Otitis Media Clinical Trial
— DoSe iTOfficial 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)
Verified date | July 2019 |
Source | Grünenthal GmbH |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 265 |
Est. completion date | December 23, 2004 |
Est. primary completion date | December 23, 2004 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 2 Years to 12 Years |
Eligibility |
Inclusion Criteria: - 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. Exclusion Criteria: - 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. - 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. |
Country | Name | City | State |
---|---|---|---|
Germany | DE11 | Balve | |
Germany | DE10 | Beckum | |
Germany | DE09 | Hameln | |
Germany | DE08 | Hannover | |
Germany | DE12 | Künzing | |
Germany | DE02 | München | |
Germany | DE03 | München | |
Germany | DE05 | München | |
Germany | DE06 | München | |
Germany | DE13 | München | |
Germany | DE14 | München | |
Germany | DE04 | Olching | |
Germany | DE07 | Pullach im Isartal | |
Germany | DE01 | Unterhaching | |
Poland | PL03 | Kozieglowy | |
Poland | PL06 | Kraków | |
Poland | PL01 | Lódz | |
Poland | PL04 | Otwock | |
Poland | PL05 | Warszawa | |
Poland | PL02 | Wroclaw |
Lead Sponsor | Collaborator |
---|---|
Grünenthal GmbH |
Germany, Poland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Day 3-5 | |
Primary | 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. | Day 11-14 | |
Primary | 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. | Day 3-5 | |
Primary | 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. | Day 11-14 | |
Primary | 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. | Day 3-5 | |
Primary | 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. | Day 11-14 | |
Primary | 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. | Day 3-5 | |
Primary | 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. |
Day 11-14 | |
Primary | 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. | Day 3-5 | |
Primary | 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. | Day 11-14 | |
Primary | 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. |
Day 3-5 | |
Primary | 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. |
Day 11-14 | |
Primary | 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. |
Day 3-5 | |
Primary | 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. |
Day 11-14 | |
Primary | 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. |
Day 11-14 | |
Primary | 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. |
Day 11-14 | |
Primary | 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. |
Day 11-14 | |
Secondary | 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. | Day 3-5 | |
Secondary | 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. | Day 11-14 |
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