Comparison of gabapentin and ondansetron for treating hyperemesis gravidarum

加巴喷丁与昂丹司琼治疗妊娠剧吐的比较

• 批准号: 9267838
• 负责人: THOMAS J GUTTUSO
• 金额: $ 32.57万
• 依托单位: STATE UNIVERSITY OF NEW YORK AT BUFFALO
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-01-05 至 2019-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9267838
• 关键词: Admission activity; Anorexia; Blood; Body Weight decreased; Buffaloes; Clinical; Clinical Trials; Dehydration; Disease; Dose; Double-Blind Method; Eligibility Determination; Enrollment; Family; Frequencies; Hospitalization; Hospitals; Hour; Hydration status; Hyperemesis Gravidarum; Inpatients; Laboratories; Measures; Nausea; Nausea and Vomiting; Ondansetron; Oral; Outcome Assessment; Outcome Measure; Outpatients; Participant; Patients; Phase; Pregnancy; Publishing; Quality of life; Randomized; Refractory; Self Care; Symptoms; Time; Universities; Vomiting; Weight; Work; arm; base; comparative efficacy; data registry; diaries; disabling disease; effective therapy; experience; fetal; flexibility; gabapentin; nutrition; open label; patient population; pill; primary outcome; psychosocial; public health relevance; satisfaction; secondary outcome

DESCRIPTION (provided by applicant): We hypothesized that gabapentin may be effective in the treatment of hyperemesis gravidarum (HG) based on previous experience we had associating gabapentin with marked reductions in refractory nausea and vomiting in other patient populations. Based on pregnancy registry data, there does not appear to be any contraindication to gabapentin use during pregnancy. We recently published the results of our open-label study using gabapentin among 7 HG patients, which showed an 80% and 94% reduction in mean nausea and emesis, respectively, after 2 weeks of gabapentin therapy and a >3x increase in mean nausea and a >7x increase in mean emesis within 2 days after gabapentin was discontinued. We now propose a randomized, double-blind, 2-arm clinical trial to compare the efficacy and tolerability of gabapentin to ondansetron in the treatment of HG. Eligible subjects will have moderate- severe refractory nausea and emesis of onset before 16 weeks gestation causing >5% weight loss from pre-pregnancy weight or 3-4+ ketonuria. Eighty (80) HG participants will be equally randomized to each of the 2 groups for 2 weeks and then open-label gabapentin with prn ondansetron will be provided for subjects for as long as needed. Subjects will be enrolled at the University at Buffalo and the University of Rochester. The Primary Outcome Measure will be the mean inter-period differences in the percent change from Baseline to the Study Endpoint in mean daily Motherisk-PUQE scores (a validated nausea and emesis diary of pregnancy). A flexible Study Endpoint will be used in order to focus assessment of the Primary Outcome Measure in the outpatient setting prior to subjects receiving IV hydration, which is when HG symptoms typically are most severe and refractory to treatment. The Study Endpoint will either be the mean values from Days 13-14 or, for subjects requiring repeat IV hydration after hospital discharge; it will be the mean values from the 48 hours prior to this repeat IV hydration administration. HG inpatients are typically discharged after 2-5 days, which will provide ample time in the outpatient setting prior to the Study Endpoint. Secondary outcomes will include oral nutrition, quality of life, global satisfaction, blood laboratory values need for IV hydration or hospital admission, and maternal and fetal outcome assessments.

描述（由申请人提供）：我们假设加巴喷丁可能会根据以前的经验有效治疗妊娠妊娠（HG），我们将加巴喷丁与其他患者人群的难治性恶心和呕吐的显着减少相关联。根据怀孕注册表的数据，怀孕期间似乎没有任何禁忌使用加巴喷丁。最近，我们在7名HG患者中使用加巴喷丁进行了开放标签研究的结果，在加巴喷丁治疗2周后，平均恶心和发育均分别降低了80％和94％，平均值均为均值和均值增加了3倍，均值增加了> 3倍，在gababapentin后2天内的发育率增加了> 7倍。 现在，我们提出了一项随机，双盲的2臂临床试验，以比较加巴喷丁对ondansetron在HG治疗中的疗效和耐受性。符合条件的受试者将在16周之前具有中度严重的难治性恶心和发作的发作，导致孕前体重或3-4+酮尿症的体重减轻> 5％。八十（80）个HG参与者将同样随机地与2个组中的每一个一起进行2周，然后将带有PRN Ondansetron的开放标签Gabapentin为受试者提供最长时间的时间。受试者将在布法罗大学和罗切斯特大学的大学入学。 主要结局指标将是平均每日母子普克评分（已验证的恶心和怀孕的疾病日记）中从基线到研究终点的百分比变化百分比变化的平均差异差异。将使用灵活的研究端点，以便在接受IV水合的受试者之前将门诊环境中的主要结局度量重点放置，这是HG症状通常最严重且对治疗难治性。研究终点将是第13-14天的平均值，或者对于需要在出院后需要重复静脉注水的受试者；这将是前48小时的平均值 这种重复的IV水合给药。 HG住院患者通常在2-5天后出院，这将在研究终点之前在门诊环境中提供足够的时间。次要结果将包括口腔营养，生活质量，全球满意度，血液实验室的价值观需要静脉注水或住院，以及孕产妇和胎儿结果评估。