EUCTR2007-004162-41-HU进行中（未招募）不适用
SAFETY AND BIOLOGICAL ACTIVITY OF A NEW PROLONGED RELEASE FORMULATION OF OCTREOTIDE ACETATE, C2L-OCT-01 PR, ADMINISTERED INTRA MUSCULARLY EVERY 6 WEEKS IN ACROMEGALIC PATIENTS
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 30
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
- •Age of 18 years and above,
- •Diagnosis of active acromegaly based on the following criteria:
- •o Typical clinical features,
- •o Failure of GH to suppress below 1 ng/mL during an oral glucose tolerance test (OGTT), and
- •o Elevated serum IGF-1 levels above gender- and age- matched values. (i.e. normal values”)
- •The following patients will be eligible:
- •o Patients presently treated with Sandostatin LAR® 10 mg or 20 mg for a minimum 12 weeks and having normal IGF-1 values.
- •o Patients not currently treated with somatostatin analogues and having elevated IGF-1 values. These patients could be naïve to somatostatin analogues or have stopped their treatment with somatostatin analogues.
- •o Patients naïve to somatostatin analogues must have demonstrated tolerance to a seven day treatment with 50 µg Sandostatin® immediate release s.c administered three times a day.
- •o If patients were previously treated with somatostatin analogue prolonged release formulation, last injection should be more than 56 days prior to the screening visit.
- •All women of reproductive age must have a negative pregnancy test prior to start of study medication.
- •Having the ability to understand the requirements of the study, provide written informed consent to participate in this study and agree to abide by the study restrictions.
- •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
- •Female patients of childbearing potential age who are not using adequate contraception. (i.e. oral or trans-dermal contraceptive drugs, intra-uterine device, diaphragm)
- •Pregnant or lactating female patients.
- •Treated with a GH receptor antagonist (pegvisomant) within 12 weeks prior to admission into the study.
- •Have undergone pituitary surgery less than 12 weeks prior to admission into the study.
- •Have undergone radiotherapy within two years prior to admission into the study.
- •Presents any contraindication (hypersensitivity to octreotide formulation) or non responder to Sandostatin-LAR® treatment.
- •Patients with liver disease such as cirrhosis, chronic active hepatitis or chronic persistent hepatitis, or patients with persistent ALT, AST> 2 X ULN, serum creatinine >2 X ULN, serum bilirubin >2 X ULN.
- •Have other conditions that could result in altered GH or IGF-1 levels (such as anorexia nervosa, Laron’s syndrome, treatment with levodopa or narcotics analgesics, heroin abuse, etc.)
- •Patients with Diabetes type I (insulin-dependent) or with uncontrolled Diabetes type II as indicated by the presence of ketoacidosis or HbA1C ? 10%.
- •Presents clinically significant signs and symptoms potentially related to a tumor compression of the optical chiasm, based on judgment of the investigator.
- •Patients with symptomatic cholelithiasis.
- •Have received an investigational drug or participated in a clinical trial within 30 days of study entry.
- •Presents clinically serious and/or unstable intercurrent infection, medical illnesses or conditions that are uncontrolled or whose control, in the opinion of the Investigator, may be jeopardized by participation in this study or by the complications of this therapy.
- •Patients who have used a dopamine agonist less than 30 days prior to study entry.
- •Patients requiring Sandostatin-LAR® to be dosed every < 21 or > 35 days per injection.
研究者
相似试验
已完成
不适用
The efficacy and the safety of the new long-acting insulin in patient with diabetesdiabetesJPRN-UMIN000020521Osaka Saiseikai Noe Hospital100
已完成
不适用
Effect of a bioactive solution on the duration of diarrhoea in adultsISRCTN10890482iveLeaf Inc150
已完成
不适用
Safety profile and pharmacokinetics of a synthetic cannabinoid (JWH-018)JWH-018, synthetic cannabinoid, safety, pharmacokineticsNL-OMON29562Maastricht University55
已完成
不适用
Safety profile and pharmacokinetics of a synthetic cannabinoid (JHW-018)NL-OMON46849niversiteit Maastricht55
招募中
不适用
Safety and efficacy of the newly developed liquid type bowel cleansing agent for bowel preparation for colonoscopy (independent study)Colon tumorJPRN-UMIN000007531The Jikei University School of Medicine30