Evaluation of the effectiveness, safety, and tolerability of tapentadol PR versus a combination of tapentadol PR and pregabalin in subjects with severe chronic low back pain with a neuropathic pain component

Grünenthal GmbH0 sites800 target enrollmentDecember 22, 2010

Overview

No summary available.

Registry

who.int

Start Date

December 22, 2010

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•Key inclusion criteria (general) at the Enrollment Visit
•1\. 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.
•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\. 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, contraceptive patch, male partner sterilization) before entry and throughout the trial.
•5\. Subjects must be appropriately communicative and able to differentiate with regard to location and intensity of the pain, and to complete the questionnaires used in this trial.
•Key inclusion criteria (trial specific) at the Enrollment Visit
•6\. Subjects must have a diagnosis of chronic low back pain; chronic pain defined as pain lasting for at least 3 months.
•7\. Subject’s pain must require a strong analgesic (defined as WHO step III) as judged by the Investigator.
•8\. The painDETECT diagnostic screening questionnaire score must be:

•Key exclusion criteria (general) at the Enrollment Visit
•Any of the following will exclude subjects from the trial:
•1\. Presence of a clinically significant disease or laboratory findings that in the Investigator’s opinion may affect efficacy or safety assessments.
•2\. 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.
•3\. History of alcohol or drug abuse, or suspicion thereof in the Investigator’s judgment.
•4\. Presence of concomitant autoimmune inflammatory conditions.
•5\. Moderate renal impairment (creatinine clearance \<60 mL/min).
•6\. Known history of or laboratory values reflecting current moderately or severely impaired hepatic function.
•7\. History of seizure disorder or epilepsy.
•8\. Any of the following within 1 year of enrollment: mild/moderate traumatic brain injury, stroke, transient ischemic attack, or brain neoplasm. Severe traumatic brain injury within 15 years of enrollment (consisting of 1 or more of the following: brain contusion, intracranial hematoma, either unconsciousness or post traumatic amnesia lasting more than 24 hours) or residual sequelae suggesting transient changes