An evaluation of the effectiveness and tolerability of tapentadol hydrochloride prolonged release, and tapentadol hydrochloride immediate release on demand, in subjects with uncontrolled severe chronic nociceptive, mixed or neuropathic low back pain taking either WHO Step I or Step II analgesics or no regular analgesics.

Conditions: ow back Pain
MedDRA version: 9.1Level: LLTClassification code 10024891Term: Low back pain

Registration Number: EUCTR2009-010427-12-PL

Lead Sponsor: Grünenthal GmbH

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 180

Inclusion Criteria

Key inclusion criteria (general)
Subjects have signed an Informed Consent Form indicating that they understand the purpose of and the 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 report a rate of satisfaction with their previous analgesic regimen not exceeding fair” on a subject satisfaction with treatment scale (5-point VRS).
If under regular, daily pretreatment:
Subjects must be taking a WHO Step I or Step II analgesic medication on a daily basis for at least 2 weeks prior to the Screening Visit.
The Investigator considers dose increase of WHO Step I analgesics (as mono- or combination therapy) and/or continuation with or dose increase of WHO Step II analgesics inadequate for the individual subject, whatever applicable.
Subjects must have an average pain intensity score (NRS 3) greater than 5 points during the last 3 days prior to the Screening Visit.
or
If no regular analgesic pretreatment is reported:
Subjects must have an average pain intensity score (NRS-3) greater than 6 points in the last 3 days prior to the Screening Visit and related to low back pain.

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

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 or history of HIV infection within the past 3 months.
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 conditions other than low back pain that could confound the assessment or self evaluation of pain, e.g., anatomical deformities, significant skin conditions such as abscess or syndromes with widespread pain such as fibromyalgia.
Any concomitant painful condition that could interfere with the subject’s trial assessments or with their ability to differentiate low back pain from other painful conditions.
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.
Intake of Step III analgesics within the 30 days prior to the Screening Visit.