Tapentadol in Chronic Malignant Tumour Related Pain

NCT ID: NCT01264887

Last Updated: 2019-11-04

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-03-31
• Study Completion Date: 2014-05-31

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 the United States the prolonged-release formulation is also referred to as the extended-release formulation.

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 KF5503/15 trial (i.e., within 7 days of Visit 8 of the KF5503/15 trial) is scheduled: a Transfer Visit, an Open-label Treatment Period and a Follow-up Period.

For participants with 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 the following is scheduled: 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 prolonged release (PR).

The protocol scheduled visits every 28 days during the open-label treatment period. Unscheduled visits (or at least unscheduled telephone calls) were planned when dose adjustment is required. If a visit is not possible at the time of dose change, it could be done up to 7 days later. Unscheduled visits could also be performed whenever considered necessary (i.e., for evaluation of adverse events).

Conditions

Cancer; Chronic Pain; Pain

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Tapentadol Prolonged Release

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).

Group Type: EXPERIMENTAL

Tapentadol Prolonged Release

Intervention Type: DRUG

Titration to achieve sufficient pain relief to continue with effective analgesia for as long as the participant tolerates and wishes to continue treatment.

Interventions

Tapentadol Prolonged Release

Titration to achieve sufficient pain relief to continue with effective analgesia for as long as the participant tolerates and wishes to continue treatment.

Intervention Type: DRUG

Other Intervention Names

Nucynta®; Palexia®; Yantil®

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Grünenthal GmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hans-Georg Kress, Prof. Dr. med

Role: PRINCIPAL_INVESTIGATOR

General Hospital Vienna

Locations

Site 359004

Shumen, , Bulgaria

Site 036002

Nyíregyháza, , Hungary

Site 036010

Szekszárd, , Hungary

Site 373001

Chisinau, , Moldova

Site 048004

Bydgoszcz, , Poland

Site 048001

Warsaw, , Poland

Site 040006

Brasov, , Romania

Site 040002

Bucharest, , Romania

Site 007007

Nizhny Novgorod, , Russia

Site 007012

Vladikavkaz, , Russia

Site 381001

Kamenitz, , Serbia

Site 381002

Niš, , Serbia

Countries

Bulgaria; Hungary; Moldova; Poland; Romania; Russia; Serbia

Other Identifiers

2009-013291-46

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

168935

Identifier Type: OTHER

Identifier Source: secondary_id

KF5503/52

Identifier Type: -

Identifier Source: org_study_id