Efficacy and Safety Study of Miconazole Lauriad to Treat Oropharyngeal Candidiasis in HIV Patients

HIV Infections Clinical Trial

Official title:

A Comparative Randomized, Double-blind, Double-Dummy, Multicenter Study of the Efficacy and Safety of Miconazole Lauriad 50mg Administered Once a Day and Mycelex Troches (Clotrimazole 10mg) Administered Five Times a Day in the Treatment of Oropharyngeal Candidiasis in Immunocompromised Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00390780
• Other study ID #: BA/2004/01/04
• Status: Completed
• Phase: Phase 3
• First received: October 19, 2006
• Last updated: September 5, 2013
• Start date: July 2006
• Est. completion date: January 2008

Study information

• Verified date: February 2013
• Source: Onxeo
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the clinical cure of miconazole Lauriad 50 mg (1x50mg) Bioadhesive buccal tablets compared with clotrimazole troches (5x10mg) after 14 days of treatment (at the test of cure visit, at Day 17-19).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 578
• Est. completion date: January 2008
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with clinical picture of oropharyngeal candidiasis

• Confirmation of oropharyngeal candidiasis by candida culture positive

• HIV-positive patients

• Patients 18 years of age

Exclusion Criteria:

• Patients with signs or symptoms of systemic candidiasis

• Patients with signs or symptoms of esophagitis

• Pregnant or breast-feeding women

• Patients who have taken systemic antifungals within the past 30 days

• Patients who have taken local antifungals within the past 7 days

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Candidiasis
• HIV Infections

Intervention

Drug:
• miconazole Lauriad
50 mg buccal tablet once a day for 14 days
• Clotrimazole
10mg troches administered Five Times a Day for 14 days

Locations

Country	Name	City	State
Canada	Montreal Chest Institutes immunodeficiency clinic	Montreal	Quebec
Canada	Montreal General Hospital	Montreal	Quebec
Canada	University of Ottawa Health Services	Ottawa	Ontario
Canada	Downtown Infectious Disease Clinic	Vancouver	British Columbia
Canada	Providence Health Center British Columbia Centre for excellence in HIV/AIDS	Vancouver	British Columbia
Canada	Health Sciences Center	Winnipeg	Manitoba
United States	Lehigh Valley Hospital Clinical Research Department of Medicine	Allentown	Pennsylvania
United States	Plus Clinic, University of Maryland Dental school	Baltimore	Maryland
United States	University of Alabama, Department of diagnostic Sciences School of Dentistry	Birmingham	Alabama
United States	Department Diagnostics Sciences, UNC	Chapel Hill	North Carolina
United States	Department of oral medicine and diagnostic sciences UIC college of dentistry	Chicago	Illinois
United States	Henry Ford Hospital and Wayne State University, Division of infectious diseases	Detroit	Michigan
United States	University of Connecticut, School of dental medicine	Farmington	Connecticut
United States	Therafirst Medical Center	Fort Lauderdale	Florida
United States	East Carolina University, Brody School of Medicine	Greenville	North Carolina
United States	Bering Omega Dental Clinic	Houston	Texas
United States	Ryan White Title III Clinic	Labelle	Florida
United States	L.A. Gay & Lesbian center, Health & Mental, health services	Los Angeles	California
United States	University of Miami	Miami	Florida
United States	AIDS Community Research Initiative of America	New-York	New York
United States	Eastern Virginia Medical Center, Center for comprehensive care of immune deficiency	Norfolk	Virginia
United States	East Bay AIDS Center	Oakland	California
United States	1401 Noth Palm Canyon	Palm Springs	California
United States	Roger Williams Medical Center	Providence	Rhode Island
United States	University of Oklahoma, College of medicine	Tulsa	Oklahoma
United States	Triple O Medical Services	West Palm Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Onxeo

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Cure (Defined as a Complete Resolution of Signs and Symptoms) After 14 Days of Treatment at the Test of Cure Visit (Day 17-Day 22) Using Murray Scoring Scale	Murray scoring scale range: extent of oral lesions (signs) 0 (none) to 3 (extensive or confluent), ordinal; symptoms (soreness/burning) 0 (absent) to 3 (severe), ordinal. Clinical cure was defined as a complete resolution of signs and symptoms (extent of oral lesions score = 0, symptoms score = 0). Clinical failure was defined as any patient who failed to be clinically cured by the treatment.	17 to 22 days	No
Secondary	Clinical Cure at Day 7 (Using Murray Scoring Scale)	Murray scoring scale range: extent of oral lesions (signs) 0 (none) to 3 (extensive or confluent), ordinal; symptoms (soreness/burning) 0 (absent) to 3 (severe), ordinal. Clinical cure was defined as a complete resolution of signs and symptoms (extent of oral lesions score = 0, symptoms score = 0). Clinical failure was defined as any patient who failed to be clinically cured by the treatment.	7 days	No
Secondary	Clinical Success at Test-of-cure Visit (Day 17-22) (Using Murray Scoring Scale)	Murray scoring scale range: extent of oral lesions (signs) 0 (none) to 3 (extensive or confluent), ordinal; symptoms (soreness/burning) 0 (absent) to 3 (severe), ordinal. Clinical success was defined as clinical cure or clinical improvement. Clinical cure was defined as a complete resolution of signs and symptoms (extent of oral lesions score = 0, symptoms score = 0). Clinical improvement was defined as having no visible lesion (extent of lesions score = 0) and minimal symptoms (soreness/burning score <2). Clinical failure was defined as any patient who failed to be clinically cured by the treatment.	17 to 22 days	No
Secondary	Clinical Success at Day 7 (Using Murray Scoring Scale)	Murray scoring scale range: extent of oral lesions (signs) 0 (none) to 3 (extensive or confluent), ordinal; symptoms (soreness/burning) 0 (absent) to 3 (severe), ordinal. Clinical success was defined as clinical cure or clinical improvement. Clinical cure was defined as a complete resolution of signs and symptoms (extent of oral lesions score = 0, symptoms score = 0). Clinical improvement was defined as having no visible lesion (extent of lesions score = 0) and minimal symptoms (soreness/burning score <2). Clinical failure was defined as any patient who failed to be clinically cured by the treatment.	7 days	No
Secondary	Partial Response at Test of Cure Visit (Days 17-22) Using Murray Scoring Scale	Murray scoring scale range: extent of oral lesions (signs) 0 (none) to 3 (extensive or confluent), ordinal; symptoms (soreness/burning) 0 (absent) to 3 (severe), ordinal. Clinical success was defined as clinical cure or clinical improvement. Partial response is having decrease in Murray extent of oral lesions score by at least 1 level and a stable Murray symptoms score, with partial symptom response defined as having a decrease in the Murray symptoms (soreness/burning) score by at least 1 level and a stable Murray extent of oral lesions score, and partial clinical/symptom response defined as decrease in Murray extent of oral lesions score by at least 1 level and a decrease in the Murray symptoms (soreness/burning) score by at least 1 level	17 to 22 days	No
Secondary	Mycological Cure at the Test of Cure Visit (Day 17-22)	Mycological cure was defined as a patient who had "no yeast isolated" when oral specimens were cultured for fungi.	17 to 22 days	No
Secondary	Relapse at the Late Post-Therapy Visit (Day 35-38)	"Number of patients" represents the number of participants who completed visit 6 (the late post-therapy visit on Days 35-38) and had been a clinical success at test-of-cure visit (visit 5). For this subset of participants, relapse was defined as a patient who responded to treatment by clinical cure or improvement (i.e., "clinical success") on Days 17-22 at the test-of-cure visit (visit 5) and subsequently had an increase in the extent of oral lesions or symptoms, as assessed at the late post-therapy visit on Days 35-38 (visit 6). No relapse indicates participants who were considered a "clinical success" at visit 5 and did not have a subsequent increase in the extent of oral lesions or symptoms, as assessed at the late post-therapy visit (visit 6). The remaining number of participants in the Intent-to-Treat population who did not meet the criteria for relapse assessment at visit 6 is listed under "Not Analyzed-ITT".	35 to 38 days	No
Secondary	Oral Discomfort Using Visual Analog Scale (VAS)	Visual analog scale was used by the patient in the patient diary. The scale ranged from 0 (no oral discomfort) to 10 (maximum oral discomfort)	14 days	No
Secondary	General and Local Tolerability and Oral Discomfort	Overall local adverse reactions, including gingival inflammation, gum pain, alterations in taste of food when eating, alterations in taste when not eating, and dry mouth. Visit 4 occurred on Day 14.	14 days	No
Secondary	Duration of Adhesion of Miconazole Lauriad 50 mg Mucoadhesive Buccal Tablet	The mean durations of adhesion from initiation of treatment to Day 14 of miconazole Lauriad 50 mg mucoadhesive buccal tablet (or, in the case of the Clotrimazole troches treatment arm, the placebo mucoadhesive buccal tablet) were rounded to the nearest hour	14 days	No
Secondary	Systemic Exposure of Miconazole Lauriad 50 mg Bioadhesive Buccal Tablet	Number of patients with detectable plasma concentration at Visit 3 (day 7)	7 days	No
Secondary	Susceptibility of Candida Species by Microdilution Test	minimum inhibitory concentration (MIC) in nonresponders at test-of-cure visit	Initiation of treatment to Day 17 to 22	No
Secondary	Treatment Compliance	Number of patients who were 100% compliant with the treatment regimen	Initiation of treatment to Day 14	No