Evaluate Analgesic/Sedative Efficacy of Naproxen Sodium and Diphenhydramine
Information source: Bayer
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Sleep
Intervention: Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg (Drug); Naproxen Sodium 440 mg (BAYH6689) (Drug); Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg (Drug); Naproxen Sodium 220 mg (BAYH6689) (Drug); DPH 50mg (Drug); Ibuprofen 400 mg / Diphenhydramine citrate 76 mg (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Bayer Official(s) and/or principal investigator(s): Bayer Study Director, Study Director, Affiliation: Bayer
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
Clinical Details
Official title: A Double-Blind, Randomized, Pilot Study Assessing the Analgesic and Hypnotic Effect of Naproxen Sodium and Diphenhydramine Combination in Dental Pain
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Primary outcome: Total Sleep Time Measured by Actigraphy
Secondary outcome: Wake After Sleep Onset (WASO) Measured by ActigraphySleep Latency Measured by Actigraphy Global Assessment of Study Medication as a Sleep-aid Karolinska Sleep Diary - Sleep Quality Karolinska Sleep Diary - Calmness of Sleep Karolinska Sleep Diary - Easiness to Fall Asleep Karolinska Sleep Diary - Premature Awakening Karolinska Sleep Diary - Ease of Awakening Karolinska Sleep Diary - Well Rested Karolinska Sleep Diary - Sufficient Sleep Total Sleep Time by Subject Assessment Sleep Quality Index Overall Rating of Severity in Categorical Pain Rating Scale Score Change From Baseline in Categorical Pain Rating Scale Score Overall Rating of Severity in Visual Analog Scale (VAS) Score Change From Baseline in Visual Analog Scale (VAS) Score Overall Rating of Pain Relief Time to Rescue Medication Cumulative Proportion of Participants Taking Rescue Medication by Hour Global Assessment of Study Medication as a Pain Reliever Number of Times Participants Took Rescue Medication Total Wake Time Measured by Actigraphy Sleep Efficiency Measured by Actigraphy Activity Mean Measured by Actigraphy Wake Episode Measured by Actigraphy
Eligibility
Minimum age: 16 Years.
Maximum age: 45 Years.
Gender(s): Both.
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;
Locations and Contacts
Salt Lake City, Utah 84124, United States
Additional Information
Click here and search for drug information provided by the FDA. Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.
Starting date: January 2008
Last updated: May 13, 2015
|