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Trial record 1 of 1 for:    Evaluate the Efficacy and Safety of HL151 Versus Talion Tab. in Pruritus Cutaneus
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Evaluate the Efficacy and Safety of HL151 Versus Talion Tab. in Pruritus Cutaneus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03317301
Recruitment Status : Completed
First Posted : October 23, 2017
Last Update Posted : August 28, 2018
Sponsor:
Information provided by (Responsible Party):
Hanlim Pharm. Co., Ltd.

Study Description
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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


Condition or disease Intervention/treatment Phase
Pruritus Drug: HL151 Drug: Talion Tab Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 189 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : May 17, 2017
Actual Primary Completion Date : November 13, 2017
Actual Study Completion Date : January 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Itching

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


Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Changes in VAS(Visual Analogue Scale) score at 1st week after clinical drug administration [ Time Frame: 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)

  2. Changes in VAS(Visual Analogue Scale) score at 1st and 2nd week(Day) 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

  3. Changes in VAS(Visual Analogue Scale) score at 1st and 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)

  4. Investigator's assessment of overall treatment(Cochran-Mantel-Haenszel method) [ Time Frame: Visit 4 (2 weeks) ]

    VAS score: 0 Point ~ 10 Point (asymptomatic ~ Maximum pruritus)

    • Evaluation period: Visit 4 (2 weeks)


Eligibility Criteria
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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03317301


Locations
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Korea, Republic of
Hanyang Univ. Guri Hospital
Guri-si, Kyeonggi-do, Korea, Republic of, 471-701
Sponsors and Collaborators
Hanlim Pharm. Co., Ltd.
More Information
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Responsible Party: Hanlim Pharm. Co., Ltd.
ClinicalTrials.gov Identifier: NCT03317301    
Other Study ID Numbers: HL_HL151_302
First Posted: October 23, 2017    Key Record Dates
Last Update Posted: August 28, 2018
Last Verified: October 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hanlim Pharm. Co., Ltd.:
Pruritus cutaneus
Additional relevant MeSH terms:
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Pruritus
Skin Diseases
Skin Manifestations
 Signs and Symptoms
Bepotastine besilate
Anti-Allergic Agents