Spinal Stenosis LumbarPhase 4NCT03584074
Clinical Trial of Pregabalin and COX2 in Spinal Stenosis
A Phase 4 study testing Pregabalin 75mg and Celebrex 200Mg Capsule in people with Spinal Stenosis Lumbar, run by Seoul National University Bundang Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Spinal Stenosis Lumbar
- What is being tested?
- Pregabalin 75mg and Celebrex 200Mg Capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2018to 31 Dec 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Spinal stenosis
Who cannot join
- Koval grade >=3
- Other musculoskeletal disorders which cause pain on other joint
- Bleeding risk or ulcer history
- Severe cardiovascular, pulmonary, renal, brain, liver dysfunction
Trial locations and contacts
No sites are listed yet.
About this study
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
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.
Read the 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.
- Conditions
- Spinal Stenosis Lumbar
- Being tested
- Pregabalin 75mg, Celebrex 200Mg Capsule
- Keywords
- Pregabalin, Selective COX-2 inhibitor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pregabalin 75mgDrug
Orally taken twice daily for 8 weeks
Celebrex 200Mg CapsuleDrug
Orally taken once daily for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Pregabalin and COX-2 inhibitor | Experimental | Pregabalin 75mg BID + Celecoxib 200mg qd Receives: Drug: Pregabalin 75mg; Drug: Celebrex 200Mg Capsule |
| COX-2 inhibitor | Active comparator | Celecoxib 200mg qd Receives: Drug: Celebrex 200Mg Capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analog scale
Pain score for low back and lower leg
Measured: At 8 weeks
Secondary outcomes (2)
Pain sensitivity questionnaire (PSQ)
Level of pain sensitivity
Measured: At 8 weeks
Oswestry disability index (ODI)
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
Measured: At 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2018
- Study start1 Jul 2018 (estimated)
- Primary completion30 May 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Stenosis LumbarStudies of the same condition, open and under way.
- More trials run by Seoul National University Bundang HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ho-Joong Kim, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03584074
- Sponsor's protocol ID
- PreCox2
- Status last verified
- Jun 2018
- First submitted
- 29 Jun 2018
- Last updated
- 12 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03584074
- Acronym / sponsor ID
- PreCox2
- Conditions
- Spinal Stenosis Lumbar
- Keywords
- Pregabalin, Selective COX-2 inhibitor
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Study start
- 1 Jul 2018 (estimated)
- Primary completion
- 30 May 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 12 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pregabalin and COX-2 inhibitor | Experimental | Drug: Pregabalin 75mg, Drug: Celebrex 200Mg CapsulePregabalin 75mg BID + Celecoxib 200mg qd |
| COX-2 inhibitor | Active comparator | Drug: Celebrex 200Mg CapsuleCelecoxib 200mg qd |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Spinal stenosis
Key exclusion criteria (4 listed)
- Koval grade >=3
- Other musculoskeletal disorders which cause pain on other joint
- Bleeding risk or ulcer history
- Severe cardiovascular, pulmonary, renal, brain, liver dysfunction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pregabalin 75mgOrally taken twice daily for 8 weeks | Drug | Pregabalin and COX-2 inhibitor |
| Celebrex 200Mg CapsuleOrally taken once daily for 8 weeks | Drug | COX-2 inhibitor, Pregabalin and COX-2 inhibitor |
Primary outcome
Visual analog scale
Time frame: At 8 weeks
Pain score for low back and lower leg
2 secondary outcomes
Pain sensitivity questionnaire (PSQ)
Time frame: At 8 weeks
Oswestry disability index (ODI)
Time frame: At 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Pregabalin 75mg and Celebrex 200Mg Capsule in people with Spinal Stenosis Lumbar, run by Seoul National University Bundang Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ho-Joong Kim, M.D., Ph.D (+82317872300, oshjkim@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual analog scale (time frame: At 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2018.