Evaluating Dong-A Opalmon® Tablet for 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
Dong-A ST Co., Ltd. · NCT06654856
This study is testing if the Dong-A Opalmon® Tablet can help people with lumbar spinal stenosis feel better and stay safe while using it.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 243 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Dong-A ST Co., Ltd. (industry) |
| Locations | 1 site (Seoul) |
| Trial ID | NCT06654856 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the effectiveness and safety of Dong-A Opalmon® Tablet in patients diagnosed with acquired lumbar spinal stenosis. Participants will include men and women aged 19 and older who exhibit symptoms such as intermittent claudication and have normal results in the Straight Leg Raising test. The study will involve monitoring the outcomes of these patients as they receive treatment with the tablet. The research is sponsored by Dong-A ST Co., Ltd. and conducted at VHS Medical Center in Seoul.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 19 and older with acquired lumbar spinal stenosis who experience intermittent claudication.
Not a fit: Patients who are pregnant, have certain genetic disorders, or are deemed unsuitable by the investigators will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide significant relief and improved quality of life for patients suffering from lumbar spinal stenosis.
How similar studies have performed: While this specific approach may be novel, similar studies evaluating treatments for lumbar spinal stenosis have shown varying degrees of success.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Seoul
- VHS Medical Center — Seoul, Korea, Republic of (RECRUITING)
Study contacts
- Study coordinator: Young-Bae Kim, PhD
- Email: benspine@gmail.com
- Phone: 82-2-2225-1352
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Lumbar Spinal Stenosis