Acute Otitis Media Clinical Trial
— OTV_PRE_01Official 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
Verified date | May 2018 |
Source | University Hospital Tuebingen |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 296 |
Est. completion date | October 2017 |
Est. primary completion date | October 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 12 Months to 59 Months |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Germany | University Children's Hospital Tuebingen | Tuebingen |
Lead Sponsor | Collaborator |
---|---|
University Hospital Tuebingen |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of acute otitis media episodes diagnosed by a physician | within 6 months after enrolment per patient | ||
Secondary | Total number of acute otitis media per treatment group | diagnosed in each patient within 6 months after enrolment | ||
Secondary | Number of unscheduled visits due to AOM | within 6 months after enrolment | ||
Secondary | Number of AOM treated with antibiotics | within 6 months after enrolment | ||
Secondary | Number of unscheduled visits due to URI | within 6 months after enrolment | ||
Secondary | Number of URI treated with antibiotics | within 6 months after enrolment | ||
Secondary | Number of days with URI | within 6 months after enrolment | ||
Secondary | Subjective evaluation of efficacy by parent | at indivdual study completion 6 months after enrolment | ||
Secondary | Subjective evaluation of tolerability by parent | at indivdual study completion 6 months after enrolment | ||
Secondary | Occurence of adverse events | within 6 months of enrolment | ||
Secondary | number of days with use of antipyretic, analgesic and antibiotic medication | within 6 months of enrolment | ||
Secondary | Number of absent days from daycare (patient) / work (parent) | within 6 months of enrolment |
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