Clinical Trial of Pregabalin and COX2 in Spinal Stenosis
NCT ID: NCT03584074
Last Updated: 2018-07-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
60 participants
INTERVENTIONAL
2018-07-01
2019-12-31
Brief Summary
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Detailed Description
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We will compare the efficacy of the combination of a selective COX-2 inhibitor (celecoxib) and an antineuropathic drug, pregabalin, versus celecoxib only monotherapy, in the treatment of spinal stenosis.
Each treatment lasted 8 weeks
Primary outcome is mean pain reduction following different treatments regimes. Secondary outcomes are the changes of pain sensitivity, Oswestry disability index, adverse effects due to the treatments under study.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Pregabalin and COX-2 inhibitor
Pregabalin 75mg BID + Celecoxib 200mg qd
Pregabalin 75mg
Orally taken twice daily for 8 weeks
Celebrex 200Mg Capsule
Orally taken once daily for 8 weeks
COX-2 inhibitor
Celecoxib 200mg qd
Celebrex 200Mg Capsule
Orally taken once daily for 8 weeks
Interventions
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Pregabalin 75mg
Orally taken twice daily for 8 weeks
Celebrex 200Mg Capsule
Orally taken once daily for 8 weeks
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Other musculoskeletal disorders which cause pain on other joint
* Bleeding risk or ulcer history
* Severe cardiovascular, pulmonary, renal, brain, liver dysfunction
40 Years
ALL
No
Sponsors
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Seoul National University Bundang Hospital
OTHER
Responsible Party
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Ho-Joong Kim
Associate Professor
Central Contacts
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Other Identifiers
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PreCox2
Identifier Type: -
Identifier Source: org_study_id
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