Low back Pain MedDRA version: 9.1 Level: LLT Classification code 10024891 Term: Low back pain
Conditions
Interventions
Sponsors
Grünenthal GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects must have signed an Informed Consent Form indicating that they understand the purpose of and procedures required for the trial and are willing to participate in it. Subjects are men or non-pregnant, non-lactating women. Sexually active women must be postmenopausal, surgically sterile, or practicing an effective method of birth control (e.g., prescription oral contraceptives, contraceptive injections, intrauterine device, double barrier method, contraceptive patch, male partner sterilization) before entry and throughout the trial. Women of childbearing potential must have a negative pregnancy test at screening. Subjects must be appropriately communicative to verbalize and to differentiate with regard to location and intensity of the pain. Key inclusion criteria (trial specific) Subjects must be at least 18 years of age. Subjects must have a diagnosis of chronic low back pain; chronic pain defined as pain lasting for at least 3 months If the subject has radicular pain, this must have been present for at least 3 months and stable for the 4 weeks before enrollment. Subject’s pain must require a strong analgesic (defined as WHO Step III) as judged by the Investigator. Subjects must be taking a WHO Step III analgesic on a daily basis for at least 2 weeks prior to the Screening Visit. Subjects must have responded to the WHO Step III analgesic, i.e., subjects must have a confirmed average pain intensity score (NRS 3) of ?5 points during the last 3 days prior to the Screening Visit. Subjects must report opioid-related side effects as the reason to change their analgesic. Subjects must report a rate of satisfaction with their previous analgesic regimen not exceeding “fair” on a subject satisfaction with treatment scale (5-point VRS). 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Key exclusion criteria (general) Presence of a clinically significant disease or laboratory findings that in the Investigator’s opinion may affect efficacy or safety assessments. Presence of active systemic or local infection that may, in the opinion of the Investigator, affect the efficacy, quality of life/function or safety assessments. History of alcohol or drug abuse, or suspicion of in Investigator’s judgement. Presence of concomitant autoimmune inflammatory conditions. Known history of or laboratory values reflecting severe renal impairment. Known history of moderately or severely impaired hepatic function. History of or active hepatitis B or C within the past 3 months or history of HIV infection. History of seizure disorder or epilepsy. Any of the following within 1 year: mild/moderate traumatic brain injury, stroke, transient ischemic attack, or brain neoplasm. Severe traumatic brain injury within 15 years (consisting of 1 or more of the following: brain contusion, intracranial hematoma, either unconsciousness or post traumatic amnesia lasting more than 24 h) or residual sequelae suggesting transient changes in consciousness. Pregnant or breast-feeding. History of allergy to, or hypersensitivity to tapentadol hydrochloride or its excipients, or contraindications related to tapentadol hydrochloride including: Subjects with acute or severe bronchial asthma or hypercapnia. Subjects who have or are suspected of having paralytic ileus. Employees of the Investigator or trial site, with direct involvement in this trial or other trials under the direction of the Investigator or trial site, as well as family members of employees of the Investigator. Participation in another trial concurrently or within 4 weeks prior to the Screening Visit. Known to or suspected of not being able to comply with the protocol and the use of the IMPs. Use of monoamine oxidase inhibitors within 14 days before the Screening Visit. Non-stable dosing of selective serotonin reuptake inhibitors within 30 days before the Screening Visit (the doses must remain stable during the trial). Key exclusion criteria (trial specific) Presence of concomitant painful condition other than low back pain that could confound the subject’s trial assessments or self evaluation of pain, e.g., anatomical deformities, significant skin conditions such as abscess or syndromes with widespread pain such as fibromyalgia. Any painful procedures during the trial (e.g., major surgery) that may, in the opinion of the Investigator, affect the efficacy or safety assessments. Pending litigation due to chronic pain or disability.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluate the effectiveness, tolerability, and safety of tapentadol hydrochloride PR in subjects with severe chronic nociceptive, mixed or neuropathic low back pain who are taking WHO Step III analgesics and show lack of tolerability.;Secondary Objective: Evaluate equipotency ratios of tapentadol and WHO Step III analgesics calculated using morphine-equivalent doses. Evaluate the conversion of subjects from previous WHO Step III analgesics to tapentadol hydrochloride. Evaluate the titration of tapentadol hydrochloride PR in clinical practice. Evaluate the efficacy of tapentadol hydrochloride PR versus previous treatment for low back pain with mixed and neuropathic origins. Evaluate the efficacy of tapentadol hydrochloride PR versus previous treatment in subjects with nociceptive low back pain. Evaluate the efficacy of tapentadol hydrochloride PR in subjects with neuropathic or mixed versus nociceptive low back pain. Evaluate the impact of tapentadol hydrochloride PR on function and quality of life parameters (subject-reported outcomes) in subjects with low back pain. ;Primary end point(s): The primary endpoint is defined as responder rate 1, the percentage of subjects with the same or less pain (on the NRS-3) at Week 6 compared with Week -1. | — |
Countries
Belgium, Czech Republic, France, Germany, Netherlands, Spain
Outcome results
None listed