Degenerative Disc DiseasePhase 1/2NCT01526330
Safety, Tolerability and Efficacy of YH14618 in Patients With Degenerative Disc Disease
A Phase 1/2 study testing YH14618 in people with Degenerative Disc Disease, run by Yuhan Corporation at 1 site in South Korea.
Trial summary
The objective of this study is to assess the safety and tolerability of YH14618 during 24 weeks of follow-up period after single administration in patients with degenerative disc disease. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Degenerative Disc Disease
- What is being tested?
- YH14618
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2012to Jul 2014
- Phase
- Phase 1/2
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have signed a written informed consent voluntarily, prior to the any procedure
- Degenerative disc disease patients of aged over 20 years
- Have one or more of the symptomatic lumbar level(L1~S1) as confirmed using radiology(X-ray, MRI and/or discogram/CT)
- Have been diagnosed 2~3 degree of MRI index by modified thompson classification
- Oswestry diability index(ODI) of 30 or greater
- Visual analog scale(VAS) of 4 or greater
Who cannot join
- Subjects unable to have radiological examination
- Have history of neurological disease, herniated lumbar disc, compression fractures and lumbar spinal surgery
- Sacroiliac joint dysfunction
- Have been treated with any drugs for pain control within 7 days prior to the first administration
- Hypersensitivity to drugs
- Pregnant women, nursing mothers or subjects who do not agree to assigned contraception in the study
- Participated in any other clinical trials within 30 days prior to the first administration
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-blind, Randomized, Parallel, Placebo Controlled, Phase I/II Clinical Trial to Investigate the Safety, Tolerability and Efficacy of YH14618 Following Single Intradiscal Injection in Patients With Degenerative Disc Disease
The objective of this study is to assess the safety and tolerability of YH14618 during 24 weeks of follow-up period after single administration in patients with degenerative disc disease.
- Conditions
- Degenerative Disc Disease
- Being tested
- YH14618, Placebo
- Keywords
- Degenerative disc disease, YH14618, Penial 2000, Penial 2K
- 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.
YH14618Drug
A mg/disc
YH14618Drug
B mg/disc
YH14618Drug
C mg/disc
PlaceboDrug
0mg/disc
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Not described Receives: Drug: YH14618 |
| Group B | Experimental | Not described Receives: Drug: YH14618 |
| Group C | Experimental | Not described Receives: Drug: YH14618 |
| Group D | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaulate the safety and tolerability after single intradiscal administation
Safety outcomes
- Adverse events
- 12-lead EKG
- Physical examination
- Standard lab results(hematology, blood chemistry, coagulation, urinalysis etc.)
Measured: 12 weeks of observational period
Secondary outcomes (4)
Change from baseline in disc height index at 12 week
Measured: Baseline, Week 12
Change from baseline in magnetic resonance imaging(MRI) index
Measured: Baseline, Week 12
Change from oswestry diability index(ODI) at week 12
Measured: Baseline, Week 12
Change from baseline in visual analogue scale(VAS) at week 12
Measured: Baseline, Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2012 (estimated)
- Study startMay 2012
- Primary completionJan 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Degenerative Disc 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yuhan Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Young-joon Kwon, MD, PhD., Principal investigator, Kangbuk Samsung Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01526330
- Sponsor's protocol ID
- YH14618-201
- Status last verified
- Jul 2014
- First submitted
- 31 Jan 2012
- Last updated
- 29 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Randomized, Parallel, Placebo Controlled, Phase I/II Clinical Trial to Investigate the Safety, Tolerability and Efficacy of YH14618 Following Single Intradiscal Injection in Patients With Degenerative Disc Disease
- ClinicalTrials.gov ID
- NCT01526330
- Acronym / sponsor ID
- YH14618-201
- Conditions
- Degenerative Disc Disease
- Keywords
- Degenerative disc disease, YH14618, Penial 2000, Penial 2K
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Yuhan CorporationIndustry (pharma, biotech, devices)
- Study start
- May 2012
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 3 Feb 2012 (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.
The objective of this study is to assess the safety and tolerability of YH14618 during 24 weeks of follow-up period after single administration in patients with degenerative disc disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: YH14618 |
| Group B | Experimental | Drug: YH14618 |
| Group C | Experimental | Drug: YH14618 |
| Group D | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Have signed a written informed consent voluntarily, prior to the any procedure
- Degenerative disc disease patients of aged over 20 years
- Have one or more of the symptomatic lumbar level(L1~S1) as confirmed using radiology(X-ray, MRI and/or discogram/CT)
- Have been diagnosed 2~3 degree of MRI index by modified thompson classification
- Oswestry diability index(ODI) of 30 or greater
Key exclusion criteria (7 listed)
- Subjects unable to have radiological examination
- Have history of neurological disease, herniated lumbar disc, compression fractures and lumbar spinal surgery
- Sacroiliac joint dysfunction
- Have been treated with any drugs for pain control within 7 days prior to the first administration
- Hypersensitivity to drugs
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 |
|---|---|---|
| YH14618A mg/disc | Drug | Group A |
| YH14618B mg/disc | Drug | Group B |
| YH14618C mg/disc | Drug | Group C |
| Placebo0mg/disc | Drug | Group D |
Primary outcome
Evaulate the safety and tolerability after single intradiscal administation
Time frame: 12 weeks of observational period
Safety outcomes * Adverse events * 12-lead EKG * Physical examination * Standard lab results(hematology, blood chemistry, coagulation, urinalysis etc.)
4 secondary outcomes
Change from baseline in disc height index at 12 week
Time frame: Baseline, Week 12
Change from baseline in magnetic resonance imaging(MRI) index
Time frame: Baseline, Week 12
Change from oswestry diability index(ODI) at week 12
Time frame: Baseline, Week 12
Change from baseline in visual analogue scale(VAS) at week 12
Time frame: Baseline, Week 12
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 29 May 2015.
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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.
Young-joon Kwon, MD, PhD. principal investigator
Kangbuk Samsung Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing YH14618 in people with Degenerative Disc 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 6 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 29 May 2015. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Evaulate the safety and tolerability after single intradiscal administation (time frame: 12 weeks of observational period). 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 29 May 2015.