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Efficacy and Safety of HCP1102 Capsule

Efficacy and Safety of HCP1102 Capsule : A Randomized, Double-blind, Active-controlled, Multicenter Phase 3 Clinical Trial

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02552667
Enrollment
228
Registered
2015-09-17
Start date
2014-09-30
Completion date
2015-07-31
Last updated
2015-09-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma With Allergic Rhinitis

Keywords

Asthma, Allergic rhinitis

Brief summary

Efficacy and safety of HCP1102 capsule : A randomized, double-blind, active-controlled, multicenter phase 3 clinical trial.

Interventions

DRUGHCP1102+HGP0711Placebo

Coadministration of HCP1102 with HGP0711 Placebo for 4-week

DRUGHCP1102Placebo+HGP0711

Coadministration of HCP1102 Placebo with HGP0711 for 4-week

Sponsors

Hanmi Pharmaceutical Company Limited
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
15 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Inclusion: * Age≥15 * Mild or moderate asthma patients with allergic rhinitis * Patient who meet all criteria of rhinitis * Patients understood the contents and purpose of this trial and signed informed consent form * Patients who are capable and willing to write subject diary * Patients who agree with maintain same environment during clinical trials Exclusion: * Nonallergic rhinitis * Severe asthma * Other pulmonary disease (pulmonary tuberculosis, COPD) except Asthma * Medical history of hypertrophic cardiomyopathy, cancer, renal disease, Liver disease, cardiovascular disease, respiratory disease, endocrine disorder, CNS disorder that effect safety * Medical history of gastrointestinal surgery or gastrointestinal disorders that effect drug absorption * Alcohol abuse or Drug abuse * Genetic factor of galactose intolerance or Lapp lactase deficiency or glucose-galactose malabsorption * pregnant or breast-feeding women or men/women of childbearing age that they don't use contraceptives * Patient who administered other investigational products within 30 days * Current smoker Judged to be inappropriate for the study by the investigator after reviewing other reasons

Design outcomes

Primary

MeasureTime frame
Change of Mean Daytime Nasal Symptom Scorebase line, 3-4week(2weeks)

Secondary

MeasureTime frame
Change of Runny nose (Mean Daytime Nasal Symptom Score)base line, 1-2week(2weeks), 3-4week(2weeks)
Change of Mean Nighttime Nasal Symptom Scorebase line, 1-2week(2weeks), 3-4week(2weeks)
Change of Mean Daytime Nasal Symptom Scorebase line, 1-2week(2weeks), 3-4week(2weeks)
Change of sneezing (Mean Daytime Nasal Symptom Score)base line, 1-2week(2weeks), 3-4week(2weeks)
Change of pruritus (Mean Daytime Nasal Symptom Score)base line, 1-2week(2weeks), 3-4week(2weeks)
Change of Mean Composite Symptom Scorebase line, 1-2week(2weeks), 3-4week(2weeks)

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 6, 2026