Novel Use of Ketotifen (Mast Cell Stabilizer) in Fibromyalgia: A Pilot Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- Change From Baseline in Weekly Average Pain Score on the Visual Analog Scale at Week 10
研究概览
简要总结
The purpose of this 10-week study is to determine the effects of a medication called Ketotifen on pain sensitivity; and fibromyalgia-related pain.
Ketotifen works by inhibiting (to prevent or slow down) certain substances in the body that are known to cause inflammation. It is an antihistamine that reduces the harmful effects of histamine. The ophthalmic (eye drops) formulation of ketotifen has been approved by the Food and Drug Administration (FDA) and has been available in the United States for more than a decade. Oral (taken by mouth) ketotifen has been in available in other countries for several decades. Commonly prescribed for the maintenance treatment of asthma and allergic rhinitis, ketotifen has long track record of safety. To date, the oral form of ketotifen has not been approved by the FDA, therefore this study is referred to as an "investigational drug study." Prior to opening recruitment an "investigational new drug" (IND) application which included scientific data and information regarding human safety plans was submitted to and approved by the FDA.
详细描述
Approximately 46 subjects will be participating in this research. Each subject will be randomized (like flipping a coin) to one of two groups; approximately 23 volunteers will be randomized to receive the active medication and 23 will receive the placebo. Both groups will be "blinded" (will not know) to which group they have been assigned.
The study will be conducted at the Indiana University Clinical Research Center for Pain (CRCP), located on the IUPUI campus in the National Institute of Fitness and Sport building,at 250 University Blvd.,Suite 118 Indianapolis, Indiana, 46202.
To summarize: The subject will be asked to visit the CRCP on four separate occasions: Initial Screening, Week 1, Week 2, and Week 10. This study also includes, answering questionnaires, taking study medication, maintaining a written medication diary and agreeing to remain in weekly contact with the study team to answer a short side effect questionnaire. The side effect questionnaire will be conducted from week 1-4 and then once every 2 weeks from week 4-10.
Study Overview:
Week 0 (clinic visit 1):
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •In order to qualify the subject:
- •must have been diagnosed with fibromyalgia by a medical doctor
- •must be between the ages of 18 to 65 years of age
- •must have a weekly overall body pain average score ≥ 4
- •must pass a screening questionnaire that calculates a physical impairment of ≥ 10
- •must be on stable doses of his/her current medication for at least past four weeks
- •must limit any changes in his/her medication(s) (e.g., dose change, addition or discontinuation of any medication that effects the central nervous system, e.g., benzodiazepines, sedative/hypnotic, etc. ) during the 10-week study period unless medically necessary
- •must report all medication including herbal supplements and over-the-counter medications, e.g. cold medication, eye drops, etc. that he/she is currently taking to a member of the research team
- •must be willing to maintain a medication diary provided to him/her during the 10-week study period
- •must be willing to abstain (not take) any fibromyalgia related medication including over-the-counter for at least 8-hours prior to each of the two testing visits (Otherwise, he/she may take these medication(s) immediately after pain sensitivity testing has been completed and as prescribed in-between visits)
- •must agree to use a proven method of contraception to prevent pregnancy throughout this study
排除标准
- •The subject will not be allowed to participate if:
- •he/she has a history of seizures
- •he/she has atopic dermatitis (also called eczema) or chronic urticaria (hives)
- •he/she has chronic thrombocytopenia (a low blood platelet count)
- •she is currently pregnant, are planning to become pregnant, or is breastfeeding
- •he/she has been diagnosed by a psychiatrist with Schizophrenia or bipolar disorder
- •he/she has been diagnosed with another major rheumatic conditions (i.e. rheumatoid arthritis, systemic lupus erythematosus, scleroderma and/or other connective tissue diseases)
- •he/she plans to undergo an elective surgery within the study timeline
- •he/she is in the process of filing, or plan to file for disability benefits within the study timeline
- •his/her screening labs results are abnormal (i.e., elevated SGPT and low platelet count)
- •he/she is currently using any anti-allergy drugs (ophthalmic or oral histamine antagonist), leukotriene inhibitors (e.g., montelukast) or prednisone
研究组 & 干预措施
Active Ketotifen
After meeting the full eligibility requirement, participants will be randomized. Approximately 26 of the 51 participants will assigned to this arm of the study.
干预措施: Ketotifen (Drug)
Placebo for Ketotifen
After meeting the full eligibility requirement, participants will be randomized. Approximately 25 of the 51 participants will assigned to this arm of the study. Subjects in this arm will receive the placebo drug.
干预措施: Placebo (Sugar Pill) (Drug)
结局指标
主要结局
Change From Baseline in Weekly Average Pain Score on the Visual Analog Scale at Week 10
时间窗: baseline and week 10
Change in weekly average pain score from baseline to week 10 (range from -10 to +10): interpretation= the more negative the value is, the larger reduction in pain severity at week 10 is
次要结局
- Change From Baseline in Evoked Pain Score at Week 10(baseline and week 10)
- Fibromyalgia Impact Questionnaire(baseline and week 10)
- Change From Baseline in the Blood Levels of IL-8, MCP-1 and Eotaxin at Week 10(baseline and week10)