malignant tumor related pain MedDRA version: 8.1 Level: LLT Classification code 10058019 Term: Cancer pain
Conditions
Interventions
R331333
Pharmaceutical Form: Prolonged-release tablet
INN or Proposed INN: Tapentadol
CAS Number: 175591-09-0
Current Sponsor code: CG5503
R331333
Other descriptive name: (-)-(1R, 2R)-3-(3-dimethylamino-1-ethyl- 2-methyl-propyl)-phenol hydrochloride
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-
R331333
Other descriptive name: (-)-(1R, 2R)-3-(3-dimethylamino-1-ethyl- 2-methyl-propyl)-phenol hydrochloride
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 200-
Sponsors
Grünenthal GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Subjects must have signed an informed consent document indicating that they understand the purpose of and procedures required for the trial and are willing to participate in the trial. • 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 (eg, prescription oral contraceptives, contraceptive injections, intrauterine device, double barrier method, contraceptive patch, male partner sterilization) before entry and throughout the trial. Female subjects must have a negative pregnancy test at Screening. • At least 18 years of age. • Chronic malignant tumor-related pain. • Subjects who are opioid-naïve or pretreated with an equianalgesic dose range equivalent of up to 160 mg oral morphine per day and are dissatisfied with prior treatment. • Subjects with a mean pain intensity =5 points (11-point NRS) on the day of randomization at the start of Titration phase. • Expected course of the disease and the pain that will permit compliance with the trial protocol over the entire trial period. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: General: • History of alcohol and/or drug abuse in the investigator’s judgment, based on patient history and physical examination. • The subject has a clinically significant disease other than cancer which in the investigator's opinion may affect efficacy or safety assessments eg, significant unstable cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurological, psychiatric (resulting in disorientation, memory impairment or inability to report accurately) or metabolic disturbances. • Any scheduled surgery during the trial. • Any painful procedure during the trial that may, in the opinion of the Investigator, affect the efficacy or safety assessments. • Employees of the investigator or trial center, with direct involvement in the proposed trial or other trials under the direction of that investigator or trial center, as well as 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 CG5503 or morphine. • Have received an experimental drug or used an experimental medical device within 30 days before the planned start of treatment. • Participation in another trial concurrently. • Subjects who have participated in previous trials of CG5503. Trial Specific: • Life-long history of seizure disorder or epilepsy, or any of the following within one year: mild/moderate traumatic brain injury, stroke, transient ischemic attack, or severe traumatic brain injury within 15 years (consisting of =1 of the following: brain contusion, intracranial hematoma, either unconsciousness or post-traumatic amnesia lasting for more than 24 hours) or with residual sequelae suggesting transient changes in consciousness. • Known history and/or presence of cerebral metastases. • Subjects with moderately or severely impaired hepatic function, or subjects with laboratory values reflecting inadequate hepatic function (ALT, AST greater than three-fold upper limit of normal). • Inadequate baseline bone marrow reserve with WBC count =3 500/µL, platelet count =100 000/µL, and hemoglobin level =9.5 mg/dL. • Subjects with severely impaired renal function. • Subjects with hypercalcemia, ie, corrected total serum calcium levels higher than 3.0 mmol/L. • Subjects taking any prohibited concomitant medications (as specified below) • Uncontrolled hypertension (repeated measurements of systolic blood pressure > 160 mmHg or diastolic blood pressure > 95 mmHg). • Clinically relevant history of hypersensitivity, allergy or contraindications to morphine or any of the excipients. • Chronic hepatitis B or C, or HIV, or presence of active hepatitis B or C within the past 3 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this trial is to evaluate the safety and efficacy of orally administered CG5503 PR tablets BID over 4 weeks (Maintenance phase) in subjects with moderate to severe chronic malignant tumor-related pain in comparison with placebo.;Secondary Objective: Secondary objectives of this trial are: • To compare efficacy and safety of CG5503 PR with morphine PR during the Titration phase as well as over the whole treatment phase. • To collect pharmacokinetic information for dose verification and population pharmacokinetic analyses ;Primary end point(s): The primary efficacy endpoint is the proportion of subjects classified as responders at the end of the 4-week maintenance treatment phase. Responders are subjects who meet all of the following criteria: • Complete 28 days of the Maintenance phase. • Have a mean pain intensity <5.0 point on an 11-point NRS during the Maintenance phase (the twice daily current pain score averaged over Days 18 to 43). • Do not use more than 2.0 doses of rescue medication/day on average during the Maintenance phase (Days 18 to 43) | — |
Countries
Austria, Bulgaria, Czech Republic, France, Germany, Hungary, Italy, Netherlands, Spain, Sweden
Outcome results
None listed