EUCTR2006-004997-28-BG进行中（未招募）不适用
A randomized withdrawal, active- and placebo-controlled, double-blind, multi-center Phase III trial assessing safety and efficacy of oral CG5503 PR in subjects with moderate to severe chronic malignant tumor-related pain - n.a.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 432
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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 (e.g., prescription
- •oral contraceptives, contraceptive injections, intrauterine device,
- •double barrier method, contraceptive patch, male partner
- •sterilization) before entry and throughout the trial. Female subjects
- •of childbearing potential must have a negative pregnancy test at
- •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.
- •[For Hungary (Amendment 1-1) the inclusion criterion reads:
- •Subjects who are dissatisfied with prior treatment and requiring
- •analgesia equivalent to a maximum of 160 mg oral morphine per
- •Subjects with a pain intensity =5 points (11-point NRS) on the day
- •of randomization at the start of Titration phase (Visit 2).
- •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
排除标准
- •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 e.g., 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 tapentadol 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 tapentadol.
- •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 tumor or cerebral
- •metastases.
- •Subjects with moderately or severely impaired hepatic function, or
- •subjects with an ALT and/or AST greater than three-fold the 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 g/dL.
- •Subjects with severely impaired renal function.
- •Subjects with hypercalcemia, i.e., 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 tapentadol or 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.
- •[For Switzerland (Amendment 1-2) the exclusion criterion reads:
- •Chronic hepatitis B or C, or HIV (known by history) , or presence of
- 另有 1 项未显示
研究者
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