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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-005049-67 | EudraCT Number |
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To compare the duration of analgesic efficacy as determined by the time to rescue medication of a single oral dose of naproxen sodium 440 mg (2 x 220 mg tablets) relative to ibuprofen 400 mg (2 x 200 mg tablets) and placebo over 24 hours in subjects experiencing moderate to severe post-impaction surgery dental pain.
To compare the overall analgesic effect (SPID 0-24) of a single dose of naproxen sodium 440 mg (2 x 220 mg tablets) relative to ibuprofen 400 mg (2 x 200 mg tablets) and placebo.
To compare the overall relief from pain (TOTPAR 0-24) of a single dose of naproxen sodium 440 mg (2 x 220 mg tablets) relative to ibuprofen 400 mg (2 x 200 mg tablets) and placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Naproxen Sodium (Aleve, BAY117031) | Experimental | Participants received one single dose of 440 mg naproxen sodium tablets (200 mg x 2 tablets, oral) after randomization |
|
| Ibuprofen (Advil) | Active Comparator | Participants received one single dose of 400 mg ibuprofen tablets (200 mg x 2 tablets, oral) after randomization |
|
| Placebo | Placebo Comparator | Participants received one single dose of matching placebo tablets (2 tablets, oral) after randomization |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Naproxen Sodium (Aleve, BAY117031) | Drug | 220 mg x 2 tablets, oral, single dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to First Use of Rescue Medication | Time to first use of rescue medication was estimated using Kaplan-Meier method. If a subject did not take the rescue medication during the treatment period, (s)he was censored at the time of last assessment. | Up to 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Sum of Pain Intensity Difference (SPID) | Pain intensity was measured using Numerical Rating Scale (from 0 to 10: 0 = no pain, 10 = worst possible pain). For each postdose time point, pain intensity differences (PIDs) were derived by subtracting the pain intensity at the postdose time point from the baseline intensity score (baseline score - post-baseline score). A positive difference was indicative of improvement. Time-weighted sum of pain intensity differences (SPIDs) were calculated by multiplying the PID score at each postdose time point by the duration (in hours) since the preceding time point and then summing these values. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jean Brown Research | Salt Lake City | Utah | 84124 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31402718 | Derived | Cooper SA, Desjardins P, Brain P, Paredes-Diaz A, Troullos E, Centofanti R, An B. Longer analgesic effect with naproxen sodium than ibuprofen in post-surgical dental pain: a randomized, double-blind, placebo-controlled, single-dose trial. Curr Med Res Opin. 2019 Dec;35(12):2149-2158. doi: 10.1080/03007995.2019.1655257. Epub 2019 Aug 27. |
| Label | URL |
|---|---|
| Click here to find information about studies related to Bayer Healthcare products conducted in Europe | View source |
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Overall, 387 participants completed surgical teeth extraction, and all of them were randomized and received the treatment.
The study was conducted at one center in the United States, between 12 February 2018 (first patient first visit) and 10 July 2018 (last patient last visit).
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| ID | Title | Description |
|---|---|---|
| FG000 | Naproxen Sodium (Aleve, BAY117031) | Participants received one single dose of 440 mg naproxen sodium tablets (200 mg x 2 tablets, oral) after randomization |
| FG001 | Ibuprofen (Advil) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 15, 2018 | Jun 27, 2019 |
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| Ibuprofen (Advil) | Drug | 200 mg x 2 tablets, oral, single dose |
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| Placebo | Drug | Matching placebo, 2 tablets, oral, single dose |
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| Up to 24 hours |
| Total Pain Relief (TOTPAR) | Pain relief was measured using Categorical Pain Relief Rating Scale (0 = No relief, 1 = a little relief, 2 = some relief, 3 = a lot of relief, 4 = complete relief). Total pain relief scores (TOTPARs) were calculated by multiplying the pain relief score at each postdose time point by the duration (in hours) since the preceding time point and then summing these values. | Up to 24 hours |
Participants received one single dose of 400 mg ibuprofen tablets (200 mg x 2 tablets, oral) after randomization
| FG002 | Placebo | Participants received one single dose of matching placebo tablets (2 tablets, oral) after randomization |
| COMPLETED |
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| NOT COMPLETED |
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Safety Population (included all subjects who were randomized and took at least one dose of investigational product)
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| ID | Title | Description |
|---|---|---|
| BG000 | Naproxen Sodium (Aleve, BAY117031) | Participants received one single dose of 440 mg naproxen sodium tablets (200 mg x 2 tablets, oral) after randomization |
| BG001 | Ibuprofen (Advil) | Participants received one single dose of 400 mg ibuprofen tablets (200 mg x 2 tablets, oral) after randomization |
| BG002 | Placebo | Participants received one single dose of matching placebo tablets (2 tablets, oral) after randomization |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Pain Intensity Score | Categorical pain intensity scale - no pain (0), mild pain (1), moderate pain (2), or severe pain (3) was used for pain intensity assessments. | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Time to First Use of Rescue Medication | Time to first use of rescue medication was estimated using Kaplan-Meier method. If a subject did not take the rescue medication during the treatment period, (s)he was censored at the time of last assessment. | Per-protocol population | Posted | Number | hours | Up to 24 hours |
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| Secondary | Sum of Pain Intensity Difference (SPID) | Pain intensity was measured using Numerical Rating Scale (from 0 to 10: 0 = no pain, 10 = worst possible pain). For each postdose time point, pain intensity differences (PIDs) were derived by subtracting the pain intensity at the postdose time point from the baseline intensity score (baseline score - post-baseline score). A positive difference was indicative of improvement. Time-weighted sum of pain intensity differences (SPIDs) were calculated by multiplying the PID score at each postdose time point by the duration (in hours) since the preceding time point and then summing these values. | Per-protocol population | Posted | Mean | Standard Deviation | Scores on a scale * hours | Up to 24 hours |
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| Secondary | Total Pain Relief (TOTPAR) | Pain relief was measured using Categorical Pain Relief Rating Scale (0 = No relief, 1 = a little relief, 2 = some relief, 3 = a lot of relief, 4 = complete relief). Total pain relief scores (TOTPARs) were calculated by multiplying the pain relief score at each postdose time point by the duration (in hours) since the preceding time point and then summing these values. | Per-protocol population | Posted | Mean | Standard Deviation | Scores on a scale * hours | Up to 24 hours |
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From start of study drug up to 10 days after the administration of study drug
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Naproxen Sodium (Aleve, BAY117031) | Subjects received one single dose of 440 mg naproxen sodium tablets (200 mg x 2 tablets, oral) after randomization | 0 | 166 | 1 | 166 | 25 | 166 |
| EG001 | Placebo | Subjects received one single dose of matching placebo tablets (2 tablets, oral) after randomization | 0 | 55 | 0 | 55 | 16 | 55 |
| EG002 | Ibuprofen (Advil) | Subjects received one single dose of 400 mg ibuprofen tablets (200 mg x 2 tablets, oral) after randomization | 0 | 166 | 0 | 166 | 31 | 166 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Appendicitis | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ear pain | Ear and labyrinth disorders | MedDRA 20.1 | Non-systematic Assessment |
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| Eye pain | Eye disorders | MedDRA 20.1 | Non-systematic Assessment |
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| Eye swelling | Eye disorders | MedDRA 20.1 | Non-systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
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| Aphthous ulcer | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
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| Breath odour | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
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| Paraesthesia oral | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 20.1 | Non-systematic Assessment |
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| Pyrexia | General disorders | MedDRA 20.1 | Non-systematic Assessment |
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| Hypersensitivity | Immune system disorders | MedDRA 20.1 | Non-systematic Assessment |
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| Alveolar osteitis | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
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| Ear infection | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
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| Periodontitis | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
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| Pharyngitis streptococcal | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 20.1 | Non-systematic Assessment |
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| Incision site pain | Injury, poisoning and procedural complications | MedDRA 20.1 | Non-systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 20.1 | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 20.1 | Non-systematic Assessment |
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| Paraesthesia | Nervous system disorders | MedDRA 20.1 | Non-systematic Assessment |
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| Tremor | Nervous system disorders | MedDRA 20.1 | Non-systematic Assessment |
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| Nervousness | Psychiatric disorders | MedDRA 20.1 | Non-systematic Assessment |
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| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Non-systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Non-systematic Assessment |
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| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area Head | Bayer | 1-888-8422937 | clinical-trials-contact@bayer.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 24, 2018 | Jun 27, 2019 | SAP_001.pdf |
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D009288 | Naproxen |
| D007052 | Ibuprofen |
| ID | Term |
|---|---|
| D009280 | Naphthaleneacetic Acids |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D010666 | Phenylpropionates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Black or African American |
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| American Indian or Alaska Native |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Other |
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| Mild Pain (1) |
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| Moderate Pain (2) |
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| Severe Pain (3) |
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| Title | Measurements |
|---|---|
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| 50th Percentile |
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| 75th Percentile |
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| Maximum |
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| Superiority |
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| Counts |
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| Participants |
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