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

NCT01725087 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 1089

Last updated 2021-07-15

No results posted yet for this study

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

DRUG

Matching Placebo

DRUG

Low Dose GRT6005

DRUG

Medium Dose GRT6005

DRUG

High Dose GRT6005

DRUG

Tapentadol

Sponsors & Collaborators

  • Forest Laboratories

    collaborator INDUSTRY

  • Tris Pharma, Inc.

    lead INDUSTRY

Principal Investigators

  • Study Director · Grünenthal GmbH

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-11-30
Primary Completion
2014-07-31
Completion
2014-07-31

Countries

  • Austria
  • Belgium
  • Denmark
  • Finland
  • Germany
  • Hungary
  • Netherlands
  • Poland
  • Spain
  • Sweden
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01725087 on ClinicalTrials.gov