Tapentadol in Chronic Malignant Tumour Related

Condition(s) targeted: Cancer; Chronic Pain; Pain; Tumour Related Pain

Intervention: tapentadol prolonged release (extended release - depending on the region of the world) (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Grünenthal GmbH

Official(s) and/or principal investigator(s):
Hans-Georg Kress, Prof. Dr. med, Principal Investigator, Affiliation: General Hospital Vienna

Overall contact:
René Allard, Phone: +49 241 569 3223, Email: Clinical-Trials@grunenthal.com

The purpose of this trial is the characterization of the long term safety profile and long-term dose requirements of tapentadol ER in patients with malignant tumor-related pain.

Official title: Open-label, Single-arm, Flexible Dosing, Phase III Trial, With Oral Tapentadol PR in Subjects With Chronic Malignant Tumor-related Pain Who Have Completed the Maintenance Period of the KF5503/15 Trial.

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Number of subjects with Adverse Events as a measure of safety and tolerability

Secondary outcome: Assess consumption of tapentadol during long term use

Detailed description: The prevalence of tumor-related pain is high and the treatment of chronic tumor-related pain remains a challenging therapeutic problem.

This is a clinical trial with only 1 treatment group: tapentadol ER 100 mg to 250 mg twice daily.

For subjects who have directly entered the KF5503/52 trial from the KF5503/15 trial (i. e., within 7 days of Visit 8 of the KF5503/15 trial): a Transfer Visit, an Open-label Treatment Period and a Follow-up Period.

For subjects who have 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: 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 PR.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Subjects 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 subjects 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 subjects with moderate to severe chronic malignant tumor related pain.

- Subject 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.

- Subjects must be willing to take tapentadol PR throughout their participation in the

trial.

Exclusion Criteria:

- History of alcohol and/or drug abuse.

- The subject has a clinically significant disease other than cancer that in the

Investigator's opinion may affect the safety of the subject.

- 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 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 4) Investigational Medicinal Product dose.

- Subjects 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

mu-opioid receptor agonists.

René Allard, Phone: +49 241 569 3223, Email: Clinical-Trials@grunenthal.com

Investigator 2, Klagenfurt, Austria; Not yet recruiting

Investigator 1, Vienna, Austria; Not yet recruiting

Investigator 3, Gabrovo, Bulgaria; Not yet recruiting

Investigator 2, Pleven, Bulgaria; Not yet recruiting

Investigator 4, Plovdiv, Bulgaria; Not yet recruiting

Site 1, Shoumen, Bulgaria; Recruiting

Investigator 2, Osijek, Croatia; Not yet recruiting

Investigator 1, Zagreb, Croatia; Not yet recruiting

Investigator 1, Brno, Czech Republic; Not yet recruiting

Investigator 2, Hradec Kralove, Czech Republic; Not yet recruiting

Investigator 3, Liberec, Czech Republic; Not yet recruiting

Investigator 4, Olomouc, Czech Republic; Not yet recruiting

Investigator 1, Tarbes, France; Not yet recruiting

Investigator 4, Kecskemet, Hungary; Not yet recruiting

Investigator 2, Komarom, Hungary; Active, not recruiting

Investigator 1, Nyiregyhaza, Hungary; Recruiting

Investigator 3, Szekszard, Hungary; Active, not recruiting

Investigator 2, Bydgoszcz, Poland; Not yet recruiting

Investigator 1, Warszawa, Poland; Not yet recruiting

Investigator 4, Brasov, Romania; Not yet recruiting

Investigator 2, Bucharest, Romania; Recruiting

Investigator 3, Cluj-Napoca, Romania; Not yet recruiting

Investigator 1, Iasi, Romania; Not yet recruiting

Investigator 3, Arkhangelsk, Russian Federation; Not yet recruiting

Investigator 2, Nizhniy Novgorod, Russian Federation; Not yet recruiting

Investigator 1, Yaroslavl, Russian Federation; Not yet recruiting

Investigator 3, Belgrade, Serbia; Not yet recruiting

Investigator 2, Nis, Serbia; Not yet recruiting

Investigator 1, Sremska Kamenica, Serbia; Not yet recruiting

Investigator 2, Barcelona, Spain; Not yet recruiting

Investigator 3, Sabadell Barcelona, Spain; Not yet recruiting

Investigator 4, Sagunto Valencia, Spain; Not yet recruiting

Investigator 1, Sevilla, Spain; Not yet recruiting

Starting date: December 2010
Last updated: December 21, 2012