Efficacy, safety, and tolerability of GRT6005 in subjects with moderate to severe chronic low back pai

Conditions: moderate to severe chronic low back pain
MedDRA version: 16.1Level: LLTClassification code 10024891Term: Low back painSystem Organ Class: 100000004859
Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Registration Number: EUCTR2012-001920-36-DE

Lead Sponsor: Grünenthal GmbH

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 600

Inclusion Criteria

• Male or female subject 18 years to 80 years of age at Visit 1.
• Documented clinical diagnosis of chronic LBP of non-malignant origin and pain present for at least 3 months.
• Average 24 hour pain =5 on an 11 point NRS during the 3 days prior to Visit 3 without the use of rescue medication. Subjects must have 3 out of three 24 hour pain assessments during this 3 day period.
• Subjects must be on stable analgesic medications (non-opioid and/or opioid medications) for their chronic LBP with regular intake (i.e., at least 4 days per week) for at least 3 months prior to Visit 1 according to their medical history and dissatisfied with current analgesic treatment.
• Subjects requiring opioid treatment must be taking daily doses of opioid-based analgesic equivalent to =160 mg of oral morphine.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 480
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 120

Exclusion Criteria

• Female subjects who are pregnant or are breastfeeding.
• Any clinically significant disease or laboratory findings that in the
investigator's opinion may affect efficacy or safety assessments or may compromise the subject's safety during trial participation
• Subjects with moderate to severe functional hepatic impairment corresponding to Child-Pugh classification B and C. Subjects with impaired hepatic cellular integrity.
• History of acute hepatitis within 3 months of Visit 1 or chronic hepatitis or a positive result on anti-hepatitis A IgM antibody within 6 months of Visit 1, hepatitis B surface antigen, or anti–hepatitis C antibody. History of human immunodeficiency virus (HIV) infection.
• Subjects with impaired renal function.
• History of any major gastrointestinal prior procedures or
gastrointestinal conditions that might affect the absorption or
metabolism of GRT6005.
• Presence of risk factors for Torsade de Pointes
• Presence of QTcF >450 ms at Visit 1.
• History of seizure disorder and/or epilepsy or any condition associated with a significant risk for seizure disorder or epilepsy
• History or presence of malignancy, with the exception of curative
treated subjects or subjects being in remission of cancer for at least 2 years and not requiring treatment.
• Subjects with chronic LBP potentially associated with a specific spinal cause
• Subjects with >1 previous low back surgeries or recent low-back
surgery (within the last 12 months) or scheduled low back surgery
during the trial or any other scheduled surgery or painful procedure during the course of the trial that, in the opinion of the investigator, may affect efficacy or safety assessments.
• Any invasive procedures aimed to reduce LBP (e.g., epidural injections, facet joint or sacroiliac joint blocks) within the past 3 months and throughout the trial.
• Subjects with any kind of neuromodulation
• Clinically relevant history of hypersensitivity, allergy or
contraindications to any of the IMPs' excipients,
paracetamol/acetaminophen, tapentadol HCl, or opioid analgesics (or excipients).
• Presence of conditions other than LBP that could confound the
assessment or self-evaluation of pain.
• Increased intracranial pressure, caused e.g., by severe traumatic brain injury or ischemic brain injury.
• Subjects with significant respiratory depression, with acute or severe bronchial asthma or hypercapnia, and suspected or diagnosed sleep apnea.
• Presence or suspicion of paralytic ileus.