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| Tracking Information | |
|---|---|
| First Received Date ICMJE | November 2, 1999 |
| Last Updated Date | June 23, 2005 |
| Start Date ICMJE | |
| Primary Completion Date | |
| Current Primary Outcome Measures ICMJE | |
| Original Primary Outcome Measures ICMJE | |
| Change History | Complete list of historical versions of study NCT00002304 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE | |
| Original Secondary Outcome Measures ICMJE | |
| Descriptive Information | |
| Brief Title ICMJE | A Comparison of Fluconazole and Ketoconazole in the Treatment of Fungal Infections of the Throat in Patients With Weakened Immune Systems |
| Official Title ICMJE | A Randomized Comparative Multicenter Trial of Fluconazole and Ketoconazole in the Treatment of Esophageal Candidiasis in Immunocompromised Patients |
| Brief Summary | To compare the safety, tolerance, and effectiveness of fluconazole and ketoconazole in the treatment of candidal esophagitis in immunocompromised patients. |
| Detailed Description | |
| Study Phase | |
| Study Type ICMJE | Interventional |
| Study Design ICMJE | Treatment |
| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arms / Comparison Groups | |
| Publications * | Laine L, Dretler RH, Conteas CN, Tuazon C, Koster FM, Sattler F, Squires K, Islam MZ. Fluconazole compared with ketoconazole for the treatment of Candida esophagitis in AIDS. A randomized trial. Ann Intern Med. 1992 Oct 15;117(8):655-60. |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |
| Recruitment Status ICMJE | Completed |
| Enrollment ICMJE | |
| Completion Date | |
| Primary Completion Date | |
| Eligibility Criteria ICMJE | Inclusion Criteria Prior Medication: Allowed:
Exclusion Criteria Co-existing Condition: Patients with the following are excluded:
Concurrent Medication: Excluded:
Concurrent Treatment: Excluded:
Patients with the following are excluded:
Prior Medication: Excluded:
Patients must meet the CDC criteria for the diagnosis of AIDS or be otherwise immunocompromised (e.g., malignancy, renal transplant) and have a diagnosis of oral candidiasis and/or esophageal symptoms of dysphagia and/or odynophagia. Illicit or illegal drug use. |
| Gender | Both |
| Ages | 13 Years to 70 Years |
| Accepts Healthy Volunteers | No |
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
| Location Countries ICMJE | United States, Canada |
| Administrative Information | |
| NCT ID ICMJE | NCT00002304 |
| Responsible Party | |
| Study ID Numbers ICMJE | 012B, 056-150 |
| Study Sponsor ICMJE | Pfizer |
| Collaborators ICMJE | |
| Investigators ICMJE | |
| Information Provided By | NIH AIDS Clinical Trials Information Service |
| Verification Date | February 1990 |
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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