NCT00701363已完成4 期
A Prospective, International, Multi-centric, Open-label Study to Assess the Efficacy of an Extended Injection Interval Schedule of Lanreotide Autogel 120 mg in Acromegalic Subjects Who Are Biochemically Controlled on the Long Term Treatment With Octreotide LAR 10 or 20 mg
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Ipsen
- 入组人数
- 124
- 试验地点
- 44
- 主要终点
- Percentage of Subjects Having Maintained Their Injection Interval Schedule of Six Weeks or Increased Their Injection Interval to Eight Weeks Whilst Keeping Their Normalised Insulin Growth Factor (IGF-1) Levels (Age and Sex Adjusted)
研究概览
简要总结
The purpose of the study is to assess the efficacy of an extended injection interval schedule of lanreotide Autogel 120 mg in acromegalic subjects who are biochemically controlled on long term treatment with octreotide LAR 10 or 20 mg
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 has given written informed consent prior to any study-related procedures
- •The subject is male or female and is over 18 years of age
- •The subject must have had documentation supporting the diagnosis of acromegaly, based on elevated IGF-1 and/or GH levels
- •The subject has been receiving octreotide LAR (10 or 20 mg) treatment for at least six months and is biochemically controlled. Control is defined as normal (age and sex adjusted) IGF 1 levels for two consecutive measurements (at least two months apart) preceding study entry
- •If the subject is receiving dopamine agonist therapy, treatment should be stable for at least four months, and no change in their dopamine-agonist medication is expected during the entire study period
排除标准
- •The subject has received radiation therapy to the pituitary gland before study entry
- •The subject has a history of hypersensitivity to lanreotide or drugs with a similar chemical structure
- •The subject has received a growth hormone receptor antagonist (pegvisomant) therapy within three months before study entry
- •The subject has undergone treatment with any other investigational drug in the 30 days before study entry or is scheduled to receive an investigational drug, other than lanreotide 120 mg, during the course of the study
- •The subject has received any unlicensed drug within the 30 days prior to the baseline visit or is scheduled to receive an unlicensed drug during the course of the study
研究组 & 干预措施
Lanreotide Autogel 120 mg
Experimental
干预措施: Lanreotide Autogel 120 mg (Drug)
结局指标
主要结局
Percentage of Subjects Having Maintained Their Injection Interval Schedule of Six Weeks or Increased Their Injection Interval to Eight Weeks Whilst Keeping Their Normalised Insulin Growth Factor (IGF-1) Levels (Age and Sex Adjusted)
时间窗: At week 48 (End of Study)
A subject was responder if he maintained his injection interval schedule of 6 weeks or increased his injection interval to eight weeks whilst keeping his normalised IGF-1 level (age and sex adjusted) at the end of the study (Week 48)
次要结局
- Percentage of Subjects Having Maintained an Injection Interval of Six Weeks or Increasing Their Injection Interval to Eight Weeks(During phase 2 of the study (up to week 48))
- Percentage of Subjects Who Extend Their Injection Interval to Eight Weeks During Phase 2 of the Study, Whilst Maintaining Normalised IGF-1 Levels(At week 48)
- Mean Change From Baseline in IGF-1 Values [Expressed as % of Upper Limit of Normal (ULN)], Overall and by Injection Interval(Baseline (visit 1) and week 48)
- Symptoms of Acromegaly (Headache, Excessive Perspiration, Fatigue, Soft Tissue Swelling and Arthralgia)(At baseline, week 24 and week 48)
- Mean Changes From Baseline in Quality of Life Scores (AcroQoL)(At weeks 24 and 48)
- Mean Changes From Baseline in Quality of Life Scores (SF-36)(At weeks 24 and 48)
- Percentage of Subjects With Normalized IGF-1 Levels (Age and Sex Adjusted), Without Any Worsening of the AcroQoL Change Score Between Inclusion and Week 48(At week 48 (End of Study))
- Correlation Between the Changes From Baseline in Quality of Life (AcroQoL) With the Corresponding Changes in IGF-1 Level (Expressed as % of ULN) at Each Visit(At weeks 24 and 48)
- Serum Growth Hormone (GH) Levels(At Baseline, week 24 and week 48)
- Treatment Group (A, B or C) Mean Baseline IGF-1 Levels (Expressed as % of ULN) in Subjects Who Maintained Normalised IGF-1 Values at Week 48. Comparisons Will be Made as Follows: A Versus B, A Versus C, A Versus (B+C) and B Versus C(Baseline (visit 1))
- Mean Baseline IGF-1 Levels (Expressed as % of ULN) in All Groups (A, B and C) Versus Mean Baseline IGF-1 Levels (Expressed as % of ULN) in Subjects With Uncontrolled IGF-1 Levels at Week 24(Baseline (visit 1))
- Percentage of Subjects With GH Level Less Than or Equal to 2.5 ng/mL(At weeks 24 and 48)
- Subject Treatment Schedule Preference(At weeks 24 and 48)
- Percentage of Subjects With Normalised IGF-1 Levels (Age and Sex Adjusted)(At week 24)
研究者
研究点 (44)
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