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: 0581 NCT Study Phase: N/A Official Study Title: Multicenter study of the efficacy and tolerability of clotrimazole 10% vaginal cream in the treatment of vaginal candidosis Therapeutic Area: Anti-Infectives Test Product Name of Test Product: Canesten (Clotrimazole, BAYB5097), 10% vaginal cream Name of Active Ingredient: Dose and Mode of Administration: bis-phenyl(2-chlorophenyl)-1-imidazolyl-methane (Clotrimazole) Single application of 5 g of Bay B % vaginal cream inserted into the vagina at night before retiring to bed using a pre-filled applicator. The subject's partner applied clotrimazole 1% cream at the discretion of the investigator. Reference Therapy/Placebo Reference Therapy: Not applicable Dose and Mode of Administration: Not applicable Duration of Treatment: Duration of treatment was one day. Studied period: Date of first subjects first visit: January 1985 Date of last subjects last visit: August 1985 Page 1 of 4

3 Study Center(s): The study was conducted at eight sites in the United Kingdom. Methodology: This was a multicenter, open, non-comparative study of a single dose of BAY B % vaginal cream to test the efficacy (clinical and mycological) and tolerability in subjects with vaginal candidosis. A total of 87 females with signs and symptoms of vaginal candidosis were enrolled into the study. Single application of 5 g of BAY B % cream into the vagina was carried out with the aid of a pre-filled applicator at night before retiring to bed. Indication/ Main Inclusion Criteria: Study Objectives: High vaginal swabs were taken for mycological study by microscopy and culture prior to commencement of treatment, and seven and 35 days after the commencement of treatment respectively. Seven days and 35 days after commencement of treatment, the therapeutic results were evaluated based on mycological tests (microscopy and culture) and clinical findings, the latter being assessed by itching, burning and discharge. The acceptability and local tolerance to the drug was also evaluated. All data were recorded in subject sheets suitable for documentation. Indication: Vaginal candidosis Inclusion criteria: Female subjects over the age of 16 years, presenting with signs and symptoms of acute vaginal candidosis for the first time in 3 months, were eligible for inclusion in the study providing that they: had no more than two episodes of clinically diagnosed vaginal candidosis in the previous 12 months were not treated with any topical or systemic antifungal within the previous four weeks had no history of any hypersensitivity reactions to the trial medication were not known to have any concurrent or mixed vaginal infection requiring additional therapy were not known to be pregnant had no history of using any concurrent antibiotic or immunosuppressive therapy Overall: To investigate the therapeutic activity and tolerability of BAY B % vaginal cream in subjects suffering from vaginal candidosis. Primary: To demonstrate therapeutic activity and local tolerability of BAY B % vaginal cream. Page 2 of 4

4 Evaluation Criteria: Efficacy (Primary): Before the start of treatment, brief subject details, medical history and details of the infection were recorded. The severity of infection was classified according to the four point scale on the basis of the clinical findings: 0: none 1: mild 2: moderate 3: severe The following criteria were taken into consideration as evidence of disease and of therapeutic result (prior to commencement and seven days and 35 days after the commencement of treatment): Detection of the pathogen by microscopy and by culture Clinical criteria: itching, burning and discharge Safety: Tolerance by the subject to the test drug Statistical Methods: Efficacy (Primary): The results for the subjects were given as percentages according to age, sex, diagnosis, mycological and clinical findings and success of therapy. Safety: Data regarding tolerability of the drug was collected. Number of Subjects: The study was planned for 10 centers, with a maximum of 15 subjects per center. Eighty-seven subjects were enrolled at eight centers. Out of the 87, 12 were omitted from analysis. Seventy-five subjects were valid for assessment of acceptability and tolerability, including 18 subjects who were otherwise indeterminate for assessment of clinical and mycological efficacy. Fifty-seven subjects were available for analysis of efficacy. Of these, 49 had acute vaginal candidosis and eight had recurrent vaginal candidosis. Study Results Results Summary Subject Disposition and Baseline Eighty-seven subjects were enrolled in the study. Out of the 87 subjects, 12 were omitted from analysis since they defaulted from any follow-up. Seventy-five subjects were valid for assessment including 18 subjects who were otherwise indeterminate for clinical and mycological efficacy. There were therefore 57 subjects available for analysis of efficacy: 49 subjects with acute vaginal candidosis and eight with recurrent vaginal candidosis. The majority of subjects were between 18 and 39 years of age (median age: 23.7; Range: 17-45). Page 3 of 4

5 None of the subjects were pregnant. 12% had completed a course of systemic antibiotics within the previous four weeks. The majority of subjects (62.7%) used oral contraceptives. Thirty-seven subjects (49.3%) had experienced no previous episodes of vaginal candidosis and 8 subjects (10.7%) had more than two previous episodes. The mean duration of the episode of vaginal candidosis was 13.4 days. In the majority of the subjects (58.6%) the duration was seven days or less. In 70 subjects (93.4%), mycology results (according to culture) were positive, with Candida albicans identified as the predominant organism. Results Summary Efficacy Fifty-seven subjects were available for analysis of efficacy, including 49 with acute vaginal candidosis and eight with recurrent vaginal candidosis. Forty-five subjects (79%) were mycologically cured after treatment. At follow-up, nine subjects (26.5%) who returned were reinfected. Of the subjects with acute vaginal candidosis, 39 (78%) were cured. At follow-up, eight (27.6%) were reinfected. Of the subjects with recurrent vaginal candidosis, six (85.7%) of the subjects were cured. At followup one subject (20%) had become reinfected. Therapeutic success was assessed at the end of treatment based on clinical findings. Of the 57 subjects, "cure" was achieved in 46 subjects (80.7%), "improvement" in seven subjects (12.3%). Four subjects (7%) were therapeutic failures. At follow-up, four subjects (11.8%) had relapsed. Of the subjects with acute vaginal candidosis, 40 subjects (80%) were "cured", six (12%) improved, four (8%) failed and at follow-up four (13.8%) relapsed. Of the subjects with recurrent vaginal candidosis, 6 subjects (85.7%) were "cured" and one subject (14.3%) "improved". In this group, no subjects failed and there were no relapses. 88% of the subjects with acute candidosis and 85.7% of the subjects with recurrent candidosis were without symptoms up to 14 days after treatment. Later 13.8% subjects with acute infection relapsed clinically and required retreatment. Results Summary Safety All 75 subjects including the 18 who were otherwise indeterminate for clinical and mycological efficacy were evaluated for assesment of tolerability. 96% of the subjects reported no side effects. Three subjects reported adverse events: one subject reported mild, transient burning immediately after application and one subject reported lower abdominal pain. Both resolved without further action. One subject experienced severe burning and swelling of the vulva that was treated with 1% hydrocortisone cream. All subjects were assessed for acceptability. The majority of subjects (98.7%) indicated that the single dose clotrimazole 10% vaginal cream was satisfactory regarding ease of application. Conclusion(s) Single dose of BAY B % vaginal cream was effective in treating both acute and recurrent vaginal candidosis. In this study, Bay B % vaginal cream was tolerated by 96% of the subjects. Date Created or Date Last Updated: 18 Aug 2011 Page 4 of 4