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| Tracking Information | |||||
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| First Received Date ICMJE | June 19, 2007 | ||||
| Last Updated Date | June 5, 2008 | ||||
| Start Date ICMJE | June 2007 | ||||
| Estimated Primary Completion Date | December 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Plasma levels acitretin [ Time Frame: 2009 ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
Plasma levels acitretin [ Time Frame: 2009 ] | ||||
| Change History | Complete list of historical versions of study NCT00488384 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Acitretin Plasma Levels Under Hemodialysis | ||||
| Official Title ICMJE | Acitretin Plasma Levels Under Hemodialysis | ||||
| Brief Summary | Acitretin is given to hemodialysis patients who have developed in-situ or invasive squamous cell carcinoma of the skin in increasing doses up to 25 mg daily for one year. |
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| Detailed Description | Acitretin is given to hemodialysis patients who have developed in-situ or invasive squamous cell carcinoma of the skin in increasing doses up to 25 mg daily for one year. Plasma levels of acitretin will be monitored and influence of hemodialysis on acitretin plasma levels will be determined. Number of in-situ or invasive squamous cell carcinoma of the skin cases will be determined.
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| Study Phase | Phase IV | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Prevention, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Pharmacokinetics/Dynamics Study | ||||
| Condition ICMJE | Carcinoma, Squamous Cell | ||||
| Intervention ICMJE | Drug: Chemopreventive application (Acitretin) | ||||
| Study Arms / Comparison Groups | Other: single arm only. | ||||
| Publications * | |||||
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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 | Recruiting | ||||
| Estimated Enrollment ICMJE | 2009 | ||||
| Estimated Completion Date | June 2011 | ||||
| Estimated Primary Completion Date | December 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion criteria:
Exclusion criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | Switzerland | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00488384 | ||||
| Responsible Party | hofbauer, university hospital zurich | ||||
| Study ID Numbers ICMJE | 2007DR2065 EK674 | ||||
| Study Sponsor ICMJE | University of Zurich | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | University of Zurich | ||||
| Verification Date | June 2008 | ||||
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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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