This trial is completed!
Search for a recruiting clinical trial for your condition
Your journey
1What's a trial
4Get in touch
More info
You can access this
clinical trial
if you have
Low Back Pain
and you are
between 18 and 80
years old
This is a second phase trial assessing
efficacy and side effects of the new treatment.
Show me locations

The purpose

The purpose of this trial is to evaluate the safety and efficacy of once daily orally administered GRT6005 in a total of 3 fixed doses compared to placebo in subjects with moderate to severe chronic Low Back Pain (LBP). The study includes a maximum of 21 days screening period followed by a 2-week titration period and 12-week maintenance double-blind treatment period and a 10-14 day safety follow up period. Patients who are eligible for the double-blind treatment period will be randomized to one of the following treatment groups: GRT6005 low-dose, GRT6005 medium dose, GRT6005 high-dose, Tapentadol or placebo.

Provided treatments

  • Drug: Matching Placebo
  • Drug: Low Dose GRT6005
  • Drug: Medium Dose GRT6005
  • Drug: High Dose GRT6005
  • Drug: Tapentadol

Locations near you

Unfortunately, there are no recruiting locations near you. Please check the list with all locations below.
Tris trial is registered with FDA with number: NCT01725087. The sponsor of the trial is Grünenthal GmbH and it is looking for 1089 volunteers for the current phase.
Official trial title:
Efficacy, Safety, and Tolerability of GRT6005 in Subjects With Moderate to Severe Chronic Low Back Pain.