Lumbar Spinal StenosisNCT06654856
The Effectiveness and Safety of Dong-A Opalmon® Tablet in Patients With Acquired Lumbar Spinal Stenosis
An observational study of Lumbar Spinal Stenosis, run by Dong-A ST Co., Ltd. at 1 site in South Korea.
Trial summary
This study is to evaluate the Effectiveness and Safety of Dong-A Opalmon® Tablet in Patients With Acquired Lumbar Spinal Stenosis Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Lumbar Spinal Stenosis
- How many people
- 107 participants
- Where
- 1 siteSouth Korea
- Study dates
- 16 Aug 2024to 23 Feb 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects who require treatment of Dong-A Opalmon® tab due to acquired Lumbar Spinal Stenosis
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
- Conditions
- Lumbar Spinal Stenosis
- Medical subject headings
- Spinal Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Dong-A Opalmon® Tab | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from baseline at 8 weeks
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: Change from baseline at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2024
- Study start16 Aug 2024
- Primary completion23 Feb 2026
- Study completion23 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Spinal StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dong-A ST Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06654856
- Sponsor's protocol ID
- OMT_LSS_OS
- Status last verified
- Feb 2026
- First submitted
- 21 Oct 2024
- Last updated
- 27 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06654856
- Acronym / sponsor ID
- OMT_LSS_OS
- Conditions
- Lumbar Spinal Stenosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- Dong-A ST Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 16 Aug 2024 (actual)
- Primary completion
- 23 Feb 2026 (actual)
- Study completion
- 23 Feb 2026 (actual)
- First posted
- 23 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is to evaluate the Effectiveness and Safety of Dong-A Opalmon® Tablet in Patients With Acquired Lumbar Spinal Stenosis
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dong-A Opalmon® Tab | – | – |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects who require treatment of Dong-A Opalmon® tab due to acquired Lumbar Spinal Stenosis
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
3 secondary outcomes
Mean score for 'Satisfaction' item in Zurich Claudication Questionnaire at 8 weeks
Time frame: At 8 weeks
Change from baseline in Oswestry Disability Index score at 8 weeks
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
Time frame: Change from baseline at 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lumbar Spinal Stenosis, run by Dong-A ST Co., Ltd. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.