The Study About the Efficacy of Oral Limaprost After Surgery for Cervical Myelopathy

NCT ID: NCT02125981

Last Updated: 2023-04-14

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-01

Study Completion Date

2023-04-01

Brief Summary

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The limaprost alfadex can improve the surgical outcomes in patients with cervical myelopathy.

Detailed Description

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Conditions

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Cervical Myelopathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Limaprost

taking Limaprost α-Cyclodextrin Clathrate 1 Tablets (166.67 μg), three times per day

Group Type EXPERIMENTAL

Limaprost

Intervention Type DRUG

taking Limaprost α-Cyclodextrin Clathrate 1 Tablets (166.67 μg), three times per day

Control

taking placebo drug

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

taking placebo drug

Interventions

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Limaprost

taking Limaprost α-Cyclodextrin Clathrate 1 Tablets (166.67 μg), three times per day

Intervention Type DRUG

Placebo

taking placebo drug

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Older than 20 years old
* 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

* Infection or malignancy
* 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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jin S. Yeom

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status

Countries

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South Korea

Other Identifiers

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LIMA_001

Identifier Type: -

Identifier Source: org_study_id

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