E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Secondarily-Infected Dermatoses |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 7.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10012470 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The primary objective of this study is to demonstrate that topical 1% SB-275833 ointment, applied twice daily for 5 days, is at least as effective clinically as oral cephalexin, 500mg in adults, or 12.5mg/kg in children, twice daily for 10 days, in the treatment of secondarily-infected dermatoses, including atopic dermatitis, psoriasis and allergic contact dermatitis |
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E.2.2 | Secondary objectives of the trial |
The secondary objective of this study is to evaluate the bacteriological efficacy and safety of topical 1% SB-275833 ointment, applied twice daily for 5 days and oral cephalexin, 500mg in adults, or 12.5mg/kg in children, twice daily for 10 days, in the treatment of secondarily-infected dermatoses |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
A subject will be eligible for inclusion in this study only if all of the following criteria apply: 1. The subject is 13 years of age. 2. The subject and/or parent/legal guardian has given written informed, dated consent to participate in the study. 3. The subject has a diagnosis of atopic dermatitis, psoriasis or allergic contact dermatitis. 4. The subject has one or more of the following clinical signs and symptoms of secondary infection: a sudden exacerbation of the underlying dermatosis, crusting, weeping, small superficial pustules, or purulent discharge. 5. The subject has a secondarily infected dermatosis which is suitable for treatment with oral or topical antibacterial therapy. 6. The infected lesion/lesions is/are 100 cm2 in area, or up to a maximum of 2% body surface area for subjects < 18 years of age. 7. The subject has a Skin Infection Rating Scale score of at least 8 (see Appendix A). 8. The subject has had a negative urine pregnancy test prior to enrollment (if of childbearing potential). 9. The subject is willing and able to comply with the study protocol. Additional Pediatric Inclusion Criteria (pending IDMC review of Studies 275833/030A and 275833/030B): 10. The subject is 9 months of age. 11. The parent/legal guardian is willing to comply with the protocol. 12. The parent/legal guardian has given written informed, dated consent for the subject to participate in the study
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E.4 | Principal exclusion criteria |
A subject will not be eligible for inclusion in this study if any of the following criteria apply: 1. The subject has demonstrated a previous hypersensitivity reaction to penicillins, cephalosporins, or other beta-lactam antibiotics, or the subject has demonstrated a previous hypersensitivity reaction to pleuromutilin or any component of the ointment (refer to the Investigator Brochure [GlaxoSmithKline Document Number UM2003/00089/00] for composition of 1% SB-275833 ointment). 2. The subject has a chronic ulcerative lesion that is unlikely to have Staphylococcus aureus or Streptococcus pyogenes as the causative agent. 3. The subject has systemic signs and symptoms of infection (such as fever; defined as an oral temperature greater than 101° F or 38.3° C). 4. The subject requires surgical intervention, such as incision and drainage, for treatment of the infection prior to enrollment in the study, or is likely to require such intervention during the course of the study. 5. The subject has received one or more days of treatment with a systemic and/or topical antibacterial within 72 hours of study entry. 6. The subject is receiving systemic corticosteroids at a dose of >10mg per day of prednisone (or the equivalent). 7. The subject is receiving concomitant renal tubular secretion inhibitors (e.g., probenecid). 8. The subject has a serious underlying disease that could be imminently life-threatening. 9. The subject is pregnant, breast feeding or planning a pregnancy during the study, or of childbearing potential or less than one year post-menopausal and not using an accepted method of contraception (i.e., surgical sterilization, intra-uterine contraceptive device, oral contraception plus barrier contraception, other hormone delivery systems plus barrier contraception, diaphragm or condom in combination with contraceptive cream, jelly or foam) . 10. The subject has used an investigational drug within 30 days prior to entering the study. 11. The subject has been previously enrolled in this study or in any other study involving SB-275833.
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E.5 End points |
E.5.1 | Primary end point(s) |
Clinical response at follow-up (7-9 days post-therapy; day 12-14 for 1% SB-275833 ointment and day 17-19 for cephalexin) The hypothesis to be tested by the primary endpoint is that the clinical efficacy at follow-up of 1% SB-275833 ointment b.i.d. in the treatment of subjects with SID is non-inferior to subjects treated with cephalexin
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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Last subject last visit (visit 5) |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 6 |