Phase 3
Completed N=267
Evaluate Analgesic / Sedative Efficacy of Naproxen Sodium and Diphenhydramine in Patients With Postsurgical Dental Pain
Pain, Postoperative
Source: ClinicalTrials.gov NCT01495858 ↗
Enrolled (actual)
267
Serious AEs
0.0%
Results posted
Jun 2014
Primary outcomePrimary: Wake Time After Sleep Onset (WASO) Measured by Actigraphy — 155.25; 180.08; 364.83 Minutes — p=0.3047
Summary
The objective of the study is to evaluate the efficacy and safety of a single oral dose of naproxen sodium 440 mg in combination with DPH (diphenhydramine) 25 mg in subjects with postsurgical dental pain and phase advanced sleep.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Wake Time After Sleep Onset (WASO) Measured by Actigraphy |
155.25; 180.08; 364.83 | 0.3047 |
| PRIMARY Sleep Latency Measured by Actigraphy |
23.50; 16.75; 27.50 | 0.1677 |
| SECONDARY Total Sleep Time Measured by Actigraphy |
418.66; 392.38; 206.61 | 0.2764 |
| SECONDARY Sleep Efficiency Measured by Actigraphy |
69.777; 65.396; 34.436 | 0.2764 |
| SECONDARY Global Assessment of Investigational Product as a Sleep Aid |
2; 13; 1; 12; 24; 7 | <0.0001 sig |
| SECONDARY Karolinska Sleep Diary - Sleep Quality |
1; 3; 9; 12; 22; 11 | 0.0004 sig |
| SECONDARY Karolinska Sleep Diary - Calmness of Sleep |
1; 3; 5; 26; 29; 17 | 0.0145 sig |
| SECONDARY Karolinska Sleep Diary - Easiness to Fall Asleep |
3; 8; 9; 29; 33; 6 | >0.05 |
| SECONDARY Karolinska Sleep Diary - Premature Awakening |
24; 31; 21; 45; 52; 11 | 0.0387 sig |
| SECONDARY Karolinska Sleep Diary - Ease of Awakening |
0; 3; 0; 1; 0; 2 | 0.0305 sig |
| SECONDARY Karolinska Sleep Diary - Well Rested |
7; 9; 13; 53; 55; 17 | 0.0176 sig |
| SECONDARY Karolinska Sleep Diary - Sufficient Sleep |
2; 10; 13; 8; 10; 6 | <0.0001 sig |
| SECONDARY Subjective Sleep Questionnaire - Quality of Your Sleep Last Night |
6.5; 5.8; 4.9 | 0.0036 sig |
| SECONDARY Subjective Sleep Questionnaire - Refreshing Nature of Your Sleep Last Night |
6.6; 5.7; 4.6 | <0.0001 sig |
| SECONDARY Subjective Sleep Questionnaire - Time to Fall Asleep Last Night |
39.5; 40.2; 40.0 | >0.05 |
| SECONDARY Subjective Sleep Questionnaire - Number of Minutes You Think That You Were Awake From the Time You Fell Asleep Until the Time You Got Out of Bed |
111.1; 144.8; 98.4 | >0.05 |
| SECONDARY Change From Baseline in Pain Intensity |
2.4; 2.4; 2.5 | 0.4519 |
| SECONDARY Overall Rating of Pain Relief |
24; 30; 35; 5; 3; 4 | 0.3707 |
| SECONDARY Time to Rescue Medication |
NA; NA; 146.50 | >0.05 |
| SECONDARY Cumulative Proportion of Participants Taking Rescue Medication by Hour |
0; 1; 0; 9; 12; 21 | — |
| SECONDARY Global Assessment of Investigational Product as a Pain Reliever |
1; 1; 1; 4; 3; 5 | 0.3765 |
Eligibility Criteria
Inclusion Criteria
- Healthy, ambulatory, male and female volunteers ages 12 and older
- Scheduled to undergo surgical removal of a minimum of two third molars of which at least one has to be a mandibular third molar. The mandibular extraction(s) required by each subject must meet one of the following scenarios:
- one full bony impaction
- two partial bony impactions
- one full bony impaction and one partial bony impaction
- one full bony impaction and one soft tissue impaction
- one full bony impaction and one erupted third molar. Two full bony mandibular impactions are not allowed. Maxillary third molars may be removed regardless of impaction level.
- 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 between 1600 hour and 1830 hour 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 non-childbearing potential must be amenorrheic for at least 2 years or had a hysterectomy and/or bilateral oophorectomy.
Exclusion Criteria
- History of hypersensitivity to naproxen, diphenhydramine, nonsteroidal anti-inflammatory drug (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 positive 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
- Habitually spends less than 6.5 hours in bed
Data sourced from ClinicalTrials.gov (NCT01495858). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.