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

This study has been completed.
Sponsor:
Collaborator:
Forest Laboratories
Information provided by (Responsible Party):
Grünenthal GmbH
ClinicalTrials.gov Identifier:
NCT01725087
First received: November 8, 2012
Last updated: April 17, 2014
Last verified: April 2014
  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.


Condition Intervention Phase
Low Back Pain
Drug: Matching Placebo
Drug: Low Dose GRT6005
Drug: Medium Dose GRT6005
Drug: High Dose GRT6005
Drug: Tapentadol
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy, Safety, and Tolerability of GRT6005 in Subjects With Moderate to Severe Chronic Low Back Pain.

Resource links provided by NLM:


Further study details as provided by Grünenthal GmbH:

Primary Outcome Measures:
  • European Union: the change from baseline pain to the weekly average 24-hour pain during the entire 12 weeks of the maintenance phase of the double-blind Treatment Period. [ Time Frame: Baseline to End of Treatment (Week 14) ] [ Designated as safety issue: No ]
  • United States: the change from baseline pain to the average 24-hour pain during Week 12 of the maintenance phase. [ Time Frame: Baseline to End of Treatment (Week 14) ] [ Designated as safety issue: No ]

Enrollment: 1089
Study Start Date: November 2012
Study Completion Date: March 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Matching Placebo
Twice daily oral administration of matching placebo for 14 weeks
Drug: Matching Placebo
Experimental: Low Dose GRT6005
Once daily GRT6005 low dose oral administration for 12 weeks with a titration period of 2 weeks.
Drug: Low Dose GRT6005
Experimental: Medium Dose GRT6005
Once daily GRT6005 medium dose oral administration for 12 weeks with a titration period of 2 weeks.
Drug: Medium Dose GRT6005
Experimental: High Dose GRT6005
Once daily GRT6005 high dose oral administration for 12 weeks with a titration period of 2 weeks.
Drug: High Dose GRT6005
Active Comparator: Tapentadol
Twice daily oral administration of Tapentadol for 12 weeks with a titration period of 2 weeks.
Drug: Tapentadol

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Chronic Low Back Pain of non-malignant origin and present for at least 3 months.
  • Signed informed consent.
  • Pain intensity score of 5 or greater on the 11-point numeric rating scale (where 0 indicates "no pain" and 10 indicates "as bad as you can imagine").
  • On stable analgesic medications (non-opioid and/or opioid medications) for chronic low back pain with regular intake for at least 3 months and dissatisfied with current analgesic treatment.

Exclusion Criteria:

  • Female subjects who are pregnant or are breastfeeding.
  • Presence of risk factors for Torsade de Pointes.
  • Any clinically significant disease or laboratory findings that may affect efficacy or safety assessments or may compromise the safety during trial participation, e.g., significant unstable cardiac, vascular, pulmonary, gastrointestinal, endocrine, metabolic, neurological, or psychiatric disorders.
  • History of acute hepatitis within the past 3 months or chronic hepatitis or a positive result on anti-hepatitis A antibody, hepatitis B surface antigen, or anti-hepatitis C antibody. History of human immunodeficiency virus (HIV) infection.
  • History of seizure disorder.
  • Chronic low back pain potentially associated with a specific spinal cause.
  • Surgery or painful procedure during or within 3 months of enrollment.
  • Conditions that contribute and confound the assessment of pain.
  • Subjects with impaired renal function.
  • Subjects with impaired hepatic functionality.
  • Neuromodulation.
  • Cancer.
  • Clinically relevant history of hypersensitivity, allergy or contraindications to any of the Investigational Medicinal Products' excipients, paracetamol/acetaminophen, tapentadol Hydrochloride, or opioid analgesics (or excipients).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01725087

  Show 79 Study Locations
Sponsors and Collaborators
Grünenthal GmbH
Forest Laboratories
Investigators
Study Chair: Study Director Grünenthal GmbH
  More Information

No publications provided

Responsible Party: Grünenthal GmbH
ClinicalTrials.gov Identifier: NCT01725087     History of Changes
Other Study ID Numbers: KF6005/06, 2012‐001920‐36
Study First Received: November 8, 2012
Last Updated: April 17, 2014
Health Authority: Denmark: Danish Health and Medicines Authority
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Austria: Agency for Health and Food Safety
Belgium: Federal Agency for Medicinal Products and Health Products
Germany: Federal Institute for Drugs and Medical Devices
Spain: Spanish Agency of Medicines
Hungary: National Institute of Pharmacy
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Sweden: Medical Products Agency
Finland: Finnish Medicines Agency

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on August 18, 2014