NCT01725087

Efficacy and Safety of GRT6005 in Patients With Chronic Low Back Pain.

Efficacy, Safety, and Tolerability of GRT6005 in Subjects With Moderate to Severe Chronic Low Back Pain.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 1,089 (actual)
• Sponsor: Tris Pharma, Inc. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Low Back Pain

Interventions

Type	Name	Description
DRUG	Matching Placebo
DRUG	Low Dose GRT6005
DRUG	Medium Dose GRT6005
DRUG	High Dose GRT6005
DRUG	Tapentadol

Timeline

• Start date: 2012-11-01
• Primary completion: 2014-07-01
• Completion: 2014-07-01
• First posted: 2012-11-12
• Last updated: 2021-07-15

Locations

79 sites across 11 countries: Austria, Belgium, Denmark, Finland, Germany, Hungary, Netherlands, Poland, Spain, Sweden, United Kingdom