Trial record 7 of 40 for:
Clotrimazole
Clotrimazole vs. Mycelex® in Patients With Human Insufficiency Virus (HIV) Infection for the Treatment of Oropharyngeal Candidiasis
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| ClinicalTrials.gov Identifier: NCT02184351 |
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Recruitment Status :
Completed
First Posted : July 9, 2014
Last Update Posted : July 14, 2014
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Sponsor:
Boehringer Ingelheim
Information provided by (Responsible Party):
Boehringer Ingelheim
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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 |
| 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 :
- Percent of patients that have a clinical response assessed by symptoms and physical examination [ Time Frame: Day 21 ]
Secondary Outcome Measures :
- Incidence of negative fungal cultures of the oropharynx for Candida species [ Time Frame: 7 days after end of treatment ]
- Incidence of negative fungal cultures of the oropharynx for Candida species [ Time Frame: after 14 days of treatment ]
- Clinical response by symptom assessment and physical examination [ Time Frame: after 7 and 14 days of treatment ]
- Assessment of compliance with Treatment by troche Count and Patient interview [ Time Frame: after 7 and 14 days of treatment ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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 |
| ClinicalTrials.gov 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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Clotrimazole Candidiasis Candidiasis, Oral Mycoses Mouth Diseases Stomatognathic Diseases Miconazole 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 |