EUCTR2006-003541-16-HU进行中（未招募）不适用
A randomized, double-blind, placebo controlled, multi-centre, phase IIA study to assess the effect on GERD symptoms, pharmacokinetics, safety and tolerability of four weeks treatment with AZD3355 65 mg bid as add-on treatment to a PPI in patients with an incomplete response to PPI treatment - n.a.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 400
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. Provision of informed consent
- •2. Male or female (females must be post-menopausal, ((i.e >12 months without a menstrual period and > 50 years of age)) or be bilaterally oophorectomized or hysterectomized
- •3. Age 18-70 years
- •4. Weight 60-100 kg
- •5. At least 6 months history of GERD symptoms (need not to be consecutive) and a history of an incomplete response to PPI treatment
- •6. Continuously treated with an approved dose of any PPI during at least 6 weeks before enrolment
- •7. Ability to read and write and to use the e-diary
- •8. Screening questionnaire (RDQ) indicating a burning feeling behind the breastbone with a frequency of at least 3 days over the past 7 days and with at least mild intensity and/or unpleasant movement of material upwards from the stomach with a frequency of at least 3 days over the past 7 days and with at least mild intensity
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Screening questionnaire (RDQ) indicating a equal or higher intensity of pain in the centre of the upper stomach than for a burning feeling behind the breastbone, if not fulfilling the inclusion criteria regarding unpleasant movement of material upwards from the stomach.
- •2. History of clinically significant cardiovascular, respiratory, renal, hepatic, neurological, mental or gastrointestinal (excluding GERD) disease. Patients with uncomplicated and well controlled Diabetes Mellitus and patients with uncomplicated and well controlled hypertension (SBP =160 mmHg and DBP =90 mmHg) can be included.
- •3. S-creatinine >1.2 times upper limit of normal (based on laboratory results from visit 1)
- •4. History of clinically significant orthostatic reactions
- •5. Systolic blood pressure below 110 mmHg
- •6. History of heart disease (eg, ischemic heart disease, congestive heart failure, cardiac arrhythmias) or signs or symptoms of heart disease including QTc >480 ms or other ECG abnormalities
- •7. Prior surgery of the upper GI tract (open, endoscopic and laparoscopic surgery on the esophagus, the stomach and the duodenum with the exception of oversewing or endoscopic treatment of an bleeding ulcer).
- •8. History of severe allergy/hypersensitivity or symptoms/signs of ongoing allergy/hypersensivity
- •9. Need for concomitant medication with
- •- Drugs that may interfere with the pharmacodynamic effect of Investigational Product (eg, baclofen)
- •- Drugs that may influence gastrointestinal symptoms, (eg, H2 receptor antagonists, sucralphate, alginates, tegaserod, metoclopamid, drugs with significant anticholinergic effect, non-steroid anti-inflammatory drugs (NSAIDs), cyclo-oxygenase-2 (COX-2) inhibitors, acetylsalicylic acid (ASA) >160 mg, biphosphonates, antineoplastic drugs) with exception of the PPI and antacids used in the study
- •- Drugs that have a narrow therapeutic window (eg warfarin, digoxin, phenytoin, karbamazepin)
- •- Drugs that may prolong the QT interval (see supplement for common examples)
- •10. History of drug addiction, alcohol abuse or other circumstances which in the investigators judgement may compromise the patient’s ability to comply with the study requirements
- •11. Any other condition which in the opinion of the investigator would render the patient unsuitable for inclusion in the study
- •12. Blood donation within 4 weeks prior to administration of the first dose of the investigational product
- •13. Involvement in the planning and conduct of the study (applies to both AstraZeneca staff or staff at the study site)
- •14. Administration of any investigational product or participation in any clinical study within 8 weeks prior to administration of the first dose of the investigational product
- •15. Previous enrolment or randomization of treatment in the present study.
研究者
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