Condition category
Infections and Infestations
Date applied
01/06/2010
Date assigned
17/06/2010
Last edited
12/09/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.nitteuniversity.ac.in/

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

  1. 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.

Additional files

Editorial Notes