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

Primary Purpose

Pruritus

Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
HL151
Talion Tab
Sponsored by
Hanlim Pharm. Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pruritus focused on measuring Pruritus cutaneus

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hanyang Univ. Guri Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental

Active comparator

Arm Description

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)

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)

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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)
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
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)
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)

Full Information

First Posted
October 12, 2017
Last Updated
August 27, 2018
Sponsor
Hanlim Pharm. Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT03317301
Brief Title
Evaluate the Efficacy and Safety of HL151 Versus Talion Tab. in Pruritus Cutaneus
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
May 17, 2017 (Actual)
Primary Completion Date
November 13, 2017 (Actual)
Study Completion Date
January 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hanlim Pharm. Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pruritus
Keywords
Pruritus cutaneus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
189 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental
Arm Type
Experimental
Arm Description
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)
Arm Title
Active comparator
Arm Type
Active Comparator
Arm Description
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 Type
Drug
Intervention Name(s)
HL151
Intervention Description
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 Type
Drug
Intervention Name(s)
Talion Tab
Intervention Description
2 times a day(Day, Night), 2 weeks of treatment / Day: HL151 (Placebo)(1Tab)+Talion Tab (1Tab), Night: HL151 (Placebo)(1Tab)+Talion Tab (1Tab)
Primary Outcome Measure Information:
Title
Changes in VAS(Visual Analogue Scale) score at 2nd week after clinical drug administration compared to baseline
Description
VAS score: 0 Point ~ 10 Point (asymptomatic ~ Maximum pruritus) Evaluation period: Visit 2 (0 week), Visit 3 (1 week), Visit 4 (2 weeks)
Time Frame
Visit 2 (0 week), Visit 3 (1 week), Visit 4 (2 weeks)
Secondary Outcome Measure Information:
Title
Changes in VAS(Visual Analogue Scale) score at 1st week after clinical drug administration
Description
VAS score: 0 Point ~ 10 Point (asymptomatic ~ Maximum pruritus) Evaluation period: Visit 2 (0 week), Visit 3 (1 week)
Time Frame
Visit 2 (0 week), Visit 3 (1 week)
Title
Changes in VAS(Visual Analogue Scale) score at 1st and 2nd week(Day) after clinical drug administration compared to baseline
Description
VAS score: 0 Point ~ 10 Point (asymptomatic ~ Maximum pruritus) Evaluation period: Visit 2 (0 week), Visit 3 (1 week), Visit 4 (2 weeks
Time Frame
Visit 2 (0 week), Visit 3 (1 week), Visit 4 (2 weeks
Title
Changes in VAS(Visual Analogue Scale) score at 1st and 2nd week after clinical drug administration compared to baseline
Description
VAS score: 0 Point ~ 10 Point (asymptomatic ~ Maximum pruritus) Evaluation period: Visit 2 (0 week), Visit 3 (1 week), Visit 4 (2 weeks)
Time Frame
Visit 2 (0 week), Visit 3 (1 week), Visit 4 (2 weeks)
Title
Investigator's assessment of overall treatment(Cochran-Mantel-Haenszel method)
Description
VAS score: 0 Point ~ 10 Point (asymptomatic ~ Maximum pruritus) Evaluation period: Visit 4 (2 weeks)
Time Frame
Visit 4 (2 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Hanyang Univ. Guri Hospital
City
Guri-si
State/Province
Kyeonggi-do
ZIP/Postal Code
471-701
Country
Korea, Republic of

12. IPD Sharing Statement

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

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