Trial document





This trial has been registered retrospectively.
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  DRKS00004569

Trial Description

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Title

Efficacy and Safety of an Herbal-Based Medication vs. Placebo in Preventing Acute Otitis Media in Children at High Risk of Recurrence: A Prospective, Placebo Controlled, Randomized, double-blinded Parallel-Group Comparison for Superiority

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Trial Acronym

OTV.PRE.01

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Prophylaxis of middle ear inflammation is desirable to reduce burden of illness, potential longer-term consequences,treatment-associated side effects, bacterial resistance
caused by antibiotic treatment, and burden to the parents.
This study investigates whether a herbal-based medicine compared to a dummy drug (Placebo) is able to reduce the number of episodes of middle ear inflammation in children aged 12 to 35 months.
The results of this study may help to improve the quality of life of children with recurrent middle ear inflammation and may lead to reduce the use of antibiotics.

Recruitment according to protocol was impossible with the original study design. Therefore, the following essential changes were made in a protocol amendment which was accepted by the ethical committee: A) the upper age limit was increased from 35 to 59 months B) the number of AOMs in the last 12 months before study entry was reduced from 4 AOMs to 3 AOMs C) the duration of the study was reduced from 12 months to 6 months D)the list of medication not allowed during the study was reduced E) fixed number of 296 patients rather than an adaptive design with interim analysis after 180 patients.

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Brief Summary in Scientific Language

Prophylaxis of otitis media is desirable to reduce the burden of illness, potential
longer-term consequences, treatment-associated side effects, bacterial resistance
caused by antibiotic treatment, and burden to the parents. The results of this trial
may help to improve the quality of life of children with recurrent otitis media, may
reduce the use of antibiotics in this age group and hence the development of
bacteria resistance, and may help to reduce health care costs by reducing
unscheduled visits through the pediatrician and by reducing days off work for the
parents.

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Organizational Data

  •   DRKS00004569
  •   2014/01/24
  •   [---]*
  •   no
  •   Approved
  •   178/2012AMG1, Ethik-Kommission an der Medizinischen Fakultät der Eberhard-Karls-Universität und am Universitätsklinikum Tübingen
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Secondary IDs

  •   2012-000341-13 
  •   4038174 
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Health Condition or Problem studied

  •   Acute Otitis Media (AOM)
    H65.0 und H66.0
  •   Upper respiratory tract infection
  •   H65.0 -  Acute serous otitis media
  •   H66.0 -  Acute suppurative otitis media
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Interventions/Observational Groups

  •   Otovowen (Aconitum napellus Dil. D6; Capsicum annuum Dil. D4; Chamomilla recutita Ø; Echinacea purpurea Ø; Hydrargyrum bicyanatum Dil. D6; Hydrastis canadensis Dil. D4; Iodum Dil. D4; Natrium tetraboracicum Dil. D4; Sambucus nigra Ø; Sanguinaria canadensis Ø), 3 times daily 7 drops at first signs of an upper respiratory tract infection until symptoms resolve (maximally 8 weeks of continuous application).
  •   Placebo (aqueous ethanol solution non-distinguishable from verum), 3 times daily 7 drops at first signs of an upper respiratory tract infection until symptoms resolve (maximally 8 weeks of continuous application).
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, investigator/therapist
  •   Placebo
  •   Prevention
  •   Parallel
  •   III
  •   No
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Primary Outcome

To determine the number of AOM (Acute Otitis Media) episodes within 12 months after enrolment per patient. The mean difference in the number of AOMs before and during the study of both parallel groups will be used for testing the hypothesis of superiority of Otovowen.

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Secondary Outcome

- Number of doctor visits due to AOM (determined continuously during observational period)
- Number of doctor visits due to URI (determined continuously during observational period)
- Number of URI treated with antibiotics (determined continuously during observational period)
- Number of days with URI (determined continuously during observational period)
- Subjective evaluation of efficacy by parent (determined at the end of observational period)
- Subjective evaluation of tolerability by parent (determined at the end of observational period)
- Adverse events (determined continuously during observational period)
- Use of antipyretic, analgesic and antibiotic medication (determined continuously during observational period)
- Number of absent days from daycare (patient) / work (parent), (determined continuously during observational period)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Doctor's Practice 
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Recruitment

  •   Actual
  •   2013/09/24
  •   296
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   12   Months
  •   59   Months
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Additional Inclusion Criteria

1. Children aged 12 to 59 months
2. Children with at least 3 episodes of acute otitis media (AOM) during the last 12 months Prior to study inclusion as documented in their medical records.
3. Written informed consent.

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Exclusion Criteria

1. Ongoing acute otitis media or URI (subjects may be included after resolution)
2. Current prophylaxis/treatment for URI or AOM
3. Current use of phytotherapeutic and homeopathic agents with secretolytic, anti-inflammatory or immune enhancing properties
4. Use of tympanostomy tubes
5. Chronic tympanic membrane perforation (TMP)
6. Palatine cleft
7. Parents/legal representative(s) of children unable to follow study procedures, who have no internet access and are not willing to use an online diary on a weekly Basis
8. History of hypersensitivity to the investigational drug or to its ingredients.
9. Systemic, severe as well as history of uncontrolled chronic disease or a concurrent clinically significant illness, or medical condition, which in the investigator’s opinion, would contraindicate study participation or compliance with protocol mandated procedures.
10. Simultaneous participation in another clinical trial or participation in any clinical trial involving an investigational medicinal product within 30 days prior to written informed consent for this trial.

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Weber & Weber GmbH & Co. KG Biologische Arzneimittel
    • Mr.  Dr.  Reiner  Rittinghausen 
    • Herrschinger Str. 33
    • 82266  Inning a. A.
    • Germany
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    • Weber & Weber GmbH & Co. KG Biologische Arzneimittel
    • Mr.  Dr.  Ulrich  Danesch 
    • Herrschinger Str. 33
    • 82266  Inning a. A.
    • Germany
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    • Weber & Weber GmbH & Co. KG Biologische Arzneimittel
    • Mr.  Dr.  Ulrich  Danesch 
    • Herrschinger Str. 33
    • 82266  Inning a. A.
    • Germany
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Sources of Monetary or Material Support

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    • Weber & Weber GmbH & Co. KG Biologische Arzneimittel
    • Mr.  Dr.  Reiner  Rittinghausen 
    • Herrschinger Str. 33
    • 82266  Inning a. A.
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2015/06/03
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Trial Publications, Results and other Documents

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