NCT03584074

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jul 2018

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 29, 2018

Completed
2 days until next milestone

Study Start

First participant enrolled

July 1, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 12, 2018

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2019

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

July 12, 2018

Status Verified

June 1, 2018

Enrollment Period

11 months

First QC Date

June 29, 2018

Last Update Submit

June 29, 2018

Conditions

Spinal Stenosis Lumbar

Keywords

PregabalinSelective COX-2 inhibitor

Outcome Measures

Primary Outcomes (1)

  • Visual analog scale

    Pain score for low back and lower leg

    At 8 weeks

Secondary Outcomes (2)

  • Pain sensitivity questionnaire (PSQ)

    At 8 weeks

  • Oswestry disability index (ODI)

    At 8 weeks

Study Arms (2)

Pregabalin and COX-2 inhibitor

EXPERIMENTAL

Pregabalin 75mg BID + Celecoxib 200mg qd

Drug: Pregabalin 75mgDrug: Celebrex 200Mg Capsule

COX-2 inhibitor

ACTIVE COMPARATOR

Celecoxib 200mg qd

Drug: Celebrex 200Mg Capsule

Interventions

Pregabalin 75mgDRUG

Orally taken twice daily for 8 weeks

Pregabalin and COX-2 inhibitor
Celebrex 200Mg CapsuleDRUG

Orally taken once daily for 8 weeks

COX-2 inhibitorPregabalin and COX-2 inhibitor

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Spinal stenosis

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

PregabalinCelecoxib

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric AcidAminobutyratesButyratesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsAmino AcidsAmino Acids, Peptides, and ProteinsBenzenesulfonamidesSulfonamidesAmidesBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsSulfonesSulfur CompoundsPyrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Central Study Contacts

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

CONTACT

+82317872300oshjkim@gmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 29, 2018

First Posted

July 12, 2018

Study Start

July 1, 2018

Primary Completion

May 30, 2019

Study Completion

December 31, 2019

Last Updated

July 12, 2018

Record last verified: 2018-06