EUCTR2016-000943-14-NL进行中（未招募）1 期
A Phase 2 Single-Center, Proof-of-Concept Safety and Efficacy Study of Orally Administered OLT1177 Capsules with Successive, Result-Dependent Dose Adaptation in Subjects with an Acute Gout Flare
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 32
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •1) Male and female subjects between 18 and 80 years old, inclusive
- •2) Gout in a joint of a subject’s lower limbs (e.g. ankle, foot, knee, toe) as indicated by the presence of monosodium urate (MSU) crystals by microscopic evaluation of synovial fluid from the target joint and in accordance with ACR/EULAR 2015 Gout Classification Criteria
- •3) Confirmation of a gout flare in the target joint that began within 96 hours prior to the Baseline visit, based on presence of subject-reported joint pain at rest of = 50 mm on a 0 - 100 mm VAS and at least two of the following criteria in the target joint:
- •a. Subject-reported flare
- •b. Subject-reported warm joint
- •c. Subject-reported swollen joint
- •4) Acceptable overall medical condition to be safely enrolled in and to complete the study (with specific regard to cardiovascular, renal and hepatic conditions) in the opinion of the Investigator
- •5) Ability to provide written, informed consent prior to initiation of any study-related procedures, and ability, in the opinion of the Investigator, to understand and comply with all the requirements of the study, which includes abstaining from use of pain or Rescue Medication (for 12 hours after first dose of investigational drug) and other prohibited medications as outlined in Section 5.6.3 of the protocol.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 20
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 12
排除标准
- •1) Women of childbearing potential, or men whose sexual partner(s) is a woman of childbearing potential, who:
- •a. Are or intend to become pregnant (including use of fertility drugs) during the study
- •b. Are nursing [female subjects only]
- •c. Are not using an acceptable, highly effective method of contraception until all follow-up procedures are complete.
- •2) Presence of an acute gout flare in more than one joint at the Baseline visit
- •3) Presence of another inflammatory arthritis in addition to gout
- •4) Presence or known history of other autoimmune conditions (e.g. systemic lupus erythematosus, hypophysitis, etc.)
- •5) Clinically significant general pain or non-gout related joint pain that would interfere with the subject’s ability to accurately assess pain in the target joint, at the discretion of the Investigator
- •6) Use of any prohibited concomitant medications/therapies over the periods defined in Section 5.6.3 or planned use of any concomitant medications/therapies during the Treatment Period (including the use of paracetamol within 4 hours prior to the Baseline visit or other pain medications within 12 hours prior to the Baseline visit)
- •7) Active infection within 3 days prior to the Baseline visit
- •8) History of or known positive for HIV, Hepatitis B surface antigen (HBsAg) or antibodies to Hepatitis C Virus (HCV)
- •9) Diagnosed with any form of internal cancer within the past 5 years
- •10) Any other concomitant medical or psychiatric conditions, diseases or prior surgeries that in the opinion of the Investigator would impair the subject from safely participating in the trial and/or completing protocol requirements
- •11) History of alcohol or substance abuse within the 12 months prior to the Baseline visit
- •12) Enrollment in any trial and/or use of any investigational product or device within the immediate 30-day period prior to the Baseline visit
- •13) Enrollment in any study previously sponsored by Olatec Therapeutics LLC, specifically Study OLT1177-01, Study OLT1177-02, Study OLT1177-03 or Study OLT1177-04
- •14) Known diagnosis of chronic kidney disease or known history of renal impairment (e.g. calculated glomerular filtration rate [GFR] less than 40 mL/min)
研究者
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A Phase 2 Single-Center, Proof-of-Concept Safety and Efficacy Study of Orally Administered OLT1177 Capsules with Successive, Result-Dependent Dose Adaptation in Subjects with an Acute Gout FlareAcute gout flareGout10023213NL-OMON47412Olatec Therapeutics LLC32
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