Status:
TERMINATED
Tapentadol in Chronic Malignant Tumour Related Pain
Lead Sponsor:
Grünenthal GmbH
Conditions:
Cancer
Chronic Pain
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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...
Detailed Description
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 KF5...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2014
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT01264887
Start Date
March 1 2011
End Date
May 1 2014
Last Update
November 4 2019
Active Locations (12)
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1
Site 359004
Shumen, Bulgaria, 9700
2
Site 036002
Nyíregyháza, Hungary, 4412
3
Site 036010
Szekszárd, Hungary, 7100
4
Site 373001
Chisinau, Moldova, 2025