NCT00449696

Brief Summary

The purpose of this study is to determine if a single intra-articular injection of Gel-200 is superior to a single injection of Phosphate Buffered Saline (PBS) in subjects with symptomatic osteoarthritis of the knee.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
379

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Sep 2006

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

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, 2006

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

March 20, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 21, 2007

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
3.8 years until next milestone

Results Posted

Study results publicly available

September 15, 2011

Completed
Last Updated

October 7, 2011

Status Verified

October 1, 2011

Enrollment Period

1.2 years

First QC Date

March 20, 2007

Results QC Date

April 15, 2011

Last Update Submit

October 3, 2011

Conditions

Osteoarthritis of the Knee

Outcome Measures

Primary Outcomes (1)

  • Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Visual Analog Scale (VAS) Pain Subscore

    Observed WOMAC pain subscore on VAS of 100 mm; 0 mm meaning no pain; 100 mm meaning extreme pain. Change in score from baseline to week 13 was calculated as baseline minus week 13. Primary endpoint was the model estimated difference between Gel-200 and PBS placebo.

    Baseline and Week 13

Secondary Outcomes (8)

  • Change From Baseline in WOMAC VAS Stiffness Subscore

    Baseline and Week 13

  • Change From Baseline in WOMAC VAS Physical Function Subscore

    Baseline and Week 13

  • Change From Baseline in WOMAC VAS Total Score

    Baseline and Week 13

  • Outcome Measures in Rheumatology Arthritis Clinical Trials (OMERACT)- and the Osteoarthritis Research Society International (OARSI) Response

    Weeks 6 to 13

  • Change From Baseline in Short Form - 36 (SF-36)

    Baseline and Week 13

  • +3 more secondary outcomes

Study Arms (2)

Gel-200

EXPERIMENTAL
Device: Gel-200

PBS

PLACEBO COMPARATOR
Device: Placebo

Interventions

Gel-200DEVICE

Single intra-articular injection

Gel-200
PlaceboDEVICE

Single intra-articular injection

PBS

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects with a diagnosis of painful, symptomatic tibio-femoral osteoarthritis of the knee (Grade 1-3 on Kellgren - Lawrence (K-L) score).

You may not qualify if:

  • Subjects with Grade 4 on K-L score
  • Subjects with inflammatory diseases of the knee other than osteoarthritis such as rheumatoid arthritis
  • Serious systemic diseases
  • Female subjects who are pregnant or lactating

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SKK

Plantation, Florida, 33324, United States

Location

Related Publications (3)

  • Takamura J, Seo T, Strand V. A Pooled Analysis of Two Multicenter, Randomized Controlled Trials of a Single Intra-articular Injection of Gel-200 for Treatment of Osteoarthritis of the Knee. Clin Med Insights Arthritis Musculoskelet Disord. 2018 May 9;11:1179544118773068. doi: 10.1177/1179544118773068. eCollection 2018.

    PMID: 29780263DERIVED

  • Strand V, Lim S, Takamura J. Evidence for safety of retreatment with a single intra-articular injection of Gel-200 for treatment of osteoarthritis of the knee from the double-blind pivotal and open-label retreatment clinical trials. BMC Musculoskelet Disord. 2016 Jun 1;17:240. doi: 10.1186/s12891-016-1101-0.

    PMID: 27250845DERIVED

  • Strand V, Baraf HSB, Lavin PT, Lim S, Hosokawa H. A multicenter, randomized controlled trial comparing a single intra-articular injection of Gel-200, a new cross-linked formulation of hyaluronic acid, to phosphate buffered saline for treatment of osteoarthritis of the knee. Osteoarthritis Cartilage. 2012 May;20(5):350-356. doi: 10.1016/j.joca.2012.01.013. Epub 2012 Feb 1.

    PMID: 22342928DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Results Point of Contact

Title
Clinical Development Dept.
Organization
Seikagaku Corporation
hiroyuki.hosokawa@seikagaku.co.jp
81-3-5220-8950

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

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

Study Record Dates

First Submitted

March 20, 2007

First Posted

March 21, 2007

Study Start

September 1, 2006

Primary Completion

December 1, 2007

Study Completion

December 1, 2007

Last Updated

October 7, 2011

Results First Posted

September 15, 2011

Record last verified: 2011-10

Locations

US(1)