH 50mg

Ibuprofen 400 mg / Diphenhydramine citrate 76 mg DRUG

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

Ibuprofen 400 mg / Diphenhydramine citrate 76 mg

Eligibility Criteria

• Age: 16 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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;

Sponsors & Collaborators

• Bayer: lead

Study Sites (1)

Unknown Facility

Salt Lake City, Utah, 84124, United States

Location

MeSH Terms

Interventions

Naproxen; Ibuprofen; Diphenhydramine

Intervention Hierarchy (Ancestors)

Naphthaleneacetic Acids; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Ethylamines; Amines; Benzhydryl Compounds; Benzene Derivatives

Results Point of Contact

• Title: Therapeutic Area Head
• Organization: BAYER

clinical-trials-contact@bayerhealthcare.com

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2010
• First Posted: May 6, 2010
• Study Start: January 1, 2008
• Primary Completion: February 1, 2008
• Study Completion: February 1, 2008
• Last Updated: June 8, 2015
• Results First Posted: June 17, 2014

Record last verified: 2015-05

Locations

US (1)