NCT03317301

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
189

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started May 2017

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 17, 2017

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

October 12, 2017

Completed
11 days until next milestone

First Posted

Study publicly available on registry

October 23, 2017

Completed
21 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 13, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2018

Completed
Last Updated

August 28, 2018

Status Verified

October 1, 2017

Enrollment Period

6 months

First QC Date

October 12, 2017

Last Update Submit

August 27, 2018

Conditions

Pruritus

Keywords

Pruritus cutaneus

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • 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(Day) after clinical drug administration compared to baseline

    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

    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)

Study Arms (2)

Experimental

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)

Drug: HL151

Active comparator

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)

Drug: Talion Tab

Interventions

HL151DRUG

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)

Experimental
Talion TabDRUG

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

Active comparator

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hanyang Univ. Guri Hospital

Guri-si, Kyeonggi-do, 471-701, South Korea

Location

MeSH Terms

Conditions

Pruritus

Condition Hierarchy (Ancestors)

Skin DiseasesSkin and Connective Tissue DiseasesSkin ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 12, 2017

First Posted

October 23, 2017

Study Start

May 17, 2017

Primary Completion

November 13, 2017

Study Completion

January 30, 2018

Last Updated

August 28, 2018

Record last verified: 2017-10

Locations

KR(1)