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

February 25, 2026 updated by: Dong-A ST Co., Ltd.

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

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

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

107

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Dong-A Opalmon® Tab

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in score of 'Symptom severity' and 'Physical function' items in Zurich Claudication Questionnaire at 8 weeks
Time Frame: 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.
Change from baseline at 8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean score for 'Satisfaction' item in Zurich Claudication Questionnaire at 8 weeks
Time Frame: 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.
At 8 weeks
Change from baseline in Oswestry Disability Index score at 8 weeks
Time Frame: 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 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
Time Frame: 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.
Change from baseline at 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dong-A ST Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 16, 2024

Primary Completion (Actual)

February 23, 2026

Study Completion (Actual)

February 23, 2026

Study Registration Dates

First Submitted

October 21, 2024

First Submitted That Met QC Criteria

October 21, 2024

First Posted (Actual)

October 23, 2024

Study Record Updates

Last Update Posted (Actual)

February 27, 2026

Last Update Submitted That Met QC Criteria

February 25, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OMT_LSS_OS

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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