Tapentadol in Chronic Malignant Tumour Related Pain

• Status: Terminated
• Trial end date: 2014-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Grünenthal GmbH
• Treatments: Tapentadol

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.