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

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

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.

Study Overview

• Status: Completed
• Conditions: Acute Otitis Media
• Intervention / Treatment: Drug: Herbal-based medication; Drug: Placebo

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: Interventional
• Enrollment (Anticipated): 296
• Phase: Phase 3

Contacts and Locations

Study Locations

• Germany
  • Tuebingen, Germany, 72076
    • University Children's Hospital Tuebingen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 4 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of acute otitis media episodes diagnosed by a physician	within 6 months after enrolment per patient

Secondary Outcome Measures

Outcome Measure	Time Frame
Total number of acute otitis media per treatment group	diagnosed in each patient within 6 months after enrolment
Number of unscheduled visits due to AOM	within 6 months after enrolment
Number of AOM treated with antibiotics	within 6 months after enrolment
Number of unscheduled visits due to URI	within 6 months after enrolment
Number of URI treated with antibiotics	within 6 months after enrolment
Number of days with URI	within 6 months after enrolment
Subjective evaluation of efficacy by parent	at indivdual study completion 6 months after enrolment
Subjective evaluation of tolerability by parent	at indivdual study completion 6 months after enrolment
Occurence of adverse events	within 6 months of enrolment
number of days with use of antipyretic, analgesic and antibiotic medication	within 6 months of enrolment
Number of absent days from daycare (patient) / work (parent)	within 6 months of enrolment

Collaborators and Investigators

• Sponsor: University Hospital Tuebingen
• Investigators: Principal Investigator: Axel Franz, MD, University Hospital Tuebingen

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2013
• Primary Completion (Actual): October 1, 2015
• Study Completion (Actual): October 1, 2017

Study Registration Dates

• First Submitted: January 19, 2015
• First Submitted That Met QC Criteria: January 23, 2015
• First Posted (Estimate): January 26, 2015

Study Record Updates

• Last Update Posted (Actual): May 11, 2018
• Last Update Submitted That Met QC Criteria: May 9, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Otorhinolaryngologic Diseases; Ear Diseases; Recurrence; Otitis; Otitis Media
• Other Study ID Numbers: OTV.PRE.01.A3