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Trial record 28 of 449 for:    OTITIS

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02345447
Recruitment Status : Completed
First Posted : January 26, 2015
Last Update Posted : May 11, 2018
Sponsor:
Information provided by (Responsible Party):
Axel Franz, University Hospital Tuebingen

Tracking Information
First Submitted Date  ICMJE January 19, 2015
First Posted Date  ICMJE January 26, 2015
Last Update Posted Date May 11, 2018
Actual Study Start Date  ICMJE October 2013
Actual Primary Completion Date October 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 23, 2015)
Number of acute otitis media episodes diagnosed by a physician [ Time Frame: within 6 months after enrolment per patient ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 23, 2015)
  • Total number of acute otitis media per treatment group [ Time Frame: diagnosed in each patient within 6 months after enrolment ]
  • Number of unscheduled visits due to AOM [ Time Frame: within 6 months after enrolment ]
  • Number of AOM treated with antibiotics [ Time Frame: within 6 months after enrolment ]
  • Number of unscheduled visits due to URI [ Time Frame: within 6 months after enrolment ]
  • Number of URI treated with antibiotics [ Time Frame: within 6 months after enrolment ]
  • Number of days with URI [ Time Frame: within 6 months after enrolment ]
  • Subjective evaluation of efficacy by parent [ Time Frame: at indivdual study completion 6 months after enrolment ]
  • Subjective evaluation of tolerability by parent [ Time Frame: at indivdual study completion 6 months after enrolment ]
  • Occurence of adverse events [ Time Frame: within 6 months of enrolment ]
  • number of days with use of antipyretic, analgesic and antibiotic medication [ Time Frame: within 6 months of enrolment ]
  • Number of absent days from daycare (patient) / work (parent) [ Time Frame: within 6 months of enrolment ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Herbal-Based Medication vs. Placebo in Preventing Acute Otitis Media in Children at High Risk of Recurrence
Official Title  ICMJE 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
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Acute Otitis Media
Intervention  ICMJE
  • 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)
  • Drug: Placebo
    Aqueous ethanol solution non-distinguishable from verum
Study Arms  ICMJE
  • 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).

    Intervention: Drug: Herbal-based medication
  • 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).
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: January 23, 2015)
296
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2017
Actual Primary Completion Date October 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Months to 59 Months   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02345447
Other Study ID Numbers  ICMJE OTV.PRE.01.A3
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Axel Franz, University Hospital Tuebingen
Study Sponsor  ICMJE University Hospital Tuebingen
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Axel Franz, MD University Hospital Tuebingen
PRS Account University Hospital Tuebingen
Verification Date May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP