Otitis MediaPhase 3DoSe iTNCT04016051
Acceptance of Clarithromycin in a Straw Compared to Syrup in Children With Upper Respiratory Tract Infections
A Phase 3 study testing Clarithromycin DST (125 mg), Clarithromycin DST (187.5 mg) and Clarithromycin DST (250 mg) in people with Otitis Media and Tonsillitis, run by Grünenthal GmbH at 20 sites in 2 countries.
Trial summary
This study was performed in children with upper respiratory tract infections (acute ear infection, infection of the tonsils or throat, or bacterial inflammation of the bronchi) who needed treatment with an antibiotic (clarithromycin). Read more about this study
- Who is it for?
- Ages 2 to 12 years
- Conditions the study is for
- Otitis Media, Tonsillitis, Pharyngitis
- What is being tested?
- Clarithromycin DST (125 mg), Clarithromycin DST (187.5 mg) and Clarithromycin DST (250 mg)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 265 participants
- Where
- 20 sitesin 2 countries
- Study dates
- 22 Sep 2004to 23 Dec 2004
- 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 2 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Male and female children weighing 12-40 kg.
- Age 2 -12 years.
- Written informed consent (parents).
- Diagnosis of acute otitis media, tonsillitis, pharyngitis, or acute bacterial bronchitis requiring antibiotic treatment.
Who cannot join
- Participation in another study of investigational products or of devices parallel to, or less than 4 weeks before study entry, or previous participation in this study (for safety reasons).
- Known to or suspected of not being able to comply with the study protocol and the use of clarithromycin.
- Requirement for, or current use of, systemic antibacterial agents not specified in the protocol.
- Necessity of dose reduction due to any concomitant disease.
- Known human immunodeficiency virus (HIV) positive.
- Other inflammatory/infectious diseases of the ear, the upper respiratory tract or the nose and throat.
Show all 11Show fewer
- History or presence of disease or concomitant medication contraindicating the use of clarithromycin.
- Known or suspected intolerance / hypersensitivity to macrolides.
- Contraindications according to the clarithromycin Summary of Product Characteristics (SmPC).
- Indication for antibiotic treatment for less than 7 days or more than 10 days.
- If known before entry, bacterial isolate resistant to clarithromycin.
Trial locations and contacts
20 sites in 2 countries.
20 sites in 2 countries
Germany14 sites
DE11
Balve, 58802
DE10
Beckum, 59269
DE09
Hamelin, 31785
DE08
Hanover, 30625
DE12
Künzing, 94550
DE14
München, 80393
DE05
München, 81241
DE06
München, 81543
DE03
München, 81669
DE02
München, 81675
DE13
München, 81739
DE04
Olching, 82140
DE07
Pullach im Isartal, 82049
DE01
Unterhaching, 82008
Poland6 sites
PL03
Koziegłowy
PL06
Krakow
PL01
LÓDZ
PL04
Otwock
PL05
Warsaw
PL02
Wroclaw
About this study
Official title: Comparison of Treatment Satisfaction and Treatment Adherence of a Novel Application Form "Dose Sipping Technology" (DST) of Oral Clarithromycin vs. Clarithromycin Syrup in Children Suffering From Acute Otitis Media, Tonsillitis, Pharyngitis, or Acute Bacterial Bronchitis (DoSe iT)
This study was performed in children with upper respiratory tract infections (acute ear infection, infection of the tonsils or throat, or bacterial inflammation of the bronchi) who needed treatment with an antibiotic (clarithromycin). The study investigated a new technology which delivers the antibiotic in a straw (dose sipping technology, DST) in comparison to a marketed syrup.
Read the detailed description
The study population were children aged 2-12 years (weight 12-40 kg) suffering from upper respiratory tract infections (acute otitis media, tonsillitis, pharyngitis, or acute bacterial bronchitis) and who needed antibiotic treatment. The study compared treatment satisfaction and treatment adherence of oral clarithromycin DST (125 mg, 187.5 mg, or 250 mg twice daily) with the established oral clarithromycin syrup administered via a graduated syringe (Klacid Syrup Forte®, 250 mg/5mL) at the same fixed daily doses.
Fixed doses of 125 mg, 187.5 mg and 250 mg of clarithromycin DST offer the pediatrician the flexibility to treat children of different body weight and age adequately at the recommended daily dose of 15 (12.5-20) mg/kg. All children were treated for 7 to 10 day (14 to 20 doses). Treatment satisfaction by the guardian/caregiver in terms of handling and administration of the clarithromycin DST straw and the comparator clarithromycin syrup, convenience of the administration, acceptance of taste and aftertaste, and treatment satisfaction with respect to future use was evaluated by means of a Parents' Questionnaire once on either Day 3, 4, or 5 and once on either Day 11, 12, 13, or 14. In addition, treatment adherence/willingness of medication intake and the child's health status were assessed. The safety program comprised recording and evaluation of adverse events and countermeasures.
- Conditions
- Otitis Media, Tonsillitis, Pharyngitis, Bronchitis
- Being tested
- Clarithromycin DST (125 mg), Clarithromycin DST (187.5 mg), Clarithromycin DST (250 mg), Clarithromycin Syrup (125 mg), Clarithromycin Syrup (187.5 mg)
- Medical subject headings
- Otitis Media, Tonsillitis, Pharyngitis, Bronchitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clarithromycin DST (125 mg)Drug
Clarithromycin DST (125.0 mg clarithromycin / straw).
Clarithromycin DST (187.5 mg)Drug
Clarithromycin DST (187.5 mg clarithromycin / straw).
Clarithromycin DST (250 mg)Drug
Clarithromycin DST (250.0 mg clarithromycin / straw).
Clarithromycin Syrup (125 mg)Drug
Also called Klacid Syrup® Forte 250 mg/5mL
Clarithromycin Syrup 2.5 ml (125 mg).
Clarithromycin Syrup (187.5 mg)Drug
Also called Klacid Syrup® Forte 250 mg/5mL
Clarithromycin Syrup 3.75 ml (187.5 mg).
Clarithromycin Syrup (250 mg)Drug
Also called Klacid Syrup® Forte 250 mg/5mL
Clarithromycin Syrup 5 ml (250 mg).
| Study group | Role | What they receive |
|---|---|---|
| Clarithromycin DST | Experimental | Participants received oral administration of Clarithromycin DST twice a day:
* 125.0 mg straw, participants with body weight between 12 and 19 kg (approximate age 2-4 years).
* 187.5 mg straw, participants with body weight between 20 and 29 kg (approximate age 4-8 years).
* 250.0 mg straw, participants with body weight between 30 and 40 kg (approximate age 8-12 years).
For oral intake of DST granules, the lower end of the straw was to be dipped into a glass with a clear, cool or lukewarm, preferably flavored beverage of participant choice. Suitable beverages were lemonade (carbonated or not), clear fruit juices without pulp, tea or water. The beverage was to be sipped smoothly through the straw. Receives: Drug: Clarithromycin DST (125 mg); Drug: Clarithromycin DST (187.5 mg); Drug: Clarithromycin DST (250 mg) |
| Clarithromycin Syrup | Active comparator | Participants received oral administration of Clarithromycin Syrup twice a day:
* 2.5 ml (125 mg) participants with body weight between 12 and 19 kg (approximate age 2-4 years).
* 3.75 ml (187.5 mg) participants with body weight between 20 and 29 kg (approximate age 4-8 years).
* 5 ml (250 mg) participants with body weight between 30 and 40 kg (approximate age 8-12 years). Receives: Drug: Clarithromycin Syrup (125 mg); Drug: Clarithromycin Syrup (187.5 mg); Drug: Clarithromycin Syrup (250 mg) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preparation of the medication (during treatment)
This was analyzed by a Parents' Questionnaire by means of the question "How was the preparation of the medication?" Parents were asked to respond once on either Day 3, 4, or 5. Possible answers (tick one only) were "very simple", "simple", "complicated" and "very complicated". The best outcome was "very simple", the worst "very complicated". The percentage of responses for each of the possible answers was calculated.
Measured: Day 3-5
Preparation of the medication (after treatment)
This was analyzed by a Parents' Questionnaire by means of the question "How was the preparation of the medication?". Parents were asked to respond once on either Day 11, 12, 13, or 14. Possible answers (tick one only) were "very simple", "simple", "complicated" and "very complicated". The best outcome was "very simple", the worst "very complicated". The percentage of responses for each of the possible answers was calculated.
Measured: Day 11-14
Dosing accuracy (during treatment)
This was analyzed by a Parents' Questionnaire by means of the question "How do you rate giving the right dose?". Parents were asked to respond once on either Day 3, 4, or 5. Possible answers (tick one only) were "very simple", "simple", "difficult" and "very difficult". The best outcome was "very simple", the worst "very difficult". The percentage of responses for each of the possible answers was calculated.
Measured: Day 3-5
Dosing accuracy (after treatment)
This was analyzed by a Parents' Questionnaire by means of the question "How do you rate giving the right dose?" Parents were asked to respond once on either Day 11, 12, 13, or 14. Possible answers (tick one only) were "very simple", "simple", "difficult" and "very difficult". The best outcome was "very simple", the worst "very difficult". The percentage of responses for each of the possible answers was calculated.
Measured: Day 11-14
Handling of the medication (during treatment)
This was analyzed by a Parents' Questionnaire by means of the question "How satisfied are you with the handling of the medication?" Parents were asked to respond once on either Day 3, 4, or 5. Possible answers (tick one only) were "very satisfied", "satisfied", "less satisfied" and "not satisfied". The best outcome was "very satisfied", the worst "not satisfied". The percentage of responses for each of the possible answers was calculated.
Measured: Day 3-5
Handling of the medication (after treatment)
This was analyzed by a Parents' Questionnaire by means of the question "How satisfied are you with the handling of the medication?" Parents were asked to respond once on either Day 11, 12, 13, or 14. Possible answers (tick one only) were "very satisfied", "satisfied", "less satisfied" and "not satisfied". The best outcome was "very satisfied", the worst "not satisfied". The percentage of responses for each of the possible answers was calculated.
Measured: Day 11-14
Administration of the medication (during treatment)
This was analyzed by a Parents' Questionnaire by means of the question "How do you judge the administration of the medication?" Parents were asked to respond once on either Day 3, 4, or 5. Possible answers (tick one only) were "very simple", "simple", "complicated" and "very complicated". The best outcome was "very simple", the worst "very complicated". The percentage of responses for each of the possible answers was calculated.
Measured: Day 3-5
Administration of the medication (after treatment)
This was analyzed by a Parents' Questionnaire by means of the question "How do you judge the administration of the medication?" Parents were asked to respond once on either Day 11, 12, 13, or 14.
Possible answers (tick one only) were "very simple", "simple", "complicated" and "very complicated". The best outcome was "very simple", the worst "very complicated". The percentage of responses for each of the possible answers was calculated.
Measured: Day 11-14
Ease to follow the prescribed dosing schedule (during treatment)
This was analyzed by a Parents' Questionnaire by means of the question "How easy is it to follow the dosing schedule?" Parents were asked to respond once on either Day 3, 4, or 5. Possible answers (tick one only) were "very simple", "simple", "complicated" and "very complicated". The best outcome was "very simple", the worst "very complicated". The percentage of responses for each of the possible answers was calculated.
Measured: Day 3-5
Ease to follow the prescribed dosing schedule (after treatment)
This was analyzed by a Parents' Questionnaire by means of the question "How easy is it to follow the dosing schedule?" Parents were asked to respond once on either Day 11, 12, 13, or 14. Possible answers (tick one only) were "very simple", "simple", "complicated" and "very complicated". The best outcome was "very simple", the worst "very complicated". The percentage of responses for each of the possible answers was calculated.
Measured: Day 11-14
Child's feeling about the taste of the medication (during treatment)
This was analyzed by a Parents' Questionnaire by means of the question "What does your child feel about the taste of the medication?".
Possible answers (tick one only) were "very good", "good", "acceptable", "bad", "very bad" and "no comment". The best outcome was "very good", the worst "very bad". The percentage of responses for each of the possible answers was calculated.
Measured: Day 3-5
Child's feeling about the taste of the medication (after treatment)
This was analyzed by a Parents' Questionnaire by means of the question "What does your child feel about the taste of the medication?" Parents were asked to respond once on either Day 11, 12, 13, or 14.
Possible answers (tick one only) were "very good", "good", "acceptable", "bad", "very bad" and "no comment". The best outcome was "very good", the worst "very bad". The percentage of responses for each of the possible answers was calculated.
Measured: Day 11-14
Child's feeling about aftertaste of the medication (during treatment)
This was analyzed by a Parents' Questionnaire by means of the question "What does your child feel about the aftertaste of the medication?" Parents were asked to respond once on either Day 3, 4, or 5.
Possible answers (tick one only) were "very good", "good", "acceptable", "bad", "very bad" and "no comment". The best outcome was "very good", the worst "very bad". The percentage of responses for each of the possible answers was calculated.
Measured: Day 3-5
Child's feeling about the aftertaste of the medication (after treatment)
This was analyzed by a Parents' Questionnaire by means of the question "What does your child feel about the aftertaste of the medication?" Parents were asked to respond once on either Day 11, 12, 13, or 14.
Possible answers (tick one only) were "very good", "good", "acceptable", "bad", "very bad" and "no comment". The best outcome was "very good", the worst "very bad". The percentage of responses for each of the possible answers was calculated.
Measured: Day 11-14
Optimal administration form
This was analyzed by a Parents' Questionnaire by means of the question "Do you think the administration form is optimal for your child?". Parents were asked to respond once on either Day 11, 12, 13, or 14.
Possible answers (tick one only) were "Yes", "No", and "Do not know". The percentage of responses for each of the possible answers was calculated.
Measured: Day 11-14
Treatment preference
Treatment preference was analyzed by a Parents' Questionnaire by means of the question "Would you or your child prefer this administration form next time?" Parents were asked to respond once on either Day 11, 12, 13, or 14.
Possible answers (tick one only) were "Yes" and "No". The percentage of responses for each of the possible answers was calculated.
Measured: Day 11-14
Treatment adherence
The child's adherence to the prescribed course of therapy was checked by determining the number of unused straws or the residual volume in the medication bottles, respectively, when unused study medication was returned to the site on Day 11, 12, 13, or 14. A participant was considered to be:
- Fully treatment adherent: >90 % of prescribed doses taken within the prescribed course of therapy.
- Partially treatment adherent: 70-90% of prescribed doses taken within the prescribed course of therapy.
- Non adherent: Omission of 2 or more consecutive doses or <70% of prescribed doses taken within the prescribed course of therapy.
The percentage of participants in each of the 3 categories was calculated.
Measured: Day 11-14
Secondary outcomes (2)
Child's Health Status compared to Baseline (during treatment)
The participant's overall health status compared to baseline (= acute infection requiring antibiotic treatment) was assessed by the investigator as "cured", "improved", "no changes", or "deteriorated". The clinical assessment was made during a phone interview with the parent/caregiver on either Day 3, 4, or 5. The best outcome was "cured", the worst was "deteriorated". The percentage of participants per outcome category was calculated.
Measured: Day 3-5
Child's Health Status compared to Baseline (after treatment)
The participant's overall health status compared to baseline (= acute infection requiring antibiotic treatment) was assessed by the investigator as "cured", "improved", "no changes", or "deteriorated". The clinical assessment was made once at a site visit on either Day 11, 12, 13. or 14. The best outcome was "cured", the worst was "deteriorated". The percentage of participants per outcome category was calculated.
Measured: Day 11-14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2019
- Study start22 Sep 2004
- Primary completion23 Dec 2004
- Study completion23 Dec 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Otitis MediaStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 265 participants (actual)
Sponsor and investigators
- Lead sponsor
- Grünenthal GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Grünenthal Study Director, Study director, Grünenthal GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04016051
- Sponsor's protocol ID
- KF-DSTCLA/01
- Acronym
- DoSe iT
- Status last verified
- Jul 2019
- First submitted
- 5 Jun 2019
- Last updated
- 11 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Treatment Satisfaction and Treatment Adherence of a Novel Application Form "Dose Sipping Technology" (DST) of Oral Clarithromycin vs. Clarithromycin Syrup in Children Suffering From Acute Otitis Media, Tonsillitis, Pharyngitis, or Acute Bacterial Bronchitis (DoSe iT)
- ClinicalTrials.gov ID
- NCT04016051
- Acronym / sponsor ID
- DoSe iT / KF-DSTCLA/01
- Conditions
- Otitis Media, Tonsillitis, Pharyngitis, Bronchitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 265 participants (actual)
- Lead sponsor
- Grünenthal GmbHIndustry (pharma, biotech, devices)
- Study start
- 22 Sep 2004 (actual)
- Primary completion
- 23 Dec 2004 (actual)
- Study completion
- 23 Dec 2004 (actual)
- First posted
- 11 Jul 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.
This study was performed in children with upper respiratory tract infections (acute ear infection, infection of the tonsils or throat, or bacterial inflammation of the bronchi) who needed treatment with an antibiotic (clarithromycin). The study investigated a new technology which delivers the antibiotic in a straw (dose sipping technology, DST) in comparison to a marketed syrup.
Detailed description
The study population were children aged 2-12 years (weight 12-40 kg) suffering from upper respiratory tract infections (acute otitis media, tonsillitis, pharyngitis, or acute bacterial bronchitis) and who needed antibiotic treatment. The study compared treatment satisfaction and treatment adherence of oral clarithromycin DST (125 mg, 187.5 mg, or 250 mg twice daily) with the established oral clarithromycin syrup administered via a graduated syringe (Klacid Syrup Forte®, 250 mg/5mL) at the same fixed daily doses.
Fixed doses of 125 mg, 187.5 mg and 250 mg of clarithromycin DST offer the pediatrician the flexibility to treat children of different body weight and age adequately at the recommended daily dose of 15 (12.5-20) mg/kg. All children were treated for 7 to 10 day (14 to 20 doses). Treatment satisfaction by the guardian/caregiver in terms of handling and administration of the clarithromycin DST straw and the comparator clarithromycin syrup, convenience of the administration, acceptance of taste and aftertaste, and treatment satisfaction with respect to future use was evaluated by means of a Parents' Questionnaire once on either Day 3, 4, or 5 and once on either Day 11, 12, 13, or 14. In addition, treatment adherence/willingness of medication intake and the child's health status were assessed. The safety program comprised recording and evaluation of adverse events and countermeasures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clarithromycin DST | Experimental | Drug: Clarithromycin DST (125 mg), Drug: Clarithromycin DST (187.5 mg), Drug: Clarithromycin DST (250 mg)Participants received oral administration of Clarithromycin DST twice a day: * 125.0 mg straw, participants with body weight between 12 and 19 kg (approximate age 2-4 years). * 187.5 mg straw, participants with body weight between 20 and 29 kg (approximate age 4-8 years). * 250.0 mg straw, participants with body weight between 30 and 40 kg (approximate age 8-12 years). For oral intake of DST granules, the lower end of the straw was to be dipped into a glass with a clear, cool or lukewarm, preferably flavored beverage of participant choice. Suitable beverages were lemonade (carbonated or not), clear fruit juices without pulp, tea or water. The beverage was to be sipped smoothly through the straw. |
| Clarithromycin Syrup | Active comparator | Drug: Clarithromycin Syrup (125 mg), Drug: Clarithromycin Syrup (187.5 mg), Drug: Clarithromycin Syrup (250 mg)Participants received oral administration of Clarithromycin Syrup twice a day: * 2.5 ml (125 mg) participants with body weight between 12 and 19 kg (approximate age 2-4 years). * 3.75 ml (187.5 mg) participants with body weight between 20 and 29 kg (approximate age 4-8 years). * 5 ml (250 mg) participants with body weight between 30 and 40 kg (approximate age 8-12 years). |
Who may qualify
- Ages
- 2 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Male and female children weighing 12-40 kg.
- Age 2 -12 years.
- Written informed consent (parents).
- Diagnosis of acute otitis media, tonsillitis, pharyngitis, or acute bacterial bronchitis requiring antibiotic treatment.
Key exclusion criteria (11 listed)
- Participation in another study of investigational products or of devices parallel to, or less than 4 weeks before study entry, or previous participation in this study (for safety reasons).
- Known to or suspected of not being able to comply with the study protocol and the use of clarithromycin.
- Requirement for, or current use of, systemic antibacterial agents not specified in the protocol.
- Necessity of dose reduction due to any concomitant disease.
- Known human immunodeficiency virus (HIV) positive.
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 |
|---|---|---|
| Clarithromycin DST (125 mg)Clarithromycin DST (125.0 mg clarithromycin / straw). | Drug | Clarithromycin DST |
| Clarithromycin DST (187.5 mg)Clarithromycin DST (187.5 mg clarithromycin / straw). | Drug | Clarithromycin DST |
| Clarithromycin DST (250 mg)Clarithromycin DST (250.0 mg clarithromycin / straw). | Drug | Clarithromycin DST |
| Clarithromycin Syrup (125 mg)Also: Klacid Syrup® Forte 250 mg/5mLClarithromycin Syrup 2.5 ml (125 mg). | Drug | Clarithromycin Syrup |
| Clarithromycin Syrup (187.5 mg)Also: Klacid Syrup® Forte 250 mg/5mLClarithromycin Syrup 3.75 ml (187.5 mg). | Drug | Clarithromycin Syrup |
| Clarithromycin Syrup (250 mg)Also: Klacid Syrup® Forte 250 mg/5mLClarithromycin Syrup 5 ml (250 mg). | Drug | Clarithromycin Syrup |
Primary outcome
Preparation of the medication (during treatment)
Time frame: Day 3-5
This was analyzed by a Parents' Questionnaire by means of the question "How was the preparation of the medication?" Parents were asked to respond once on either Day 3, 4, or 5. Possible answers (tick one only) were "very simple", "simple", "complicated" and "very complicated". The best outcome was "very simple", the worst "very complicated". The percentage of responses for each of the possible answers was calculated.
Preparation of the medication (after treatment)
Time frame: Day 11-14
This was analyzed by a Parents' Questionnaire by means of the question "How was the preparation of the medication?". Parents were asked to respond once on either Day 11, 12, 13, or 14. Possible answers (tick one only) were "very simple", "simple", "complicated" and "very complicated". The best outcome was "very simple", the worst "very complicated". The percentage of responses for each of the possible answers was calculated.
Dosing accuracy (during treatment)
Time frame: Day 3-5
This was analyzed by a Parents' Questionnaire by means of the question "How do you rate giving the right dose?". Parents were asked to respond once on either Day 3, 4, or 5. Possible answers (tick one only) were "very simple", "simple", "difficult" and "very difficult". The best outcome was "very simple", the worst "very difficult". The percentage of responses for each of the possible answers was calculated.
Dosing accuracy (after treatment)
Time frame: Day 11-14
This was analyzed by a Parents' Questionnaire by means of the question "How do you rate giving the right dose?" Parents were asked to respond once on either Day 11, 12, 13, or 14. Possible answers (tick one only) were "very simple", "simple", "difficult" and "very difficult". The best outcome was "very simple", the worst "very difficult". The percentage of responses for each of the possible answers was calculated.
Handling of the medication (during treatment)
Time frame: Day 3-5
This was analyzed by a Parents' Questionnaire by means of the question "How satisfied are you with the handling of the medication?" Parents were asked to respond once on either Day 3, 4, or 5. Possible answers (tick one only) were "very satisfied", "satisfied", "less satisfied" and "not satisfied". The best outcome was "very satisfied", the worst "not satisfied". The percentage of responses for each of the possible answers was calculated.
Handling of the medication (after treatment)
Time frame: Day 11-14
This was analyzed by a Parents' Questionnaire by means of the question "How satisfied are you with the handling of the medication?" Parents were asked to respond once on either Day 11, 12, 13, or 14. Possible answers (tick one only) were "very satisfied", "satisfied", "less satisfied" and "not satisfied". The best outcome was "very satisfied", the worst "not satisfied". The percentage of responses for each of the possible answers was calculated.
Administration of the medication (during treatment)
Time frame: Day 3-5
This was analyzed by a Parents' Questionnaire by means of the question "How do you judge the administration of the medication?" Parents were asked to respond once on either Day 3, 4, or 5. Possible answers (tick one only) were "very simple", "simple", "complicated" and "very complicated". The best outcome was "very simple", the worst "very complicated". The percentage of responses for each of the possible answers was calculated.
Administration of the medication (after treatment)
Time frame: Day 11-14
This was analyzed by a Parents' Questionnaire by means of the question "How do you judge the administration of the medication?" Parents were asked to respond once on either Day 11, 12, 13, or 14. Possible answers (tick one only) were "very simple", "simple", "complicated" and "very complicated". The best outcome was "very simple", the worst "very complicated". The percentage of responses for each of the possible answers was calculated.
Ease to follow the prescribed dosing schedule (during treatment)
Time frame: Day 3-5
This was analyzed by a Parents' Questionnaire by means of the question "How easy is it to follow the dosing schedule?" Parents were asked to respond once on either Day 3, 4, or 5. Possible answers (tick one only) were "very simple", "simple", "complicated" and "very complicated". The best outcome was "very simple", the worst "very complicated". The percentage of responses for each of the possible answers was calculated.
Ease to follow the prescribed dosing schedule (after treatment)
Time frame: Day 11-14
This was analyzed by a Parents' Questionnaire by means of the question "How easy is it to follow the dosing schedule?" Parents were asked to respond once on either Day 11, 12, 13, or 14. Possible answers (tick one only) were "very simple", "simple", "complicated" and "very complicated". The best outcome was "very simple", the worst "very complicated". The percentage of responses for each of the possible answers was calculated.
Child's feeling about the taste of the medication (during treatment)
Time frame: Day 3-5
This was analyzed by a Parents' Questionnaire by means of the question "What does your child feel about the taste of the medication?". Possible answers (tick one only) were "very good", "good", "acceptable", "bad", "very bad" and "no comment". The best outcome was "very good", the worst "very bad". The percentage of responses for each of the possible answers was calculated.
Child's feeling about the taste of the medication (after treatment)
Time frame: Day 11-14
This was analyzed by a Parents' Questionnaire by means of the question "What does your child feel about the taste of the medication?" Parents were asked to respond once on either Day 11, 12, 13, or 14. Possible answers (tick one only) were "very good", "good", "acceptable", "bad", "very bad" and "no comment". The best outcome was "very good", the worst "very bad". The percentage of responses for each of the possible answers was calculated.
Child's feeling about aftertaste of the medication (during treatment)
Time frame: Day 3-5
This was analyzed by a Parents' Questionnaire by means of the question "What does your child feel about the aftertaste of the medication?" Parents were asked to respond once on either Day 3, 4, or 5. Possible answers (tick one only) were "very good", "good", "acceptable", "bad", "very bad" and "no comment". The best outcome was "very good", the worst "very bad". The percentage of responses for each of the possible answers was calculated.
Child's feeling about the aftertaste of the medication (after treatment)
Time frame: Day 11-14
This was analyzed by a Parents' Questionnaire by means of the question "What does your child feel about the aftertaste of the medication?" Parents were asked to respond once on either Day 11, 12, 13, or 14. Possible answers (tick one only) were "very good", "good", "acceptable", "bad", "very bad" and "no comment". The best outcome was "very good", the worst "very bad". The percentage of responses for each of the possible answers was calculated.
Optimal administration form
Time frame: Day 11-14
This was analyzed by a Parents' Questionnaire by means of the question "Do you think the administration form is optimal for your child?". Parents were asked to respond once on either Day 11, 12, 13, or 14. Possible answers (tick one only) were "Yes", "No", and "Do not know". The percentage of responses for each of the possible answers was calculated.
Treatment preference
Time frame: Day 11-14
Treatment preference was analyzed by a Parents' Questionnaire by means of the question "Would you or your child prefer this administration form next time?" Parents were asked to respond once on either Day 11, 12, 13, or 14. Possible answers (tick one only) were "Yes" and "No". The percentage of responses for each of the possible answers was calculated.
Treatment adherence
Time frame: Day 11-14
The child's adherence to the prescribed course of therapy was checked by determining the number of unused straws or the residual volume in the medication bottles, respectively, when unused study medication was returned to the site on Day 11, 12, 13, or 14. A participant was considered to be: * Fully treatment adherent: >90 % of prescribed doses taken within the prescribed course of therapy. * Partially treatment adherent: 70-90% of prescribed doses taken within the prescribed course of therapy. * Non adherent: Omission of 2 or more consecutive doses or <70% of prescribed doses taken within the prescribed course of therapy. The percentage of participants in each of the 3 categories was calculated.
2 secondary outcomes
Child's Health Status compared to Baseline (during treatment)
Time frame: Day 3-5
Child's Health Status compared to Baseline (after treatment)
Time frame: Day 11-14
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 Jul 2019.
- Individual participant dataSharing planned: No
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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.
Grünenthal Study Director study director
Grünenthal GmbH
20 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Clarithromycin DST (125 mg), Clarithromycin DST (187.5 mg) and Clarithromycin DST (250 mg) in people with Otitis Media and Tonsillitis, run by Grünenthal GmbH at 20 sites in 2 countries.
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 4 inclusion and 11 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 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in Germany, Poland. 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.
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?
Preparation of the medication (during treatment) (time frame: Day 3-5). The study lists 17 primary outcomes in all. 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 Jul 2019.