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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02125981
Recruitment Status : Recruiting
First Posted : April 29, 2014
Last Update Posted : April 18, 2019
Sponsor:
Information provided by (Responsible Party):
Jin S. Yeom, Seoul National University Hospital

Tracking Information
First Submitted Date  ICMJE April 24, 2014
First Posted Date  ICMJE April 29, 2014
Last Update Posted Date April 18, 2019
Actual Study Start Date  ICMJE September 1, 2014
Estimated Primary Completion Date April 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 13, 2014)
Japanese Orthopedic Association (JOA) recovery rates [ Time Frame: up to 12 months after operation ]
JOA recovery rate = [(postoperative JOA score) - (preoperative JOA score)] / [(17-(preoperative JOA score)] x 100 (%).
Original Primary Outcome Measures  ICMJE
 (submitted: April 28, 2014)
Japanese Orthopedic Association (JOA) recovery rates [ Time Frame: up to 6 months after operation ]
JOA recovery rate = [(postoperative JOA score) - (preoperative JOA score)] / [(17-(preoperative JOA score)] x 100 (%).
Change History Complete list of historical versions of study NCT02125981 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 9, 2014)
  • Visual Analog Pain Scale for neck pain [ Time Frame: up to 12 months after operation ]
  • Neck disability index score [ Time Frame: up to 12 months after operation ]
  • Japanese orthopaedic association Cervical Myelopathy Evaluation Questionnaire score [ Time Frame: up to 12 months after operation ]
  • Questionnaire Short Form 12 [ Time Frame: up to 12 months after operation ]
  • Japanese orthopaedic association score [ Time Frame: up to 12 months after surgery ]
  • assessment of the efficacy of positron emission tomography (PET) [ Time Frame: up to 12 months after operation ]
    The assessment of the efficacy of PET for prediction of drug (Limaprost) effect
Original Secondary Outcome Measures  ICMJE
 (submitted: April 28, 2014)
  • Visual Analog Pain Scale for neck pain [ Time Frame: up to 6 months after operation ]
  • Neck disability index score [ Time Frame: up to 6 months after operation ]
  • Japanese orthopaedic association Cervical Myelopathy Evaluation Questionnaire score [ Time Frame: up to 6 months after operation ]
  • Questionnaire Short Form 12 [ Time Frame: up to 6 months after operation ]
  • Japanese orthopaedic association score [ Time Frame: up to 6 months after surgery ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Study About the Efficacy of Oral Limaprost After Surgery for Cervical Myelopathy
Official Title  ICMJE A Prospective Randomized Double-blinded Clinical Trial About the Efficacy of Oral Limaprost Administration Following Surgery for Cervical Myelopathy
Brief Summary The limaprost alfadex can improve the surgical outcomes in patients with cervical myelopathy.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Cervical Myelopathy
Intervention  ICMJE
  • Drug: Limaprost
    taking Limaprost α-Cyclodextrin Clathrate 1 Tablets (166.67 μg), three times per day
  • Drug: Placebo
    taking placebo drug
Study Arms  ICMJE
  • Experimental: Limaprost
    taking Limaprost α-Cyclodextrin Clathrate 1 Tablets (166.67 μg), three times per day
    Intervention: Drug: Limaprost
  • Placebo Comparator: Control
    taking placebo drug
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 28, 2014)
160
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2020
Estimated Primary Completion Date April 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jin S. Yeom, MD 82-31-787-7195 highcervical@gmail.com
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02125981
Other Study ID Numbers  ICMJE LIMA_001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jin S. Yeom, Seoul National University Hospital
Study Sponsor  ICMJE Seoul National University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jin S. Yeom Seoul National University Bundang Hospital
PRS Account Seoul National University Hospital
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP