Evaluate Analgesic/Sedative Efficacy of Naproxen Sodium and Diphenhydramine

Sleep Clinical Trial

Official title:

A Double-Blind, Randomized, Pilot Study Assessing the Analgesic and Hypnotic Effect of Naproxen Sodium and Diphenhydramine Combination in Dental Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01118273
• Other study ID #: 13053
• Status: Completed
• Phase: Phase 4
• First received: April 15, 2010
• Last updated: May 13, 2015
• Start date: January 2008
• Est. completion date: February 2008

Study information

• Verified date: May 2015
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 162
• Est. completion date: February 2008
• Est. primary completion date: February 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 45 Years

Eligibility

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;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Sleep

Intervention

Drug:
• 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.
• Naproxen Sodium 440 mg (BAYH6689)
Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally.
• Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg
One dose of naproxen sodium 220 mg plus diphenhydramine 50 mg
• Naproxen Sodium 220 mg (BAYH6689)
Participants received 1 tablet of Naproxen Sodium 220 mg and 3 tablets of placebo, single dose, orally.
• DPH 50mg
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
Participants received 2 tablets of Advil PM (ibuprofen 200 mg and diphenhydramine citrate 38 mg) and 2 tablets of Placebo, single dose, orally.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Wake After Sleep Onset (WASO) 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. WASO was defined as minutes of awake during the period of sleep onset and offset, where sleep onset is the first 20-minute block with 19 minutes of sleep.	Up to 10 hours	No
Secondary	Sleep Latency 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. Sleep latency was defined as minutes to sleep onset since dosing, where sleep onset was the first 20-minute block with 19 minutes of sleep. For subjects who had not achieved sleep onset (e.g., due to taking rescue medication before achieving sleep onset), sleep latency was considered as censored at the time of wakening.	Up to 10 hours	No
Secondary	Global Assessment of Study Medication as a Sleep-aid	Subject rating of following question with 0 being poor to 4 being excellent: How would you rate the study medication you received as a sleep aid?	Up to 10 hours	No
Secondary	Karolinska Sleep Diary - Sleep Quality	Subject rating of following question with 1 being very poor and 5 being very good: How was your sleep?	Up to 10 hours	No
Secondary	Karolinska Sleep Diary - Calmness of Sleep	Subject rating of following question with 1 being very restless and 5 being very calm: How calm was your sleep?	Up to 10 hours	No
Secondary	Karolinska Sleep Diary - Easiness to Fall Asleep	Subject rating of following question with 1 being very difficult to 5 being very easy: How easy was it to fall asleep?	Up to 10 hours	No
Secondary	Karolinska Sleep Diary - Premature Awakening	Subject rating of following question with 1 being woke up much too early to 3 being no: Premature awakening?	Up to 10 hours	No
Secondary	Karolinska Sleep Diary - Ease of Awakening	Subject rating of following question with 1 being very difficult to 5 being very easy: Ease of awakening?	Up to 10 hours	No
Secondary	Karolinska Sleep Diary - Well Rested	Subject rating of following question with 1 being not rested at all to 3 being completely rested: Well-rested?	Up to 10 hours	No
Secondary	Karolinska Sleep Diary - Sufficient Sleep	Subject rating of following question with 1 being no, definitely too little to 5 being yes, definitely enough: Did you get enough (sufficient) sleep?	Up to 10 hours	No
Secondary	Total Sleep Time by Subject Assessment	Subject responded to: Please estimate the number of hours and minutes you think that you slept.	Up to 10 hours	No
Secondary	Sleep Quality Index	Sleep Quality Index is the mean score of items, 'sleep quality', 'calm sleep', 'ease falling asleep', and 'slept throughout' on the Karolinska Sleep Diary, ranges from 1 (worst possible) to 5 (best possible).	Up to 10 hours	No
Secondary	Overall Rating of Severity in Categorical Pain Rating Scale Score	Subject responded to question, 'My pain at this time is' by selecting one of the following choices: no pain (0), mild pain (1), moderate pain (2), or severe pain (3).	Up to 10 hours	No
Secondary	Change From Baseline in Categorical Pain Rating Scale Score	Subjects responded to question, 'My pain at this time is' with following choices: no pain (0), mild pain (1), moderate pain (2), or severe pain (3). Subjects completed this question at baseline (post-dental surgery) and after sleep period. The following measure is the change in pain rating from baseline.	Baseline and up to 10 hours	No
Secondary	Overall Rating of Severity in Visual Analog Scale (VAS) Score	Subjects marked a line on a 100-mm scale to indicate the severity of pain they are experiencing from 0 being no pain to 100 being worse possible pain.	At 10 hours	No
Secondary	Change From Baseline in Visual Analog Scale (VAS) Score	Subjects completed the VAS scale at baseline (post-dental surgery) and after completion of the sleep period. Subjects marked a line on a 100-mm scale to indicate the severity of pain they are experiencing from 0 being no pain to 100 being worse possible pain.This measure indicates the change in pain severity rating on the VAS scale from baseline.	Baseline and up to 10 hours	No
Secondary	Overall Rating of Pain Relief	Subjects responded to question, "Overall, the relief from my starting pain was" by checking one of the following choices: no relief (0), a little relief (1), some relief (2), a lot of relief (3), complete relief (4).	Up to 10 hours	No
Secondary	Time to Rescue Medication	Subjects were allowed to "rescue" and take a non-study pain reliever if the pain was not tolerable. This measure represents for the time to taking rescue medication from the time the subject took study treatment.	Up to 10 hours	No
Secondary	Cumulative Proportion of Participants Taking Rescue Medication by Hour	Subjects were allowed to "rescue" and take a non-study pain reliever if the pain was not tolerable. This measure represents for the proportion of subjects who rescued in the study.	Up to 10 hours	No
Secondary	Global Assessment of Study Medication as a Pain Reliever	Subject responded to question, 'How would you rating this study medication you received as a pain-reliever?' with the following choices: Poor (0), Fair(1), Good(2), Very Good(3), Excellent(4)	Up to 10 hours	No
Secondary	Number of Times Participants Took Rescue Medication	Subjects were allowed to "rescue" and take a non-study pain reliever if the pain was not tolerable. This measure represents for the number of times rescue medication was taken by a subject.	Up to 10 hours	No
Secondary	Total Wake 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.	Up to 10 hours	No
Secondary	Sleep Efficiency Measured by Actigraphy	Sleep efficiency was calculated as (total sleep time/total time in-bed time) × 100; total in-bed time was fixed at 10 hours. 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.	Up to 10 hours	No
Secondary	Activity Mean 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. Activity mean - average movement per minute.	Up to 10 hours	No
Secondary	Wake Episode 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. Wake Episodes - # of blocks of continuous wake epochs (defined as 2 or more consecutive epochs scored as wake that ends when there is at least one epoch scored as sleep subsequent to the start of the wake epochs).	Up to 10 hours	No

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