Acute Otitis MediaPhase 3OTV_PRE_01NCT02345447
Herbal-Based Medication vs. Placebo in Preventing Acute Otitis Media in Children at High Risk of Recurrence
A Phase 3 study testing Herbal-based medication in people with Acute Otitis Media, run by University Hospital Tuebingen at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 59 months
- Conditions the study is for
- Acute Otitis Media
- What is being tested?
- Herbal-based medication
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 296 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2013to Oct 2017
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 59 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Acute Otitis Media
- Being tested
- Herbal-based medication, Placebo
- Medical subject headings
- Otitis Media
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Herbal-based medicationDrug
Also called Otovowen(R)
Aconitum napellus, Capsicum annuum; Chamomilla recutita; Echinacea purpurea; Hydrargyrum bicyanatum; Hydrastis canadensis; Iodum; Natrium tetraboracicum; Sambucus nigra; Sanguinaria canadensis
PlaceboDrug
Aqueous ethanol solution non-distinguishable from verum
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of acute otitis media episodes diagnosed by a physician
Measured: within 6 months after enrolment per patient
Secondary outcomes (11)
Total number of acute otitis media per treatment group
Measured: diagnosed in each patient within 6 months after enrolment
Number of unscheduled visits due to AOM
Measured: within 6 months after enrolment
Number of AOM treated with antibiotics
Measured: within 6 months after enrolment
Number of unscheduled visits due to URI
Measured: within 6 months after enrolment
Number of URI treated with antibiotics
Measured: within 6 months after enrolment
Number of days with URI
Measured: within 6 months after enrolment
Subjective evaluation of efficacy by parent
Measured: at indivdual study completion 6 months after enrolment
Subjective evaluation of tolerability by parent
Measured: at indivdual study completion 6 months after enrolment
Occurence of adverse events
Measured: within 6 months of enrolment
number of days with use of antipyretic, analgesic and antibiotic medication
Measured: within 6 months of enrolment
Number of absent days from daycare (patient) / work (parent)
Measured: within 6 months of enrolment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2015 (estimated)
- Study startOct 2013
- Primary completionOct 2015
- Study completionOct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Otitis MediaStudies of the same condition, open and under way.
- More trials run by University Hospital TuebingenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 296 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Axel Franz, University Hospital Tuebingen
- Investigators
- Axel Franz, MD, Principal investigator, University Hospital Tuebingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02345447
- Sponsor's protocol ID
- OTV.PRE.01.A3
- Acronym
- OTV_PRE_01
- Status last verified
- May 2018
- First submitted
- 19 Jan 2015
- Last updated
- 11 May 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02345447
- Acronym / sponsor ID
- OTV_PRE_01 / OTV.PRE.01.A3
- Conditions
- Acute Otitis Media
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 296 participants (estimated)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Study start
- Oct 2013 (actual)
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 26 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Herbal-based Medication | Active comparator | Drug: Herbal-based medicationTrade 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). |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo 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). |
Who may qualify
- Ages
- 12 to 59 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Herbal-based medicationAlso: Otovowen(R)Aconitum napellus, Capsicum annuum; Chamomilla recutita; Echinacea purpurea; Hydrargyrum bicyanatum; Hydrastis canadensis; Iodum; Natrium tetraboracicum; Sambucus nigra; Sanguinaria canadensis | Drug | Herbal-based Medication |
| PlaceboAqueous ethanol solution non-distinguishable from verum | Drug | Placebo |
Primary outcome
Number of acute otitis media episodes diagnosed by a physician
Time frame: within 6 months after enrolment per patient
11 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Axel Franz, MD principal investigator
University Hospital Tuebingen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Herbal-based medication in people with Acute Otitis Media, run by University Hospital Tuebingen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of acute otitis media episodes diagnosed by a physician (time frame: within 6 months after enrolment per patient). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2018.