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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
BioAlliance Pharma SA
ClinicalTrials.gov Identifier:
NCT00390780
First received: October 19, 2006
Last updated: September 5, 2013
Last verified: February 2013

October 19, 2006
September 5, 2013
July 2006
December 2007   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
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.
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 19) using the scoring scale of Murray
Complete list of historical versions of study NCT00390780 on ClinicalTrials.gov Archive Site
  • Clinical Cure at Day 7 (Using Murray Scoring Scale) [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    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.
  • Clinical Success at Test-of-cure Visit (Day 17-22) (Using Murray Scoring Scale) [ Time Frame: 17 to 22 days ] [ Designated as safety issue: No ]
    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.
  • Clinical Success at Day 7 (Using Murray Scoring Scale) [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    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.
  • Partial Response at Test of Cure Visit (Days 17-22) Using Murray Scoring Scale [ Time Frame: 17 to 22 days ] [ Designated as safety issue: No ]
    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
  • Mycological Cure at the Test of Cure Visit (Day 17-22) [ Time Frame: 17 to 22 days ] [ Designated as safety issue: No ]
    Mycological cure was defined as a patient who had "no yeast isolated" when oral specimens were cultured for fungi.
  • Relapse at the Late Post-Therapy Visit (Day 35-38) [ Time Frame: 35 to 38 days ] [ Designated as safety issue: No ]
    "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".
  • Oral Discomfort Using Visual Analog Scale (VAS) [ Time Frame: 14 days ] [ Designated as safety issue: No ]
    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)
  • General and Local Tolerability and Oral Discomfort [ Time Frame: 14 days ] [ Designated as safety issue: No ]
    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.
  • Duration of Adhesion of Miconazole Lauriad 50 mg Mucoadhesive Buccal Tablet [ Time Frame: 14 days ] [ Designated as safety issue: No ]
    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
  • Systemic Exposure of Miconazole Lauriad 50 mg Bioadhesive Buccal Tablet [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    Number of patients with detectable plasma concentration at Visit 3 (day 7)
  • Susceptibility of Candida Species by Microdilution Test [ Time Frame: Initiation of treatment to Day 17 to 22 ] [ Designated as safety issue: No ]
    minimum inhibitory concentration (MIC) in nonresponders at test-of-cure visit
  • Treatment Compliance [ Time Frame: Initiation of treatment to Day 14 ] [ Designated as safety issue: No ]
    Number of patients who were 100% compliant with the treatment regimen
  • Clinical cure at Day 7
  • Clinical success rates at Day 7 and at the Test of Cure visit (Day 17-19)
  • Microbiological cure at the Test of Cure visit (Day 17-19)
  • Rate of relapse at Day 35-38
  • General and local tolerability and oral discomfort
  • Duration of adhesion of miconazole Lauriad 50 mg bioadhesive buccal tablet
  • Systemic exposure of miconazole Lauriad 50 mg bioadhesive buccal tablet
  • Susceptibility of Candida species by microdilution test
  • Compliance
Not Provided
Not Provided
 
Efficacy and Safety Study of Miconazole Lauriad to Treat Oropharyngeal Candidiasis in HIV Patients
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

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).

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
HIV Infections
  • Drug: miconazole Lauriad
    50 mg buccal tablet once a day for 14 days
  • Drug: Clotrimazole
    10mg troches administered Five Times a Day for 14 days
  • Active Comparator: Clotrimazole
    Clotrimazole troches, 10 mg, 5 times per day for 14 days
    Intervention: Drug: Clotrimazole
  • Experimental: miconazole Lauriad
    Miconazole Lauriad 50 mg mucoadhesive buccal tablet, once daily, for 14 days
    Intervention: Drug: miconazole Lauriad
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
578
January 2008
December 2007   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00390780
BA/2004/01/04
Yes
BioAlliance Pharma SA
BioAlliance Pharma SA
Not Provided
Not Provided
BioAlliance Pharma SA
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP