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Dose response studies The Applicant has presented two phase 2 studies for the claimed indications (for cSSTI: Study 200 and for cIAI: Study 202). Study 200 was a randomized, open-label, comparison study of hospitalized subjects with complicated Skin and Soft Tissue infections in which 160 patients received either tigecycline 25 or 50 mg twice daily with an initial dose of 50 or 100 mg, respectively. The clinical data from this study indicated a trend toward a dose-related clinical cure response (67% and 74%, respectively) and dose-related pathogen eradication (56% and 70%). Also dose-safety relationships appeared evident for the adverse events (AEs) of nausea (22% and 35%) and vomiting (13% and 18%). Since tigecycline is intended for use in complicated infections, efficacy was favoured in benefit/risk -balance, and the greater dosage schedule (50 mg twice daily with an initial dose of 100 mg) was used in all consecutive clinical Phase II and III trials. Study 202 was a phase 2, multicenter, open-label study in hospitalized subjects with complicated intra-abdominal infections in which 111 subjects received an initial IV loading dose of 100 mg of tigecycline followed by 50 mg every 12 hours. Treatment continued for at least 5 days but not more than 14 days. There were no comparator or placebo groups. Overall, it appears that the choice of the dosage regimen for phase 3 studies is based on pharmacokinetic considerations as well as tolerability. The safety profile in these phase 2 studies is consistent with that seen in the larger database of phase 3 clinical trials. However, it should be highlighted that one case of Clostridium difficile associated colitis has been reported in Study 202. Apparently, this was the only one serious case reported of this adverse event for subjects in Phase 2 and 3 trials. Complicated intra-abdominal infections (cIAI) Methods Two pivotal phase 3 trials (studies 301 and 306) have been submitted in support of the indication complicated intra-abdominal infections. Study 301 was carried out in the Western hemisphere, and 306 in worldwide. The study protocols were similar in all essential points. Both phase 3 were multicenter, double-blind (third-party unblinded) studies in which 1568 hospitalised patients (approximately 800 patients per trial) with complicated intra-abdominal infections who were candidates for or had received a laparotomy, laparoscopy, or percutaneous drainage of an intraabdominal abscess were randomized. Key inclusion criteria were the followings: 1. Hospitalized male or female subjects, at least 18 years of age. 2. Candidate for, or had, a laparotomy, laparoscopy, or percutaneous drainage of an intra-abdominal abscess. 3. Complicated intra-abdominal infection, such as: a. An intra-abdominal abscess. b. An intra-abdominal abscess (including liver and spleen) that developed in a postoperative subject who received more than 48 hours but not more than 5 days of a nonstudy antibiotic and an intraabdominal culture was obtained from the infected site. c. Appendicitis complicated by perforation (grossly visible) and abscess or periappendicular abscess. d. Perforated diverticulitis complicated by abscess formation or faecal contamination. e. Complicated cholecystitis with evidence of perforation or empyema. f. Perforation of the large or small intestine with abscess or fecal contamination. g. Purulent peritonitis or peritonitis associated with faecal contamination. h. Gastric or duodenal ulcer perforation with symptoms lasting at least 24 hours before operation. i. Traumatic bowel perforation with symptoms lasting at least 12 hours before operation. 4. No more than 1 dose of an antibiotic (single broad-spectrum agent or 1 dose of each antibiotic in a combination regimen such as metronidazole, ampicillin,gentamicin) after the baseline intra-abdominal culture was obtained from the infected site. [ Last edited by 痴夷子皮 on 2011-1-10 at 13:07 ] |
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