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

A Prospective, Multicenter, Single Group, Open-label and Observational Study to Evaluate the Effectiveness and Safety of Dong-A Opalmon® Tablet in Patients With Acquired Lumbar Spinal Stenosis

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06654856

Enrollment

107

Registered

2024-10-23

Start date

2024-08-16

Completion date

2026-02-23

Last updated

2026-02-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lumbar Spinal Stenosis

Brief summary

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

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

South Korea

Outcome results