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Randomized, multi-center, open label, active-comparator study to compare the efficacy and tolerability of Doryx Delayed Release Tablets to doxycycline hyclate in patients with moderate to severe acne vulgaris.
Efficacy of Doryx Delayed Release Tablets to doxycycline hyclate will be assessed using an Investigator's Global Assessment (IGA) score and the absolute change from baseline to 12 weeks in inflammatory lesion count in patients with moderate to severe facial acne vulgaris. Additionally, the absolute change from baseline to 12 weeks in non-inflammatory lesions count of Doryx Delayed Release Tablets compared to doxycycline hyclate will be evaluated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Doxycycline hyclate (Doryx) | Experimental |
| |
| Doxycycline hyclate | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Doxycycline hyclate (Doryx) | Drug | 150mg/day, oral, delayed release tablets |
|
| Measure | Description | Time Frame |
|---|---|---|
| Successful Outcome According to Investigator's Global Assessment (IGA) | The Investigator's Global Assessment (IGA) was performed at baseline and at 12 weeks. The IGA score is based on a 5-point acne severity scale from zero (clear) to 4 (severe). Successful outcome is at least a 2-point reduction in IGA score from baseline to 12 weeks. | baseline and 12 weeks |
| Change From Baseline in Inflammatory Acne Lesion Count on the Face at 12 Weeks | Acne lesions fall into 2 groups: inflammatory and non-inflammatory. The number of inflammatory acne lesions on the face was measured at baseline and after 12 weeks. The difference (change) was calculated. | baseline and 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Non-inflammatory Acne Lesion Count on the Face at 12 Weeks | Acne lesions fall into 2 groups: inflammatory and non-inflammatory. The number of non-inflammatory acne lesions on the face was measured at baseline and after 12 weeks. The difference (change) was calculated. | baseline and 12 weeks |
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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 | Vista | California | 92083 | United States | ||
| Warner Chilcott Investigational Site |
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| ID | Title | Description |
|---|---|---|
| FG000 | Doxycycline Hyclate (Doryx) Delayed-release Tablets | Doxycycline hyclate (Doryx) delayed-release tablets, 150 mg once daily |
| FG001 | Doxycycline Hyclate Immediate-release Tablets | Doxycycline hyclate immediate-release tablets, 100 mg once daily |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Doxycycline Hyclate (Doryx) Delayed-release Tablets | Doxycycline hyclate (Doryx) delayed-release tablets, 150 mg once daily |
| BG001 | Doxycycline Hyclate Immediate-release Tablets |
| 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 | Successful Outcome According to Investigator's Global Assessment (IGA) | The Investigator's Global Assessment (IGA) was performed at baseline and at 12 weeks. The IGA score is based on a 5-point acne severity scale from zero (clear) to 4 (severe). Successful outcome is at least a 2-point reduction in IGA score from baseline to 12 weeks. | Posted | Number | participants | baseline and 12 weeks |
|
12 weeks
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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 Hyclate (Doryx) Delayed-release Tablets | Doxycycline hyclate (Doryx) delayed-release tablets, 150 mg once daily |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute cholecystitis | Hepatobiliary disorders | Non-systematic Assessment | Intensity severe, unlikely related |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Grexan Wulff, Manager Regulatory Affairs | Warner Chilcott | 973-442-3376 | gwulff@wcrx.com |
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| 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 |
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| Doxycycline hyclate | Drug | 100 mg/day, oral, tablets, immediate release |
|
| Miami |
| Florida |
| 33175 |
| United States |
| Warner Chilcott Investigational Site | Louisville | Kentucky | 40217 | United States |
| Warner Chilcott Investigational Site | Rochester | New York | 14623 | United States |
Doxycycline hyclate immediate-release tablets, 100 mg once daily
| BG002 | 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 |
|
| Ethnic Origin | Number | participants |
|
| Race | Number | participants |
|
|
|
|
| Secondary | Change From Baseline in Non-inflammatory Acne Lesion Count on the Face at 12 Weeks | Acne lesions fall into 2 groups: inflammatory and non-inflammatory. The number of non-inflammatory acne lesions on the face was measured at baseline and after 12 weeks. The difference (change) was calculated. | Posted | Mean | Standard Deviation | Acne lesion count | baseline and 12 weeks |
|
|
|
|
| Primary | Change From Baseline in Inflammatory Acne Lesion Count on the Face at 12 Weeks | Acne lesions fall into 2 groups: inflammatory and non-inflammatory. The number of inflammatory acne lesions on the face was measured at baseline and after 12 weeks. The difference (change) was calculated. | intention to treat (ITT) | Posted | Mean | Standard Deviation | acne lesion count | baseline and 12 weeks |
|
|
|
|
| 1 |
| 48 |
| 10 |
| 48 |
| EG001 | Doxycycline Hyclate Immediate-release Tablets | Doxycycline hyclate immediate-release tablets, 100 mg once daily | 1 | 45 | 11 | 45 |
|
| Ruptured ectopic pregnancy | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment | Intensity severe, unlikely related |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Sunburn | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Nasopharyngitis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
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| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |