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Clinical Trial of Pregabalin and COX2 in Spinal Stenosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03584074
Recruitment Status : Unknown
Verified June 2018 by Ho-Joong Kim, Seoul National University Bundang Hospital.
Recruitment status was:  Not yet recruiting
First Posted : July 12, 2018
Last Update Posted : July 12, 2018
Sponsor:
Information provided by (Responsible Party):
Ho-Joong Kim, Seoul National University Bundang Hospital

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Spinal Stenosis Lumbar Drug: Pregabalin 75mg Drug: Celebrex 200Mg Capsule Phase 4

Detailed Description:

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparative Study for Decrease of Pain Intensity and Pain Sensitivity Between Pregabalin + COX-2 Inhibitor and COX-2 Inhibitor in Patients With Lumbar Spinal Stenosis: Randomized Controlled Trial
Estimated Study Start Date : July 1, 2018
Estimated Primary Completion Date : May 30, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Spinal Stenosis

Arms and Interventions
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Arm Intervention/treatment
Experimental: Pregabalin and COX-2 inhibitor
Pregabalin 75mg BID + Celecoxib 200mg qd
 Drug: Pregabalin 75mg
Orally taken twice daily for 8 weeks

Drug: Celebrex 200Mg Capsule
Orally taken once daily for 8 weeks
Active Comparator: COX-2 inhibitor
Celecoxib 200mg qd
 Drug: Celebrex 200Mg Capsule
Orally taken once daily for 8 weeks


Outcome Measures
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Primary Outcome Measures :
  1. Visual analog scale [ Time Frame: At 8 weeks ]
    Pain score for low back and lower leg


Secondary Outcome Measures :
  1. Pain sensitivity questionnaire (PSQ) [ Time Frame: At 8 weeks ]
    Level of pain sensitivity

  2. Oswestry disability index (ODI) [ Time Frame: At 8 weeks ]
    The self-completed questionnaire contains ten topics concerning intensity of pain, lifting, ability to care for oneself, ability to walk, ability to sit, sexual function, ability to stand, social life, sleep quality, and ability to travel


Eligibility Criteria
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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03584074


Contacts
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Contact: Ho-Joong Kim, M.D., Ph.D +82317872300 oshjkim@gmail.com

Sponsors and Collaborators
Seoul National University Bundang Hospital
More Information
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Responsible Party: Ho-Joong Kim, Associate Professor, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier: NCT03584074    
Other Study ID Numbers: PreCox2
First Posted: July 12, 2018    Key Record Dates
Last Update Posted: July 12, 2018
Last Verified: June 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ho-Joong Kim, Seoul National University Bundang Hospital:
Pregabalin
Selective COX-2 inhibitor
Additional relevant MeSH terms:
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Spinal Stenosis
Constriction, Pathologic
Pathological Conditions, Anatomical
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Celecoxib
Pregabalin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anticonvulsants
Calcium Channel Blockers
 Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors