NCT02526784已完成3 期
A Multi-Centre, Open-Label, Randomised Trial Evaluating Two Subcutaneous Injection Techniques and Intramuscular Administration of Degarelix in Patients With Prostate Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 3
- 主要终点
- Difference in the average patient reported injection site pain score between patients receiving the optimised and standard s.c. injections, as well as between patients receiving the i.m. and standard s.c. injections
研究概览
简要总结
The purpose of this trial is to compare the severity of ISRs (Injection Site Reactions) following degarelix subcutaneous (s.c.) administrations with two different injection techniques and intramuscular (i.m.) administration in patients with hormone dependent prostate cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Aged ≥18 years with a diagnosis of adenocarcinoma of the prostate (Gleason graded, all stages) where endocrine treatment is indicated.
- •Caucasian origin.
- •Able to provide written Informed Consent and willing and able to comply with trial procedures.
- •Body mass index (BMI) between 18.5-30 kg/m
- •Has a life expectancy of at least one year.
排除标准
- •Current hormonal management of prostate cancer.
- •Previous endocrine therapy for prostate cancer within 3 months prior to the screening visit.
- •Any medical injection therapy that might interfere with degarelix injections.
- •Patients with advanced muscle atrophy or cachexia which in the Investigator's opinion would preclude or pose risks of complications following ventrogluteal i.m. injection of degarelix.
- •Any medical condition that could be aggravated or may cause extreme discomfort during the trial period or could cause a moderate risk to a patient (significant heart, renal or liver disease).
- •Chronic pain syndrome or any continuous pain reported by the patient that, according to the judgement of the Investigator, could limit the evaluation of injection related pain.
研究组 & 干预措施
Injection A
Active Comparator
Degarelix s.c. standard injections
干预措施: degarelix (Drug)
Injection B
Experimental
Degarelix s.c. optimised injections
干预措施: degarelix (Drug)
Injection C
Experimental
Degarelix i.m. injections
干预措施: degarelix (Drug)
结局指标
主要结局
Difference in the average patient reported injection site pain score between patients receiving the optimised and standard s.c. injections, as well as between patients receiving the i.m. and standard s.c. injections
时间窗: From baseline to month 6
Assessed by a 10-graded numeric pain rating scale (0=no pain, 10=worst possible pain)
次要结局
- Patient reported injection site pain scores after degarelix starting dose(From starting dose to 6 days after starting dose)
- Patient reported injection site pain scores after degarelix maintenance doses(From first maintenance dose (month 1) to 6 days after last maintenance dose (month 6))
- Difference in skin colour values between pre- and post-injection(From baseline to month 6)
研究者
研究点 (3)
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