Clinical Study Synopsis

Transcription

1 Clinical Study Synopsis This document is not intended to replace the advice of a healthcare professional and should not be considered as a recommendation. Patients should always seek medical advice before making any decisions on their treatment. Healthcare Professionals should always refer to the specific labeling information approved for the patient's country or region. Data in this document or on the related website should not be considered as prescribing advice. The study listed may include approved and non-approved formulations or treatment regimens. Data may differ from published or presented data and are a reflection of the limited information provided here. The results from a single trial need to be considered in the context of the totality of the available clinical research results for a drug. The results from a single study may not reflect the overall results for a drug. The following information is the property of Bayer HealthCare AG. Reproduction of all or part of this report is strictly prohibited without prior written permission from Bayer HealthCare AG. Commercial use of the information is only possible with the written permission of the proprietor and is subject to a license fee. Please note that the General Conditions of Use and the Privacy Statement of bayerhealthcare.com apply to the contents of this file.

2 Clinical Trial Results Synopsis Study Design Description Study Sponsor: Bayer Healthcare AG Study Number: 0595 Study Phase: Not available NCT Official Study Title: Comparative study on the efficacy of clotrimazole vaginal cream 10% and econazole depot ovule 150 mg in the treatment of Candida vaginitis Therapeutic Area: Anti-Infectives Test Product Name of Test Product: Canesten (Clotrimazole, BAYB5097) Name of Active Ingredient: Dose and Mode of Administration: bis-phenyl-(2-chlorophenyl)-1-imidazolyl-methane (Clotrimazole) One single local administration of five grams of BAY B 5097 vaginal cream 10% Reference Therapy/Placebo Reference Therapy: Econazole ovula 150 mg Dose and Mode of Administration: One ovulum of 150mg econazole daily for three consecutive days Duration of Treatment: BAY B 5097 vaginal cream 10%: one day Studied period: Econazole ovula: three days Date of first subjects first visit: Aug 1985 Date of last subjects last visit: Dec 1985 Study Center(s): This study was conducted at a single site in Italy. Methodology: This was a controlled, single-blind, comparative study to evaluate the efficacy and tolerability of BAY B 5097 vaginal cream 10% compared to econazole ovula 150 mg for the treatment of vaginal infections caused by Candida albicans. Forty subjects were enrolled in the study and were randomized to two groups of 20 subjects each. The mycological investigations confirmed the presence of Candida in all cases. Group A: BAY B 5097 (Clotrimazole) vaginal cream 10%, single application of 5 g Group B: Econazole ovula 150 mg once daily for three consecutive days Therapeutic results were assessed on the basis of clinical and Page 1 of 4

3 Indication/ Main Inclusion Criteria: Study Objectives: Evaluation Criteria: mycological parameters in basal conditions, and one and four weeks after treatment. Indication Vaginal Candida infections Inclusion criteria: Age >16 years Symptoms of vaginal Candida infection Diagnosis confirmed using mycological and culture examinations Overall: To compare the efficacy and tolerability of BAY B 5097 vaginal cream 10% and econazole depot ovule 150 mg in the treatment of Candida vaginitis. Primary: To compare the efficacy of BAY B 5097 vaginal cream 10% and econazole depot ovule 150 mg in the treatment of Candida vaginitis Tolerance of the subjects to the study drugs Efficacy (Primary): Clinical and mycological parameters were investigated in basal conditions, and one and four weeks after treatment. Mycological evaluations were based on the results of direct microscopic and culture examinations and were categorized as follows: Complete elimination of the Candida Elimination with relapse (or re-infection) Persistency Indeterminate Clinical response was assessed at the two follow-up visits according to the categories below: Complete resolution : Disappearance of all signs and symptoms related to the infection Clear improvement : Disappearance of most signs and symptoms of the infection. The remaining signs and symptoms are mild. Slight improvement : Disappearance of some signs and symptoms of the infection or alleviation of most of them. Recidivation : Disappearance of signs and symptoms of the infection at the first control after the treatment but their reappearance at the last follow-up visit. Failure : Mild improvement, no alteration or worsening of the signs and symptoms of the infection. Indeterminate result : Simultaneous treatment with other antiinfective or its use during the follow-up period for other reasons than relapse or failure. Clinical response not evaluable for any other reason. Page 2 of 4

4 Statistical Methods: Safety: The tolerance by the subject to the test drug was evaluated. Side effects were assessed for their frequency, intensity, need of therapy and for their correlation with the study treatment. Efficacy: Chi-square test with Yates correction. Safety: No statistical analyses were planned for this study. Number of Subjects: Forty subjects were enrolled in the study and were randomized to two groups of 20 subjects each. Study Results Results Summary Subject Disposition and Baseline Twenty subjects randomized to the BAY B 5097 vaginal cream 10% group had a mean age of 34.1±9.7 years with a range of years. Twenty subjects randomized to Econazole ovula 150 mg group had a mean age of 31.2±8.4 years with a range of years. Results Summary Efficacy Clinical results: During the first control, clinical results were positive in all subjects of BAY B 5097 group. Complete resolution was seen in 70% subjects, clear improvement or slight improvement was seen in 15% subjects, respectively. In subjects randomized to Econazole ovula group, complete resolution was seen in 50% subjects, clear improvement was seen in 35% subjects and slight improvement was seen in 10% subjects. During the second control visit, complete resolution was established in 85% subjects of BAY B 5097 group, with a marked improvement in one subject and two recidivations. In Econazole group, complete resolution was seen in 70% subjects and clear improvement was seen in 15% subjects. Treatment failure was seen in one subject and recidivation was seen in one subject. The results of one subject were considered "indetermined" due to use of another antimycotic agent in combination with econazole. Mycological results: One week after treatment, the mycological investigations were negative in 95% subjects of BAY B 5097 group and 85% subjects of econazole group. Three weeks later, two recidivations had occurred in both groups. In one subject of econazole group, it was not possible to carry out the mycological tests. Results Summary Safety Both BAY B 5097 vaginal cream 10% and econazole ovula 150mg were tolerated in all subjects and no systemic or local adverse effects were observed. Page 3 of 4

5 Conclusion(s) On the basis of clinical and mycological findings, one day therapy with BAY B 5097 (clotrimazole) vaginal cream 10% was effective in the treatment of Candida vaginitis in this study. The product was well tolerated, no systemic or local side effects were observed. Date Created or Date Last Updated: 29 Aug 2011 Page 4 of 4