NCT00637871已完成2 期
Randomised, Double-blind, Placebo Controlled, Parallel-group, Multicentre Phase II Study to Assess Dose Response Relationship of Nolvadex (Oral Tablet) in Prophylactic Treatment of Gynaecomastia and Breast Pain Associated With CASODEX 150 mg (Oral Tablet), and to Assess the Tumour Control…..
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- AstraZeneca
研究概览
简要总结
This study looks at the relationship in the dose of nolvadex and the incidence of gynaecomastia and also Prostate Specific Antigen (PSA) inhibition when co-administered with Casodex. The aim of the study is to assess the optimal dose of nolvadex which will reduce the breast tissue adverse effects without reducing the efficacy of Casodex.
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
- Double
入排标准
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Subjects with adenocarcinoma of the prostate gland but with no evidence of distant metastasis. The stage of disease should be T1-T4, any N, M0 confirmed histologically or cytologically
- •Subjects in need of immediate hormonal therapy.
- •PSA equal or above 4 ng/ml
排除标准
- •Presence of gynaecomastia and/or breast pain at screening visit
- •Any previous endocrine therapy for prostate cancer other than neoadjuvant LHRH therapy prior to primary therapy of curative intent.
- •Current use, or within the previous 6 months, of any medication known to have a high risk of causing gynaecomastia .
- •Previous mastectomy or radiation to chest wall
研究组 & 干预措施
1
Experimental
干预措施: Casodex (Drug)
2
Active Comparator
干预措施: Tamoxifen (Drug)
研究者
相似试验
已完成
3 期
Study Evaluating Bazedoxifene/Conjugated Estrogen Combinations in Vasomotor Symptoms Associated With MenopauseVaginal AtrophyNCT00238732Wyeth is now a wholly owned subsidiary of Pfizer650
已完成
2 期
Efficacy and Safety Study of Gevokizumab to Treat Moderate to Severe Acne VulgarisAcne VulgarisNCT01498874XOMA (US) LLC127
已完成
3 期
Study Evaluating Bazedoxifene/Conjugated Estrogen Combinations in Symptoms Associated With MenopauseVasomotor Symptoms Associated With MenopauseNCT00234819Wyeth is now a wholly owned subsidiary of Pfizer325
终止
3 期
Safety and Efficacy Study of Gevokizumab to Treat Active Non-infectious UveitisUveitisNCT01684345XOMA (US) LLC200
已完成
3 期
Safety and Efficacy of Natalizumab in Combination With Avonex in the Treatment of Multiple SclerosisMultiple Sclerosis, Relapsing-RemittingNCT00030966Biogen1,200