At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 287 enrolled
Drug / intervention
Traumeel® / Zeel® Injectable Solution +1 moredrug
Likely dose
Traumeel® / Zeel® Injectable Solution 4.2 mLfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating Traumeel® / Zeel® Injectable Solution and Placebo for Osteoarthritis, Knee. Completed, enrolled 287 participants across 30 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOsteoarthritis, Knee
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
Enrollment StartJun 2013
First PostedJun 2013
Primary CompletionJan 2014
TodayJul 2026
First PostedJun 27, 2013
Enrollment StartJun 1, 2013
Primary CompletionJan 1, 2014
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 13.0 years ago
Interventions
Traumeel® / Zeel® Injectable Solutiondrug
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.
Placebodrug
Placebo is an injection of Saline