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The purpose of this study is to determine whether Indomethacin Test Formulation Capsules are safe and effective for the treatment of dental pain.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Indomethacin Test (lower dose) | Experimental |
| |
| Indomethacin Test (upper dose) | Experimental | Single dose |
|
| Celecoxib 400 mg | Active Comparator |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Celecoxib 400 mg | Drug | Capsules 2 x 200 mg Single-Dose |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Total Patient Pain Relief Over 0 to 8 Hours. | Total patient pain relief was assessed as a time-weighted sum of the patient pain assessments at each individual time point from 0-8 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 32. | 8 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Premier Research Group Limited | Austin | Texas | 78705 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Indomethacin Test (Lower Dose) | |
| FG001 | Indomethacin Test (Upper Dose) | Single dose |
| FG002 | Celecoxib 400 mg | |
| FG003 | Placebo |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Indomethacin Test (Lower Dose) | |
| BG001 | Indomethacin Test (Upper Dose) | Single dose |
| BG002 |
| 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 | Total Patient Pain Relief Over 0 to 8 Hours. | Total patient pain relief was assessed as a time-weighted sum of the patient pain assessments at each individual time point from 0-8 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 32. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | 8 hours |
|
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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 | Indomethacin Test (Lower Dose) |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Alveolar osteitis | Gastrointestinal disorders | MedDRA 9.1 or higher | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Steven Jensen | Iroko Pharmaceuticals, LLC | 267-546-3003 | sjensen@iroko.com |
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| ID | Term |
|---|---|
| D014098 | Toothache |
| ID | Term |
|---|---|
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
| D005157 | Facial Pain |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D000068579 | Celecoxib |
| ID | Term |
|---|---|
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
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| Placebo |
| Drug |
Capsules 2 Single-Dose |
|
| Indomethacin Test (lower dose) | Drug | 20-mg single dose |
|
| Indomethacin Test (upper dose) | Drug | 40-mg single dose |
|
| Celecoxib 400 mg |
| BG003 | Placebo |
| BG004 | 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 |
| Celecoxib 400 mg |
| OG003 | Placebo |
|
|
|
| 0 |
| 50 |
| 19 |
| 50 |
| EG001 | Indomethacin Test (Upper Dose) | Single dose | 0 | 51 | 26 | 51 |
| EG002 | Celecoxib 400 mg | 0 | 51 | 19 | 51 |
| EG003 | Placebo | 0 | 51 | 29 | 51 |
| Dizziness | Nervous system disorders | MedDRA 9.1 or higher | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 9.1 or higher | Systematic Assessment |
|
| Nausea | Nervous system disorders | MedDRA 9.1 or higher | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | 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 |
|
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| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001555 |
| Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011720 | Pyrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |