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

• ClinicalTrials.gov Identifier: NCT00390780
• Recruitment Status: Completed
• First Posted: October 20, 2006
• Results First Posted: August 29, 2013
• Last Update Posted: September 16, 2013
• Sponsor: Onxeo
• Information provided by (Responsible Party): Onxeo

Study Description

Brief 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).

Condition or disease	Intervention/treatment	Phase
HIV Infections	Drug: miconazole Lauriad; Drug: Clotrimazole	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 578 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Study Start Date: July 2006
• Actual Primary Completion Date: December 2007
• Actual Study Completion Date: January 2008

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Clotrimazole; Clotrimazole troches, 10 mg, 5 times per day for 14 days	Drug: Clotrimazole; 10mg troches administered Five Times a Day for 14 days
Experimental: miconazole Lauriad; Miconazole Lauriad 50 mg mucoadhesive buccal tablet, once daily, for 14 days	Drug: miconazole Lauriad; 50 mg buccal tablet once a day for 14 days

Outcome Measures

Primary Outcome Measures :

1. 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 [ Time Frame: 17 to 22 days ]
   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.

Secondary Outcome Measures :

1. Clinical Cure at Day 7 (Using Murray Scoring Scale) [ Time Frame: 7 days ]
   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.
2. Clinical Success at Test-of-cure Visit (Day 17-22) (Using Murray Scoring Scale) [ Time Frame: 17 to 22 days ]
   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.
3. Clinical Success at Day 7 (Using Murray Scoring Scale) [ Time Frame: 7 days ]
   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.
4. Partial Response at Test of Cure Visit (Days 17-22) Using Murray Scoring Scale [ Time Frame: 17 to 22 days ]
   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
5. Mycological Cure at the Test of Cure Visit (Day 17-22) [ Time Frame: 17 to 22 days ]
   Mycological cure was defined as a patient who had "no yeast isolated" when oral specimens were cultured for fungi.
6. Relapse at the Late Post-Therapy Visit (Day 35-38) [ Time Frame: 35 to 38 days ]
   "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".
7. Oral Discomfort Using Visual Analog Scale (VAS) [ Time Frame: 14 days ]
   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)
8. General and Local Tolerability and Oral Discomfort [ Time Frame: 14 days ]
   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.
9. Duration of Adhesion of Miconazole Lauriad 50 mg Mucoadhesive Buccal Tablet [ Time Frame: 14 days ]
   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
10. Systemic Exposure of Miconazole Lauriad 50 mg Bioadhesive Buccal Tablet [ Time Frame: 7 days ]
    Number of patients with detectable plasma concentration at Visit 3 (day 7)
11. Susceptibility of Candida Species by Microdilution Test [ Time Frame: Initiation of treatment to Day 17 to 22 ]
    minimum inhibitory concentration (MIC) in nonresponders at test-of-cure visit
12. Treatment Compliance [ Time Frame: Initiation of treatment to Day 14 ]
    Number of patients who were 100% compliant with the treatment regimen

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

  Show 27 Study Locations

Sponsors and Collaborators

Onxeo

More Information

• Responsible Party: Onxeo
• ClinicalTrials.gov Identifier: NCT00390780 History of Changes
• Other Study ID Numbers: BA/2004/01/04
• First Posted: October 20, 2006
• Results First Posted: August 29, 2013
• Last Update Posted: September 16, 2013
• Last Verified: February 2013

Keywords provided by Onxeo:

Miconazole Lauriad; Oropharyngeal candidiasis; HIV patients; Mycology; Clinical picture of Oropharyngeal candidiasis; Candida culture positive; Treatment Experienced

Additional relevant MeSH terms:

Candidiasis; Mycoses; Miconazole; Antifungal Agents; Anti-Infective Agents; 14-alpha Demethylase Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Steroid Synthesis Inhibitors; Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Cytochrome P-450 CYP2C9 Inhibitors; Cytochrome P-450 CYP3A Inhibitors