Trial document




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  DRKS00005334

Trial Description

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Title

Double-blind, controlled, randomised, three-fold cross-over study to investigate the efficacy of two different mouthwashes in patients with intra-oral halitosis

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Trial Acronym

X-03164-4001

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Aim of the study is to investigate the 12 hour efficacy of a commercial mouthwash (MEDA03164 mouthwash), distributed by MEDA, in comparison to water in patients with oral malodour. Different time periods (daytime/nighttime) will therefore be assessed. In total, each patient will appear on 3 successive weekends for two administrations of mouthwash in each period. 34 patients aged 18 and above will be randomised.

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Brief Summary in Scientific Language

The aim of this study is to evaluate the 12 hour lasting, VSC controlling effect of MEDA03164 mouthwash in halitosis patients after instruction compliant use (10 mL, 30 second) in a scientifically valid , double blind randomized, 3-fold-cross-over setting in 34 patients with intra-oral halitosis. 12 hour periods will therefore be assessed over night as well as over daytime passing from morning to evening while staying in a highly standardized surrounding.

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Organizational Data

  •   DRKS00005334
  •   2013/10/17
  •   [---]*
  •   no
  •   Approved
  •   013/1469, Freiburger Ethik-Kommission International
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   R19.6 -  Halitosis
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Interventions/Observational Groups

  •   Sequential use of test product (Arm 1) and water (Arm 2) twice per period (evening and morning) in three periods. Randomization in two sequences (1-2-2 or 2-1-1).
    Arm 1: Test product MEDA03164 mouthwash (CB12), 30 seconds mouthwash with 10 mL test product after tooth care with standardized toothpaste free from active components and toothbrush.
  •   Arm 2: Water, 30 seconds mouthwash with 10 mL water after tooth care with standardized toothpaste free from active components and toothbrush.
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, investigator/therapist, caregiver, assessor
  •   Other
  •   Treatment
  •   Crossover
  •   N/A
  •   N/A
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Primary Outcome

To compare the efficacy of a 30 second mouthwash with 10 mL MEDA03164 mouthwash to the efficacy of a 30 second mouthwash with 10 mL water (morning assessment 12 hours after rinsing the mouth) based on OralChroma measurements (hydrogen sulphide) and organoleptic scoring of mouth odour strength according to Rosenberg/Greenman.

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Secondary Outcome

To compare the efficacy of a 30 second mouthwash with 10 mL MEDA03164 mouthwash to the efficacy of a 30 second mouthwash with 10 mL water (morning assessment 12 hours after rinsing the mouth) based on OralChroma (Dimethyle sulphide) and Halimeter measurements of volatile sulphur compounds.

To compare the efficacy of a 30 second mouthwash with 10 mL MEDA03164 mouthwash to the efficacy of a 30 second mouthwash with 10 mL water (evening assessment 12 hours after rinsing the mouth a second time) based on OralChroma measurements, organoleptic scoring of the mouth odour strength according to Rosenberg/Greenman and Halimeter measurements.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • other 
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Recruitment

  •   Actual
  •   2013/10/19
  •   34
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

Halitosis of intra-oral origin with daily periods of noticeable bad breath; otherwise healthy in the opinion of the investigator.

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Exclusion Criteria

History of allergic or undesirable reactions to ingredients of study treatment;
pregnancy, breast-feeding or planned pregnancy during the study.
Lack of suitability for the study:
Extra-oral halitosis;
Oropharyngeal diseases affording treatmentund;
Medical history of infectious diseases;
Medical history of malignant diseases.
Systemic medication related to oral dryness;
Systemic antibiotic therapy within the preceding three months of the study;
Current smoker;
Current drug or alcohol abuse.

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Addresses

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    • MEDA Pharma GmbH & Co. KG, Scientific Affairs, Corporate Clinical Affairs
    • Benzstrasse 1
    • 61352  Bad Homburg
    • Germany
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    •   [---]*
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    • MEDA Pharma GmbH & Co. KG (a Mylan company), Scientific Affairs, Clinical Affairs Meda
    • Ms.  Dr.  Ursula  Petzold 
    • Benzstraße 1
    • 61352  Bad Homburg
    • Germany
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    • Meda Pharma GmbH & Co KG (a Mylan company), Scientific Affairs, Clinical Affairs Meda
    • Ms.  Dr.  Ursula  Petzold 
    • Benzstr. 1
    • 61352  Bad Homburg
    • Germany
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Sources of Monetary or Material Support

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    • MEDA Pharma GmbH & Co. KG, Scientific Affairs, Corporate Clinical Affairs
    • Benzstraße 1
    • 61352  Bad Homburg
    • Germany
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    •   [---]*
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Status

  •   Recruiting complete, follow-up complete
  •   2014/07/14
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.