Low Back Pain
Conditions
Brief 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.
Interventions
Sponsors
Forest Laboratories
Tris Pharma, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | Baseline to End of Treatment (Week 14) |
| United States: the change from baseline pain to the average 24-hour pain during Week 12 of the maintenance phase. | Baseline to End of Treatment (Week 14) |
Countries
Austria, Belgium, Denmark, Finland, Germany, Hungary, Netherlands, Poland, Spain, Sweden, United Kingdom
Outcome results
None listed