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Sponsored by: |
Seikagaku Corporation |
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Information provided by: | Seikagaku Corporation |
ClinicalTrials.gov Identifier: | NCT00634946 |
The purpose of this study is to determine whether SI-6603 is effective in the treatment of lumbar disc herniation.
Condition | Intervention | Phase |
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Lumbar Vertebra Hernia |
Drug: SI-6603 Drug: Placebo |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Multicenter, Randomized, Double-blind Recommended Dose-finding Study of SI-6603 in Patients With Lumbar Disc Herniation (Phase II/III Study) |
Enrollment: | 195 |
Study Start Date: | January 2008 |
Estimated Study Completion Date: | August 2010 |
Estimated Primary Completion Date: | November 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
I: Experimental |
Drug: SI-6603
SI-6603 is administrated into the nucleus pulposus of an intervertebral disc.
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II: Experimental |
Drug: SI-6603
SI-6603 is administrated into the nucleus pulposus of an intervertebral disc.
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III: Experimental |
Drug: SI-6603
SI-6603 is administrated into the nucleus pulposus of an intervertebral disc.
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IV: Placebo Comparator |
Drug: Placebo
Placebo is administrated into the nucleus pulposus of an intervertebral disc.
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Ages Eligible for Study: | 20 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Japan | |
Kanto Area | |
Kanto, Japan | |
Chubu Area | |
Chubu, Japan | |
Kansai Area | |
Kansai, Japan | |
Hokkaido Area | |
Hokkaido, Japan | |
Tohoku Area | |
Tohoku, Japan | |
Shikoku Area | |
Shikoku, Japan | |
Kyushu Area | |
Kyushu, Japan | |
Chugoku Area | |
Chugoku, Japan |
Responsible Party: | Clinical Development Dept., Research & Development Div. ( Takao Murayama ) |
Study ID Numbers: | 6603/1021, 6603/1021 |
Study First Received: | February 27, 2008 |
Last Updated: | August 19, 2009 |
ClinicalTrials.gov Identifier: | NCT00634946 History of Changes |
Health Authority: | Japan: Pharmaceuticals and Medical Devices Agency |
Chemonucleolysis Lumbar Vertebrae Hernia |
Spinal Diseases Pathological Conditions, Anatomical Signs and Symptoms Musculoskeletal Diseases |
Hernia Intervertebral Disk Displacement Bone Diseases |
Spinal Diseases Pathological Conditions, Anatomical Musculoskeletal Diseases |
Hernia Intervertebral Disk Displacement Bone Diseases |