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

NCT01888536 | Completed Phase 4

• 1 other identifier: YJ7-401
• Study Type: interventional
• Target: 182
• Locations: 1 country
• Sites: 7

Brief 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.

Conditions

Neurologic Claudication in Patients With Lumbar Spinal Stenosis

Outcome Measures

Primary Outcomes (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)

  up to 8 weeks after first administration

Secondary Outcomes (4)

• Initial Claudication Distance(ICD) on treadmill test

  4 and 8 weeks after first administration

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

  4 and 8 weeks after first administration

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

  4 and 8 weeks after first administration

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

  4 and 8 weeks after first administration

Study Arms (3)

Limaprost & Placebo

EXPERIMENTAL

Limaprost 5㎍ tablet and a capsule of Pegabalin-Placebo thrice a day for 8 weeks.

Drug: Limaprost; Drug: Placebo(for Pregabalin)

Pregabalin & Placebo

ACTIVE COMPARATOR

Pregabalin 75mg capsule and a tablet of Limaprost-Placebo thrice a day for 8 weeks.

Drug: Pregabalin; Drug: Placebo(for Limaprost)

Limaprost+Pregabalin

ACTIVE COMPARATOR

Limaprost 5㎍ tablet and Pregabalin 75mg capsule thrice a day for 8 weeks.

Drug: Limaprost; Drug: Pregabalin

Interventions

Limaprost DRUG

Also known as: Opast tablet

Limaprost & Placebo; Limaprost+Pregabalin

Pregabalin DRUG

Also known as: Rikalin capsule 75mg

Limaprost+Pregabalin; Pregabalin & Placebo

Placebo(for Pregabalin) DRUG

mimic Pregabalin 75mg capsule

Limaprost & Placebo

Placebo(for Limaprost) DRUG

mimic Limaprost tablet

Pregabalin & Placebo

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.
• At least one month before the start of the study, patients use of steroid drug except lumbar dura mater.
• 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
• 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.

Sponsors & Collaborators

• Yungjin Pharm. Co., Ltd.: lead

Study Sites (7)

Hallym University Sacred Heart Hospital

Anyang-si, Gyeonggi-do, 431-070, South Korea

Location

Hanyang University Guri Hospital

Guri-si, Gyeonggi-do, 471-701, South Korea

Location

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 463-707, South Korea

Location

Yonsei University Health System, Severance Hospital

Seoul, Seoul, 120-752, South Korea

Location

KyungHee University Medical Center

Seoul, Seoul, 130-872, South Korea

Location

Inje University Sanggye Paik Hospital

Seoul, Seoul, 139-707, South Korea

Location

SMG-SNU Boramae Medical Center

Seoul, Seoul, 156-707, South Korea

Location

Related Publications (1)

• 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.

  PMID: 27045252 DERIVED

MeSH Terms

Interventions

limaprost; Pregabalin

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Seong-Hwan Moon, M.D.,Ph.D.

  Yonsei University College of Medicine Severance Hospital

  PRINCIPAL INVESTIGATOR

• Jin Hyok Kim, M.D.,Ph.D.

  Inje University

  PRINCIPAL INVESTIGATOR

• Jae Hyup Lee, M.D.,Ph.D.

  SMG-SNU Boramae Medical Center

  PRINCIPAL INVESTIGATOR

• Suk Kyung Soo, M.D.,Ph.D.

  Kyunghee University Medical Center

  PRINCIPAL INVESTIGATOR

• Ho Joong Kim, M.D.,Ph.D.

  Seoul National University Bundang Hospital

  PRINCIPAL INVESTIGATOR

• Ye Soo Park, M.D.,Ph.D.

  Hanyang University Guri Hospital

  PRINCIPAL INVESTIGATOR

• Moon Soo Park, M.D.,Ph.D.

  Hallym University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2013
• First Posted: June 27, 2013
• Study Start: February 1, 2013
• Primary Completion: October 1, 2013
• Study Completion: February 1, 2014
• Last Updated: December 22, 2015

Record last verified: 2015-12

Locations

KR (7)