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The purposes of this study are to evaluate the safety and tolerability and to model the single-dose pharmacokinetic profile of diclofenac capsules low dose and high dose in children ages 6 to <17 years experiencing mild to moderate acute postoperative pain.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diclofenac Capsules low dose | Experimental | Diclofenac Capsules low dose three times daily for up to three days |
|
| Diclofenac Capsules high dose | Experimental | Diclofenac Capsules high dose three times daily for up to three days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diclofenac Capsules low dose | Drug |
| ||
| Diclofenac Capsules high dose |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma Concentration of Diclofenac | The estimated typical value for clearance (tvCl) following a single diclofenac dose based on population pharmacokinetic (PopPK) modeling using sparse plasma concentration data in pediatric subjects. | 0-6 hours after first dose of diclofenac |
| Measure | Description | Time Frame |
|---|---|---|
| Safety of Diclofenac Capsules Low Dose and High Dose as Assessed by the Incidence of Adverse Events From Baseline to Day 3 or Early Termination | Baseline to Day 3/Early Termination |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sheffield | Alabama | 35660 | United States | |||
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| ID | Title | Description |
|---|---|---|
| FG000 | Diclofenac Capsules Low Dose | Diclofenac Capsules low dose three times daily for up to three days Diclofenac Capsules low dose |
| FG001 | Diclofenac Capsules High Dose | Diclofenac Capsules high dose three times daily for up to three days Diclofenac Capsules high dose |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Drug |
|
| Little Rock |
| Arkansas |
| 72202 |
| United States |
| Durham | North Carolina | 27705 | United States |
| Oklahoma City | Oklahoma | 73104 | United States |
| Philadelphia | Pennsylvania | 19104 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Safety Population (all subjects receiving at least one dose of study medication)
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| ID | Title | Description |
|---|---|---|
| BG000 | Diclofenac Capsules Low Dose | Diclofenac Capsules low dose three times daily for up to three days Diclofenac Capsules low dose |
| BG001 | Diclofenac Capsules High Dose | Diclofenac Capsules high dose three times daily for up to three days Diclofenac Capsules high dose |
| BG002 | Total | Total of all reporting groups |
| 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 | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Weight | Mean | Standard Deviation | kg |
| |||||||||||||||||
| Weight Group | Count of Participants | 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 | Plasma Concentration of Diclofenac | The estimated typical value for clearance (tvCl) following a single diclofenac dose based on population pharmacokinetic (PopPK) modeling using sparse plasma concentration data in pediatric subjects. | Pharmacokinetic (PK) population. Defined as all subjects who received at least one dose of study drug and had at least one quantifiable plasma diclofenac concentration after dosing. | Posted | Mean | Standard Error | mL/hr | 0-6 hours after first dose of diclofenac |
|
|
| ||||||||||||||||||||||||||||
| Secondary | Safety of Diclofenac Capsules Low Dose and High Dose as Assessed by the Incidence of Adverse Events From Baseline to Day 3 or Early Termination | Not Posted | Baseline to Day 3/Early Termination | Participants |
Adverse Events (AEs) were collected from the signing of the informed consent document, through the study follow up visit (approximately 1 week after the final dose of diclofenac).
Standard AE definitions were used. AE data were collected using non-leading questioning for subjects who were inpatients, and were collected using a take-home signs and symptoms diary (with parent/guardian assistance) for outpatient subjects. Daily phone calls were made to outpatient subjects to ensure compliance with diary collection procedures.
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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 | Diclofenac Capsules Low Dose | Diclofenac Capsules low dose three times daily for up to three days Diclofenac Capsules low dose | 0 | 15 | 1 | 15 | 7 | 15 |
| EG001 | Diclofenac Capsules High Dose | Diclofenac Capsules high dose three times daily for up to three days Diclofenac Capsules high dose | 0 | 15 | 0 | 15 | 7 | 15 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Postoperative abcess | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Pain | General disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Pharyngitis streptococcal | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA (18.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Rash pruritic | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| SVP Medical Affairs, Pharmacovigilance and Medical Information | Iroko Pharmaceuticals | 2675463003 | 3182 | eoimagosie@iroko.com |
| 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 |
|---|---|
| D004008 | Diclofenac |
| ID | Term |
|---|---|
| D010648 | Phenylacetates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
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| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| >/=35 kg |
|