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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-005269-66 | EudraCT Number |
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To evaluate the analgesic efficacy of a single, oral dose of a naproxen sodium extended-release tablet, compared to placebo in postsurgical dental pain.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Naproxen sodium ER (BAYH6689) | Experimental | single dose (1 tablet) ER Naproxen sodium 660 mg with a full glass of water (240ml) within 1 - 4 hours post dental surgery. |
|
| Placebo | Placebo Comparator | Single dose (1 tablet) of placebo with a full glass of water (240ml) within 1 - 4 hours post dental surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Naproxen Sodium ER (BAYH6689) | Drug | Analgesic efficacy in dental pain; per oral; 1 tablet extended release Naproxen Sodium; with a full glass of water within 4 hours post surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Summed Pain Intensity Difference (SPID) | Categorical pain intensity scale - no pain (0), mild pain (1), moderate pain (2), or severe pain (3) was used for all pain intensity assessments postdose. Time-weighted Sum Pain Intensity Difference (SPID) was calculated by multiplying the Pain Intensity Difference (PID) score at each postdose time point by the duration (in hours) since the preceding time point and then summing these values over 0-24 and 16-24 hours, respectively. | 0 to 24 hours post dose |
| Measure | Description | Time Frame |
|---|---|---|
| Total Pain Relief (TOTPAR) | Pain relief categorical rating scale - no relief (0), a little relief (1), some relief (2), a lot of relief (3), or complete relief (4) was used for all pain relief assessments postdose. Time weighted total pain relief (TOTPAR) was 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Austin | Texas | 78705 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26588111 | Derived | Laurora I, An R. Efficacy of single-dose, extended-release naproxen sodium 660 mg in postsurgical dental pain: two double-blind, randomized, placebo-controlled trials. Curr Med Res Opin. 2016;32(2):331-42. doi: 10.1185/03007995.2015.1123680. Epub 2015 Dec 15. |
| Label | URL |
|---|---|
| Click here to find information about studies related to Bayer Healthcare products conducted in Europe | View source |
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The Screening Period occurred up to 28 days prior to the day of dental surgery. A total of 447 subjects were screened, of which 135 were excluded (72 did not meet inclusion criteria, 19 refused to participate, 44 other reasons); 312 subjects were randomized and included in the intent-to-treat (ITT) population for efficacy and safety analysis.
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| ID | Title | Description |
|---|---|---|
| FG000 | Naproxen Sodium ER (BAYH6689) | single dose (1 tablet) ER Naproxen sodium 660 mg with a full glass of water (240ml) within 1 - 4 hours post dental surgery. |
| FG001 | Placebo | single dose (1 tablet) of placebo with a full glass of water (240ml) within 1 - 4 hours post dental surgery. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Naproxen Sodium ER (BAYH6689) | single dose (1 tablet) ER Naproxen sodium 660 mg with a full glass of water (240ml) within 1 - 4 hours post dental surgery. |
| BG001 | Placebo | single dose (1 tablet) of placebo with a full glass of water (240ml) within 1 - 4 hours post dental surgery. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Summed Pain Intensity Difference (SPID) | Categorical pain intensity scale - no pain (0), mild pain (1), moderate pain (2), or severe pain (3) was used for all pain intensity assessments postdose. Time-weighted Sum Pain Intensity Difference (SPID) was calculated by multiplying the Pain Intensity Difference (PID) score at each postdose time point by the duration (in hours) since the preceding time point and then summing these values over 0-24 and 16-24 hours, respectively. | Randomized population is defined as all subjects who signed informed consent form, completed the screening period, and were randomized. The ITT population is defined as all subjects who were randomized and received at least one dose of the study treatment. Efficacy analyses are based on the ITT population (n=312). | Posted | Mean | Standard Deviation | units on a scale | 0 to 24 hours post dose |
|
Adverse events were recorded throughout the treatment period through 5 days after investigational product or placebo administration. All Serious Adverse Events were collected through about 30 days after the last dose of investigational product or placebo.
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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 ER (BAYH6689) | single dose (1 tablet) ER Naproxen sodium 660 mg with a full glass of water (240ml) within 1 - 4 hours post dental surgery. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tinnitus | Ear and labyrinth disorders | MedDRA (11.0) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area Head | BAYER | clinical-trials-contact@bayerhealthcare.com |
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| ID | Term |
|---|---|
| D014098 | Toothache |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
| D005157 | Facial Pain |
| D010146 | Pain |
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| Placebo | Drug | Inactive ingredient; per oral; 1 lactose based tablet; with a full glass of water within 4 hours post surgery |
|
| 0-24 hours post dose |
| Summed Pain Intensity Difference at Specific Time Intervals | Categorical pain intensity scale - no pain (0), mild pain (1), moderate pain (2), or severe pain (3) was used for all pain intensity assessments postdose. Time-weighted Sum Pain Intensity Difference (SPID) was calculated by multiplying the Pain Intensity Difference (PID) score at each postdose time point by the duration (in hours) since the preceding time point and then summing these values for 0-6, 0-12, 0-16 hour intervals, respectively. | 0-16 hours post dose |
| Time to First Use of Rescue Medication | Time to first use of rescue medication was estimated using the Kaplan-Meier method and analyzed by a Log rank test stratified by trial site and baseline pain intensity (PI). The outcome measure is time to first use of rescue medication. The criteria are if adequate pain relief is not achieved, then subjects are permitted to take rescue medication. | postdose to first use of rescue medication |
| Global Assessment of the Investigational Product as a Pain Reliever | Categorical Scale: Poor (0), Fair (1), Good (2), Very Good (3), Excellent (4). | at 24 hours postdose or immediately before first use of rescue medication |
| Time to Onset of Effect | Time to onset of effect is defined as the time to meaningful pain relief, provided that the subjects experienced both "perceptible" and "meaningful" pain relief. Perceptible pain relief was defined as when the subject first began to feel any pain-relieving effect from the investigational product. Meaningful pain relief was defined as when the subject felt the degree of pain relief was meaningful to them. | from postdose to onset of first perceptible and meaningful pain relief for up to 6 hours |
| Austin |
| Texas |
| 78744 |
| United States |
| Salt Lake City | Utah | 84124 | United States |
| Withdrawal by Subject |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Baseline Pain Intensity by Categorical Scale | Categorical scale: No Pain (0), Mild Pain (1), Moderate Pain (2), Severe Pain (3). | Number | participants |
|
| Baseline Pain Intensity by Visual Analog Scale | Visual Analog Scale 0-100 mm: 0 is no pain and 100 is worse possible pain. | Mean | Standard Deviation | scores on a scale |
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single dose (1 tablet) ER Naproxen sodium 660 mg with a full glass of water (240ml) within 1 - 4 hours post dental surgery.
| OG001 | Placebo | single dose (1 tablet) of placebo with a full glass of water (240ml) within 1 - 4 hours post dental surgery. |
|
|
|
| Secondary | Total Pain Relief (TOTPAR) | Pain relief categorical rating scale - no relief (0), a little relief (1), some relief (2), a lot of relief (3), or complete relief (4) was used for all pain relief assessments postdose. Time weighted total pain relief (TOTPAR) was 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. | Efficacy analyses were based on ITT population (n=312). | Posted | Mean | Standard Deviation | units on a scale | 0-24 hours post dose |
|
|
|
|
| Secondary | Summed Pain Intensity Difference at Specific Time Intervals | Categorical pain intensity scale - no pain (0), mild pain (1), moderate pain (2), or severe pain (3) was used for all pain intensity assessments postdose. Time-weighted Sum Pain Intensity Difference (SPID) was calculated by multiplying the Pain Intensity Difference (PID) score at each postdose time point by the duration (in hours) since the preceding time point and then summing these values for 0-6, 0-12, 0-16 hour intervals, respectively. | Efficacy analyses were based on ITT population (n=312). | Posted | Mean | Standard Deviation | units on a scale | 0-16 hours post dose |
|
|
|
|
| Secondary | Time to First Use of Rescue Medication | Time to first use of rescue medication was estimated using the Kaplan-Meier method and analyzed by a Log rank test stratified by trial site and baseline pain intensity (PI). The outcome measure is time to first use of rescue medication. The criteria are if adequate pain relief is not achieved, then subjects are permitted to take rescue medication. | Efficacy analyses are based on ITT population (n=312). | Posted | Median | Full Range | hours | postdose to first use of rescue medication |
|
|
|
|
| Secondary | Global Assessment of the Investigational Product as a Pain Reliever | Categorical Scale: Poor (0), Fair (1), Good (2), Very Good (3), Excellent (4). | Efficacy analyses are based on ITT population (n=312). | Posted | Mean | Standard Deviation | units on a scale | at 24 hours postdose or immediately before first use of rescue medication |
|
|
|
|
| Secondary | Time to Onset of Effect | Time to onset of effect is defined as the time to meaningful pain relief, provided that the subjects experienced both "perceptible" and "meaningful" pain relief. Perceptible pain relief was defined as when the subject first began to feel any pain-relieving effect from the investigational product. Meaningful pain relief was defined as when the subject felt the degree of pain relief was meaningful to them. | Efficacy analyses are based on ITT population (n=312). | Posted | Median | Full Range | hours | from postdose to onset of first perceptible and meaningful pain relief for up to 6 hours |
|
|
|
|
| 0 |
| 153 |
| 10 |
| 153 |
| EG001 | Placebo | single dose (1 tablet) of placebo with a full glass of water (240ml) within 1 - 4 hours post dental surgery. | 0 | 159 | 36 | 159 |
| Conjunctivitis | Eye disorders | MedDRA (11.0) | Non-systematic Assessment |
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| Eye Swelling | Eye disorders | MedDRA (11.0) | Non-systematic Assessment |
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| Scotoma | Eye disorders | MedDRA (11.0) | Non-systematic Assessment |
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| Abdominal Pain | Gastrointestinal disorders | MedDRA (11.0) | Non-systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDRA (11.0) | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA (11.0) | Non-systematic Assessment |
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| Stomach Discomfort | Gastrointestinal disorders | MedDRA (11.0) | Non-systematic Assessment |
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| Tooth Socket Haemorrhage | Gastrointestinal disorders | MedDRA (11.0) | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA (11.0) | Non-systematic Assessment |
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| Pyrexia | General disorders | MedDRA (11.0) | Non-systematic Assessment |
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| Abscess Oral | Infections and infestations | MedDRA (11.0) | Non-systematic Assessment |
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| Tooth Abscess | Infections and infestations | MedDRA (11.0) | Non-systematic Assessment |
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| Post Procedural Haemorrhage | Injury, poisoning and procedural complications | MedDRA (11.0) | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA (11.0) | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (11.0) | Non-systematic Assessment |
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| Syncope | Nervous system disorders | MedDRA (11.0) | Non-systematic Assessment |
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| Pharyngolaryngeal Pain | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Non-systematic Assessment |
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| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA (11.0) | Non-systematic Assessment |
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| Flushing | Vascular disorders | MedDRA (11.0) | Non-systematic Assessment |
|
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| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |
| TOTPAR 0 - 16 hours |
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| TOTPAR 0 - 24 hours |
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| TOTPAR 16 - 24 hours |
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| SIPD 0 - 16 |
|