Olfaction DisordersNCT00660868
Is Pentoxifylline Able to Improve Olfactory Sensitivity?
An observational study of Olfaction Disorders, run by Technische Universität Dresden at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Olfaction Disorders
- What is being tested?
- Pentoxifylline retard 400mg
- How many people
- 7 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2009to Jan 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Study population: 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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Zentrum für Riechen und Schmecken, Universitäts- HNO- Klinik Dresden
Dresden, 01307
About this study
Official title: Agapurin Retard Used in Patients With Smell Disorder- A Post-marketing Observational Study
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.
Read the 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.
- Conditions
- Olfaction Disorders
- Being tested
- Pentoxifylline retard 400mg
- Keywords
- smell, olfaction, olfactory sensitivity, smell loss, chemoreception
- Medical subject headings
- Olfaction Disorders, Anosmia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pentoxifylline retard 400mgDrug
Also called Agapurin retard
Agapurin retard 400mg 3/day per os for 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Patients with posttraumatic, idiopathic, and postinflammatory cause of smell loss; patients age between 18 and 50 years. Odor threshold better than 1. Receives: Drug: Pentoxifylline retard 400mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
TDI-score
Measured: at day 0 and follow up after 3 weeks
Secondary outcomes (1)
odor threshold odor discrimination odor identification
Measured: at day 0 and at follow up after 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2008 (estimated)
- Study startNov 2009
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Olfaction DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Technische Universität Dresden
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Volker Gudziol, Dr. med., Principal investigator, Technische Universität Dresden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00660868
- Sponsor's protocol ID
- EK157072007
- Status last verified
- Feb 2016
- First submitted
- 16 Apr 2008
- Last updated
- 5 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Agapurin Retard Used in Patients With Smell Disorder- A Post-marketing Observational Study
- ClinicalTrials.gov ID
- NCT00660868
- Acronym / sponsor ID
- EK157072007
- Conditions
- Olfaction Disorders
- Keywords
- smell, olfaction, olfactory sensitivity, smell loss, chemoreception
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Technische Universität DresdenUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 17 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Drug: Pentoxifylline retard 400mgPatients with posttraumatic, idiopathic, and postinflammatory cause of smell loss; patients age between 18 and 50 years. Odor threshold better than 1. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- 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
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pentoxifylline retard 400mgAlso: Agapurin retardAgapurin retard 400mg 3/day per os for 3 weeks | Drug | 1 |
Primary outcome
TDI-score
Time frame: at day 0 and follow up after 3 weeks
1 secondary outcome
odor threshold odor discrimination odor identification
Time frame: at day 0 and at follow up after 3 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Volker Gudziol, Dr. med. principal investigator
Technische Universität Dresden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Olfaction Disorders, run by Technische Universität Dresden at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TDI-score (time frame: at day 0 and follow up after 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2016.