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OpenTrials
Completed

NCT Number: NCT06654856

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

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Key information

Conditions

Lumbar Spinal Stenosis Bone Diseases Musculoskeletal Diseases Spinal Diseases Spinal Stenosis

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

VHS Medical Center

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Dong-A ST Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Oct 23, 2024
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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