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 dolor crónico severo no controlado debido a artrosis de rodilla 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 enrollmentJune 3, 2009

Overview

No summary available.

Registry

who.int

Start Date

June 3, 2009

End Date

September 2, 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) \- at the Screening Visit
•Subjects must be at least 40 years of age.
•Subjects must have a diagnosis of osteoarthritis of the knee based on the American College of Rheumatology (ACR) classification criteria:
•Knee pain and Radiographic osteophytes or Knee pain and Aged 40 years or above, and Morning stiffness of 30 minutes of duration or more, and Crepitus on motion.
•Subjects must have pain at the reference joint which has been present for at least 3 months.
•Subject?s pain must require a strong analgesic (defined as WHO Step III) as judged by the Investigator.

•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 thereof in the Investigator?s judgment.
•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.