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The purpose of this study is to determine if the calcitriol absorption in pediatric subjects is comparable to that in adults and adolescents, with no significant impact on calcium/phosphorus metabolism.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Calcitriol 3 mcg/g ointment | Experimental | Topical application every 12 hours for 14 consecutive days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Calcitriol 3 mcg/g ointment | Drug | Topical ointment; twice daily application |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cmax of Calcitriol Plasma Level | Cmax of calcitriol plasma level at Day 14 (Peak plasma concentration of calcitriol from Day 1 to Day 14) | Day 14 |
| Cmin of Calcitriol Plasma Level | Cmin of calcitriol plasma level at Day 14 | Day 14 |
| Tmax of Calcitriol Plasma Level | Tmax of calcitriol plasma level at Day 14 | Day 14 |
| AUC (0-6h) of Calcitriol Plasma Level | AUC (0-6h) of calcitriol plasma level at Day 14 (Pre-dose to 6 hours post-dose) | Day 14 |
| AUC (0-9h) of Calcitriol Plasma Level | AUC (0-9h) of calcitriol plasma level at Day 14 (Pre-dose to 9 hours post-dose. For subjects with a body weight of <15 kg, AUC (0-9h) was extrapolated based on the pre-dose to 6 hours post-dose PK samples.) | Day 14 |
| AUC (0-12h) of Calcitriol Plasma Level | AUC (0-12h) of calcitriol plasma level at Day 14 (For subjects with a body weight of < 15 kg, AUC (0-9h) was extrapolated based on the pre-dose to 6 hours post dose PK samples. For subjects with a body weight of ≥ 15 kg, AUC (0-12h) was extrapolated based on the pre-dose to 9 hours post-dose PK samples.) | Day 14 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Graeber, M.D. | Galderma R&D, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rady Children's Hospital - Pediatric and Adolescent Dermatology | San Diego | California | 92123 | United States | ||
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| ID | Title | Description |
|---|---|---|
| FG000 | Calcitriol 3 mcg/g Ointment | Topical application every 12 hours for 14 consecutive days Calcitriol 3 mcg/g ointment: Topical ointment; twice daily application |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Calcitriol 3 mcg/g Ointment | Topical application every 12 hours for 14 consecutive days Calcitriol 3 mcg/g ointment: Topical ointment; twice daily application |
| 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 | Cmax of Calcitriol Plasma Level | Cmax of calcitriol plasma level at Day 14 (Peak plasma concentration of calcitriol from Day 1 to Day 14) | Safety population: All enrolled subjects having received the treatment at least once. | Posted | Mean | Standard Deviation | pg/mL | Day 14 |
|
|
28 days
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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 | Calcitriol 3 mcg/g Ointment | Topical application every 12 hours for 14 consecutive days Calcitriol 3 mcg/g ointment: Topical ointment; twice daily application |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain upper | Gastrointestinal disorders |
Study was terminated early due to slow enrollment.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael Graeber | Galderma | (817)961-5000 | michael.graeber@galderma.com |
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| ID | Term |
|---|---|
| D002117 | Calcitriol |
| D009824 | Ointments |
| ID | Term |
|---|---|
| D004100 | Dihydroxycholecalciferols |
| D006887 | Hydroxycholecalciferols |
| D002762 | Cholecalciferol |
| D002782 | Cholestenes |
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| Dawes Fretzin Clinical Research Group, LLC |
| Indianapolis |
| Indiana |
| 46256 |
| United States |
| University of Michigan Medical Center | Ann Arbor | Michigan | 48109 | United States |
| University of North Carolina Dermatology and Skin Cancer Center | Chapel Hill | North Carolina | 27516 | United States |
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | United States |
| Menter Dermatology Research Institute | Dallas | Texas | 75246 | United States |
| Clinical Trials of Texas, Inc. | San Antonio | Texas | 78229 | United States |
| Seattle Children's Hospital | Seattle | Washington | 98105 | United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
| Primary | Cmin of Calcitriol Plasma Level | Cmin of calcitriol plasma level at Day 14 | Safety population: All enrolled subjects having received the treatment at least once. | Posted | Mean | Standard Deviation | pg/mL | Day 14 |
|
|
|
| Primary | Tmax of Calcitriol Plasma Level | Tmax of calcitriol plasma level at Day 14 | Safety population: All enrolled subjects having received the treatment at least once. | Posted | Mean | Standard Deviation | hour | Day 14 |
|
|
|
| Primary | AUC (0-6h) of Calcitriol Plasma Level | AUC (0-6h) of calcitriol plasma level at Day 14 (Pre-dose to 6 hours post-dose) | Safety population: All enrolled subjects having received the treatment at least once. | Posted | Mean | Standard Deviation | pg*h/mL | Day 14 |
|
|
|
| Primary | AUC (0-9h) of Calcitriol Plasma Level | AUC (0-9h) of calcitriol plasma level at Day 14 (Pre-dose to 9 hours post-dose. For subjects with a body weight of <15 kg, AUC (0-9h) was extrapolated based on the pre-dose to 6 hours post-dose PK samples.) | Safety population: All enrolled subjects having received the treatment at least once. | Posted | Mean | Standard Deviation | pg*h/mL | Day 14 |
|
|
|
| Primary | AUC (0-12h) of Calcitriol Plasma Level | AUC (0-12h) of calcitriol plasma level at Day 14 (For subjects with a body weight of < 15 kg, AUC (0-9h) was extrapolated based on the pre-dose to 6 hours post dose PK samples. For subjects with a body weight of ≥ 15 kg, AUC (0-12h) was extrapolated based on the pre-dose to 9 hours post-dose PK samples.) | Safety population: All enrolled subjects having received the treatment at least once. | Posted | Mean | Standard Deviation | pg*h/mL | Day 14 |
|
|
|
| 0 |
| 18 |
| 9 |
| 18 |
| Vomiting | Gastrointestinal disorders |
|
| Rhinitis | Infections and infestations |
|
| Viral infection | Infections and infestations |
|
| Sunburn | Injury, poisoning and procedural complications |
|
| Headache | Nervous system disorders |
|
| Pain of skin | Skin and subcutaneous tissue disorders |
|
| Pruritus | Skin and subcutaneous tissue disorders |
|
| Skin burning sensation | Skin and subcutaneous tissue disorders |
|
| Skin exfoliation | Skin and subcutaneous tissue disorders |
|
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| D002776 |
| Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |