Clinical Trial of Pregabalin and COX2 in Spinal Stenosis

NCT ID: NCT03584074

Last Updated: 2018-07-12

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-01

Study Completion Date

2019-12-31

Brief Summary

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Aim of this prospective, single-blind, randomized study was to compare the efficacy of the combination of celecoxib and pregabalin and celecoxib only monotherapy for treatment of chronic low-back pain.

Detailed Description

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The efficacy and safety of the association of celecoxib \[a selective cyclooxygenase-2 (COX-2) inhibitor\] and pregabalin (commonly used to control neuropathic pain), compared with monotherapy of each, were evaluated for the treatment of chronic low-back pain, a condition known to be due to neuropathic as well as nociceptive pain mechanisms.

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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Spinal Stenosis Lumbar

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Pregabalin and COX-2 inhibitor

Pregabalin 75mg BID + Celecoxib 200mg qd

Group Type EXPERIMENTAL

Pregabalin 75mg

Intervention Type DRUG

Orally taken twice daily for 8 weeks

Celebrex 200Mg Capsule

Intervention Type DRUG

Orally taken once daily for 8 weeks

COX-2 inhibitor

Celecoxib 200mg qd

Group Type ACTIVE_COMPARATOR

Celebrex 200Mg Capsule

Intervention Type DRUG

Orally taken once daily for 8 weeks

Interventions

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Pregabalin 75mg

Orally taken twice daily for 8 weeks

Intervention Type DRUG

Celebrex 200Mg Capsule

Orally taken once daily for 8 weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Spinal stenosis

Exclusion Criteria

* Koval grade \>=3
* Other musculoskeletal disorders which cause pain on other joint
* Bleeding risk or ulcer history
* Severe cardiovascular, pulmonary, renal, brain, liver dysfunction
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Bundang Hospital

OTHER

Sponsor Role lead

Responsible Party

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Ho-Joong Kim

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Ho-Joong Kim, M.D., Ph.D

Role: CONTACT

+82317872300

Other Identifiers

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PreCox2

Identifier Type: -

Identifier Source: org_study_id

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