NCT01887678

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

Multi-center Double-blind Randomized Controlled Trial to Evaluate Effectiveness and Safety of Co-administered Traumeel® / Zeel® Intra-articular Injections vs Placebo in Patients With Moderate-to-Severe Pain With Osteoarthritis of the Knee

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 287 (actual)
• Sponsor: Biologische Heilmittel Heel GmbH · Industry
• Sex: All
• Age: 45 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The primary objective is to demonstrate the superiority of Traumeel® and Zeel® co-administered intra-articular (IA) injections vs placebo IA injections on the change in knee pain in patients with moderate to severe knee pain associated with osteoarthritis. The secondary objectives are to evaluate reduction of pain and stiffness and change in physical function. Safety is evaluated by the incidence of treatment emergent adverse events during the treatment period and follow up period for all randomized patients.

Conditions

• Osteoarthritis, Knee

Interventions

Type	Name	Description
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

Timeline

• Start date: 2013-06-01
• Primary completion: 2014-01-01
• Completion: 2014-01-01
• First posted: 2013-06-27
• Last updated: 2018-04-02
• Results posted: 2015-03-20

Locations

30 sites across 1 country: United States