Follow-up study of LDH patients participated in the Phase II/III study (6603/1021) and Phase III study (6603/1031) of condoliase (SI-6603)

Follow-up study of LDH patients participated in the Phase II/III study (6603/1021) and Phase III study (6603/1031) of condoliase (SI-6603) - Follow-up study of LDH patients participated in the SI-6603 clinical study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000015221

Enrollment

356

Registered

2014-09-22

Start date

2014-07-19

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

Lumbar Disc Herniation

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: All patients who were administered SI-6603 in the clinical study

Exclusion criteria

Exclusion criteria: Patients who have not given their written informed consent to participate in the follow-up study.

Design outcomes

Primary

Measure	Time frame
Occurrence of post-treatment lumbar surgery	—

Secondary

Measure	Time frame
Occurrence of lumbar instability Clinical symptoms and daily disability resulting from lumbar diseases	—

Countries

Japan

Contacts

Public ContactSatomi Ono

Mebix, Inc. Clinical Research Division

si-6603@mebix.co.jp03-6229-8936

Outcome results