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

Recruiting

• Conditions: Lumbar Spinal Stenosis

• Registration Number: NCT06654856
• Lead Sponsor: Dong-A ST Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2024-08-16
• Status Verified: 2024-10
• Study First Submitted: 2024-10-21
• Study First Submitted QC: 2024-10-21
• Study First Posted: 2024-10-23
• Last Update Submitted: 2024-10-24
• Last Update Posted: 2024-10-28
• Primary Completion: 2025-08
• Study Completion: 2025-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 243

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Mean score for 'Satisfaction' item in Zurich Claudication Questionnaire at 8 weeks	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.
Change from baseline in Oswestry Disability Index score at 8 weeks	Change from baseline 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.
Change from baseline in score for first question (how much can you walk) of Zurich Claudication Questionnaire Part 2 'Physical Function' at 8 weeks	Change from baseline at 8 weeks	The score is rated on a scale from 1 to 4 points with higher score denoting more difficulty in walking.

Trial Locations

Locations (1)

VHS Medical Center; 🇰🇷 Seoul, Korea, Republic of