Multicenter Phase II Trial of Oral Type I Bovine Collagen in Scleroderma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 168
- 试验地点
- 12
- 主要终点
- Disease condition, as measured by physical exam, modified Rodnan skin score (MRSS), health assessment questionnaires, chest x-ray, and pulmonary function tests
研究概览
简要总结
Diffuse systemic sclerosis (SSc), or scleroderma, is a connective tissue disease causing damage to skin and other organs. The purpose of this study is to determine if taking oral bovine type I collagen (CI) will improve the condition of SSc patients.
详细描述
SSc is a chronic connective tissue disease that is caused by excess collagen deposits that damage the skin and other organs. This study will determine if a daily oral dose of bovine CI will improve the condition of patients with SSc.
Patients will be randomly assigned to one of two groups. The first group will receive 500 mcg bovine CI daily for 15 months; the second group will receive placebo. Study visits will be conducted at Months 4, 8, 12, and 15. Patients will undergo physical examination and blood tests at each visit. Patients will also be evaluated for modified Rodnan skin score (MRSS) and will be given health assessment questionnaires. A chest x-ray will be conducted at study entry and pulmonary function tests will be conducted at study entry and Month 12.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Clinical diagnosis of diffuse systemic scleroderma (by American College of Rheumatology criteria 1980) of 10 years or less
- •Stable skin involvement by history or physical examination 6 months prior to study entry
- •Stable modified Rodnan skin score (MRSS) for 1 month prior to study entry
- •Stable MRSS of 16 or more at screening and stable MRSS between screening and baseline visit
- •Agree to use acceptable forms of contraception
排除标准
- •Participation in another clinical research study involving evaluation of another investigational drug within 90 days prior to study entry
- •Concurrent serious medical condition which, in the opinion of the investigator, makes the patient inappropriate for the study
- •Systemic sclerosis-like illnesses associated with environmental, ingested, or injected agents, such as L-tryptophan, tainted rapeseed oil, vinyl chloride, or bleomycin
- •Limited and localized (morphea) or linear SSc
- •Tenderness or swelling of the extremities (eosinophilic fasciitis)
- •Pregnancy
- •Use of certain medications
- •Allergy to beef or dairy products
- •Nonsteroidal anti-inflammatory drugs (NSAIDs) within 1 week before baseline visit. Aspirin at 325 mg or less daily for stroke or heart attack prevention is allowed.
- •Use of herbal and some alternative therapies
- •Any organ transplant or stem cell transplant
研究组 & 干预措施
1
Participants will receive oral bovine type I collagen (CI) daily for 15 months
干预措施: Oral bovine type I collagen (Drug)
2
Participants will receive placebo daily for 15 months.
干预措施: Placebo (Drug)
结局指标
主要结局
Disease condition, as measured by physical exam, modified Rodnan skin score (MRSS), health assessment questionnaires, chest x-ray, and pulmonary function tests
时间窗: Measured at Month 12
次要结局
未报告次要终点