Contact information
Type
Scientific
Primary contact
Mr Harish Nairy
ORCID ID
Contact details
Department of Pharmaceutics
NGSM Institute of Pharmaceutical Sciences
Paneer
Deralakatte
Karnataka
Mobile Tel: +91 (0)984 4897869
Mangalore
575 018
India
+91 (0)824 2203991
harishnayari@gmail.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Development and evaluation of polymeric in situ gels of antifungal agents for oral candidiasis: A single blind, randomised controlled trial
Acronym
Study hypothesis
1. To assess the effect of fluconazole in situ gels locally applied in the oral cavity on the number of Candida species
2. To assess the therapeutic efficacy of the dosage for in eradiation of local candidiasis
3. To estimate the drug release with respect to time in the oral cavity
4. To understand whether the present dosage will help to improve patient compliance using Likert's rating scale
Ethics approval
Local medical ethics committee at A.B.Shetty Memorial Institute of Dental Sciences approved on the 25th of June 2008 (ref: ABSM/EC/18/2008)
Study design
2 centre single blind randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details below to request a patient information sheet
Condition
Oropharyngeal candidiasis
Intervention
A bicenter, open-label, single blind clinical trial design was followed, to compare the efficacy of fluconazole in situ gel (0.5% w/v) with that of fluconazole tablets (100 mg) for 14 days. The patients with OPC were divided into 3 groups, each comprising of 15 patients.
1. Group I: comprised of patients having HIV/AIDS treated with in situ gel
2. Group II: comprised of patients with partial or complete dentures, treated with in situ gel
3. Group III (active control): comprised of patients with either HIV or partial/complete dentures were treated with fluconazole tablets 100 mg for 14 days given by oral route
Following the initial (base line) visit, the subsequent visits were scheduled on day 3, day 7, day 14, day 22, day 34, and 44th day. The efficacy of the dosage form was compared with tablets for the successful clinical response and changes from baseline for the symptoms of OPC, which included the soreness erythema, extent of oral lesions and quantification of colony forming units (CFU) of Candida spp. Clinical assessment were made and recorded by a Registered clinical practitioners. The severity of baseline symptoms was assessed on a scale of 0 to 3 (0= absent, 1= mild, 2= moderate, 3= severe).
The quantification of CFU of Candida spp., was done by taking oral swabs at three different locations. Oral swabs were then streaked on hichrome® medium. The specimen was examined microscopically for hyphae, colour of colony to distinguish the strain. The microscopic study of the culture was done before the drug was dispensed.
Intervention type
Drug
Phase
Not Specified
Drug names
Fluconazole
Primary outcome measures
The primary efficacy parameter for clinical response was rated according to an evaluations assessment of the change in signs and symptoms from the baseline. The assessment was rated as "cured" (clearance of all signs and symptoms), "improved" (minimal signs and symptoms with no residual visible candida lesions), unchanged (no change in signs and symptoms), or "deteriorated" (worsening or increasing signs and symptoms). Patients with a clinical evaluation of "cured" or "improved" were considered as a successful outcome of the study.
Secondary outcome measures
Secondary efficacy parameters included the quantification in terms of CFUs of Candida spp. and results of culture from swabs taken at the same sites used at baseline. A mycological cure was defined as a yeast quantification of <10 CFU/ml based on comparison of mycological culture from swabs collected from healthy volunteers.
To analyze the data of clinical efficacy statistically, a two-factor repeated measures analysis of variance was used between the treated groups over a period of 44 days. The criterion for significance was set at p<0.05.
Overall trial start date
20/07/2008
Overall trial end date
05/09/2008
Reason abandoned
Eligibility
Participant inclusion criteria
1. Patients of either sex, aged 18 or above
2. HIV-antibody seropositive or with partial or complete denture and the clinical picture of oropharyngeal candidiasis (OPC), which is characterised by creamy, white, curd like patches, removable erythematous lesions on the oral mucosal surfaces
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
45
Participant exclusion criteria
1. History of significant hepatic abnormalities or clinical evidence of significant hepatic diseases within 2 months of entering the study
2. Life expectancy of less than 1 month or a clinical condition such that study completion could not be assured
3. History of hypersensitivity to imidazole or azole compound
4. Patients requiring therapy with other antifungal agents, H2-receptor blockers, antacids, rifampicin, phenobarbital,
pheytoin, carbamazeme, terfenadine, or astimazole
5. Pregnant or lactating females
Recruitment start date
20/07/2008
Recruitment end date
05/09/2008
Locations
Countries of recruitment
India
Trial participating centre
Department of Pharmaceutics
Mangalore
575 018
India
Sponsor information
Organisation
Nitte University (India)
Sponsor details
Paneer
Deralakatte Post
Mangalore
575018
India
+91 (0)824 2204572
absmids@nitte.ac.in
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
Rajiv Gandhi University of Health Sciences (India)
Alternative name(s)
Rajiv Gandhi University of Health Sciences, Karnataka, RGUHS
Funding Body Type
government organisation
Funding Body Subtype
government non-federal
Location
India
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21504616
Publication citations
-
Results
Nairy HM, Charyulu NR, Shetty VA, Prabhakara P, A pseudo-randomised clinical trial of in situ gels of fluconazole for the treatment of oropharngeal candidiasis., Trials, 2011, 12, 99, doi: 10.1186/1745-6215-12-99.