Proof of Concept Trial to Test the Efficacy of Treatment With Ketotifen on Pain Sensitivity and Association Between Level of Activity and Reactivity of White Blood Cells and Pain Sensitivity in Teenagers With Chronic Widespread Pain
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Patients' Global Impression of Change (PGIC) scale
研究概览
简要总结
Our goal is to conduct a proof-of-concept trial to test the efficacy of KF treatment in adolescents with severe CWP not responding to the standard of care (SOC) treatment program in a multidisciplinary tertiary care chronic pain clinic. The changes associated to the interventions (KF or placebo) will be quantified using the Patients' Global Impression of Change (PGIC) scale after 16 weeks of treatment. Secondary, we aim to evaluate the effects of KF on the pain sensitivity, physical and emotional functioning, and we will also explore the potential biological underlying mechanisms.
详细描述
We have designed a proof-of-concept (POC) trial composed of three arms. The first two arms will be a randomized, controlled, double-blind, parallel-group study, designed to assess the potential efficacy of KF for the treatment of pain and associated symptoms in adolescent with CWP. The third arm will consists of assessing standard of care (SOC) data from patients who do not wish to participate in the study, but agree to allow us to use their SOC data to be compared with that of patients participating in the study. This arm will help to evaluate the potential beneficial effect of being part of the study ("placebo" effect) receiving a new treatment for a condition where the SOC have limited success rate.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 14 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Female and male adolescents aged between 14 to 18 years old;
- •For female adolescents of child bearing potential: negative serum pregnancy test at base line screening;
- •For female adolescents of child bearing potential: being willing and able to use contraceptive methods for the duration of the study and for 30 days after receiving the last dose of the study drug;
- •Diffuse body pain that has been present for at least 3 months, and who also have symptoms of fatigue, sleep disturbance, cognitive changes and mood disorder;
- •Accompanied by at least one somatic symptoms to variable degree including irritable bowel syndrome, headaches, menstrual pain, lower urinary tract symptoms, myofascial pain, and temporomandibular pain;
- •Symptoms cannot be explained by some other illness;
- •Physical examination which should be within normal limits except for tenderness on pressure of soft tissues (i.e. tactile hyperalgesia which is increased pain following a painful stimulus)
- •Overall body pain average score ≥ 4
- •Moderate to severe physical impairment Functional Disability Inventory > 12 points.
- •Stable doses of his/her current medication for at least four weeks
- •Not having significant changes in their health conditions (PIGS less than 6 points) after 8 weeks of treatment
排除标准
- •Be part of other trials;
- •Have a specific diagnosis that can explain the symptoms; including rheumatoid arthritis, systemic lupus erythematosus, scleroderma and/or other connective tissue diseases
- •Refuse to donate blood sample;
- •Not be able to fill electronic records;
- •Cognitive impairment interfering with the clinical evaluations;
- •Known intolerance or allergies to KF;
- •Been under treatment with other mast cell stabilizer agent;
- •Seizures history or actual treatment;
- •Coagulopathies or chronic thrombocytopenia;
- •Atopic dermatitis (eczema) or chronic urticaria (hives)
- •Schizophrenia or bipolar disorder
- •Elective surgery within the study timeline
- •Abnormal labs results (i.e., elevated SGPT and low platelet count, low Hb or Ht) in the last 6 months or in the base line evaluation
- •Patients who are pregnant or are breast-feeding;
- •Patients who are on oral antidiabetic agents;
研究组 & 干预措施
KF group
In each study visit, patients will receive enough pills for the next month. At the first visit, patients receiving ketotifen (KF) will receive four vials sequentially numbered (1 to 4) containing enough pills for one week each, and will be instructed by the clinician and by the pharmacist to use vial 1 for the first week (0.5 mg of KF BDI), vial 2 for the second week (1mg of KF BDI), vial 3 for the third week (2 mg of KF BDI), and vial 4 for the fourth week (3mg of KF BDI). As for weeks 4, 8 and 12 visits, patients treated with KF will receive four equal vials containing enough pills for one week each (3 mg of KF BDI)
干预措施: Ketotifen Fumarate (Drug)
Placebo group
Patients participating in the placebo group will also receive sequentially numbered vials at the first visit. Similarly, patients taking placebo will also receive four equal vials of pills on the next visits.
干预措施: Placebo (Drug)
SOC
Standard of care - patients who refuse to participate in the study but allow us to compare their clinical data to that of participants of the study
干预措施: Standard of Care (Other)
结局指标
主要结局
Patients' Global Impression of Change (PGIC) scale
时间窗: Baseline versus week 16
"Since beginning treatment, how would you describe the change (if any) in ACTIVITY LIMITATIONS, SYMPTOMS, EMOTIONS and OVERALL QUALITY OF LIFE related to your painful condition?" (CHOOSE ONE). * No change (or condition has got worse) * Almost the same, hardly any change at all * A little better, but not noticeable change at all * Somewhat better, but the change has not made any real difference * Moderately better, and a slight but noticeable change * Better, and a definite improvement that has made a real and worthwhile difference * A great deal better, and a considerable improvement that has made all the difference Patients scoring either 6 or 7 on the PGIC scale are categorized as "improved". Patients scoring either 6 or 7 on the PGIC scale are categorized as "improved". We will use this definition as a dichotomous variable.
次要结局
- Sleep(Compare values at baseline, with those of weeks 4, 8, 12 and 16.)
- Role Functioning(Compare values at baseline, with those of weeks 4, 8, 12 and 16.)
- Analgesic medication reduction(Compare baseline with weeks 4, 8, 12 and 16.)
- Adverse events(Compare weeks 4, 8, 12 and 16.)
- RNA expression(Baseline versus week 16)
- Pain sensitivity(Baseline versus week 16)
- Proportion of patients with pain sensitivity reduced by half(Baseline versus week 16)
- Daily profile of pain index(Across baseline and weeks 4, 8, 12 and 16 will be evaluated)
- Pressure pain sensitivity(Across baseline and weeks 4, 8, 12 and 16 will be evaluated)
- Functional Disability Inventory(Compare values at baseline, with those of weeks 4, 8, 12 and 16.)
- Revised Child Anxiety and Depression Scale (RCADS)(Compare values at baseline, with those of weeks 4, 8, 12 and 16.)
研究者
Pablo Ingelmo
Associate Professor, Department of Anesthesia; Director, Chronic Pain Service (Pediatric), Montreal Children's Hospital
McGill University Health Centre/Research Institute of the McGill University Health Centre