Evaluation of the effectiveness, safety, and tolerability of tapentadol PRversus oxycodone/naloxone PR in non-opioid pre-treated subjects withuncontrolled severe chronic low back pain with a neuropathic paincomponent.

Grünenthal GmbH0 个研究点目标入组 240 人开始时间: 2013年1月28日最近更新: 2013年11月26日

试验速览

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•1. Informed consent signed. 2. Male or female subject 18 years of age.3. Women of childbearing potential must have a negative pregnancy test at the Enrollment Visit. 4. Women of childbearing potential must practice medically acceptable methods of birth control during the trial. 5. Subjects must be appropriately communicative and able to differentiate with regard to location and intensity of the 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 240
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 240

•1. Presence of a clinically significant disease or clinical laboratory
•values that in the investigator's opinion may affect effectiveness, quality of life, or safety/tolerability assessments 2. Presences of active systemic or local infections that may, in the opinion of the investigator, affect the effectiveness, quality of life, or safety/tolerability assessments. 3. 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. 4. Participation in another trial concurrently, or within 4 weeks prior to the
•Enrollment Visit. 5. Known to or suspected of not being able to comply with the protocol and/or appropriate use of the IMPs. 6. Any painful procedures (e.g., major surgery) scheduled during the trial duration (Enrollment Visit until Final Evaluation Visit) that may, in the opinion of the investigator, affect the effectiveness, quality of life, or safety assessments

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