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Trial record 2 of 6 for:    Clotrimazole AND Oropharyngeal

Clotrimazole vs. Mycelex® in Patients With Human Insufficiency Virus (HIV) Infection for the Treatment of Oropharyngeal Candidiasis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02184351
Recruitment Status : Completed
First Posted : July 9, 2014
Last Update Posted : July 14, 2014
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
The objectives of this study are to compare the efficacy and safety of Roxane's clotrimazole troches vs. Mycelex troches in HIV positive patients with oropharyngeal candidiasis, where this condition has been diagnosed by clinical examination and confirmed by fungal culture.

Condition or disease Intervention/treatment Phase
Candidiasis, Oral Drug: Roxanes's clotrimazole troches Drug: Mycelex® troches Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 187 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: A Prospective Randomized, Blinded Parallel Group Study of Clotrimazole Troches vs. Mycelex® Troches (10 mg Troche Five Times a Day for 14 Days) in Patients With Human Insufficiency Virus (HIV) Infection for the Treatment of Oropharyngeal Candidiasis
Study Start Date : May 2001
Actual Primary Completion Date : November 2001

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Roxanes's clotrimazole troches Drug: Roxanes's clotrimazole troches
Active Comparator: Mycelex® troches Drug: Mycelex® troches

Primary Outcome Measures :
  1. Percent of patients that have a clinical response assessed by symptoms and physical examination [ Time Frame: Day 21 ]

Secondary Outcome Measures :
  1. Incidence of negative fungal cultures of the oropharynx for Candida species [ Time Frame: 7 days after end of treatment ]
  2. Incidence of negative fungal cultures of the oropharynx for Candida species [ Time Frame: after 14 days of treatment ]
  3. Clinical response by symptom assessment and physical examination [ Time Frame: after 7 and 14 days of treatment ]
  4. Assessment of compliance with Treatment by troche Count and Patient interview [ Time Frame: after 7 and 14 days of treatment ]

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Documented HIV positive status
  • Clinical examination of oropharynx is consistent with diagnosis of oral Candidiasis (such as creamy, white, curdlike patches or erythematous lesions on mucosal surfaces)
  • Findings on direct microscopic examination (Gram Stain or potassium hydroxide smear) consistent with Candida species or positive fungal culture for Candida species, with culture obtained in the 2 days preceding initiation of therapy with the study drug
  • Male or female patients ≥ 18 years
  • For women of childbearing potential: negative blood or urine pregnancy test and agreement to use adequate contraception (investigator's discretion) while on study drug
  • Mental status allows comprehension of instructions for troche administration
  • Written informed consent

Exclusion Criteria:

  • Sings of symptoms suggestive of esophageal Candidiasis (such as dysphagia or odynophagia) unless the results of an endoscopic evaluation of the esophagus are negative
  • Presence of perioral lesions only
  • Use of other antifungal agents within 5 days of enrollment to the study
  • Pregnant or lactating women
  • History of hypersensitivity to imidazole or azole compounds
  • Patient unwilling or unable to be followed at the study center for the duration of the study (3 weeks)
  • Patients has received an investigational drug in the last 30 days
  • Treatment with another investigational drug is planned within the next 3 weeks

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Responsible Party: Boehringer Ingelheim Identifier: NCT02184351     History of Changes
Other Study ID Numbers: 1190.1
First Posted: July 9, 2014    Key Record Dates
Last Update Posted: July 14, 2014
Last Verified: July 2014
Additional relevant MeSH terms:
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Candidiasis, Oral
Mouth Diseases
Stomatognathic Diseases
Anti-Infective Agents, Local
Anti-Infective Agents
Antifungal 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