MedDataX Logo

Gel-200 Versus Placebo in Osteoarthritis of the Knee

NCT ID: NCT00449696

Last Updated: 2011-10-07

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

379 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-30

Study Completion Date

2007-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Osteoarthritis of the Knee

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Gel-200

Group Type EXPERIMENTAL

Gel-200

Intervention Type DEVICE

Single intra-articular injection

PBS

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DEVICE

Single intra-articular injection

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Gel-200

Single intra-articular injection

Intervention Type DEVICE

Placebo

Single intra-articular injection

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

* 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
Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Seikagaku Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Seikagaku Corporation

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

SKK

Plantation, Florida, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 29780263 (View on PubMed)

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.

Reference Type DERIVED
PMID: 27250845 (View on PubMed)

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.

Reference Type DERIVED
PMID: 22342928 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

SI-6606/01

Identifier Type: -

Identifier Source: org_study_id