Effectiveness and Safety of Ilaprazole versus Rabeprazole in patients of uninvestigated dyspepsia: A Randomized controlled study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 122
- 试验地点
- 1
- 主要终点
- Global Overall Symptom Scale (7 point Likert scale)
研究概览
简要总结
Ilaprazole,a proton pump inhibitor, has been newly introduced in India, that is beingmarketed for the treatment of peptic ulcer disease, gastroesophageal refluxdisease and functional dyspepsia.
Thereare no published reports from India of head-to-head comparison betweenIlaprazole and the other proton pump inhibitors, which have known efficacy insuppressing gastric acid secretion, in the treatment of acid-peptic disorders.We therefore decided to conduct a double blind , randomized, controlled trial to compare Ilaprazolewith Rabeprazole in uninvestigated dyspepsia.
Studysubjects would be recruited from the General Medicine OPD of Institute of PostGraduate Medical Education & Research (IPGME&R) and Seth SukhlalKarnani Memorial (SSKM) Hospital, Kolkata. Adult subjects (18-55 years) ofeither sex, complaining of dyspepsia for at least 1 month would be included.Subjects with alarm symptoms (indicating risk of gastroesophageal malignancy orother serious gastrointestinal disorders), those taking drugs that might causedyspeptic symptoms and those with serious concomitant disease of vital organswould be excluded. Subjects would be randomized to receive either Ilaprazole 10mg once daily or Rabeprazole 20 mg once daily, before breakfast. Drugs would beadministered in double blind manner. Treatment would be for 6weeks and subjects would beassessed at the end of 3 and 6 weeks. Target sample size, adjusting fordropouts, is 61 patients per group.
Theprimary outcome measure for effectiveness would be total symptom score asassessed by Global Overall Symptom Scale (each symptom scored on a 7-pointLikert scale). For each symptom, relief would be taken as a score or 3 or lessand resolution as a score of 1 or less. Secondary efficacy variables would bescore on Modified frequency scale for the symptoms of gastroesophageal refluxdisease and Quality of life assessed by SF8 QOL questionnaire. Standardbiochemical test parameters and treatment emergent adverse events would berecorded as safety variables.
Datawould be analyzed in the Department of Pharmacology, IPGME&R.
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, fixed
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- All
入选标准
- •â€¢Patients, of either sex, aged between
- •55 years. •Symptoms of dyspepsia for at least 1 months •Moderate-to severe symptoms (score ≥ 4 on the7-point Likert scale for each symptom in global overall symptoms scale).
排除标准
- •â€¢Patient with alarm features (unintentional weight loss, persistent vomiting, dysphagia, hemetemesis, melena, fever, jaundice, or anemia), •History of serious gastrointestinal disease (including peptic ulcers, malignancy, esophageal dysmotility, a previous endoscopic or radiological diagnosis of GERD and Barrett’s esophagus) •History of irritable bowel syndrome.
- •â€¢Recent gastrointestinal surgery i.e. within 30 days •Patients with angina pectoris.
- •â€¢Patients who show any of the following values at the baseline laboratory tests: Hemoglobin < 9.5 g/dL, total leukocyte count < 3,000/mm3, platelet count < 75,000/mm3, AST and ALT ≥ 100 IU/L, Creatinine ≥ 1.5 mg/dL The blood tests should have been done not more than 4 weeks prior to enrollment.
- •â€¢Treatment with non-steroidal anti-inflammatory drugs (NSAIDs), H2-blockers, proton pump inhibitors, prokinetic agents, misoprostol or sucralfate 15 days prior to enrollment •Concomitant use of psychotropic drugs.
- •â€¢Concomitant serious disease of vital organs such as the liver, kidney, heart or lungs.
- •â€¢Women who are pregnant, lactating, or not willing to use adequate methods of contraception.
- •â€¢History of substance abuse.
- •â€¢Any other condition which can lead the study investigators to consider the subject unsuitable for selection.
- •â€¢Patient participating in any other clinical trial or have participated in the last three months.
结局指标
主要结局
Global Overall Symptom Scale (7 point Likert scale)
时间窗: 0 months,3 months, 6 months
次要结局
- 1.Modified Frequency Scale for the Symptom of gastroesophageal reflux disease (mFSSGERD)(2. Quality of life (QOL) as measured by SF8 QOL questionnaire)