a Multicenter, Randomized, Double-blinded, Active-controlled, Parallel, Phase Ⅲ Study to Evaluate the Efficacy and Safety of HL151 Versus Talion Tab. in Pruritus Cutaneus

Hanlim Pharm. Co., Ltd.1 site in 1 country189 target enrollmentMay 17, 2017

ConditionsPruritus

InterventionsHL151 Talion Tab

DrugsHL151 Talion Tab

Overview

Phase: Phase 3
Intervention: HL151
Conditions: Pruritus
Sponsor: Hanlim Pharm. Co., Ltd.
Enrollment: 189
Locations: 1
Primary Endpoint: Changes in VAS(Visual Analogue Scale) score at 2nd week after clinical drug administration compared to baseline
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

a Multicenter, Randomized, Double-blinded, Active-controlled, Parallel, Phase Ⅲ Study to Evaluate the Efficacy and Safety of HL151 versus Talion Tab. in Pruritus cutaneus.

Endpoint: VAS Score Change, Investigator's assessment of overall treatment

Registry

clinicaltrials.gov

Start Date

May 17, 2017

End Date

January 30, 2018

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Hanlim Pharm. Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Both gender, 19 years ≤ age
•Patients with pruritus due to the following diseases
•① acute eczema, chronic eczema, monetary eczema, sebaceous deficiency eczema
•② contact dermatitis, atopic dermatitis, seborrheic dermatitis, neurodermatitis
•③ Acute prurigo (Strofus, Urticaria, lichen urticatus), subacute prurigo, chronic prurigo (nodular prurigo)
•④ systemic skin pruritus, focal skin pruritus
•In visit 2, during the run-in period previous week the VAS score of day and night time were 2 or more average points per day (maximum 4 points)
•Those who can ability to record subject diary
•Written consent voluntarily to participate in this clinical trial after understanding and detailed explanation about this clinical trial

Exclusion Criteria

•Patients with pruritus due other medical causes (liver disease, heart failure, etc.)
•Among patients with skin disease, malignant tumors and patients with chronic urticaria skin disease
•Patients with systemic infection symptoms at the time of clinical trials
•Asthmatic patients requiring steroid treatment
•Patients with Spastic diseases such as epilepsy

Arms & Interventions

Experimental

Experimental: 2 times a day(Day, Night), 2 weeks of treatment / Day: HL151 (1Tab)+Talion Tab (Placebo)(1Tab), Night: HL151 (Placebo)(1Tab)+Talion Tab (Placebo)(1Tab)

Intervention: HL151

Active comparator

Comparator: 2 times a day(Day, Night), 2 weeks of treatment / Day: HL151 (Placebo)(1Tab)+Talion Tab (1Tab), Night: HL151 (Placebo)(1Tab)+Talion Tab (1Tab)

Intervention: Talion Tab

Outcomes

Primary Outcomes

Changes in VAS(Visual Analogue Scale) score at 2nd week after clinical drug administration compared to baseline

Time Frame: Visit 2 (0 week), Visit 3 (1 week), Visit 4 (2 weeks)

VAS score: 0 Point \~ 10 Point (asymptomatic \~ Maximum pruritus) Evaluation period: Visit 2 (0 week), Visit 3 (1 week), Visit 4 (2 weeks)

Secondary Outcomes

Changes in VAS(Visual Analogue Scale) score at 1st week after clinical drug administration(Visit 2 (0 week), Visit 3 (1 week))
Changes in VAS(Visual Analogue Scale) score at 1st and 2nd week after clinical drug administration compared to baseline(Visit 2 (0 week), Visit 3 (1 week), Visit 4 (2 weeks))
Investigator's assessment of overall treatment(Cochran-Mantel-Haenszel method)(Visit 4 (2 weeks))
Changes in VAS(Visual Analogue Scale) score at 1st and 2nd week(Day) after clinical drug administration compared to baseline(Visit 2 (0 week), Visit 3 (1 week), Visit 4 (2 weeks)