Study of Intra-articular Injections vs Placebo in Patients With Pain From Osteoarthritis of the Knee

Summary

The aim of this study is to evaluate the effectiveness and safety of a combined Traumeel® / Zeel® injection against placebo (saline) in patients with moderate-to-severe pain associated with osteoarthritis of the knee.

Conditions

• Osteoarthritis, Knee

Interventions

DRUG

Traumeel® / Zeel® Injectable Solution

Injection volume is 4.2 mL for active study medication (2.0 mL Zeel plus 2.2 mL Traumeel in one IA injection) on treatment days 1, 8 and 15.

DRUG

Placebo

Placebo is an injection of Saline

Sponsors & Collaborators

• Biologische Heilmittel Heel GmbH

  lead INDUSTRY

Principal Investigators

• Nebojsa Skrepnik, MD · Tucson Orthopaedic Institute

• Royal Anspach, MD · Clinical Research Advantage - Arizona II

• Hans Barthel, MD · Hans Richard Barthel, M.D., Inc.

• Shariar Cohen-Gadol, MD · Westlake Medical Research

• David Bolshoun, MD · Radiant Research Inc. - Denver

• Linda Murray, DO · Radiant Research Inc

• Susan Hole, DO · Riverside Clinical Research

• Agustin Latorre, MD · AppleMed Research, Inc.

• Richard Radnovich, DO · Injury Care Medical Center

• Moges Sisay, MD · Global Scientific Innovations

• Larkin T Wadsworth, MD · Sundance Clinical Research, LLC

• Kurian Abraham, MD · New Hope Clinical Research

• Rakesh Patel, MD · PMG Research of Salisbury

• George Raad, MD · PMG Research of Charlotte

• Martin VanCleeff, MD · PMG Cary Medical Research

• John Rubino, MD · PMG Research of Raleigh

• Howard R Adelglass, MD · Research Across America - NY

• Louis Re, MD · Manhattan Medical Research

• Daniel Whitmer, MD · Clinical Inquest Center Ltd.

• Jeffrey Klein, MD · Radiant Research Inc. - Akron

• Rakesh Davit, MD · Sterling Research Group, Ltd.

• Glenn Smith, DO · Hillcrest Clinical Research

• Shawn Saylor, DO · Blair Orthopedic Associates, Inc

• Alex Slandzicki, MD · Clinical Research Solutions

• Sadia Dar, MD · Clinical Research Solutions

• Rickey Manning, MD · PMG Research of Knoxville

• Paul Wakefield, MD · PMG Research of Knoxville

• Michael R Adams, MD · Radiant Research Inc. - Salt Lake City

• Teresa Sligh, MD · Providence Clinical Research

• David. Cardona, MD · Universal BioPharma Research Inc.

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

45 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-06-30

Primary Completion

2014-01-31

Completion

2014-01-31

Countries

• United States

Study Locations