Disc Degenerative DiseasePhase 2NCT02320019
Clinical Trial of YH14618 in Patients With Degenerative Disc Disease
A Phase 2 study testing YH14618 in people with Disc Degenerative Disease, run by Yuhan Corporation at 1 site in South Korea.
Trial summary
Research Hypothesis: There will be a greater proportion of VAS responders defined as those who achieve ≥ 50% reduction from baseline in VAS for low back pain at week 12 following intradiscal injection of YH14618 compared to placebo. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Disc Degenerative Disease
- What is being tested?
- YH14618
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 326 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2015to Aug 2016
- Phase
- Phase 2
- 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
- Patients diagnosed as one or two symptomatic early lumbar (L1/L2 ~ L5/S1) degenerative disc disease defined as Pfirrmann grade 2 to 4 using MRI performed within 4 weeks prior to randomization.
- Patients have suffered from persistent low back pain with at least 3-month conservative therapy.
- Patients have low back pain measured by VAS≥4cm and mODI≥30% at screening and randomization visit (Day 0).
Who cannot join
- Clinically significant spine compression fracture, spinal stenosis, or spinal instability.
- Clinically significant sacroiliac joint dysfunction, facet joint pain, or those who are suspected.
- Modic change type III assessed by X-ray and MRI
- History of spine surgery
- Neurologic disorders.
- Any other systemic disease which can influence spine such as rheumatoid arthritis, ankylosing spondylitis, or autoimmune disease.
- Participation in other clinical trials with intradiscal injection (eg, Phase 1/2a YH14618-201 trial, or Cell therapy, etc.)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 2b Trial to Evaluate the Efficacy and Safety of YH14618 in Patients With Lumbar Degenerative Disc Disease
Research Hypothesis:
There will be a greater proportion of VAS responders defined as those who achieve ≥ 50% reduction from baseline in VAS for low back pain at week 12 following intradiscal injection of YH14618 compared to placebo. Patients have been diagnosed as one or two symptomatic lumbar degenerative disc disease defined as Pfirrmann grade 2 to 4 using MRI. Patients have suffered from persistent low back pain with at least 3 months of conservative therapy and must have low back pain measured by VAS≥4 cm and modified Oswestry disability index (mODI) ≥30% at the baseline.
- Conditions
- Disc Degenerative Disease
- Being tested
- Placebo, YH14618
- Medical subject headings
- Intervertebral Disc Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Placebo matching YH14618
YH14618Drug
| Study group | Role | What they receive |
|---|---|---|
| Placebo group | Placebo comparator | Placebo Receives: Drug: Placebo |
| Group A | Experimental | YH14618 A mg/disc Receives: Drug: YH14618 |
| Group B | Experimental | YH14618 B mg/disc Receives: Drug: YH14618 |
| Group C | Experimental | YH14618 C mg/disc Receives: Drug: YH14618 |
| Group D | Experimental | YH14618 D mg/disc Receives: Drug: YH14618 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of VAS responders
Proportion of VAS responders defined as those who achieve ≥ 50% reduction in VAS at week 12 from baseline
Measured: at 12-week
Secondary outcomes (4)
Proportion of VAS responders
Measured: at 24-week
Proportion of mODI responder
Measured: at 12-week, 24-week
Changes in VAS score from baseline
Measured: Each visit for 24 weeks
Changes in mODI score from baseline
Measured: Each visit for 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2014 (estimated)
- Study startMar 2015
- Primary completionApr 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disc Degenerative DiseaseStudies of the same condition, open and under way.
- More trials run by Yuhan CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 326 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yuhan Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Su Youn Nam, M.D., Ph.D., Study director, Yuhan Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02320019
- Sponsor's protocol ID
- YH14618-202
- Status last verified
- Nov 2016
- First submitted
- 11 Dec 2014
- Last updated
- 10 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 2b Trial to Evaluate the Efficacy and Safety of YH14618 in Patients With Lumbar Degenerative Disc Disease
- ClinicalTrials.gov ID
- NCT02320019
- Acronym / sponsor ID
- YH14618-202
- Conditions
- Disc Degenerative Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 326 participants (actual)
- Lead sponsor
- Yuhan CorporationIndustry (pharma, biotech, devices)
- Study start
- Mar 2015
- Primary completion
- Apr 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 19 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Research Hypothesis:
There will be a greater proportion of VAS responders defined as those who achieve ≥ 50% reduction from baseline in VAS for low back pain at week 12 following intradiscal injection of YH14618 compared to placebo. Patients have been diagnosed as one or two symptomatic lumbar degenerative disc disease defined as Pfirrmann grade 2 to 4 using MRI. Patients have suffered from persistent low back pain with at least 3 months of conservative therapy and must have low back pain measured by VAS≥4 cm and modified Oswestry disability index (mODI) ≥30% at the baseline.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Placebo group | Placebo comparator | Drug: PlaceboPlacebo |
| Group A | Experimental | Drug: YH14618YH14618 A mg/disc |
| Group B | Experimental | Drug: YH14618YH14618 B mg/disc |
| Group C | Experimental | Drug: YH14618YH14618 C mg/disc |
| Group D | Experimental | Drug: YH14618YH14618 D mg/disc |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients diagnosed as one or two symptomatic early lumbar (L1/L2 ~ L5/S1) degenerative disc disease defined as Pfirrmann grade 2 to 4 using MRI performed within 4 weeks prior to randomization.
- Patients have suffered from persistent low back pain with at least 3-month conservative therapy.
- Patients have low back pain measured by VAS≥4cm and mODI≥30% at screening and randomization visit (Day 0).
Key exclusion criteria (7 listed)
- Clinically significant spine compression fracture, spinal stenosis, or spinal instability.
- Clinically significant sacroiliac joint dysfunction, facet joint pain, or those who are suspected.
- Modic change type III assessed by X-ray and MRI
- History of spine surgery
- Neurologic disorders.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboPlacebo matching YH14618 | Drug | Placebo group |
| YH14618 | Drug | Group A, Group B, Group C, Group D |
Primary outcome
Proportion of VAS responders
Time frame: at 12-week
Proportion of VAS responders defined as those who achieve ≥ 50% reduction in VAS at week 12 from baseline
4 secondary outcomes
Proportion of VAS responders
Time frame: at 24-week
Proportion of mODI responder
Time frame: at 12-week, 24-week
Changes in VAS score from baseline
Time frame: Each visit for 24 weeks
Changes in mODI score from baseline
Time frame: Each visit for 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Su Youn Nam, M.D., Ph.D. study director
Yuhan Corporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing YH14618 in people with Disc Degenerative Disease, 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 3 inclusion and 7 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 10 Nov 2016. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Proportion of VAS responders (time frame: at 12-week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Nov 2016.