Evaluación de la efectividad y la tolerabilidad de clorhidrato de tapentadol de liberación prolongada y de clorhidrato de tapentadol de liberación inmediata a demanda en pacientes con lumbalgia crónica severa no controlada de origen nociceptivo, neuropático o mixto no tratados con regularidad o en tratamiento con analgésicos de los Escalones I o II de la clasificación de la OMS

Grünenthal GmbH0 sites0 target enrollmentJuly 29, 2009

Overview

No summary available.

Registry

who.int

Start Date

July 29, 2009

End Date

July 6, 2010

Last Updated

7 years ago

Study Type

Interventional clinical trial of medicinal product

Sponsor

•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).

•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.
•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.
•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.