Phase IV Study of Nasal Salmon Calcitonin in the Treatment of Symptoms and Signs of Fibromyalgia
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Functional status as assessed by the Fibromyalgia Impact Questionnaire (FIQ), a self-report inventory developed to measure health status in patients with fibromyalgia
研究概览
简要总结
The purpose of this study is to determine whether nasal administration of salmon calcitonin is effective and safe in the treatment of symptoms and signs of primary fibromyalgia.
详细描述
Fibromyalgia is a common, chronic musculoskeletal disorder that is characterized by widespread pain and tenderness. Fibromyalgia occurs in around 2% of the US general population, is more common in women and is associated with substantial morbidity and disability. Treatment of fibromyalgia has been disappointing; roughly one-third of patients have had a clinically important therapeutic response to medications or no-medicinal treatment, event with the newest drugs reported in the literature. Pathophysiology of fibromyalgia is unknown, but abnormalities in central neurotransmission might play a role. Some studies have shown that salmon calcitonin increases peripheral and central levels of endorphins. Increasing endorphins levels may decrease pain. Then, it is feasible that nasal administered salmon calcitonin may decrease several of the symptoms and signs of patients suffering fibromyalgia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients between 18 and 50 years
- •Fibromyalgia diagnosis (ACR criteria)
- •Must be able to apply the nasal medication
- •Must be able to comply with study visits
- •Must be able to understand informed consent
- •Must be able to answer self-administered questionnaires
- •Must have an active disease(VAS > 60mm)
排除标准
- •Comorbid conditions (i.e. hypothyroidism, diabetes mellitus, etc.)
- •Any disturbance in the nasal tissue
- •Use of concomitant opioid analgesics
- •Contraindication to use salmon calcitonin (allergy, hypocalcemia, hypophosphatemia)
- •Other rheumatic diseases
- •Diagnosis of major depressive disorder
研究组 & 干预措施
A
200 U.I. of intranasal salmon calcitonin
干预措施: salmon calcitonin (Drug)
B
intranasal saline solution and glycerol
干预措施: intranasal saline solution plus glycerol (Drug)
结局指标
主要结局
Functional status as assessed by the Fibromyalgia Impact Questionnaire (FIQ), a self-report inventory developed to measure health status in patients with fibromyalgia
时间窗: Day 0, Day 14, Day 28 and Day 56
次要结局
- Health related quality of life as assessed by WHO-DAS II, self-report questionnaire. Dolorimetry will be also used(Day 0, Day 14, Day 28 and Day 56)
研究者
Cesar Ramos Remus
M.D, Director
Unidad de Investigacion en Enfermedades Cronico-Degenerativas