Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of the study is to determine whether Naproxen Test Formulation Capsules are safe and effective for the treatment of dental pain.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Naproxen Test (lower dose) | Experimental | 200-mg |
|
| Naproxen Test (upper dose) | Experimental | 400-mg (2 x 200-mg) |
|
| Naprosyn 250 mg | Active Comparator |
| |
| Naprosyn 500 mg | Active Comparator |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Naproxen Test | Drug | 200-mg single dose |
| |
| Naproxen Test |
| Measure | Description | Time Frame |
|---|---|---|
| Analysis of Total Pain Relief (TOTPAR) Over 0 to 12 Hours (TOTPAR-12) After Time 0 | Total pain relief as computed as a time-weighted sum of individual patient pain relief scores at each timepoint from 0-12 hours. Values for TOTPAR are measured from 0 to 4 on the Pain Relief Scale 0 None Min; 1 A little; 2 Some; 3 A lot; 4 Complete Max The TOTPAR is a weighted measure of the observations; the minimum possible value is 0 and the maximum possible value is 60. | Over 0 to 12 Hours |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Premier Research Group Limited | Austin | Texas | 78705 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24127200 | Derived | Young CL, Strand V, Altman R, Daniels S. A phase 2 study of naproxen submicron particle capsules in patients with post-surgical dental pain. Adv Ther. 2013 Oct;30(10):885-96. doi: 10.1007/s12325-013-0057-9. Epub 2013 Oct 15. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Naproxen Test (Lower Dose) | |
| FG001 | Naproxen Test (Upper Dose) | |
| FG002 | Naprosyn 250 mg | |
| FG003 | Naprosyn 500 mg | |
| FG004 | Placebo |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Naproxen Test (Lower Dose) | |
| BG001 | Naproxen Test (Upper Dose) | |
| BG002 | Naprosyn 250 mg |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Analysis of Total Pain Relief (TOTPAR) Over 0 to 12 Hours (TOTPAR-12) After Time 0 | Total pain relief as computed as a time-weighted sum of individual patient pain relief scores at each timepoint from 0-12 hours. Values for TOTPAR are measured from 0 to 4 on the Pain Relief Scale 0 None Min; 1 A little; 2 Some; 3 A lot; 4 Complete Max The TOTPAR is a weighted measure of the observations; the minimum possible value is 0 and the maximum possible value is 60. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Over 0 to 12 Hours |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Naproxen Test (Lower Dose) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Adverse drug reaction | General disorders | MedDRA 9.1 or higher | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dizziness | Nervous system disorders | MedDRA 9.1 or higher | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Steven Jensen | Iroko Pharmaceuticals, LLC | 267-546-3003 | sjensen@iroko.com |
Not provided
| ID | Term |
|---|---|
| D014098 | Toothache |
| ID | Term |
|---|---|
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
| D005157 | Facial Pain |
| D010146 | Pain |
Not provided
Not provided
| ID | Term |
|---|---|
| D009288 | Naproxen |
| ID | Term |
|---|---|
| D009280 | Naphthaleneacetic Acids |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
400-mg (2 x 200-mg) |
|
| Naprosyn | Drug | single dose |
|
| Naprosyn | Drug | single dose |
|
| Placebo | Drug | single dose |
|
| BG003 | Naprosyn 500 mg |
| BG004 | Placebo |
| BG005 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | Naprosyn 250 mg |
| OG003 | Naprosyn 500 mg |
| OG004 | Placebo |
|
|
|
| 1 |
| 50 |
| 28 |
| 51 |
| EG001 | Naproxen Test (Upper Dose) | 0 | 51 | 27 | 51 |
| EG002 | Naprosyn 250 mg | 0 | 50 | 25 | 50 |
| EG003 | Naprosyn 500 mg | 0 | 51 | 26 | 51 |
| EG004 | Placebo | 0 | 51 | 31 | 51 |
| Headache | Nervous system disorders | MedDRA 9.1 or higher | Systematic Assessment |
|
| Nasopharyngitis | Respiratory, thoracic and mediastinal disorders | MedDRA 9.1 or higher | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 9.1 or higher | Systematic Assessment |
|
| Post procedural complication | Injury, poisoning and procedural complications | MedDRA 9.1 or higher | Systematic Assessment |
|
| Post procedural swelling | Injury, poisoning and procedural complications | MedDRA 9.1 or higher | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 9.1 or higher | Systematic Assessment |
|
Not provided
Not provided
| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |