NCT02345447

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
296

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Oct 2013

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

January 19, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 26, 2015

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
Last Updated

May 11, 2018

Status Verified

May 1, 2018

Enrollment Period

2 years

First QC Date

January 19, 2015

Last Update Submit

May 9, 2018

Conditions

Acute Otitis Media

Outcome Measures

Primary Outcomes (1)

  • Number of acute otitis media episodes diagnosed by a physician

    within 6 months after enrolment per patient

Secondary Outcomes (11)

  • 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

  • +6 more secondary outcomes

Study Arms (2)

Herbal-based Medication

ACTIVE COMPARATOR

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

Placebo

PLACEBO COMPARATOR

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

Interventions

Herbal-based medicationDRUG

Aconitum napellus, Capsicum annuum; Chamomilla recutita; Echinacea purpurea; Hydrargyrum bicyanatum; Hydrastis canadensis; Iodum; Natrium tetraboracicum; Sambucus nigra; Sanguinaria canadensis

Also known as: Otovowen(R)
Herbal-based Medication
PlaceboDRUG

Aqueous ethanol solution non-distinguishable from verum

Placebo

Eligibility Criteria

Age12 Months - 59 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • parental written consent

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Children's Hospital Tuebingen

Tübingen, 72076, Germany

Location

MeSH Terms

Conditions

Otitis Media

Condition Hierarchy (Ancestors)

OtitisEar DiseasesOtorhinolaryngologic Diseases

Study Officials

  • Axel Franz, MD

    University Hospital Tuebingen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 19, 2015

First Posted

January 26, 2015

Study Start

October 1, 2013

Primary Completion

October 1, 2015

Study Completion

October 1, 2017

Last Updated

May 11, 2018

Record last verified: 2018-05

Locations

DE(1)