EUCTR2020-002515-21-BE进行中（未招募）1 期
A Phase III Study to Assess the Efficacy and Safety of NEXIUM for Maintenance of Healing of Erosive Esophagitis in Pediatric Patients 1 to 11 Years of Age - SOLACE
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 100
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
- 性别
- All
入选标准
- •1. Patient must be 1 to 11 years of age, inclusive, at the time of their guardian signing the informed consent and the patient signing the informed assent (if applicable).
- •2. Patients must have a history of GERD for at least 3 months before the start of study treatment in the healing phase, as judged by the Investigator.
- •3. For the healing phase: Patients must have confirmed presence of EE at endoscopy performed within one week of the start of the healing phase.
- •4. For the maintenance phase: Patients must have completed the healing phase and have endoscopy-verified healed EE (Grade 0 ie, no LA Grade A, B, C, or D) at the 8-week endoscopy visit.
- •5. Patients must weigh = 10 kg.
- •6. Patients may be male or female.
- •7. All postmenarcheal female patients must have a negative pregnancy test (urine) before
- •starting treatment.
- •8. Sexually active patients must be abstinent or maintain effective contraception from informed consent day up to the last day of IMP treatment.
- •9. Patient’s guardian must be capable of giving signed informed consent
- •Assent forms will be signed by patients who are old enough to express their general understanding of the study as per local regulations.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 100
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1 Presence of other diseases, such as severe heart, lung, liver, renal, blood, or neurological disease or similar, that the Investigator judges could be a risk for the patient or impact the ability to participate in the study (patients with neurological disabilities or hiatal hernia may be included if the Investigator considers it appropriate).
- •2 Significant clinical illness within 4 weeks prior to the start of treatment, eg, unintentional weight loss, gastrointestinal bleeding requiring abstinence from food, jaundice, or any other signs indicating serious or malignant diseases.
- •3 Any conditions that are predicted to require a surgery during the study period (from the day of informed consent to the day of the last scheduled visit).
- •4 Previous total gastrectomy.
- •5 Anticipated need for concomitant therapy with any of the following after enrollment in
- •this study:
- •-PPIs (except for the IMPs)
- •- H2-receptor antagonists
- •-Anticholinergic agents for gastrointestinal-related diseases or symptoms
- •-Prostaglandin analog indicated for peptic ulcers (eg, misoprostol)
- •-Gastrointestinal promotility drugs
- •-Bismuth-containing drugs
- •-Mucosal protectants (antacids are accepted as rescue medication)
- •-Any drug known to have the potential for a drug-drug interaction with NEXIUM
- •6 Participation in another clinical study with an IMP administered in the last 4 weeks before enrollment.
- •7 Patients with a known hypersensitivity to NEXIUM, or any other PPI, or any of the excipients of the product.
- •8 Involvement in the planning and/or conduct of the study (applies to both AstraZeneca
- •staff and/or staff at the study site).
- •9 Judgment by the Investigator that the patient should not participate in the study if the patient or guardian is unlikely to comply with study procedures, restrictions, and requirements.
- •10 Previous screening, or enrollment and randomization in the present study.
研究者
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