CTRI/2012/01/002373进行中（未招募）3 期
A RANDOMIZED, DOUBLE BLIND, ACTIVE CONTROLLED, COMPARATIVE, PARALLEL GROUP, MULTICENTER STUDY TO ASSESS THE EFFICACY AND SAFETY OF DEXLANSOPRAZOLE VERSUS LANSOPRAZOLE FOR GASTROESOPHAGEAL REFLUX DISEASE (GERD)
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- Cipla Ltd
- 入组人数
- 242
- 试验地点
- 13
- 主要终点
- Mean Change in GSAS questionnaire sum scores (frequency, severity and distress scale)
研究概览
简要总结
This study is designed to assess the efficacy and safety of dexlansoprazole versus lansoprazole in patients with Gastroesophageal Reflux Disease (GERD). Total 242 patients will be participating in the study from 13 centers throughout xml:namespace prefix = st1 ns = "urn:schemas-microsoft-com:office:smarttags" /India. The study will consist of 7-14 days of screening period and 8 weeks of treatment period. The primary endpoint of the study is to determine mean change in GSAS questionnaire sum scores from baseline to week 2, week 4 and week 8. Adverse events will be recorded during entire study period of the study. xml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" /
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Note: There is no upper age limit Screening Visit 1 1.Written, signed, dated and ethics committee approved informed consent obtained from patients before performing any study related procedures.
- •2.Patients of both the sexes of age 18 years and above, who can read and write.
- •3.The patients with the symptoms of GERD having a history of episodes of heartburn for more than or equal to 2 months prior to screening.
- •Screening Visit 2 and Baseline Visit 1.The patients who experience heartburn on at least 4 of the 7 days of the screening period.
排除标准
- •Screening Visit 1: 1.Patient chronically using non steroidal anti inflammatory drugs including COX-2 inhibitors (greater than 12 doses per month) other than aspirin (less than or equal to 325 mg is allowed) within last 14 days.
- •2.Need for continuous anticoagulant therapy 3.History of hypersensitivity to study drugs or any of its components 4.Severe unstable or uncontrolled disease 5.History of alcohol or drug abuse or dependence 6.Participation in an investigational study within 30 days prior to screening 7.Female who is pregnant or lactating or planning to become pregnant.
- •8.Woman of child bearing potential who is unwilling to use adequate methods of contraception.
- •Screening Visit 2 and Baseline Visit 1.Patient with GERD complications like Endoscopic Barretts oesophagus and/or definite dysplastic changes in the oesophagus 2.Patient with Zollinger-Ellision syndrome or other hypersecretory condition 3.Patient with pyloric stenosis, oesophageal stricture, Schatzkis ring, oesophageal or Gastroesophageal surgery and planned surgery during the study duration.
- •4.A history of or active gastric or duodenal ulcers within 4 weeks prior or had significant acute upper gastrointestinal hemorrhage within 4 weeks of the baseline endoscopy.
- •5.Clinically significant laboratory values, as judged by the investigator (as per the assessment on screening visit 2 / Baseline visit).
结局指标
主要结局
Mean Change in GSAS questionnaire sum scores (frequency, severity and distress scale)
时间窗: From baseline to 2, 4 and 8 weeks of treatment period.
次要结局
- Percentage of days without daytime heartburn(From baseline to week 2, 4 and 8)
- Percentage of treatment emergent adverse events(During study period.)
- Percentage of Patients who achieved sustained resolution of heartburn (7 consecutive heartburn-free days)(At week 2, 4 and 8)
- Clinically significant changes in laboratory values(During study period.)
- Percentage of 24 hours heartburn free days(From baseline to week 2, 4 and 8)
- Percentage of nights without night time heartburn(From baseline to week 2, 4 and 8)
- Reduction in mean severity of heartburn(From baseline to week 2, 4 and 8)
- Clinically significant changes in vital signs & systemic examinations(During study period.)
- Percentage of days without rescue medication use(During study period.)
- Incidence and nature of adverse events(During study period.)
研究者
研究点 (13)
Loading locations...
相似试验
已完成
3 期
Efficacy and Safety of Dexlansoprazole on Heartburn Relief in Chinese PatientsHeartburnGastroesophageal Reflux DiseaseNCT02873689Takeda217
已完成
1 期
Study to Evaluate the Pharmacokinetics and Safety of Dexlansoprazole in Pediatric Subjects With Symptomatic Gastroesophageal Reflux DiseaseGastroesophageal RefluxNCT01045096Takeda36
已完成
3 期
A Study of Dexlansoprazole Modified Release Formulation to Treat Night HeartburnGastroesophageal RefluxNCT00627016Takeda305
招募中
3 期
A Randomized Controlled Trial of Dexlansoprazole vs. Double Dose Omeprazole in Non-responsive Nonerosive Esophageal Reflux DiseaseNERDHeartburnacid regurgitationNERDnonerosive esophageal reflux diseaseHeartburnacid regurgitationnonerosive esophageal reflux diseaseTCTR20160517003Faculty of Medicine Siriraj Hospital, Mahidol University118
终止
2 期
A Study to Check the Safety of Dexlansoprazole and Learn If it Can Heal Erosive Esophagitis (EE) and Keep it Healed in Children 2 to 11 Years OldErosive EsophagitisNCT02615184Takeda24