Clinical Trial of YH14618 in Patients With Degenerative Disc Disease
NCT ID: NCT02320019
Last Updated: 2016-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
326 participants
INTERVENTIONAL
2015-03-31
2016-08-31
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Placebo group
Placebo
Placebo
Placebo matching YH14618
Group A
YH14618 A mg/disc
YH14618
Group B
YH14618 B mg/disc
YH14618
Group C
YH14618 C mg/disc
YH14618
Group D
YH14618 D mg/disc
YH14618
Interventions
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Placebo
Placebo matching YH14618
YH14618
Eligibility Criteria
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Inclusion Criteria
* 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).
Exclusion Criteria
* 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.)
19 Years
ALL
No
Sponsors
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Yuhan Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Su Youn Nam, M.D., Ph.D.
Role: STUDY_DIRECTOR
Yuhan Corporation
Locations
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Severance Hospital
Seoul, , South Korea
Countries
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Other Identifiers
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YH14618-202
Identifier Type: -
Identifier Source: org_study_id