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More info
You can access this
clinical trial
if you have
Low Back Pain
and you are
between 18 and 80
years old
2
This is a second phase trial assessing
efficacy and side effects of the new treatment.
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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.