Cerumen Impaction of Both EarsRemo-WaxNCT03802903
Efficacy and Safety of Remo-Wax for Removal of Impacted Earwax
A study testing Remo-Wax in people with Cerumen Impaction of Both Ears, run by Orion Corporation, Orion Pharma at 1 site in Lithuania.
Trial summary
The study evaluates if Remo-Wax ear drops can soften impacted earwax. Read more about this study
- Who is it for?
- Ages 1 year and older
- Conditions the study is for
- Cerumen Impaction of Both Ears
- What is being tested?
- Remo-Wax
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteLithuania
- Study dates
- 12 Mar 2019to 29 Apr 2019
- Phase
- Interventional
- 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 1 year and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Written informed consent obtained.
- Male or female patients over 1 year old who have cerumen impaction.
- Presence of excessive or impacted cerumen [excessive or impacted cerumen is identified as causing partial (> 50%) or complete occlusion of at least one ear canal when attempting to visualize the tympanic membrane.
Who cannot join
- Hypersensitivity to any product ingredient(s) or history of anaphylactic/anaphylactoid reactions.
- History of tympanic membrane perforation, tympanostomy tubes, or otitis externa in the previous 6 months.
- External ear infection.
- Middle ear infection
- Past ear surgery.
- Otorrhea.
Show all 14Show fewer
- Temporal bone neoplasm.
- Presence of known or suspected mastoiditis.
- Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data (e.g. ear eczema or seborrhoea, ear canal stenosis, exostoses).
- Deafness in the contralateral ear (single sided deafness).
- Use of any ototopical drug or cerumen-removal product (with the exception of water or physiologic saline) during the preceding 3 days.
- Use of hearing aids.
- Participation in another drug study within 60 days prior to the start of the present study.
- Predictable poor compliance or inability to communicate well with the investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety of Remo-Wax for Removal of Impacted Earwax; an Open, Single-arm, Non-randomised, Multicentre Clinical Study
The study evaluates if Remo-Wax ear drops can soften impacted earwax.
Read the detailed description
This is an open, single-arm multicentre study to confirm the efficacy and safety of a commercially available Remo-Wax ear drops containing allantoin for dissolving and removing impacted earwax. Subjects that qualify for enrollment and provide informed consent wil be treated with topical earwax softening product.
- Conditions
- Cerumen Impaction of Both Ears
- Being tested
- Remo-Wax
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remo-WaxDevice
topical treatment
| Study group | Role | What they receive |
|---|---|---|
| Remo-Wax | Experimental | Test product will be applied into ear canal for 20-60 minutes. Receives: Device: Remo-Wax |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tympanic membrane visuality
Tympanic membrane will be assessed in five grades of occlusion's severity after each treatment application.
Normal - insignificant earwax present, Minimal - minimal impacted cerumen in ear canal, Mild - some impacted cerumen in ear canal, Moderate - moderate impacted cerumen in ear canal, Severe - excessive impacted cerumen in ear canal
Measured: 20-60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2019
- Study start12 Mar 2019
- Primary completion29 Apr 2019
- Study completion29 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerumen Impaction of Both EarsStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Orion Corporation, Orion Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03802903
- Sponsor's protocol ID
- 3126001
- Acronym
- Remo-Wax
- Status last verified
- May 2019
- First submitted
- 11 Jan 2019
- Last updated
- 15 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Remo-Wax for Removal of Impacted Earwax; an Open, Single-arm, Non-randomised, Multicentre Clinical Study
- ClinicalTrials.gov ID
- NCT03802903
- Acronym / sponsor ID
- Remo-Wax / 3126001
- Conditions
- Cerumen Impaction of Both Ears
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Orion Corporation, Orion PharmaIndustry (pharma, biotech, devices)
- Study start
- 12 Mar 2019 (actual)
- Primary completion
- 29 Apr 2019 (actual)
- Study completion
- 29 Apr 2019 (actual)
- First posted
- 14 Jan 2019 (actual)
- 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 study evaluates if Remo-Wax ear drops can soften impacted earwax.
Detailed description
This is an open, single-arm multicentre study to confirm the efficacy and safety of a commercially available Remo-Wax ear drops containing allantoin for dissolving and removing impacted earwax. Subjects that qualify for enrollment and provide informed consent wil be treated with topical earwax softening product.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Remo-Wax | Experimental | Device: Remo-WaxTest product will be applied into ear canal for 20-60 minutes. |
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Written informed consent obtained.
- Male or female patients over 1 year old who have cerumen impaction.
- Presence of excessive or impacted cerumen [excessive or impacted cerumen is identified as causing partial (> 50%) or complete occlusion of at least one ear canal when attempting to visualize the tympanic membrane.
Key exclusion criteria (14 listed)
- Hypersensitivity to any product ingredient(s) or history of anaphylactic/anaphylactoid reactions.
- History of tympanic membrane perforation, tympanostomy tubes, or otitis externa in the previous 6 months.
- External ear infection.
- Middle ear infection
- Past ear surgery.
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 |
|---|---|---|
| Remo-Waxtopical treatment | Device | Remo-Wax |
Primary outcome
Tympanic membrane visuality
Time frame: 20-60 minutes
Tympanic membrane will be assessed in five grades of occlusion's severity after each treatment application. Normal - insignificant earwax present, Minimal - minimal impacted cerumen in ear canal, Mild - some impacted cerumen in ear canal, Moderate - moderate impacted cerumen in ear canal, Severe - excessive impacted cerumen in ear canal
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 15 May 2019.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remo-Wax in people with Cerumen Impaction of Both Ears, run by Orion Corporation, Orion Pharma at 1 site in Lithuania.
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 3 inclusion and 14 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 15 May 2019. 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 Lithuania. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Tympanic membrane visuality (time frame: 20-60 minutes). 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 15 May 2019.