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

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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:
Information provided by (Responsible Party):

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
Primary Completion Date : December 2007
Study Completion Date : January 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00390780


  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    Key Record Dates
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:
HIV Infections
Candidiasis
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
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