NCT01941563

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of SI-6603 (condoliase) in patients with lumbar disc herniation.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
385

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Sep 2013

Typical duration for phase_3

Geographic Reach
1 country

32 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

September 4, 2013

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 13, 2013

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
Last Updated

March 23, 2023

Status Verified

March 1, 2023

Enrollment Period

2.2 years

First QC Date

September 4, 2013

Last Update Submit

March 21, 2023

Conditions

Intervertebral Disc DiseaseLumbar Disc Disease

Outcome Measures

Primary Outcomes (1)

  • Leg pain

    Assessed by Visual Analog Scale (VAS)

    13 weeks

Secondary Outcomes (1)

  • Responder rate evaluation

    13 weeks

Study Arms (2)

SI-6603

EXPERIMENTAL

SI-6603 is administrated into the nucleus pulposus of the intervertebral disc

Drug: Condoliase

Control

SHAM COMPARATOR

Sham injection

Drug: placebo

Interventions

CondoliaseDRUG

1.25U, intradiscal injection, one time

SI-6603
placeboDRUG
Control

Eligibility Criteria

Age30 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with lumbar disc herniation (L4-L5 or L5-S1) as assessed by MRI and clinical symptoms corresponding to position of the impaired nerve root.
  • Patients assessed as positive in the SLR test.
  • Patients with sciatica in either leg.
  • Patients with no improvement from conservative treatment

You may not qualify if:

  • Patients who have 2 or more lumbar disc herniations as assessed by MRI.
  • Patients in whom a rupture into the posterior longitudinal ligament is identified by MRI.
  • Patients who have received spinal injection, epidural injection, nerve block within 3 weeks prior to the time of informed consent.
  • Patients who have undergone lumbar operation, or lumbar percutaneous nucleotomy or lumbar intradiscal therapies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (32)

Unknown Facility

Phoenix, Arizona, United States

Location

Unknown Facility

Gold River, California, United States

Location

Unknown Facility

Laguna Hills, California, United States

Location

Unknown Facility

Los Gatos, California, United States

Location

Unknown Facility

Murrieta, California, United States

Location

Unknown Facility

Riverside, California, United States

Location

Unknown Facility

Denver, Colorado, United States

Location

Unknown Facility

Hialeah, Florida, United States

Location

Unknown Facility

Jacksonville, Florida, United States

Location

Unknown Facility

Merritt Island, Florida, United States

Location

Unknown Facility

Miami, Florida, United States

Location

Unknown Facility

Naples, Florida, United States

Location

Unknown Facility

North Miami Beach, Florida, United States

Location

Unknown Facility

Orlando, Florida, United States

Location

Unknown Facility

Pinellas Park, Florida, United States

Location

Unknown Facility

Sarasota, Florida, United States

Location

Unknown Facility

St. Petersburg, Florida, United States

Location

Unknown Facility

Sunrise, Florida, United States

Location

Unknown Facility

Winter Park, Florida, United States

Location

Unknown Facility

Marietta, Georgia, United States

Location

Unknown Facility

Newnan, Georgia, United States

Location

Unknown Facility

Bloomington, Illinois, United States

Location

Unknown Facility

Carmel, Indiana, United States

Location

Unknown Facility

Shreveport, Louisiana, United States

Location

Unknown Facility

City of Saint Peters, Missouri, United States

Location

Unknown Facility

Hartsdale, New York, United States

Location

Unknown Facility

Eugene, Oregon, United States

Location

Unknown Facility

State College, Pennsylvania, United States

Location

Unknown Facility

Charleston, South Carolina, United States

Location

Unknown Facility

Dallas, Texas, United States

Location

Unknown Facility

Sandy City, Utah, United States

Location

Unknown Facility

Edmonds, Washington, United States

Location

MeSH Terms

Conditions

Intervertebral disc disease

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 4, 2013

First Posted

September 13, 2013

Study Start

September 1, 2013

Primary Completion

November 1, 2015

Study Completion

August 1, 2017

Last Updated

March 23, 2023

Record last verified: 2023-03

Locations

US(32)