Evaluate the Efficacy and Safety of HL151 Versus Talion Tab. in Pruritus Cutaneus

Phase 3

Completed

• Conditions: Pruritus
• Interventions: Drug: Talion Tab; Drug: HL151

• Registration Number: NCT03317301
• Lead Sponsor: Hanlim Pharm. Co., Ltd.

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

Detailed Description

Not available

Study Timeline

• Study Start: 2017-05-17
• Status Verified: 2017-10
• Study First Submitted: 2017-10-12
• Study First Submitted QC: 2017-10-19
• Study First Posted: 2017-10-23
• Primary Completion: 2017-11-13
• Study Completion: 2018-01-30
• Last Update Submitted: 2018-08-27
• Last Update Posted: 2018-08-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 189

Inclusion Criteria

1. Both gender, 19 years ≤ age

2. 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

3. 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)

4. Those who can ability to record subject diary

5. Written consent voluntarily to participate in this clinical trial after understanding and detailed explanation about this clinical trial

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active comparator	Talion Tab	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)
Experimental	HL151	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)

Primary Outcome Measures

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

Name	Time	Method
Changes in VAS(Visual Analogue Scale) score at 1st week after clinical drug administration	Visit 2 (0 week), Visit 3 (1 week)	VAS score: 0 Point \~ 10 Point (asymptomatic \~ Maximum pruritus); * Evaluation period: 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)	VAS score: 0 Point \~ 10 Point (asymptomatic \~ Maximum pruritus); * Evaluation period: 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)	VAS score: 0 Point \~ 10 Point (asymptomatic \~ Maximum pruritus); * Evaluation period: 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	VAS score: 0 Point \~ 10 Point (asymptomatic \~ Maximum pruritus); * Evaluation period: Visit 2 (0 week), Visit 3 (1 week), Visit 4 (2 weeks

Trial Locations

Locations (1)

Hanyang Univ. Guri Hospital; 🇰🇷 Guri-si, Kyeonggi-do, Korea, Republic of