tapentadol in chronic malignant tumour related pain

Conditions: Cancer; Chronic Pain; Pain

Summary: the purpose of this trial is the characterization of the long term safety profile and long-term dose requirements of tapentadol pr (prolonged release) in patients with malignant tumor-related pain. in the united states the prolonged-release formulation is also referred to as the extended-release formulation.

the prevalence of tumor-related pain is high and the treatment of chronic tumor-related pain remains a challenging therapeutic problem. participants directly entering the kf5503/52 trial from the kf5503/15 trial (i.e., within 7 days of visit 8 of the kf5503/15 trial) is scheduled: a transfer visit, an open-label treatment period and a follow-up period. for participants with a gap of more than 7 days and less than 24 weeks, between their full completion of the kf5503/15 trial and entry into the kf5503/52 trial the following is scheduled: an enrollment visit, an entry visit for assessment of eligibility, an open-label treatment period and a follow-up period. this trial was designed to offer patients with chronic malignant tumor-related pain the option of continuing treatment by receiving tapentadol prolonged release (pr). the protocol scheduled visits every 28 days during the open-label treatment period. unscheduled visits (or at least unscheduled telephone calls) were planned when dose adjustment is required. if a visit is not possible at the time of dose change, it could be done up to 7 days later. unscheduled visits could also be performed whenever considered necessary (i.e., for evaluation of adverse events).

Eligibility criteria:
inclusion criteria: * participants must have signed an informed consent form. * at least 18 years of age. * male and non-pregnant, non-lactating female subjects. sexually active women must be post menopausal, surgically sterile, or practicing an effective method of birth control before entry and throughout the trial. female participants of child-bearing potential must have a negative pregnancy test at enrollment. * within 24 weeks of either full completion or completion of the double-blind treatment period (visit 8) of kf5503/15 trial performed in participants with moderate to severe chronic malignant tumor related pain. * participant is, in the opinion of the investigator, expected to continue to have an overall positive benefit/risk ratio from continuing analgesic treatment within this trial. * participant must be willing to take tapentadol prolonged release (pr) throughout their participation in the trial. exclusion criteria: * history of alcohol and/or drug abuse. * the participant has a clinically significant disease other than cancer that in the investigator's opinion may affect the safety of the participant. * employees of the investigator or trial center or family members of the employees or the investigator. * known to or suspected of not being able to comply with the protocol and the use of tapentadol prolonged release (pr). * concurrent participation in another trial (except for participation in the kf5503/15 trial) or planning to be enrolled in another clinical trial during the course of this trial. * previous participation in another trial between the end of kf5503/15 and enrollment into the current trial, kf5503/52. * history of seizure disorder, epilepsy, traumatic brain injury, stroke or transient ischemic attack. * known history and/or presence of cerebral tumors or metastases. * rapidly escalating pain or pain uncontrolled by therapy and was previously treated with maximum dose level of investigational medicinal product. * participant is taking any prohibited concomitant medications. * uncontrolled hypertension. * known moderate or severe hepatic impairment. * known severe renal impairment. * clinically relevant history of hypersensitivity, allergy, or contraindications to tapentadol or its excipients.

Keywords: analgesia analgesics chronic pain tumour related pain chronic malignant tumor-related pain