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A randomized comparative study of Celecoxib and Limaprost alfadex on the patients with lumber spinal stenosis for the effectiveness for symptoms and QOL

A randomized comparative study of Celecoxib and Limaprost alfadex on the patients with lumber spinal stenosis for the effectiveness for symptoms and QOL - A randomized comparative study of medications for patients with lumber spinal stenosis

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000004825
Enrollment
134
Registered
2011-01-06
Start date
2011-01-01
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

Lumbar spinal stenosis

Interventions

15ug/day Limaprost arfadex for 8 weeks 200mg/day Celecoxib for 8 weeks

Sponsors

University of Tsukuba, Course of life-style related disorders donated by JA Ibaraki Public Welfare Federation
Lead Sponsor
Mito Kyodo Hospital
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1.Above seven point of the score for a diagnostic support tool for lumbar spinal stenosis 2.Radiologic diagnosis of lumbar spinal stenosis 3.Capable of giving informed consent

Exclusion criteria

Exclusion criteria: 1.Congenital lumbar spinal stenosis 2.Operation for lumbar spinal stenosis before three months 3.Indication for operation 4.Taking NSAIDs, Limaprost and Steroids before a week 5.Exclusion criteria a)ASO and below 0.9 of ABI b)Cerebral infarction c)Gait disturbance with Knee and hip osteoarthritis d)Diabetes (HbA1c>10% or diabetic neuropathy) 6. Severe low back pain and vertebral body fracture 7. Severe systemic past history such as heart, liver or kidney disease 8. Peptic ulcer 9. Severe abnormal symptom of blood 10. Pregnant or intend to become pregnant during the study period 11. History of hypersensitivity to Limaprost, celecoxib and sulfonamide 12. Aspirin-induced asthma 13. Patients who were recognized unsuitable for this study by primary physician

Design outcomes

Primary

MeasureTime frame
Zurich claudication questionnaire

Secondary

MeasureTime frame
6-minute walk test JOA back pain evaluation questionnaire SF-36 Lumber extension test Safety: adverse events

Countries

Japan

Contacts

Public ContactKoichi Hashimoto

University of Tsukuba Tsukuba Critical Path Research and Education Integrated Leading Center, Course of life-style related

029-853-3076

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026