To Evaluate the Efficacy and Safety of HL151 Versus Placebo in Perennial Allergic Rhinitis Patients
NCT ID: NCT03655210
Last Updated: 2018-08-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
272 participants
INTERVENTIONAL
2017-02-07
2017-10-16
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Experimental
HL151(1Tab,Bepostatine salicylate) once a day, 4 weeks of treatment
HL151
HL151(1Tab) once a day for 4 weeks of treatments
Placebo Comparator
HL151 Placebo (1Tab,Placebo of Bepostatine salicylate) once a day, 4 weeks of treatment
placebo
HL151 placebo(1Tab, Placebo of Bepostatine salicylate) once a day for 4 weeks of treatments
Interventions
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HL151
HL151(1Tab) once a day for 4 weeks of treatments
placebo
HL151 placebo(1Tab, Placebo of Bepostatine salicylate) once a day for 4 weeks of treatments
Eligibility Criteria
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Inclusion Criteria
2. At least two years history of allergic rhinitis prior to participate in clinical trial
3. Patients with positive reaction for perennial allergen in tests(prick test or Intradermal test or MAST(Multiple Allergen Simultaneous Test) or Immuno CAP test) within 12 months
4. In visit 2, patients with over mean 5 points of the total reflective TNSS score per day (during the run-in period) (highest value 12 points)
5. Patients who can ability to record subject diary
6. Patients who agreed to maintain the same environment throughout the entire clinical trial period.
7. Written consent voluntarily to participate in this clinical trial after understanding and detailed explanation about this clinical trial
Exclusion Criteria
2. Patients with asthma due to the following diseases(but patients with mild and intermittent asthma are available to participate in clinical trials)
* Within four weeks from the date of screening, patients who visit the emergency room or have been hospitalized within 12 weeks or
* patients with asthma who need other treatment except short-acting Beta-efficient respiratory relaxants Inhalation
3. Patients with obstructive nasal polyp or severe deviated nasal septum
4. Patients who Within 12 weeks from the date of screening, had damage or surgery around nasal cavity
5. Patients with anamnesis in acute /chronic sinusitis
19 Years
ALL
No
Sponsors
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Hanlim Pharm. Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Seoul National University Hospital
Gyeonggi-do, , South Korea
Countries
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Other Identifiers
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HL_HL151_301
Identifier Type: -
Identifier Source: org_study_id