CTIS2023-505144-19-00招募中1 期
A prospective, multicentre open-label clinical trial to evaluate the efficacy of the fixed-dose combination of Doxylamine and Pyridoxine 10/10 mg modified-release capsules on the quality of life of pregnant women presenting with nausea and vomiting of pregnancy (NVP). - RES-6131-C1
Itf Research Pharma S.L.0 个研究点目标入组 80 人开始时间: 2023年5月29日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 80
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 64（—）
入选标准
- •Pregnant adult woman aged between 18-45 years (both included)., Patient with gestational age between 5 and 12 weeks (both included: week 5+0 – week 12+6). Gestational age and viability of clinical pregnancy should have been confirmed with ultrasound prior to study inclusion., Patient presenting with nausea and vomiting of pregnancy (nausea and/or vomiting), of PUQE intensity =6., Patient who has not planned the discontinuation of her pregnancy., Patient who has signed informed consent to participate in the study and agrees to follow the investigational product's administration instructions and complete all study visits., Patient who has not previously received Doxylamine/Pyridoxine for the treatment of nausea and vomiting in pregnancy, or alternatively, who has received Doxylamine/Pyridoxine prior to inclusion in the study as long as it has not exceeded a daily dose of 20/20 mg. For this inclusion criterion, the 5 days prior to inclusion in the study will be taken into consideration.
排除标准
- •Patient who is taking multivitamins or vitamin B6 (pyridoxine) supplements containing more than 10 mg or plans to do so during the study., Patients with any contraindication by data sheet to the use of Cariban® 10/10mg (such as, for example, suffering from porphyria, having hypersensitivity to antihistamines, etc.)., Patient treated with other antihistamines, anticholinergics, drugs with anticholinergic activity (e.g. tricyclic antidepressants), dopamine or serotonin antagonists, from the beginning of pregnancy., Patient who has used ginger or other antiemetic therapy (e.g. acupressure, acupuncture, homeopathy, medical hypnosis, relief bands, etc.) during the past 48 hours or plans to do so during the study., Patient who is taking oral progesterone or plans to do so during pregnancy., A patient who has received an investigational product within 30 days prior to study inclusion, or plans to do so during the course of the study., Patient who presents difficulty in comprehension, reading or writing, as well as difficulty in following the requirements of the study., Patient in whom, in the opinion of the investigator, adherence to the prescribed treatment is not expected, sufficient relevant data cannot be available (sociodemographic, clinical, obstetric, nausea and vomiting of pregnancy pathology and/or therapeutic approach), or are not suitable candidates to receive the investigational product or participate in the study., Patient with trophoblastic disease of gestation., Patients with nausea and vomiting of etiology other than pregnancy: gastrointestinal pathology, pyelonephritis, vertigo, etc., Patient previously hospitalized for nausea and vomiting of pregnancy or hyperemesis gravidarum during current pregnancy., Patient with hypersensitivity to any of the active ingredients or excipients of treatment, or contraindication to treatment with antihistamines (epilepsy, alcoholism, glaucoma, chronic lung disease, etc.)., Patient with a medical condition that results in gastrointestinal malabsorption, such as celiac disease, Crohn's disease, and ulcerative colitis (i.e., may result in low or deficient vitamin B6 levels).
研究者
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