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Is Pentoxifylline Able to Improve Olfactory Sensitivity?

This study is currently recruiting participants.
Study NCT00660868.   Last updated on April 16, 2008.   Information provided by Dresden University of Technology

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Descriptive Information Fields
Brief Title  Is Pentoxifylline Able to Improve Olfactory Sensitivity?
Official Title  Agapurin Retard Used in Patients With Smell Disorder- A Post-Marketing Observational Study
Brief Summary

Signal processing in the olfactory neuron could be influenced by inhibition of enzymes like phosphodiesterase. Pentoxifylline is a unspecific phosphodiesterase inhibitor. The hypothesis is that pentoxifylline could lead to increased sensitivity to odors.

Detailed Description

Olfactory signal processing is conducted by a G-protein linked increase of intracellular concentration of adenosine 3´,5´-cyclic monophosphate (cAMP). In the cilia of olfactory sensory neurons (OSN) cAMP is degraded by phosphodiesterase 1C2 (PDE1C2). Inhibition of PDE1C2 could result in an increased response of OSN to chemical stimuli. Aim of the present prospective post-marketing surveillance study was to investigate the impact of pentoxifylline, an unspecific phosphodieasterase inhibitor, on olfactory function.

Study Phase
Study Type  Observational
Study Design  Other, Prospective
Primary Outcome Measure  TDI-score [ Time Frame: at day 0 and follow up after 3 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measure  odor threshold odor discrimination odor identification [ Time Frame: at day 0 and at follow up after 3 weeks ] [ Designated as safety issue: No ]
Condition  Olfaction Disorders
Intervention  Drug: Pentoxifylline retard 400mg
MEDLINE PMIDs
Links
Recruitment Information Fields
Recruitment Status  Recruiting
Enrollment  30
Start Date  November 2007
Completion Date November 2009
Eligibility Criteria 

Inclusion Criteria:

  • hyposmic or functionally anosmic patients TDI-score <31
  • age: 18-50 years
  • odor threshold: better than 1
  • cause of smell loss: post traumatic, postinflammatory, idiopathic

Exclusion Criteria:

  • normosmic patients,
  • patients with contraindications for application of pentoxifylline
  • patients that cannot give written agreement to the study
  • patients under 18 years and over 50 years of age
Gender Both
Ages 18 Years to 50 Years
Accepts Healthy Volunteers No
Contacts ††
Contact: Volker Gudziol, Dr. med.     49-351-458-4420     volker.gudziol@uniklinikum-dresden.de    
Contact: Thomas Hummel, Prof. Dr.     49-351-458-4189     thummel@mail.zih.tu-dresden.de    
Location Countries  Germany
Administrative Information Fields
NCT ID  NCT00660868
Organization ID EK157072007
Secondary IDs ††
Study Sponsor  Dresden University of Technology
Collaborators ††
Investigators 
Principal Investigator:     Volker Gudziol, Dr. med.     Technische Universität Dresden    
Information Provided By Dresden University of Technology
Verification Date April 2008
First Received Date  April 16, 2008
Last Updated Date April 16, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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