Tapentadol in Chronic Malignant Tumour Related Pain
Condition: Cancer; Chronic Pain; Pain
MeSH terms: Neoplasms; Chronic Pain; Cancer Pain
Intervention: Tapentadol Prolonged Release
Intervention description: Titration to achieve sufficient pain relief to continue with effective analgesia for as long as the participant tolerates and wishes to continue treatment.
Intervention MeSH terms: Tapentadol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 31.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: analgesia; analgesics; chronic pain; tumour related pain; chronic malignant tumor-related 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.
    

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.