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

Pruritus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03317301
• Other study ID #: HL_HL151_302
• Status: Completed
• Phase: Phase 3
• Start date: May 17, 2017
• Est. completion date: January 30, 2018

Study information

• Verified date: October 2017
• Source: Hanlim Pharm. Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 189
• Est. completion date: January 30, 2018
• Est. primary completion date: November 13, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

1. Both gender, 19 years = age

2. Patients with pruritus due to the following diseases

? acute eczema, chronic eczema, monetary eczema, sebaceous deficiency eczema

? contact dermatitis, atopic dermatitis, seborrheic dermatitis, neurodermatitis

? Acute prurigo (Strofus, Urticaria, lichen urticatus), subacute prurigo, chronic prurigo (nodular prurigo)

? 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

Related Conditions & MeSH terms

• Pruritus

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Hanyang Univ. Guri Hospital	Guri-si	Kyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
Hanlim Pharm. Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in VAS(Visual Analogue Scale) score at 2nd week after clinical drug administration compared to baseline	VAS score: 0 Point ~ 10 Point (asymptomatic ~ Maximum pruritus) Evaluation period: Visit 2 (0 week), Visit 3 (1 week), Visit 4 (2 weeks)	Visit 2 (0 week), Visit 3 (1 week), Visit 4 (2 weeks)
Secondary	Changes in VAS(Visual Analogue Scale) score at 1st week after clinical drug administration	VAS score: 0 Point ~ 10 Point (asymptomatic ~ Maximum pruritus); Evaluation period: Visit 2 (0 week), Visit 3 (1 week)	Visit 2 (0 week), Visit 3 (1 week)
Secondary	Changes in VAS(Visual Analogue Scale) score at 1st and 2nd week(Day) after clinical drug administration compared to baseline	VAS score: 0 Point ~ 10 Point (asymptomatic ~ Maximum pruritus); Evaluation period: Visit 2 (0 week), Visit 3 (1 week), Visit 4 (2 weeks	Visit 2 (0 week), Visit 3 (1 week), Visit 4 (2 weeks
Secondary	Changes in VAS(Visual Analogue Scale) score at 1st and 2nd week after clinical drug administration compared to baseline	VAS score: 0 Point ~ 10 Point (asymptomatic ~ Maximum pruritus); Evaluation period: Visit 2 (0 week), Visit 3 (1 week), Visit 4 (2 weeks)	Visit 2 (0 week), Visit 3 (1 week), Visit 4 (2 weeks)
Secondary	Investigator's assessment of overall treatment(Cochran-Mantel-Haenszel method)	VAS score: 0 Point ~ 10 Point (asymptomatic ~ Maximum pruritus); Evaluation period: Visit 4 (2 weeks)	Visit 4 (2 weeks)