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| ID | Type | Description | Link |
|---|---|---|---|
| WC2055 |
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Randomized, multi-center, double-blind, placebo-controlled 12-week study to assess the safety and efficacy of 3 doses of an oral formulation of Doxycycline oral tablets using the Investigator's Global Assessment (IGA) score and the absolute change from baseline in inflammatory lesion count in patients with moderate to severe facial acne vulgaris. Additionally, the absolute change from baseline in non-inflammatory and total lesions of the active study medication to placebo will be evaluated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Doxycyline 0.6 mg/kg/day | Experimental | Doxycycline dosed at 40 mg/day to subjects of appropriate weights |
|
| Doxycycline 1.2 mg/kg/day | Experimental | Doxycycline dosed at 80 mg/day to subjects of appropriate weights |
|
| Doxycycline 2.4 mg/kg/day | Experimental | Doxycycline dosed at 160 mg/day to subjects of appropriate weights |
|
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Doxycycline 0.6 mg/kg/day | Drug | doxycycline 40 mg/day, oral, 12 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage Patients With Successful Outcome Investigator's Global Assessment (IGA) Score at Week 12, Intent to Treat (ITT) Population | IGA: 0/clear (clear skin no lesions, inflammatory or non-inflammatory), 1/almost clear (rare non-inflammatory lesion w/no more than 1 small inflammatory lesion), 2/mild (some non-inflammatory lesions with no more than a few inflammatory lesions, papules/pustules only, no nodular lesions), 3/moderate (up to many non-inflammatory lesions, some inflammatory lesions, no more than 1 small nodular lesion), 4/severe (many non-inflammatory & inflammatory lesions, no more than a few nodular lesions. Lower score improvement in score. Success=IGA decrease of at least 2 grades from baseline score. | Week 12 |
| Absolute Change in Inflammatory Lesion Count From Baseline to Week 12, ITT Population | Change derived as Baseline evaluation minus the Week 12 evaluation. Thus a positive change reflects a reduction in lesion count. Inflammatory Lesion Count includes nodules, papules and pustules. | Baseline to Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Absolute Change From Baseline to Week 12 in NonInflammatory Lesion Count, ITT Population | Noninflammatory Lesion Count includes open and closed comedones. | Baseline to Week 12 |
| Absolute Change From Baseline to Week 12 in Total Lesion Count, ITT Population |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Angelo Secci, MD | Warner Chilcott | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Warner Chilcott Investigational Site | Encino | California | 91436 | United States | ||
| Warner Chilcott Investigational Site |
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Recruitment began 4 Mar '08
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| ID | Title | Description |
|---|---|---|
| FG000 | Doxycycline 0.6 mg/kg/Day | 40 mg doxycycline tablet plus 2 placebo tablets daily |
| FG001 | Doxycycline 1.2 mg/kg/Day | 80 mg doxycycline (1-80 mg tablet) plus 2 placebo tablets daily |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Doxycycline 1.2 mg/kg/day |
| Drug |
doxycycline 80 mg/day, 12 weeks |
|
| Doxycycline 2.4 mg/kg/day | Drug | doxycycline 160 mg/day, 12 weeks |
|
| Placebo | Drug | Placebo, 12 weeks |
|
Total Lesion Count is the sum of inflammatory and noninflammatory lesions. |
| Baseline to Week 12 |
| Fremont |
| California |
| 94538 |
| United States |
| Warner Chilcott Investigational Site | Los Angeles | California | 90045 | United States |
| Warner Chilcott Investigational Site | Sacramento | California | 95816 | United States |
| Warner Chilcott Investigational Site | Denver | Colorado | 80210 | United States |
| Warner Chilcott Investigational Site | Miami | Florida | 33175 | United States |
| Warner Chilcott Investigational Site | Newnan | Georgia | 30263 | United States |
| Warner Chilcott Investigational Site | Snellville | Georgia | 30078 | United States |
| Warner Chilcott Investigational Site | Louisville | Kentucky | 40217 | United States |
| Warner Chilcott Investigational Site | Clinton Township | Michigan | 48038 | United States |
| Warner Chilcott Investigational Site | Albuquerque | New Mexico | 87106-5239 | United States |
| Warner Chilcott Investigational Site | Rochester | New York | 14623 | United States |
| Warner Chilcott Investigational Site | Winston-Salem | North Carolina | 27103 | United States |
| Warner Chilcott Investigational Site | Cincinnati | Ohio | 45219 | United States |
| Warner Chilcott Investigational Site | Portland | Oregon | 97210 | United States |
| Warner Chilcott Investigational Site | Broomall | Pennsylvania | 19008 | United States |
| Warner Chilcott Investigational Site | Fort Washington | Pennsylvania | 19034 | United States |
| Warner Chilcott Investigational Site | Austin | Texas | 78759 | United States |
| Warner Chilcott Investigational Site | College Station | Texas | 77845 | United States |
| Warner Chilcott Investigational Site | Dallas | Texas | 75246 | United States |
| Warner Chilcott Investigational Site | Houston | Texas | 77056 | United States |
| Warner Chilcott Investigational Site | San Antonio | Texas | 78229 | United States |
| Warner Chilcott Investigational Site | Spokane | Washington | 99204 | United States |
| FG002 | Doxycycline 2.4 mg/kg/Day | 160 mg doxycyline (2-80 mg tablets) plus 1 placebo tablet daily |
| FG003 | Placebo Comparator | 3 placebo tablets daily matching active 40 & 80 mg tablets |
| COMPLETED |
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| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Doxycycline 0.6 mg/kg/Day | 40 mg doxycycline tablet plus 2 placebo tablets daily |
| BG001 | Doxycycline 1.2 mg/kg/Day | 80 mg doxycycline (1-80 mg tablet) plus 2 placebo tablets daily |
| BG002 | Doxycycline 2.4 mg/kg/Day | 160 mg doxycyline (2-80 mg tablets) plus 1 placebo tablet daily |
| BG003 | Placebo Comparator | 3 placebo tablets daily matching active 40 & 80 mg tablets |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Age, Customized | Number | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
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| 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 | Percentage Patients With Successful Outcome Investigator's Global Assessment (IGA) Score at Week 12, Intent to Treat (ITT) Population | IGA: 0/clear (clear skin no lesions, inflammatory or non-inflammatory), 1/almost clear (rare non-inflammatory lesion w/no more than 1 small inflammatory lesion), 2/mild (some non-inflammatory lesions with no more than a few inflammatory lesions, papules/pustules only, no nodular lesions), 3/moderate (up to many non-inflammatory lesions, some inflammatory lesions, no more than 1 small nodular lesion), 4/severe (many non-inflammatory & inflammatory lesions, no more than a few nodular lesions. Lower score improvement in score. Success=IGA decrease of at least 2 grades from baseline score. | ITT Population | Posted | Number | 95% Confidence Interval | Percentage of Participants | Week 12 |
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| Primary | Absolute Change in Inflammatory Lesion Count From Baseline to Week 12, ITT Population | Change derived as Baseline evaluation minus the Week 12 evaluation. Thus a positive change reflects a reduction in lesion count. Inflammatory Lesion Count includes nodules, papules and pustules. | ITT Population | Posted | Mean | Standard Deviation | Lesions | Baseline to Week 12 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Absolute Change From Baseline to Week 12 in NonInflammatory Lesion Count, ITT Population | Noninflammatory Lesion Count includes open and closed comedones. | ITT Population | Posted | Mean | Standard Deviation | Lesions | Baseline to Week 12 |
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| Secondary | Absolute Change From Baseline to Week 12 in Total Lesion Count, ITT Population | Total Lesion Count is the sum of inflammatory and noninflammatory lesions. | ITT Population | Posted | Mean | Standard Deviation | Lesions | Baseline to Week 12 |
|
|
4 Mar 2008 thru 6 Nov 2008
12 week treatment period for each participant
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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 | Doxycycline 0.6 mg/kg/Day | 40 mg doxycycline tablet plus 2 placebo tablets daily | 0 | 64 | 22 | 64 | ||
| EG001 | Doxycycline 1.2 mg/kg/Day | 80 mg doxycycline (1-80 mg tablet) plus 2 placebo tablets daily | 0 | 65 | 20 | 65 | ||
| EG002 | Doxycycline 2.4 mg/kg/Day | 160 mg doxycyline (2-80 mg tablets) plus 1 placebo tablet daily | 0 | 61 | 29 | 61 | ||
| EG003 | Placebo Comparator | 3 placebo tablets daily matching active 40 & 80 mg tablets | 1 | 67 | 25 | 67 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fracture (Left Radius) | Injury, poisoning and procedural complications | MedDRA (11.0) | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Systematic Assessment |
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| Dermatitis Contact | Skin and subcutaneous tissue disorders | MedDRA (11.0) | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
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| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA (11.0) | Systematic Assessment |
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| Fungal Infection | Skin and subcutaneous tissue disorders | MedDRA (11.0) | Systematic Assessment |
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| Gastroenteritis | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Systematic Assessment |
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| Nasopharyngitis | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
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| Pharyngolaryngeal Pain | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
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| Procedural Pain | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
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| Seasonal Allergy | Immune system disorders | MedDRA (11.0) | Systematic Assessment |
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| Sunburn | Injury, poisoning and procedural complications | MedDRA (11.0) | Systematic Assessment |
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| Toothache | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
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| Upper Respiratory Tract Infection | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Grexan Wulff, Manager Regulatory Affairs | Warner Chilcott | 973-442-3376 | gwulff@wcrx.com |
| ID | Term |
|---|---|
| D000152 | Acne Vulgaris |
| ID | Term |
|---|---|
| D017486 | Acneiform Eruptions |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012625 | Sebaceous Gland Diseases |
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| ID | Term |
|---|---|
| D004318 | Doxycycline |
| ID | Term |
|---|---|
| D013754 | Tetracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
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| < 18 years |
|
| Male |
|
Stratified by Investigational Site |
| 0.983 |
| Mean Change from Baseline |
| -0.69 |
| Standard Deviation |
| 0.90 |
| 2-Sided |
| 95 |
| -13.7 |
| 11.7 |
| No |
| Superiority or Other |
| Cochran-Mantel-Haenszel | Stratified by Investigational Site | 0.087 | Mean Change from Baseline | -0.92 | Standard Deviation | 0.97 | 2-Sided | 95 | -1.5 | 27.3 | No | Superiority or Other |
| Units | Counts |
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| Participants |
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| Participants |
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| Participants |
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