Tapentadol in Chronic Malignant Tumour Related Pain

NCT01264887 | Terminated Phase 3 Results

• 3 other identifiers: KF5503/522009-013291-46168935
• Study Type: interventional
• Target: 31
• Locations: 7 countries
• Sites: 12

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.

Conditions

Cancer; Chronic Pain; Pain

Keywords

analgesia; analgesics; chronic pain; tumour related pain; chronic malignant tumor-related pain

Outcome Measures

Primary Outcomes (4)

• Severity of Adverse Events

  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.

  Day 1; up to 144 weeks

• Relatedness Assessment of Treatment Emergent Adverse Events

  Participant-based analysis of treatment emergent adverse events (TEAEs) regarding the relationship to the study drug (tapentadol). The TEAEs were reported by the participants or were captured by the investigator. The relationship was rated by the investigator. The categorization of relatedness into one of the two categories was based on the following: Related included "possible", "probable/likely", and "certain"; whilst unrelated treatment emergent adverse events include those rated by the investigator as "unlikely", "conditional/unclassified", "un-assessable/unclassifiable", and "not related".

  Day 1; up to 144 weeks

• Countermeasures Taken Due to Treatment Emergent Adverse Events

  Participant-based analysis of treatment emergent adverse events (TEAEs) regarding countermeasure to the study drug (tapentadol). The TEAEs were reported by the participants or were captured by the investigator. The countermeasure taken by the investigator were reported.

  Day 1; up to 144 weeks

• Time Dependence of Adverse Events

  The onset and duration of TEAEs was not evaluated for this trial.

  Day 1; 144 weeks

Secondary Outcomes (2)

• Assess Consumption of Tapentadol During Long Term Use

  Day 1; up to 144 weeks

• Tapentadol Prolonged Release Exposure

  Day 1; up to 144 weeks

Other Outcomes (2)

• Average Pain Intensity (Over a Twelve-week Period)

  Day 1; up to Week 144

• Average Daily Total Tapentadol Prolonged Release Dose

  Day 1; up to 144 weeks

Study Arms (1)

Tapentadol Prolonged Release

EXPERIMENTAL

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).

Drug: Tapentadol Prolonged Release

Interventions

Tapentadol Prolonged Release DRUG

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

Also known as: Nucynta®, Palexia®, Yantil®

Tapentadol Prolonged Release

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Grünenthal GmbH: lead

Study Sites (12)

Site 359004

Shumen, 9700, Bulgaria

Location

Site 036002

Nyíregyháza, 4412, Hungary

Location

Site 036010

Szekszárd, 7100, Hungary

Location

Site 373001

Chisinau, 2025, Moldova

Location

Site 048004

Bydgoszcz, 85796, Poland

Location

Site 048001

Warsaw, 02781, Poland

Location

Site 040006

Brasov, 500074, Romania

Location

Site 040002

Bucharest, 022328, Romania

Location

Site 007007

Nizhny Novgorod, 603140, Russia

Location

Site 007012

Vladikavkaz, 362007, Russia

Location

Site 381001

Kamenitz, 21204, Serbia

Location

Site 381002

Niš, 18000, Serbia

Location

MeSH Terms

Conditions

Neoplasms; Chronic Pain; Pain; Agnosia

Interventions

Tapentadol

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Limitations and Caveats

The trial was stopped for administrative reasons. Three years after trial initiation 2 participants were in the trial and to permit analysis and reporting the sponsor decided to terminate the trial.

Results Point of Contact

• Title: Director Clinical Trials
• Organization: Grünenthal GmbH

clinical-trials@grunenthal.com

+49 241 569

Study Officials

• Hans-Georg Kress, Prof. Dr. med

  General Hospital Vienna

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2010
• First Posted: December 22, 2010
• Study Start: March 1, 2011
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: November 4, 2019
• Results First Posted: June 22, 2015

Record last verified: 2019-10

Locations

RU (2); BU (1); MO (1); SE (2); RO (2); HU (2); PL (2)