Trial document




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  DRKS00008914

Trial Description

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Title

Safety, Usability, acceptance, and operative readiness for osmotic agent release from an intraorally cartridge - applied to healthy adults.

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Trial Acronym

OPTIMED-1

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URL of the Trial

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Brief Summary in Lay Language

The System OPTIMED contains of a cartridge with an osmotic membrane (osmosis= substitution of fluids via a concentration gradient). This specific development shall enable a later release of medication to the oral cavity and resorption via the soft tissues of the mouth. This would be very helpful for medication of Parkinson's disease. The oral application of an osmotic system can be simulated with artificial saliva in a laboratory setting (in-vitro). However, even if this was performed successfully, the physical and biological environment of the oral cavity cannot be simulated successfully and sufficiently in-vitro. Especially the formation of biofilms due to germs (microorganisms, bacteria) and the nutrition or drinks (containing sugar, carbohydrates, proteins, cellulose) as well as changes of temperature due to nutrition (coffee, ice cream, sport drinks). These influences may interfere the functionality of the system so far, that the release of medications may drop down. Thereby the system would fail functioning during application. That's why, before further clinical trials with medications and patients as well as accreditation as a medical device, a basic evaluation towards this functioning is necessary. To perform such a clinical trial, the cartridge must be retained for 8 to 10 hours within the oral cavity. Therefore the cartridge must be protected against beeing swallowed or inhaled by the patient. That's why subjects are provided with dental bite guards (this appliances are known broadly to prevent grinding). Such bite guards are normally worn for about 10 hours during the night. The subject is able to insert and remove the bite guard on its own. A docking area for the OptiMed cartridge is is embedded by dental technicians to these bite guards. These measurements were approved by a clinical observation already and can be considered as save. Furthermore the subject is able to change the cartridge every day. Magnetic force as well as geometric design ensures a safe sit and hinders the cartridge to detach unintentionally. This system allows the subject to wear the cartridge 8 to 10 hours a day for three consecutive days. To evaluate the release of the substance from the cartridge Vitamin C is added to the cartridge. This substance is not pharmacologically effective and besides comparable to the later pharmacological substances. Furthermore, Vitamin C doesn't interfere with the oral micro flora - which alternatives like sugar or sugar substitutes would de. The maximum of 285 mg even do not allow a clinical relevant overdose of Vitamin C. To prove the functionality of the cartridge the remaining substance of Vitamin C will be determined after the three days. This is performed - without the patient - within a laboratory. The measurements are compared with the documented wearing time of the cartidges during the trial (disclosure of the subjects within an trial diary). The diary is necessary to consider individual courses of the day. That is also why the subject has to wear the system on three consecutive days for 8 to 10 hours. For this the subjects are expected to note their nutrition behaviour during these days. At the end of every day the subject puts the cartridge into a bag and hands all cartridges over to the investigators at the day of discharge from the trial. Should 60% of the initial amount of vitamin C been released within eight hours to osmotic capacity within clinical performance will be assigned as successfully. The used bite guard can be changed free of charge in means of a modification (removal of the cartridge docking). This enables the patient to use it as a regular nocturnal bite guard. No further incentives are given to the patient. The patients profits from a dental and hygiene status and oral inspectation for diseases of the mouth and dentition (teeth, jaws, tongue).

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Brief Summary in Scientific Language


Within the recent years the development of osmotic intraoral releasing systems for medication was enforced tremendously (i.e. Naltroxon). Besides easy handling (the user or patient can do it on its own) and minimal (or even missing) invasivity as well as to circumvent the hepatic circulation, a continuous release of medication is the major impetus for scientists and phycisians. This idea of continuous oral application of medication is very interesting for the treatment of Parkinson's disease (PD).Parkinson's disease is a neurodegenerative non curable disease of the central nervous system, which interferes and reduces patient's ability to move/ movements.PD is treated with the intake of pills usually. With the progression of the disease, the blood drug levels have to be adjusted very thoroughly, because the time of virtue is shortened. With tablet intake this is only possible with high limitations. Alternative such as brain stimulation, medication pumps (subcutaneous or intra-iudenal infusion, or PEJ) are invasive and very expensive. Furthermore, there are remarks that an early continuous application of medications can reduce later side-effects. Within the current trial, the security and ability and acceptance of an intraoral cartridge with osmotic membrane for the later release of medications is focused. These cartridges are fixed to a classical intraoral bite guard and form a system. This system can be worn for about 10 hours a day and shall be worn by healthy subjects for three consecutive days. Instead of PD medication, vitamin C is filled to the cartridge. Vitamin C has comparable osmotic properties like Levodopa-Ethylesther (LDEE), which might be a suitable medication for Parkinson disease and for an intraoral release. The bite guards will be produced and provided by the Centre for Dentistry, Oral medicine, and Maxillofacial Surgery of University Hospital Tuebingen. These bite guards are conform to German law for medical devices (MPG). The intraoral cartridge will be provided by the Institute for Microsystems and Information technology of the Hahn-Schickard-Gesellschaft (HSG), Villingen-Schwenningen, Germany. The cartridge is a further development of the already clinically tested intraoral medication dosage system.

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Organizational Data

  •   DRKS00008914
  •   2015/09/11
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  •   yes
  •   Approved
  •   300/2015MPG, Ethik-Kommission an der Medizinischen Fakultät der Eberhard-Karls-Universität und am Universitätsklinikum Tübingen
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Secondary IDs

  •   CIV-15-05-013564 
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Health Condition or Problem studied

  •   Healthy participants
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Interventions/Observational Groups

  •   Intra-oral appliance and cartridge, filled with 285mg Vitamin C
    To perform such a clinical trial, the dental bite guard with the cartridge must be retained for 8 to 10 hours within the oral cavity for 3 days.
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Characteristics

  •   Interventional
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  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Basic research/physiological study
  •   Single (group)
  •   II
  •   N/A
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Primary Outcome

Safety of the device: not more than 10% adverse events within the cohort.

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Secondary Outcome

functioning of the device: at least 60% release of Vitamin C after 8 hours of intraoral service.
usability of the device: no report of habitual problems, which led to a intraoral service time below 6 hours within one day

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2015/09/18
  •   10
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   80   Years
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Additional Inclusion Criteria

capacity to contract and signed "informed consent", stable conditions of the dentition at least in one jaw, no acute dental treatment need (no caries, no extractions, no tooth loosening of grade 2 or higher at two or more teeth, no periodontits acc. PSI Code <=2) no inflammation or irritation of oral soft tissues esp. at the planum buccale

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Exclusion Criteria

addictions (excl. nicotine), ongoing dental or orthodontic treatment(s), problems with swallowing, removable partial dentures in both jaws, no availablitiy or travelling during the 3 days of study phase, mouth opening below 25mm distance between the incisal edges.

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Addresses

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    • Universitätsklinikum Tübingen
    • Geissweg 3
    • 72076  Tübingen
    • Germany
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    • Hahn-Schickard-GesellschaftStandort Villingen-Schwenningen
    • Mr.  Dipl.-Ing.  Simon  Herrlich 
    • Wilhelm-Schickard-Str. 10
    • 78052  Villingen-Schwenningen
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    • Poliklinik für Zahnärztliche Prothetik mit Propädeutik am Zentrum Zahn-, Mund- und Kieferheilkunde des Universitätsklinikums Tübingen
    • Mr.  Dr.  Fabian  Huettig 
    • Osianderstr. 2-8
    • 72070  Tuebingen
    • Germany
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    • Abteilung für Neurologie mit Schwerpunkt Neurodegenerative ErkrankungenHertie-Institut für Klinische HirnforschungUniversität Tübingen
    • Mr.  Prof. Dr.  Walter  Maetzler 
    • Hoppe Seyler-Straße 3
    • 72076  Tübingen
    • Germany
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    • Poliklinik für Zahnärztliche Prothetik mit Propädeutik am Zentrum Zahn-, Mund- und Kieferheilkunde des Universitätsklinikums Tübingen
    • Mr.  Dr.  Fabian  Huettig 
    • Osianderstr. 2-8
    • 72070  Tuebingen
    • Germany
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Sources of Monetary or Material Support

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    • Bundesministerium für Bildung und Forschung Dienstsitz Berlin
    • Friedrichstraße 130 B
    • 10117  Berlin
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2015/11/23
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Trial Publications, Results and other Documents

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