Randomized, Controlled, Double-Blind Study of Itraconazole Oral Solution Versus Fluconazole Tablets for the Treatment of Esophageal Candidiasis.
To evaluate the safety and efficacy of itraconazole oral solution versus fluconazole tablets for the treatment of esophageal candidiasis in immunocompromised patients...
Brief Summary
Official Title: “Randomized, Controlled, Double-Blind Study of Itraconazole Oral Solution Versus Fluconazole Tablets for the Treatment of Esophageal Candidiasis.”
To evaluate the safety and efficacy of itraconazole oral solution versus fluconazole tablets for the treatment of esophageal candidiasis in immunocompromised patients.
- Study Type: Interventional
- Study Design: Endpoint Classification: Safety Study, Masking: Double-Blind, Primary Purpose: Treatment
Intervention(s) in this Clinical Trial
- Drug: Itraconazole
- Drug: Fluconazole
Criteria for Participation in this Clinical Trial
Inclusion Criteria
Patients must have:
- Esophageal candidiasis.
- Histological evidence of Candida spp. at baseline with confirmation by positive mycological culture.
- HIV infection or other predisposing risk factor.
- Life expectancy of at least 2 months.
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
- Malignancies of the head or neck, if the treatment or disease will interfere with response assessment.
- Evidence of systemic fungal infection.
- Underlying clinical condition that would preclude study completion.
- Judged to be unreliable in regard to following physician's directives.
Concurrent Medication:
Excluded:
- Rifampin.
- Rifabutin.
- Phenobarbital.
- Phenytoin.
- Carbamazepine.
- Terfenadine.
- Astemizole.
- H2 blockers.
- Continual antacids.
- Any investigational drug (expanded access drugs are allowed).
Patients with the following prior conditions are excluded:
- History of significant hepatic abnormalities or clinical evidence of hepatic disease within 2 months prior to study entry.
- History of hypersensitivity to imidazole or azole compounds.
Prior Medication:
Excluded:
- Other orally administered antifungal therapy within 3 days prior to study entry.
- Any investigational drug within 1 month prior to study entry (expanded access drugs are allowed).
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 13 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Investigator Information
Lead Investigator: Janssen, LP Industry
Related Publications
References
Barbaro G, Barbarini G, Di Lorenzo G. Fluconazole compared with itraconazole in the treatment of esophageal candidiasis in AIDS patients: a double-blind, randomized, controlled clinical study. Scand J Infect Dis. 1995;27(6):613-7.
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00002132
Study ID Number: 236A
ClinicalTrials.gov Identifier: NCT00002132
Health Authority: United States: Food and Drug Administration
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00002132
