NL-OMON37009撤回2 期
Treatment of Complex Regional Pain Syndrome type 1: A randomized placebo controlled double-blind study with ARA 290, The CRPSARA Study - Treatment of CRPS with ARA290
适应症
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Inclusion criteria will be the *Budapest Criteria* for CRPS1. These criteria have a high specificity and sensitivity for the diagnosis of the disease [1]. The criteria are:
- •(1) Continuing pain, which is disproportionate to any inciting event;
- •(2) Must report at least one symptom in three of the four following categories:
- •a. Sensory: reports of hyperesthesia and/or allodynia;
- •b. Vasomotor: reports of temperature asymmetry and/or skin color changes and/or color asymmetry;
- •c. Sudomotor/edema: reports of edema and/or sweating changes and sweating asymmetry;
- •d. Motor/trophic: reports of decreased motor ranges and/or motor dysfunction (weakness, tremor, dystonia) and/or trophic changes (hair, nail, skin);
- •(3) Must display at least one sign at time of evaluation in two or more of the following categories:
- •a. Sensory: hyperalgesia (to pinprick) and/or allodynia (to light touch and/or deep somatic pressure and/or joint movement);
- •b. Vasomotor: evidence of temperature asymmetry and/or skin color changes and/or color asymmetry;
- •c. Sudomotor/edema: evidence of edema and/or sweating changes and sweating asymmetry;
- •d. Motor/trophic: evidence of decreased motor ranges and/or motor dysfunction (weakness, tremor, dystonia) and/or trophic changes (hair, nail, skin);
- •(4) There is no other diagnosis that better explains the signs and symptoms.
- •(5) Pharmacotherapy for CRPS symptoms (e.g., analgesics, antidepressants, and/or anticonvulsants ) has been stable for at least 4 weeks
排除标准
- •Exclusion criteria are:
- •* Inability to give informed consent;
- •* Patients suffering from other pain syndromes;
- •* Clinically relevant abnormal history of physical and mental health, as determined by medical history taking and physical examinations obtained during the screening visit and/or prior to the administration of the initial dose of the study drug (as judged by the investigator);
- •* A semi recumbent systolic blood pressure of >160 mmHg and/or diastolic blood pressure of > 95 mmHg at screening;
- •* History of alcoholism or substance abuse within three years prior to screening;
- •* Positive pregnancy test or lactation
- •* Male subjects habitually using more than 21 units of alcohol per week and female subjects using more than 14 units of alcohol per week;
- •* Subject has a history of severe allergies, or has had an anaphylactic reaction or significant intolerability to prescription or non-prescription drugs or food;
- •* Subjects that received a vaccination or immunization within the last month;
- •* Participation in an investigational drug trial in the 3 months prior to administration of the initial dose of study drug or more than 4 times per year;
- •* Subject has undergone major surgery within three months prior to screening;
- •* Inability or unwillingness to self-administer ARA 290 via subcutaneous injections
- •* Any other condition that in the opinion of the investigator would complicate or compromise the study, or the well being of the subject
研究者
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