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Trial record 28 of 436 for:    OTITIS

Herbal-Based Medication vs. Placebo in Preventing Acute Otitis Media in Children at High Risk of Recurrence (OTV_PRE_01)

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ClinicalTrials.gov Identifier: NCT02345447
Recruitment Status : Completed
First Posted : January 26, 2015
Last Update Posted : May 10, 2018
Sponsor:
Information provided by (Responsible Party):
Axel Franz, University Hospital Tuebingen

Brief Summary:
The purpose of this study is to study whether a herbal-based medication is superior to placebo for prevention of acute otitis media in pre-school children with upper respiratory tract infection.

Condition or disease Intervention/treatment Phase
Acute Otitis Media Drug: Herbal-based medication Drug: Placebo Phase 3

Detailed Description:

This is a prospective, controlled parallel-group comparison for superiority of Otovowen®.

Patient will be identified by screening of patient cards. Patients with recurrent AOM aged 12 to 59 months will be randomly assigned either to Otovowen® or placebo. Randomization will be stratified by age at enrolment (12-35 versus 36-59 months).

The observation period per subject will be 6 months. Data collection and documentation will be performed weekly via online diary by the parents/legal representative(s) and by the investigator via eCRF.

Patients will be seen by the doctor at baseline and at end of study. Unscheduled visits in case of AOM or severe URI or any other disease are initiated by the parents/legal representative(s).

Study medication will be sent to the patient/parents/legal representative(s) after randomization. and will be administered at first signs or symptoms of URI (e. g. elevated temperature, common cold, influenza, coughing, sore throat, hoarse voice, frequent sneezing, running or stuffy nose, sinusitis, fever, headache, etc.) until resolved (maximally 8 weeks of continuous application).

AOM will be diagnosed during unscheduled visits according to the criteria detailed in the study protocol. An AOM will be considered as resolved through confirmation by the investigator only.

Compliance will be assessed by weighing contents of bottles of IMPs.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 296 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Efficacy and Safety of an Herbal-Based Medication vs. Placebo in Preventing Acute Otitis Media in Children at High Risk of Recurrence: A Placebo Controlled, Randomized, Double-blinded Parallel-Group Comparison for Superiority
Actual Study Start Date : October 2013
Actual Primary Completion Date : October 2015
Actual Study Completion Date : October 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ear Infections

Arm Intervention/treatment
Active Comparator: Herbal-based Medication

Trade Name of active comparator: Otovowen® Substances: Aconitum napellus Dil. D6; Capsicum annuum Dil. D4; Chamomilla recutita; Echinacea purpurea; Hydrargyrum bicyanatum Dil. D6; Hydrastis canadensis Dil. D4; Iodum Dil. D4; Natrium tetraboracicum Dil. D4; Sambucus nigra; Sanguinaria canadensis.

Manufacturer: Weber & Weber, Inning/Ammersee Dose: Three times daily 7 drops Mode of Application: orally Duration of Treatment: at first signs of Upper respirtory tract infection until symptoms resolve (maximally 8 weeks of continuous application).

Drug: Herbal-based medication
Aconitum napellus, Capsicum annuum; Chamomilla recutita; Echinacea purpurea; Hydrargyrum bicyanatum; Hydrastis canadensis; Iodum; Natrium tetraboracicum; Sambucus nigra; Sanguinaria canadensis
Other Name: Otovowen(R)

Placebo Comparator: Placebo
Placebo Substance: Aqueous ethanol solution non-distinguishable from verum. Manufacturer: Weber & Weber, Inning/Ammersee Dose: Three times daily 7 drops Mode of Application: orally Duration of Treatment: at first signs of URI until symptoms resolve (maximally 8 weeks of continuous application).
Drug: Placebo
Aqueous ethanol solution non-distinguishable from verum




Primary Outcome Measures :
  1. Number of acute otitis media episodes diagnosed by a physician [ Time Frame: within 6 months after enrolment per patient ]

Secondary Outcome Measures :
  1. Total number of acute otitis media per treatment group [ Time Frame: diagnosed in each patient within 6 months after enrolment ]
  2. Number of unscheduled visits due to AOM [ Time Frame: within 6 months after enrolment ]
  3. Number of AOM treated with antibiotics [ Time Frame: within 6 months after enrolment ]
  4. Number of unscheduled visits due to URI [ Time Frame: within 6 months after enrolment ]
  5. Number of URI treated with antibiotics [ Time Frame: within 6 months after enrolment ]
  6. Number of days with URI [ Time Frame: within 6 months after enrolment ]
  7. Subjective evaluation of efficacy by parent [ Time Frame: at indivdual study completion 6 months after enrolment ]
  8. Subjective evaluation of tolerability by parent [ Time Frame: at indivdual study completion 6 months after enrolment ]
  9. Occurence of adverse events [ Time Frame: within 6 months of enrolment ]
  10. number of days with use of antipyretic, analgesic and antibiotic medication [ Time Frame: within 6 months of enrolment ]
  11. Number of absent days from daycare (patient) / work (parent) [ Time Frame: within 6 months of enrolment ]


Information from the National Library of Medicine

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Ages Eligible for Study:   12 Months to 59 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Children with at least 3 episodes of acute otitis media (AOM) within 12 months prior to study inclusion as documented in their medical records. Diagnosis criteria for AOM see study protocol
  • parental written consent

Exclusion Criteria:

  • Ongoing acute otitis media or URI
  • Current prophylaxis/treatment for URI or AOM
  • Current use of phytotherapeutic and homeopathic agents with secretolytic, anti-inflammatory or immune enhancing properties
  • Use of tympanostomy tubes
  • Chronic tympanic membrane perforation (TMP)
  • Palatine cleft
  • 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
  • History of hypersensitivity to the investigational drug or to its ingredients.
  • 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.
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02345447


Locations
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Germany
University Children's Hospital Tuebingen
Tuebingen, Germany, 72076
Sponsors and Collaborators
University Hospital Tuebingen
Investigators
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Principal Investigator: Axel Franz, MD University Hospital Tuebingen

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Responsible Party: Axel Franz, Associate Professor, University Hospital Tuebingen
ClinicalTrials.gov Identifier: NCT02345447     History of Changes
Other Study ID Numbers: OTV.PRE.01.A3
First Posted: January 26, 2015    Key Record Dates
Last Update Posted: May 10, 2018
Last Verified: May 2018
Additional relevant MeSH terms:
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Otitis
Otitis Media
Recurrence
Disease Attributes
Pathologic Processes
Ear Diseases
Otorhinolaryngologic Diseases