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Neurologic Claudication in Patients With Lumbar Spinal StenosisPhase 4NCT01888536

A Study to Evaluate Efficacy of 『Opast Tablet』for Neurologic Claudication in Patients With Lumbar Spinal Stenosis

A Phase 4 study testing Limaprost and Pregabalin in people with Neurologic Claudication in Patients With Lumbar Spinal Stenosis, run by Yungjin Pharm. Co., Ltd. at 7 sites in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This trial is a comparative study of Opast tablet and Rikalin capsule 75mg and Rikalin capsule 75mg in combination with Opast tablet to evaluate improvement effectiveness of Opast tablet on subjective symptoms and neurologic claudication in patients with lumbar spinal stenosis. Read more about this study

Who is it for?
Ages 20 to 75 years
What is being tested?
Limaprost and Pregabalin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
182 participants
Where
7 sitesSouth Korea
Study dates
Feb 2013to Feb 2014
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 20 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subject is fully understand the clinical trial and obtained informed consent.
  • Age 20-75years.
  • Patients with a confirmed diagnosis of waist of spinal canal stenosis.
  • Limb pain caused by waist of spinal canal stenosis index of VAS 3 or more patients.
  • Subject who has numbness symptom on lower extremity(ies) and intermittent claudication that are due to spinal canal stenosis and fulfills both of following criteria at the same time
  • When screening visit, a medical examination by interview had the following symptoms in subjects ; In daily life walking, when walked by within 20 minutes on flatland, the subject can feel the symptoms (numbness, pain or tightness on lower extremity(ies), etc.)
  • Subject who experienced numbness, pain, tightness or other similar symptom(s) on lower extremity within 15 minutes from test start at baseline(D1) evaluation.
  • speed: 3km/hr, grade:0%, posture: should keep their lumbar spinal extended

Who cannot join

  • Pregnant or lactating women of childbearing potential not employing adequate contraception.
  • Patients who have the hereditary problem of galactose intolerance, Lapp lactase deficiency or grape sugar-galactose absorption defect.
  • Patients with systemic disease affecting the lower limbs.
  • Patients who have cauda equina syndrome.
  • Patients with acute osteoporosis compression fracture in lumbar vertebra.
  • Patients who have gait disturbance of degenerative arthritis by hip joint, knee joint, ankle joint.
Show all 15Show fewer
  • At least one month before the start of the study, patients use of steroid drug except lumbar dura mater.
  • 6 month before the start of the study, patients with ischaemic disease in blood vessel, lung or the coronary artery, varicose artery.
  • Patients with lumbar necrosis in head of femur avascular necrosis, necrotic foot ulcer.
  • Patients surgery by lumbar fusion and lumbar decompression.
  • Patients with renal disease or need to hemodialysis.
  • serum creatinine > 2xUNL
  • 3 month before the start of the study, patients participated in another clinical research.
  • Patients with difficult understanding spirit incompetence, lack of will or language barrier.
  • The investigator judged seriously ill patients need surgery patient.

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

South Korea7 sites

  • Hallym University Sacred Heart Hospital

    Anyang-si, Gyeonggi-do, 431-070

  • Hanyang University Guri Hospital

    Guri-si, Gyeonggi-do, 471-701

  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggi-do, 463-707

  • Yonsei University Health System, Severance Hospital

    Seoul, Seoul, 120-752

  • KyungHee University Medical Center

    Seoul, Seoul, 130-872

  • Inje University Sanggye Paik Hospital

    Seoul, Seoul, 139-707

  • SMG-SNU Boramae Medical Center

    Seoul, Seoul, 156-707

Other trials in South Korea

About this study

Official title: A Randomized, Double-Blind, Comparative, Multi-Center, Phase Ⅳ Clinical Trial to Evaluate Efficacy of 『Opast Tablet』for Neurologic Claudication in Patients With Lumbar Spinal Stenosis

This trial is a comparative study of Opast tablet and Rikalin capsule 75mg and Rikalin capsule 75mg in combination with Opast tablet to evaluate improvement effectiveness of Opast tablet on subjective symptoms and neurologic claudication in patients with lumbar spinal stenosis.

Read the detailed description

Subjects who provided written consents voluntarily after receiving a sufficient explanation about this trial will be assigned to one of groups(study group; limaprost, comparative group 1; pregabalin, comparative group 2; limaprost+ pregabalin) by randomization at the rate of 1:1:1.

Subjects will take assigned investigational drugs thrice a day for eight weeks by double-blind and double-dummy methods, and they will visit the site two times at intervals of four weeks.

At each site visit point, the improvement effectiveness will be comparatively evaluated by evaluation of following endpoints;

Efficacy endpoints: ICD(initial claudication distance) at treadmill test (speed:3km/hr, grade:0%), VAS in pain on lower extremities, EQ-5D and ODI Safety endpoints: Vital signs, hematology/blood chemistry tests and adverse events, etc.

Being tested
Limaprost, Pregabalin, Placebo(for Pregabalin), Placebo(for Limaprost)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LimaprostDrug

    Also called Opast tablet

  • PregabalinDrug

    Also called Rikalin capsule 75mg

  • Placebo(for Pregabalin)Drug

    mimic Pregabalin 75mg capsule

  • Placebo(for Limaprost)Drug

    mimic Limaprost tablet

Study groups in NCT01888536
Study groupRoleWhat they receive
Limaprost & PlaceboExperimentalLimaprost 5㎍ tablet and a capsule of Pegabalin-Placebo thrice a day for 8 weeks.
Receives: Drug: Limaprost; Drug: Placebo(for Pregabalin)
Pregabalin & PlaceboActive comparatorPregabalin 75mg capsule and a tablet of Limaprost-Placebo thrice a day for 8 weeks.
Receives: Drug: Pregabalin; Drug: Placebo(for Limaprost)
Limaprost+PregabalinActive comparatorLimaprost 5㎍ tablet and Pregabalin 75mg capsule thrice a day for 8 weeks.
Receives: Drug: Limaprost; Drug: Pregabalin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. baseline-adjusted Oswestry Disability Index score at 8 weeks after treatment

    baseline-adjusted Oswestry Disability Index score at 8 weeks after treatment between study group(limaprost) and comparative group1(pregabalin) and combination group (limaprost + pregabalin)

    Measured: up to 8 weeks after first administration

Secondary outcomes (4)

  1. Initial Claudication Distance(ICD) on treadmill test

    • Improvement of ICD at 4 weeks after first administration compared to baseline, between study group(limaprost) and comparative group1(pregabalin)
    • Improvement of ICD at 4, 8 weeks after first administration compared to baseline, between study group(limaprost) and comparative group 2(limaprost+ pregabalin)

    Measured: 4 and 8 weeks after first administration

  2. lower extremity pain score measured by Visual Analog Scale(VAS) 10cm

    • Change in VAS at 4, 8 weeks after first administration compared to baseline, between study group(limaprost) and comparative group1(pregabalin)
    • Change in VAS at 4, 8 weeks after first administration compared to baseline, between study group(limaprost) and comparative group 2(limaprost+ pregabalin)

    Measured: 4 and 8 weeks after first administration

  3. Mean ratio of change in score of EuroQuol 5D (EQ-5D)

    • Change in EQ-5D at 4, 8 weeks after first administration compared to baseline, between study group(limaprost) and comparative group1(pregabalin)
    • Change in EQ-5D at 4, 8 weeks after first administration compared to baseline, between study group(limaprost) and comparative group 2(limaprost+ pregabalin)

    Measured: 4 and 8 weeks after first administration

  4. Mean ratio of change in score of Oswestry Disability Index(ODI)

    • Change in ODI at 4, 8 weeks after first administration compared to baseline, between study group(limaprost) and comparative group1(pregabalin)
    • Change in ODI at 4, 8 weeks after first administration compared to baseline, between study group(limaprost) and comparative group 2(limaprost+ pregabalin)

    Measured: 4 and 8 weeks after first administration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jun 2013 (estimated)
  2. Study startFeb 2013
  3. Primary completionOct 2013
  4. Study completionFeb 2014

Resources

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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
182 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01888536
Sponsor's protocol ID
YJ7-401
Status last verified
Dec 2015
First submitted
25 Jun 2013
Last updated
22 Dec 2015
Results posted
No
Data monitoring committee
No

Publications

  • Kim HJ, Kim JH, Park YS, Suk KS, Lee JH, Park MS, Moon SH. Comparative study of the efficacy of limaprost and pregabalin as single agents and in combination for the treatment of lumbar spinal stenosis: a prospective, double-blind, randomized controlled non-inferiority trial. Spine J. 2016 Jun;16(6):756-63. doi: 10.1016/j.spinee.2016.02.049. Epub 2016 Mar 29.

    PubMed 27045252

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Limaprost and Pregabalin in people with Neurologic Claudication in Patients With Lumbar Spinal Stenosis, run by Yungjin Pharm. Co., Ltd. at 7 sites in South Korea.

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 8 inclusion and 15 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: finished, as of the sponsor's last update on 22 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

baseline-adjusted Oswestry Disability Index score at 8 weeks after treatment (time frame: up to 8 weeks after first administration). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01888536, which also lists 1 linked publication.

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 22 Dec 2015.

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