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

NCT06654856 | Completed

• 1 other identifier: OMT_LSS_OS
• Study Type: observational
• Target: 107
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Lumbar Spinal Stenosis

Outcome Measures

Primary Outcomes (1)

• 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.

  Change from baseline at 8 weeks

Secondary Outcomes (3)

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

  At 8 weeks

• Change from baseline in Oswestry Disability Index score at 8 weeks

  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

  Change from baseline at 8 weeks

Study Arms (1)

Dong-A Opalmon® Tab

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects who require treatment of Dong-A Opalmon® tab due to acquired Lumbar Spinal Stenosis

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dong-A ST Co., Ltd.: lead

Study Sites (1)

VHS Medical Center

Seoul, South Korea

Location

MeSH Terms

Conditions

Spinal Stenosis

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2024
• First Posted: October 23, 2024
• Study Start: August 16, 2024
• Primary Completion: February 23, 2026
• Study Completion: February 23, 2026
• Last Updated: February 27, 2026

Record last verified: 2026-02

Locations

KR (1)