E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Seasonal Allergic Rhinitis |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Ear, nose and throat diseases [C09] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10039776 |
E.1.2 | Term | Seasonal allergic rhinitis |
E.1.2 | System Organ Class | 100000004870 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The purpose of this study was to demonstrate the superiority of Olopatadine Hydrochloride (HCl) Nasal Spray 0.6% relative to Olopatadine HCl Nasal Spray Vehicle when given twice daily (BID) for the treatment of Seasonal Allergic Rhinitis (SAR) for a 2-week period. |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. 6 to <12 years of age when Visit 1 is completed (first dose of single-blind medication administered)
2. must confirm absence of significant anatomic abnormalities, infection,
bleeding, and mucosal ulcerations prior to administration of test article at Visits 1 and 2.
Alternatively, a finding of “present” for any of these parameters disqualifies the patient
from the study, regardless of clinical relevance.
3. Allergy to a current prevalent seasonal allergen of the area;
4. Observe drug washout times, as specified in the protocol;
5. Post-menarchal females of childbearing potential must have a negative pregnancy test prior to entry into the study, and, if sexually active, agree to use adequate birth control methods throughout the study. If a female of childbearing potential who is not sexually active at the start of the study becomes sexually active during the study, she must agree to use adequate birth control for the duration of the study;
6. Other protocol-specified inclusion criteria may apply.
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E.4 | Principal exclusion criteria |
1. Concurrent disease that might complicate or interfere with the investigation or evaluation of the study medications;
2. Use of prohibited medications or inadequate washout of any medication, as specified in the protocol;
3. Known non-responder to antihistamines for symptoms of SAR;
4. Any systemic or ocular disorder that could interfere with the evaluation of the study medication;
5. Hypersensitivity to the study medication or any component of the test articles;
6. A confirmed diagnosis of chronic rhino sinusitis (within the last year).
7.Chronic or intermittent use of inhaled, oral, intramuscular, or intravenous
corticosteroids or dermal potent or super-potent topical corticosteroids.
8. Other protocol-specified exclusion criteria may apply.
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E.5 End points |
E.5.1 | Primary end point(s) |
Percent Change from Baseline in rTNSS |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Baseline, up through first 14 complete days of treatment |
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E.5.2 | Secondary end point(s) |
Percent Change from Baseline in rTOSS |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Baseline, up through first 14 complete days of treatment |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 4 |
E.8.3 |
Will this trial be conducted at a single site globally?
| No |
E.8.4 | Will this trial be conducted at multiple sites globally? | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.2 | Trial being conducted completely outside of the EEA | Yes |
E.8.6.3 | Specify the countries outside of the EEA in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 2 |