ActaVisc and ActaVisc Mx Intra-articular Injection for Pain Associated With Osteoarthritis in the Knee

NCT ID: NCT00665574

Last Updated: 2009-07-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-31

Study Completion Date

2009-06-30

Brief Summary

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To evaluate the safety and performance of ActaVisc™ intra-articular injection (ActaVisc) and ActaVisc Mx, for management of pain associated with osteoarthritis in the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy and simple analgesics

Detailed Description

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Conditions

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Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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1

ActaVisc

Group Type EXPERIMENTAL

ActaVisc and ActaVisc Mx Intra-articular Injection

Intervention Type OTHER

ActaVisc is a hyaluronan based device intended to alleviate the pain associated with osteoarthritis of the knee with a single injection and ActaVisc Mx is the same material combined with a corticosteroid.

2

ActaVisc Mx Intra-articular Injection

Group Type EXPERIMENTAL

ActaVisc and ActaVisc Mx Intra-articular Injection

Intervention Type OTHER

ActaVisc is a hyaluronan based device intended to alleviate the pain associated with osteoarthritis of the knee with a single injection and ActaVisc Mx is the same material combined with a corticosteroid.

3

Saline

Group Type PLACEBO_COMPARATOR

ActaVisc and ActaVisc Mx Intra-articular Injection

Intervention Type OTHER

ActaVisc is a hyaluronan based device intended to alleviate the pain associated with osteoarthritis of the knee with a single injection and ActaVisc Mx is the same material combined with a corticosteroid.

4

Corticosteroid

Group Type ACTIVE_COMPARATOR

ActaVisc and ActaVisc Mx Intra-articular Injection

Intervention Type OTHER

ActaVisc is a hyaluronan based device intended to alleviate the pain associated with osteoarthritis of the knee with a single injection and ActaVisc Mx is the same material combined with a corticosteroid.

Interventions

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ActaVisc and ActaVisc Mx Intra-articular Injection

ActaVisc is a hyaluronan based device intended to alleviate the pain associated with osteoarthritis of the knee with a single injection and ActaVisc Mx is the same material combined with a corticosteroid.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Osteoarthritis (OA) grade 2 or 3.
* Symptoms in the treatment knee for at least 12 months.
* Fully ambulatory patient.

Exclusion Criteria

* Secondary OA resulting from rheumatoid arthritis, chondrocalcinosis, osteonecrosis, chronic fibromyalgia or other autoimmune disease.
* Generalized symptomatic OA in lower extremity joints other than the knees, inflammatory joint disease, bursitis, OA in the hips, or other condition that may interfere with study assessments.
Minimum Eligible Age

40 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Carbylan Therapeutics, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Carbylan BioSurgery, Inc.

Locations

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Daugavpils Pilsetas Centrala Slimnica

Daugavpils, , Latvia

Site Status

State Hospital of Traumatology and Orthopaedics

Riga, , Latvia

Site Status

Countries

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Latvia

Other Identifiers

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AIM 1.0

Identifier Type: -

Identifier Source: org_study_id

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