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PruritusPhase 3NCT03317301

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

A Phase 3 study testing HL151 and Talion Tab in people with Pruritus, run by Hanlim Pharm. Co., Ltd. at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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 Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Pruritus
What is being tested?
HL151 and Talion Tab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
189 participants
Where
1 siteSouth Korea
Study dates
17 May 2017to 30 Jan 2018
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 9Show fewer
  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Hanyang Univ. Guri Hospital

    Guri-si, Kyeonggi-do, 471-701

Other trials in South Korea

About this study

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

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
Conditions
Pruritus
Being tested
HL151, Talion Tab
Keywords
Pruritus cutaneus
Medical subject headings
Pruritus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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)

  • 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)

Study groups in NCT03317301
Study groupRoleWhat they receive
ExperimentalExperimentalExperimental: 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)
Receives: Drug: HL151
Active comparatorActive comparatorComparator: 2 times a day(Day, Night), 2 weeks of treatment / Day: HL151 (Placebo)(1Tab)+Talion Tab (1Tab), Night: HL151 (Placebo)(1Tab)+Talion Tab (1Tab)
Receives: Drug: Talion Tab

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: Visit 2 (0 week), Visit 3 (1 week), Visit 4 (2 weeks)

Secondary outcomes (4)

  1. 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)

    Measured: 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

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

    • Evaluation period: Visit 2 (0 week), Visit 3 (1 week), Visit 4 (2 weeks

    Measured: 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

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

    • Evaluation period: Visit 2 (0 week), Visit 3 (1 week), Visit 4 (2 weeks)

    Measured: Visit 2 (0 week), Visit 3 (1 week), Visit 4 (2 weeks)

  4. 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)

    Measured: Visit 4 (2 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Oct 2017
  2. Study start17 May 2017
  3. Primary completion13 Nov 2017
  4. Study completion30 Jan 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
189 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03317301
Sponsor's protocol ID
HL_HL151_302
Status last verified
Oct 2017
First submitted
12 Oct 2017
Last updated
28 Aug 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing HL151 and Talion Tab in people with Pruritus, run by Hanlim Pharm. Co., Ltd. at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03317301.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2018.

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