Effect of Sarpogrelate on Spinal Stenosis: A prospective, randomized controlled, multicenter study

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CRIS

Registry ID

KCT0003795

Enrollment

100

Registered

2019-04-16

Start date

2019-02-08

Completion date

Unknown

Last updated

2024-08-19

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

Conditions

None listed

Interventions

Drug : Patients with diagnosed spinal stenosis should be included. If there is a drug that has been previously taken by the patients participating in the experiment, participate in the study and stop

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Adults aged between 50-79 years old 2. Neurogenic claudication greater thanVAS 3 of due to spinal stenosis 3. Radiological confirmation of spinal stenosis on X-ray, CT or MRI in last 6 months 4. No history of receiving lumbar intervention in last 1 month 5. Able to express the accurate quality of pain and discomfort 6. Exclusion criteria 7. Bleeding tendency (Hemophilia, Capillary vasculopathy, GI ulcer, hematuria, hemoptysis, vitreous hemorrhage etc.)

Exclusion criteria

Exclusion criteria: 1. Age ? 50 and > 85 years old 2. Sensory deficit or motor weakness below knee level in last 3 days. 3. Epidural intervention in the level of stenosis within 1month 4. Taking an anticoagulation or antiplatelet agent, currently. 7. Participating in another clinical trial that may interfere with the present trial 8. Not able to comply fully with the protocol, including treatment, follow-up or study procedures (psychosocially, mentally and physical). 9. Hypersensitivity on sarpogrelate, NSAIDs or other salicylic acid 10. Congestive heart failure 11. Significant liver disease (AST or ALT > 100 U/ml) 12. Renal dysfunction (Cr: >1.8mg/dl or GFR: <40ml/min ) 13. Pregrant or feeding women. 14. Hypersensitivity on esomeprozole or benzimidazole 15. Patient who take atazanavir, nelfinavir or rilpivirine. 16. Allergy or contraindication to any of the study medications (Sarpogrelate, pregabalin, aceclofenac, esomeprazole)

Design outcomes

Primary

Measure	Time frame
claudication distance	—

Secondary

Measure	Time frame
Oswestry Disability Index (ODI), Visual Analog Scale (VAS), claudication distance, ABI;Visual Analog Scale (VAS);claudication distance;Oswestry Disability Index (ODI);Visual Analog Scale (VAS);Visual Analog Scale (VAS)	—

Countries

Korea, Republic of

Contacts

Public ContactKim Kyung

Samsung Medical Center

eunbead21@naver.com+82-2-2008-4140

Outcome results