The Study About the Efficacy of Oral Limaprost After Surgery for Cervical Myelopathy
NCT ID: NCT02125981
Last Updated: 2023-04-14
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
PHASE3
160 participants
INTERVENTIONAL
2014-09-01
2023-04-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Limaprost
taking Limaprost α-Cyclodextrin Clathrate 1 Tablets (166.67 μg), three times per day
Limaprost
taking Limaprost α-Cyclodextrin Clathrate 1 Tablets (166.67 μg), three times per day
Control
taking placebo drug
Placebo
taking placebo drug
Interventions
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Limaprost
taking Limaprost α-Cyclodextrin Clathrate 1 Tablets (166.67 μg), three times per day
Placebo
taking placebo drug
Eligibility Criteria
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Inclusion Criteria
* Compressive cervical myelopathy, confirmed by MRI, including C1-C2 instability, ossification of posterior longitudinal ligament
* Plan to undergo cervical surgery for myelopathy
* JOA score less than 15 points
* Signed informed consent of patient or legal guardian
Exclusion Criteria
* Taking Limaprost before surgery
* Pregnancy or expected to be pregnant or breast feeding
* severe cardiovascular, pulmonary, renal disease or distress, brain pathology
* any related coagulopathy
* any drug to cause bleeding tendency
* severe pain from other disease
* any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study
* patient cannot follow study protocol, for any reason
20 Years
ALL
No
Sponsors
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Seoul National University Hospital
OTHER
Responsible Party
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Jin S. Yeom
Professor
Principal Investigators
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Jin S. Yeom
Role: PRINCIPAL_INVESTIGATOR
Seoul National University Bundang Hospital
Locations
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Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea
Countries
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Other Identifiers
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LIMA_001
Identifier Type: -
Identifier Source: org_study_id
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