The Effectiveness and Safety of Dong-A Opalmon® Tablet in Patients With Acquired Lumbar Spinal Stenosis

Dong-A ST Co., Ltd.107 enrolled

Overview

This study is to evaluate the Effectiveness and Safety of Dong-A Opalmon® Tablet in Patients With Acquired Lumbar Spinal Stenosis

Study Type

OBSERVATIONAL

Enrollment

107

Conditions

Lumbar Spinal Stenosis

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Men or women aged ≥ 19 years * Subjects with acquired Lumbar Spinal Stenosis who show normal results in the Straight Leg Raising (SLR) test and exhibit intermittent claudication, requiring treatment with Dong-A Opalmon® tab * Subjects who voluntarily consent to participate in this observational study Exclusion Criteria: * Subject for whom the medicinal products administration is contraindicated according to the approved domestic drug information: Pregnant women or those who may be pregnant, Subject with genetic disorders such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption * Subjects considered as unsuitable for participation in this observational study by the principal investigator or sub-investigator

Locations (1)

VHS Medical Center

Seoul, South Korea

Outcomes

Primary Outcomes

Change from baseline in score of 'Symptom severity' and 'Physical function' items in Zurich Claudication Questionnaire at 8 weeks

The total score for 'Symptom severity' is rated on a scale from 7 to 35 points, with higher score denoting more severe symptoms. The total score for 'Physical function' is rated on a scale from 5 to 20 points, with higher score denoting more severe disability.

Time frame: Change from baseline at 8 weeks

Secondary Outcomes

Mean score for 'Satisfaction' item in Zurich Claudication Questionnaire at 8 weeks

The total score for 'Satisfaction' is rated on a scale from 6 to 24 points, with higher score denoting lower rate of satisfaction.

Time frame: At 8 weeks

Change from baseline in Oswestry Disability Index score at 8 weeks

The score for Oswestry Disability Index is rated on a scale from 0% to 100%, with higher score denoting more severe disability in everyday life.

Time frame: Change from baseline at 8 weeks

Change from baseline in score for first question (how much can you walk) of Zurich Claudication Questionnaire Part 2 'Physical Function' at 8 weeks

The score is rated on a scale from 1 to 4 points with higher score denoting more difficulty in walking.

Time frame: Change from baseline at 8 weeks

Data from ClinicalTrials.gov

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