The purpose of this study will be to determine whether tapentadol (CG5503) is effective and
safe in the treatment of chronic tumor related pain compared to placebo. In addition
tapentadol (CG5503) will also be compared to morphine controlled release, also referred to
as slow release (SR).
*Tapentadol prolonged-release (PR) is the term used in the European Union and is referred to
as extended release (ER) in the United States.
Average Daily Pain Intensity Scores, Averaged Per Week by Treatment, During the Titration Phase in the Tapentadol Treatment Arm.Average Daily Pain Intensity Scores, Averaged Per Week by Treatment, During the Titration Phase in the Morphine Treatment Arm.
Average Daily Pain Intensity Scores, Averaged Per Week by Treatment, During the Maintenance Phase.
Current Pain Intensity Scores, Averaged Per Week, During the Titration Phase in the Tapentadol Arm.
Current Pain Intensity Scores, Averaged Per Week, During the Titration Phase in the Morphine Arm.
Current Pain Intensity Scores, Averaged Per Week by Treatment, During the Maintenance Phase.
Use of Rescue Medication in the Titration Phase.
Number of Participants Using Immediate Release Morphine Rescue Medication in the Maintenance Phase
The Average Mean Total Daily Dose of Rescue Medication.
Changes in the Short Form 36® Health Survey (SF-36®) During the Titration Phase.
Changes in the Short Form 36® Health Survey (SF-36®) During the Maintenance Phase.
Change in the EuroQoL (EQ-5D) Health Status Index (United Kingdom Time Trade-off Value Set) Change From Start of Titration to Endpoint Titration.
Health Related Quality of Life: EuroQol-5D Health State Visual Analog Scale (VAS) Titration Phase.
Change in the EuroQoL (EQ-5D) Health Status Index (United Kingdom Time Trade-off Value Set) Over Time in the Maintenance Phase for Tapentadol and the Placebo Randomized Withdrawal Treatment Arms.
Changes in Health Related Quality of Life: EuroQol-5D Health State Visual Analog Scale (VAS) Maintenance Phase.
Patient Global Impression of Change
Quality of Sleep (Sleep Questionnaire) in the Titration Phase.
Quality of Sleep (Sleep Questionnaire) During the Maintenance Phase of the Trial.
Clinical Opioid Withdrawal Scale (COWS) at the End of the Titration Phase.
Clinical Opioid Withdrawal Score (COWS) at the End of the Maintenance Phase.
Change in the Patient Assessment of Constipation Symptoms (PAC-SYM) During the Titration Phase
Change in the Patient Assessment of Constipation Symptoms (PAC-SYM) During the Maintenance Phase
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Inclusion Criteria
- Male and non-pregnant, non-lactating female subjects.
- Of at least 18 years of age with chronic malignant tumor-related pain with a mean
pain intensity (NRS) of 5 points or higher.
- Subjects who are opioid-naĂŻve or pretreated with an equianalgesic dose range
equivalent of up to 160 mg oral morphine per day and are dissatisfied with prior
treatment.
- Women must be postmenopausal, surgically sterile, or practicing or agree to practice
an effective method of birth control throughout the trial.
- Expected course of the disease and the pain that would permit compliance with the
trial protocol over the entire trial period.
Exclusion Criteria
Key Exclusion Criteria:
- Subjects will be excluded from the study if they have a history of seizure disorder
or epilepsy;
- known history and/or presence of cerebral tumor or cerebral metastases.
- history of alcohol or drug abuse;
- uncontrolled hypertension,
- clinical laboratory values reflecting severe renal insufficiency,
- moderate or severe hepatic impairment,
- hepatitis B or C, HIV,
- inadequate bone marrow reserve
- currently treated with radiotherapy,
- pain-inducing chemotherapy,
- anti-parkinsonian drugs, neuroleptics, monoamine oxidase inhibitors, serotonin
norepinephrine reuptake inhibitor (SNRI) or any other analgesic therapy than
investigational medication or rescue medication during the trial.
- selective serotonin reuptake inhibitor (SSRI) treatments are allowed if taken for at
least 30 days before the screening period of the study at an unchanged dose.
Site 043004, Klagenfurt 9020, Austria
Site 043001, Vienna 1090, Austria
Site 043002, Vienna 1020, Austria
Site 043005, Vienna 1100, Austria
Site 359013, Gabrovo 5300, Bulgaria
Site 359011, Pleven 5800, Bulgaria
Site 359014, Plovdiv 4004, Bulgaria
Site 359004, Shoumen 9700, Bulgaria
Site 359008, Sofia 1784, Bulgaria
Site 359012, Varna 9003, Bulgaria
Site 385007, Osijek 31000, Croatia
Site 385001, Slavonski Brod 35000, Croatia
Site 385004, Varazdin 42000, Croatia
Site 385006, Zabok 49210, Croatia
Site 385002, Zagreb 10000, Croatia
Site 385003, Zagreb 10000, Croatia
Site 420005, Brno 62500, Czech Republic
Site 420002, Ceske Budejovice 37087, Czech Republic
Site 420006, Hradec Kralove 50005, Czech Republic
Site 420007, Liberec 46063, Czech Republic
Site 420008, Olomouc 77520, Czech Republic
Site 420001, Pilsen 30460, Czech Republic
Site 420004, Prague 18181, Czech Republic
Site 033101, Tarbes 65000, France
Site 049009, Berlin 12627, Germany
Site 049014, Essen 45122, Germany
Site 049012, Köln 50996, Germany
Site 049007, Loewenstein 74245, Germany
Site 049020, Potsdam 14467, Germany
Site 049006, Waldkirch 79183, Germany
Site 049002, Wiesbaden 65185, Germany
Site 036001, Debrecen 4043, Hungary
Site 036005, Komárom 2900, Hungary
Site 036003, Mátraháza 3233, Hungary
Site 036002, Nyiregyhaza 4412, Hungary
Site 036010, Szekszard 7100, Hungary
Site 036006, Székesfehérvár 8000, Hungary
Site 036009, Székesfehérvár 8000, Hungary
Site 039001, Napoli 80131, Italy
Site 373001, Chisinau 2025, Moldova, Republic of
Site 373002, Chisinau 2025, Moldova, Republic of
Site 048004, Bydgoszcz 85796, Poland
Site 048005, Gdanks 80286, Poland
Site 048007, Poznan 60355, Poland
Site 048001, Warszawa 02781, Poland
Site 040006, Brasov 500074, Romania
Site 040002, Bucharest 022328, Romania
Site 040003, Bucharest 022328, Romania
Site 040004, Bucharest 022328, Romania
Site 040005, Cluj-Napoca 400015, Romania
Site 040001, Iasi 700106, Romania
Site 040007, Timisoara 300239, Romania
Site 007010, Arkhangels 163045, Russian Federation
Site 007003, Moscow 125284, Russian Federation
Site 007007, Nizhniy Novgorod 603140, Russian Federation
Site 007012, Vladikavkaz 362007, Russian Federation
Site 007005, Yaroslavl 150054, Russian Federation
Site 381003, Belgrade 11000, Serbia
Site 381004, Belgrade 11000, Serbia
Site 381005, Belgrade 11000, Serbia
Site 381002, Nis 18000, Serbia
Site 381001, Sremska Kamenica 21204, Serbia
Site 421005, Banska Bystrica 97517, Slovakia
Site 421001, Kosice 04191, Slovakia
Site 034005, Barcelona 08221, Spain
Site 034009, Barcelona 08208, Spain
Site 034006, Mahon Menorca 07703, Spain
Site 034012, Pamplona 31008, Spain
Site 034004, Sevilla 1013, Spain
Site 034002, Valencia 46014, Spain
Site 046001, Stockholm 17176, Sweden