Efficacy and Safty of Long Acting Beraprost (TRK-100STP) for Lumbar Spinal Canal Stenosis with Intermittent Claudication :A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial

Efficacy and Safty of Long Acting Beraprost (TRK-100STP) for Lumbar Spinal Canal Stenosis with Intermittent Claudication :A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial - Phase2 exploratory study of TRK-100STP

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000005575

Enrollment

150

Registered

2011-05-10

Start date

2011-05-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acquired degenerative lumbar spinal canal stenosis

Interventions

Placebo TRK-100STP 120ug/day TRK-100STP 240ug/day

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1)Patients with spondylotic or degenerative spondylolosthetic LSCS, who does not have degenerative scoliotic and spondylolytic spondylolisthetic findings. (2)Patients have cauda equine lesion type (cauda equine type or mixed type) symptoms.

Exclusion criteria

Exclusion criteria: (1)Patients who have any complication, which could affect efficacy assessments. (2)ABI is more than 0.9 (3)Patients who is bleeding or have a tendency to bleed. (4)Patients are allergic to beraprost sodium. (5)Patients have severe disorders. (6)Patients who determined the principal investigator or the sub-investigator to be inadequate to participate in the trial.

Design outcomes

Primary

Measure	Time frame
1.Efficacy outcome measures Objective assessments Subjective assessments QOL assessments 2.Safety outcome measures Adverse events Laboratory values Vital signs	—

Countries

Japan

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026