EUCTR2008-005105-18-NL进行中（未招募）不适用
A phase 2B, randomised, double-blind, placebo-controlled, parallel group, dose-ranging, multi-centre study to investigate the efficacy, safety and tolerability of the mGluR5 negative allosteric modulator ADX10059 in patients with Gastroesophageal Reflux Disease (GERD) who are partial responders to proton pump inhibitor (PPI) treatment.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 320
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
- •A patient will be invited to participate if he/she meets the following inclusion criteria: 1. is willing and able to provide written informed consent
- •2. is male or female and aged 18 to 70 years, inclusive
- •3. is diagnosed with typical GERD and is a partial responder to a stable standard clinical symptom control” dose of PPI therapy. A partial responder is defined as a patient who experiences symptom improvement on PPI treatment but who has residual moderate or severe typical symptoms (heartburn or regurgitation) on at least 2 days / week but no more than 5 days / week whilst on their standard PPI dose (defined as the indicated dose for the treatment of clinical symptoms), as confirmed from the eDiary data recorded on Days -8 to -2 inclusive
- •4. has a body mass index (BMI) of =32 kg/m2
- •5. has an ability to communicate well with the study staff and to comply with the requirements of the entire study including compliance with eDiary completion
- •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
- •A patient will be excluded from study participation if he/she meets any of the
- •following criteria:
- •1. has exclusively atypical symptoms of GERD, such as coughing, sore throat,
- •respiratory symptoms etc. (i.e. atypical symptoms in the absence of heartburn and / or regurgitation)
- •2. has symptoms that have been shown not to be associated with GERD, acid or non-acid
- •3. has a history of erosive oesophagitis as demonstrated by endoscopy within the
- •previous 12 months of Grade B or worse (Los Angeles classification grading score)
- •4. has been treated or is currently treated with a dose of PPI greater than the dose
- •indicated for clinical symptom control of GERD
- •5. has a documented history of hiatus hernia > 3 cm
- •6. has a current diagnosis of co-existing psychiatric disease that, according to the investigator, could interfere with the conduct of the study
- •7. has a known clinically significant allergy or known hypersensitivity to drugs that, in the opinion of the investigator, may affect the patient’s safety
- •8. has clinically significant abnormal laboratory parameters at Screening, in particular, liver or renal functions tests greater than twice the upper limit of normal (ULN) or any other clinically significant biochemical or haematological abnormality as determined by the investigator
- •9. has known or suspected human immunodeficiency virus (HIV) or hepatitis B or C
- •10. is pregnant or breast-feeding. Female patients who are of child-bearing potential
- •must be using adequate contraceptive methods (e.g. oral contraceptive, doublebarrier method, intra-uterine device, intra-muscular hormonal contraceptive), and have a negative pregnancy test at Screening and prior to randomisation on Day -1
- •11. is an habitual user of recreational drugs (including amphetamine,
- •methamphetamine, cocaine and opiates), and who has used them within 14 days prior to Screening or has a positive test for drugs of abuse at Screening
- •12. has received sodium valproate or topiramate within 30 days of Screening
- •13. has a history of a significant medical condition that may affect the safety of the
- •patient or preclude adequate participation in the study, including but not limited to
- •coronary artery disease, chronic obstructive pulmonary disease, arrhythmias, diabetes and epilepsy
- •14. has received any investigational drug within 30 days of Screening
研究者
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