Clinical trial · Interventional
Tapentadol in Chronic Malignant Tumour Related Pain
Open-label, Single-arm, Flexible Dosing, Phase III Trial, With Oral Tapentadol Prolonged Release (PR) in Subjects With Chronic Malignant Tumor-related Pain Who Have Completed the Maintenance Period of the KF5503/15 Trial.
NCT01264887CI-TRIAL-00041427terminatedPhase 3Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Administrative reasons
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Chronic Pain | — | UNRESOLVED | — |
| Pain | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Tapentadol Prolonged Release | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Tapentadol Prolonged Release
- description
- Participants allocated to this treatment arm can be flexibly dosed between 100 to 250 mg tapentadol twice daily (50 and 100 mg tablets to be dispensed).
- interventionNames
- Drug: Tapentadol Prolonged Release
Primary outcomes (4)
- measure
- Severity of Adverse Events
- timeFrame
- Day 1; up to 144 weeks
- description
- The severity of treatment emergent adverse events was any untoward medical occurrence in a patient administered tapentadol. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of the (investigational) medicinal product whether or not related to the use of tapentadol. The clinical "intensity" of adverse event were classified as: Mild: signs and symptoms which can be easily tolerated. Symptoms could be ignored and disappeared when the participant is distracted. Moderate: symptoms caused discomfort but were tolerable, they could not be ignored and affect concentration. Severe: symptoms affected the usual daily activity.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.