EUCTR2012-001316-35-ES进行中（未招募）不适用
Efficacy, safety, and tolerability of oral GRT6005 versus morphine sulphate PR in subjects with chronic moderate to severe pain related to cancer.
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 652
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
- •1. Subjects must have signed an informed consent form (ICF) indicating that they understand the purpose of and procedures required for the trial and are willing to participate in the trial.
- •2. Subjects must be at least 18 years of age at the Enrollment Visit (Visit 1).
- •3. Subjects willing to use medically acceptable and highly effective
- •methods of birth control.
- •For women of childbearing potential a medically acceptable and
- •highly effective method of birth control is defined as any form of
- •contraception with a low failure rate defined as <1% per year. For
- •? Hormonal contraceptives for at least 2 months prior to the
- •Enrollment Visit (Visit 1) and until at least 4 weeks after the End
- •of Treatment Visit (Visit 11).
- •? An intra-uterine device.
- •Additional barrier contraception must be used by the partner for the duration of the trial, defined as from the time of the Enrollment Visit until 4 weeks after the End of Treatment Visit. Women of non-childbearing potential may be included if post-menopausal for at least 2 years and ?55 years old.
- •Men have to use barrier contraception (condom) during sexual
- •intercourse from the first administration of IMP until 4 weeks after the End of Treatment Visit. The male subject has to take care that the female sexual partner uses at least 1 additional method of contraception with a low failure rate defined as <1% per year (e.g.,oral contraceptives for at least 2 months prior to the Enrollment Visit) during this time frame. A double-barrier method should be supplemented by the use of spermicidal agents.
- •4. Subjects
- •? Requiring daily basic pain analgesia diagnosed with active cancer
- •including hematological malignant diseases.
- •? Opioid-naïve or receiving daily opioid treatment in doses not
- •higher than 90 mg morphine taken orally or its equivalent
- •(including World Health Organization [WHO] Step II analgesics).
- •? Suffering from cancer-related but not cancer therapy-related
- •chronic pain for a period of ?4 weeks prior to Visit 1.
- •5. Performance Status: Eastern Cooperation Oncology Group
- •(ECOG) ?2.
- •Additional inclusion criteria at Visit 2
- •1. Subjects with a mean score of ?5 points (11-point NRS) for the ?average pain intensity over the last 24 hours? calculated from the pain assessments recorded during the last 3 days prior to Visit 2.
- •2. Compliance with the use of the e-diary defined as 100% of all NRS entries available during the 3 days prior to Visit 2 and at least 75% of all NRS entries available between Visit 1 and Visit 2 (as assessed at Visit 2).
- •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 652
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 652
排除标准
- •1. Evidence of ongoing alcohol/drug abuse or history of alcohol/drug abuse within the last 2 years in the investigator?s judgment, based on patient history and physical examination.
- •2. 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, infectious disease, psychiatric (resulting in disorientation, memory impairment or inability to report accurately) or
- •metabolic disorders.
- •3. Subjects with any gastrointestinal disorder that could, in the
- •investigator?s opinion, limit the intake and/or elimination of IMP.
- •4. Any pre-scheduled major surgery requiring general anesthesia during the trial.
- •5. Known to or suspected of not being able to comply with the trial protocol and the use of IMP.
- •6. History of seizure disorder and/or epilepsy or any condition associated with a significant risk of seizure or epilepsy.
- •7. Known history and/or presence of symptomatic cerebral tumor or cerebral metastases.
- •8. Subjects with impaired hepatic functionality or cellular integrity
- •determined by a bilirubin value greater than 2 x the upper limit of
- •normal, international normalized ratio (INR) >1.7, or aspartate
- •transaminase (AST) or alanine transaminase (ALT) greater than
- •3 x the upper limit of normal (ULN) at the Enrollment Visit (Visit 1).
- •9. Inadequate baseline bone marrow reserve with a white blood cell count <2000/?L, a platelet count ?100 000/?L, and a hemoglobin level <8 g/dL at the Enrollment Visit (Visit 1).
- •10. Subjects with impaired renal function. Creatinine clearance less than 60 mL per minute at the Enrollment Visit (Visit 1) (calculated from the Cockcroft-Gault formula).
- •11. Subjects taking any forbidden concomitant medications at enrollment the trial.
- •12. Uncontrolled hypertension (repeated measurements of systolic blood pressure >160 mmHg or diastolic blood pressure >95 mmHg).
- •13. Clinically relevant history of hypersensitivity, allergy or
- •contraindications to opioid medication or any of the excipients of
- •morphine sulfate (PR or IR), or GRT6005 film-coated tablets.
- •14. Chronic hepatitis B or C, or human immunodeficiency virus (HIV) known by history, or presence of active hepatitis B or C within the 3 months before the Enrollment Visit.
- •15. History of torsade de pointes and/or presence of risk factors for torsade de pointes (e.g., heart failure, hypokalemia, or bradycardia).
- •16. Marked prolongation of QTc (>450 ms for men, >470 ms for women) at the Enrollment Visit (Visit 1) confirmed by repeated measurement.
- •17. Employees of the sponsor, investigator, or trial site or family members of the employees, sponsor, or investigator.
- •18. Concurrent participation in another trial or planning to be enrolled in another clinical trial during the course of this trial.
- •19. Previous participation in this or other trials with GRT6005.
- •20. Have received an experimental drug or used an experimental medical device within 30 days before the planned start of treatment.
研究者
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