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Peripheral Neuropathic PainPhase 3NCT02985216

Clinical Trial of YHD1119 in Patients With Peripheral Neuropathic Pain

A Phase 3 study testing YHD1119 and Lyrica in people with Peripheral Neuropathic Pain, run by Yuhan Corporation 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 Randomized, Double-blind, Active-Controlled, Multi-center, Phase 3 Trial to Compare the Safety and Efficacy between YHD1119 and Pregabalin in Patients with Peripheral Neuropathic Pain Read more about this study

Who is it for?
Ages 19 to 80 years
Conditions the study is for
Peripheral Neuropathic Pain
What is being tested?
YHD1119 and Lyrica
Could I receive a placebo?
No, everyone receives an active treatment
How many people
371 participants
Where
1 siteSouth Korea
Study dates
7 Feb 2017to 2 May 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 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Signed Informed Consent
  • HbA1c ≤ 9.5% diabetes mellitus patients with pain over 6 months in Diabetic Peripheral Neuropathy or postherpetic Neuralgia patients at least 3 months pain after diagnosis of skin rash due to herpes zooster

Who cannot join

  • Have Brittle diabetes mellitus

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Yong Chul Kim

    Seoul

Other trials in South Korea

About this study

Official title: A Randomized, Double-blind, Active-Controlled, Multi-center, Phase 3 Trial to Compare the Safety and Efficacy Between YHD1119 and Pregabalin in Patients With Peripheral Neuropathic Pain

A Randomized, Double-blind, Active-Controlled, Multi-center, Phase 3 Trial to Compare the Safety and Efficacy between YHD1119 and Pregabalin in Patients with Peripheral Neuropathic Pain

Being tested
YHD1119, Lyrica

What participants receive

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

  • YHD1119Drug

    Also called Pregabalin

    YHD1119 150mg, PO YHD1119 300mg, PO

    YHD1119 600mg, PO

  • LyricaDrug

    Also called Pregabalin

    Lyrica 75mg, PO Lyrica 150mg, PO Lyrica 300mg, PO

Study groups in NCT02985216
Study groupRoleWhat they receive
YHD1119ExperimentalYHD1119 150mg for the first 1 week, then forced titrated to YHD1119 300mg for the 1 week. And then YHD1119 150~600mg for the 2 weeks, then YHD1119 fixed dose was administrated for 8 weeks.
Receives: Drug: YHD1119
LyricaActive comparatorLyrica 150mg for the first 1 week, then forced titrated to Lyrica 300mg for the 1 week. And then Lyrica 150~600mg for the 2 weeks, then Lyrica fixed dose was administrated for 8 weeks.
Receives: Drug: Lyrica

What is being measured

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

  1. Change From Baseline to End of Treatment (EOT) in Weekly Mean Pain Score on the Daily Pain Rating Scale (DPRS)

    Measured: Baseline, Day 85

Secondary outcomes (8)

  1. Change From Baseline in Mean Pain Score on the Daily Pain Rating Scale (DPRS)

    Measured: Day 1, 8, 15, 22, 29, 57, 85

  2. Mean Pain Score on the Daily Pain Rating Scale at each visit

    Measured: Day 1, 8, 15, 22, 29, 57, 85

  3. Patients proportion of reduction over 30% in Mean Pain Score from Baseline

    Measured: Day 1, 8, 15, 22, 29, 57, 85

  4. Change of duration-modification from baseline in Mean Pain Score on the Daily Pain Rating Scale (DPRS)

    Measured: Day 1, 8, 15, 22, 29, 57, 85

  5. Patient Global Impression of Change (PGIC)

    Measured: Day 85

  6. Clinical Global Impression of Change (CGIC)

    Measured: Day 85

  7. SF-12 (Short form-12)

    Measured: Baseline, Day 85

  8. C-SSRS (Columbia Suicide Severity Rating Scale)

    Measured: Baseline, Day 8, 29, 85

Timeline

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

  1. First posted7 Dec 2016 (estimated)
  2. Study start7 Feb 2017
  3. Primary completion27 Apr 2018
  4. Study completion2 May 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
Double blind
Who is masked
Participant, Investigator
Enrolment
371 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02985216
Sponsor's protocol ID
YHD1119-301
Status last verified
Feb 2017
First submitted
1 Dec 2016
Last updated
16 Jan 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Lee S, An T, Kim S. Quality of life outcomes with a new sustained-release pregabalin in a phase 3 trial of peripheral neuropathic pain. Curr Med Res Opin. 2026 Aug 20:1-9. doi: 10.1080/03007995.2026.2719074. Online ahead of print.

    PubMed 42622433

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing YHD1119 and Lyrica in people with Peripheral Neuropathic Pain, run by Yuhan Corporation 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 2 inclusion and 1 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 16 Jan 2019. 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?

Change From Baseline to End of Treatment (EOT) in Weekly Mean Pain Score on the Daily Pain Rating Scale (DPRS) (time frame: Baseline, Day 85). 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 NCT02985216, which also lists 1 linked publication.

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 16 Jan 2019.

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