A Multi Center Open Label Study to Assess the Ability of Subjects With Acromegaly or Their Partners to Administer Somatuline Autogel
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Ipsen
- 入组人数
- 59
- 试验地点
- 13
- 主要终点
- The Percentage of Subjects or Their Partners That Are Competent to Self-administer Somatuline Autogel at the End of the Study, (Week 24/Early Termination), as Assessed by the Competence Questionnaire Score.
研究概览
简要总结
The purpose of this study is to determine whether subjects with acromegaly (or their partners) are able to self administer Somatuline Autogel at home.
详细描述
Clinical experience with Somatuline Autogel to date has raised the possibility of self or partner injection. Previous microparticle somatostatin analogue formulations required careful reconstitution and as a result the cost of the analogues and the inconvenience of reconstitution meant self or partner injection was not a viable option.
Somatuline Autogel does not require reconstitution as it comes ready-mixed in a pre-filled syringe, thus making it more user-friendly than its predecessor and introducing the possibility of self or partner injection.
Patients with acromegaly often travel considerable distances every 28 days in order to receive their somatostatin analogue injections in the clinic. If Somatuline Autogel can be safely administered unsupervised, while maintaining disease control, this could offer patients considerable benefits in terms of reduced frequency of visits to the clinic.
This study is designed to allow suitably motivated patients with acromegaly or their partners to learn how to successfully inject Somatuline Autogel while maintaining their mean GH level control. Disease control in these patients will be assessed by comparing their GH and IGF-1 levels to accepted medical standards for control of acromegaly and by comparing the levels of GH and IGF-1 control achieved with baseline values.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The subject must give signed informed consent before any study-related activities.
- •The partner, if applicable, must give signed informed consent before administration of Somatuline Autogel.
- •The subject must be able to understand the protocol requirements.
- •The subject must have a clinical diagnosis of acromegaly due to pituitary tumor.
- •The subject must be treated with a long-acting somatostatin analogue with or without a dopamine agonist and have been on the current medical regimen for at least 3 months prior to screening and have IGF-1 levels no higher than 10% above the upper limit of the normal range for age and gender at the screening visit or be somatostatin analogue naïve (if the subject is treated with a dopamine agonist he/she must have been on the current dose for at least 3 months prior to screening).
- •Subjects who are treated with a dopamine agonist have to stay on their current dose for the duration of the study.
- •Switch subjects must have had their last pre-study routine clinical treatment with Sandostatin LAR between 28 and 35 days before Visit 2 (enrollment).
- •The subject must be able to store the study medication in a refrigerator in his/her own or his/her partner's home.
- •The subject must be ≥18 years of age.
- •Female subjects of childbearing potential must use adequate contraception.
- •Female subjects of childbearing potential who are taking oral contraceptives must agree to stay on their current contraceptive dose for the duration of the study.
- •The partner, if applicable, must be ≥18 years of age.
排除标准
- •The subject has had pituitary surgery (adenomectomy) within 3 months prior to screening.
- •The subject has received pituitary radiotherapy within 3 years prior to screening.
- •The subject has received a GH receptor antagonist within 6 months prior to screening.
- •The subject is currently on a higher dose of Sandostatin LAR than 30mg q28d
- •The subject is pregnant or breastfeeding.
- •The subject has clinically significant renal or hepatic abnormalities.
- •The subject has a symptomatic, untreated biliary lithiasis.
- •The subject has uncontrolled diabetes or thyroid disease.
- •The subject has a known hypersensitivity to any of the test materials or related compounds.
- •The subject is unable or unwilling to comply with the protocol.
- •The subject has received any investigational drug within 30 days prior to screening.
- •The subject has participated in a medical device study within 30 days prior to screening.
- •The subject has previously participated in this study.
研究组 & 干预措施
Somatuline Autogel (lanreotide acetate)
Somatuline Autogel (lanreotide acetate) Injection
干预措施: Somatuline Autogel (lanreotide acetate) (Drug)
Somatuline Autogel (lanreotide acetate)
Somatuline Autogel (lanreotide acetate) Injection
干预措施: Home administration (Behavioral)
结局指标
主要结局
The Percentage of Subjects or Their Partners That Are Competent to Self-administer Somatuline Autogel at the End of the Study, (Week 24/Early Termination), as Assessed by the Competence Questionnaire Score.
时间窗: 24 weeks
The primary efficacy endpoint was the percentage of patients (Switch and other) or their partners who were competent to self-administer lanreotide at the end of the study (Week 24/Early Termination), as assessed by the Assessment of Competence Questionnaire (0 = 'No' and 1 = 'Yes').
次要结局
- Percentage of Switch Subjects Who Find Self-administration of Somatuline Autogel Convenient as Assessed by the Subject Convenience Questionnaire Score.(24 weeks)
- Percentage of Switch Subjects That Have IGF-1 Levels Within the Normal Range for Age and Gender at the End of the Study(24 weeks)
- Percentage of Switch Subjects That Have Glucose Suppressed GH Levels ≤ 2.5 ng/ml at the End of the Study, Week 24/Termination.(24 Weeks)
- Change of GH Concentration Levels From Basaeline to Week 24 in Switch Patients(24 Weeks)
- Total Symptom Questionnaire Score at Week 24/Termination(24 Weeks)
- Total Health Care Professional Convenience Questionnaire Score at Week 24/Termination(24 weeks)