EUCTR2008-002124-28-IT进行中（未招募）不适用
Studio in doppio cieco, intra-soggetto, controllato con placebo, per valutare l?efficacia di Juvista (avotermina) unitamente alla revisione chirurgica delle cicatrici per il miglioramento delle cicatrici deturpanti. - Juvista in scar revision surgery of disfiguring scars
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- RENOVO LTD
- 入组人数
- 350
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
- •General Inclusion Criteria The following general inclusion criteria are required to ensure that the patients included in the trial are suitable for entry in terms of their general health and the provision of informed consent. - Patients aged 18-85 years who have provided written informed consent. - A body mass index between 15 and 35 kg/m2 (calculated using Quetelet?s index [weight (kg)/height m2] - Patients with, in the opinion of the Investigator, clinically acceptable results for the laboratory tests specified in the trial protocol. All laboratory tests must be performed within 28 days of the first trial dose administration. - If females of child bearing potential, patients must be using a highly effective method(s) of contraception and agree to do so from at least the screening visit until one month after administration of the final study dose. For the purposes of the protocol, highly effective method(s) of contraception will be defined as consistently and correctly used implants, injectables, combined oral contraceptives, sexual abstinence or a vasectomised partner. For ``Scar Specific Inclusion Criteria `` please refer to the Protocol
- •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
- •General Exclusion Criteria The general exclusion criteria are required to exclude patients whose medical history, ongoing conditions or lifestyle could affect the assessment of efficacy or safety during the trial. The following criteria exclude patients who have compromised healing rates which may impact on scarring and subsequent treatment assessment: - Patients who on direct questioning and / or physical examination, have evidence of any past or present clinically significant medical condition that would impair wound healing including : *Significant rheumatoid arthritis. *Significant hepatic impairment (LFTs >3 times upper limit of normal). *Inadequately or uncontrolled congestive heart failure. *Currently active malignancy or history of any malignancy in the 5 years prior to the screening visit. *Immunosuppression or chemotherapy in the twelve months prior to the screening visit. *A history of radiotherapy to the study scar area. *Diabetes mellitus (unless controlled by diet and exercise alone). *A bleeding disorder or current use of anti-thrombotic therapy (aspirin, ticlopidine and clopidogrel are permitted). - Patients with a creatinine clearance (CLcr) of 80ml/min or less. Creatinine clearance will be determined from the serum creatinine level at pre-study screening using the following formula : *CLcr = (140-age (years)) x weight(kg)/ 72 x serum creatinine (mg/dL) { x 0.85 for females } - Patients with a skin disorder that is chronic or currently active. The following criteria exclude patients who may not complete the trial assessments or who have conditions which may interfere with the assessment of drug safety: - Patients who, in the opinion of the Investigator, have significant ongoing psychiatric disorders, which may interfere with the trial assessments / visits. - Patients with a history of clinically significant hypersensitivity to any of the drugs or surgical dressings to be used in this trial. - Patients who are taking, or have taken, any investigational drugs within 3 months prior to the screening visit. - Patients undergoing investigations or changes in management for an existing medical condition (excluding the scar for revision). - Patients who are or who become pregnant up to and including Day 0 or who are lactating. - In the opinion of the Investigator, a patient who is not likely to complete the trial for whatever reason.For ``Scar Specific Exclusion Criteria `` please refer to the Protocol
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