EUCTR2012-000678-44-GB进行中（未招募）不适用
A single-centre, randomised, four-way crossover study to investigate the measurement of the acid pocket and subsequent gastro-oesophageal reflux episodes using a novel pH/impedance catheter in subjects receiving Gaviscon® Double Action, Gaviscon® Advance and Placebo Liquid versus no treatment. - Gaviscon® Double Action Acid Pocket Investigation
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
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
- •Only subjects to whom all of the following conditions apply will be included:
- •1)Male or female subjects aged = 18 years, = 50 years
- •2)Subjects who have used over the counter medication to treat for heartburn, typically at least twice per month for the previous 3 months
- •3)Those whose cigarette consumption is <6 per day and are willing to abstain from smoking while at the study centre
- •4)Willingness to consume the refluxogenic meal
- •5)Otherwise healthy subjects, in the opinion of the Investigator
- •6)Those who are willing to volunteer and have provided written informed consent
- •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 16
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
- •Only subjects to whom all of the following conditions apply will be included:
- •1)Male or female subjects aged = 18 years, = 50 years
- •2)Subjects who have used over the counter medication to treat for heartburn, typically at least twice per month for the previous 3 months
- •3)Those whose cigarette consumption is <6 per day and are willing to abstain from smoking while at the study centre
- •4)Willingness to consume the refluxogenic meal
- •5)Otherwise healthy subjects, in the opinion of the Investigator
- •6)Those who are willing to volunteer and have provided written informed consent
- •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 16
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Subjects to whom any of the following conditions apply must be excluded:
- •1)Those with a history of gastro-oesophageal reflux disease, or reflux symptoms typically requiring self medication with over the counter or prescription medication more than twice a week on an ongoing basis.
- •2)Those who have a history of active gastrointestinal disease (gastroduodenal ulcer, gastrointestinal haemorrhage, mechanical obstruction or perforation) within the last year.
- •3)Those who show clinically significant allergic, pulmonary, neurological, renal, hepatic, cardiovascular, psychiatric, metabolic, endocrine, or haematological disease.
- •4)Those who are observed at screening to have a hiatus hernia with a diameter which exceeds 3cm.
- •5)Those who have a history of basal skull facture or who have undergone trans-sphenoidal surgery.
- •6)Those who have been hospitalised within the previous three months for major surgery or medical illness.
- •7)Those who have had a clinically significant illness within the previous four weeks.
- •8)Those who have taken any prescription medication or non-prescription medication (other than hormonal contraceptives) within seven days, prior to the screening visit, which the Principal Investigator considers may interfere with the study.
- •9)Those who have taken H2 antagonists or motility stimulants in the two weeks prior to enrolment in the study and during the study.
- •10)Those who have taken proton pump inhibitors 4 weeks prior to enrolment into the study and during the study.
- •11)Any previous history of allergy or known intolerance to any of the study drugs or the following formulation constituents.
- •12)Those who have a current or recent (one year) history of alcohol abuse or abuse of any legal or illegal drugs, substances, solvents.
- •13)Those who consume abnormal quantities of coffee, tea or cola (e.g. more than six cups) according to the Principal Investigator’s judgement.
- •14)Those who have taken part in any clinical study within the previous three months, or have taken part in a total of four or more studies in the last 12 months.
- •15)Those who are unable to communicate well with the Investigator (i.e. language problem, poor mental development or impaired cerebral function) in the opinion of the Investigator.
- •16)Those who have evidence of columnar lined oesophagus, or any other significant abnormality in the opinion of the endoscopist and Investigator (as determined during the endoscopy procedure to place the catheter).
- •17)Woman of childbearing potential, who are pregnant or lactating, seeking pregnancy or failing to take adequate contraceptive precautions. Adequate contraceptive precautions include oral or injectable contraceptives, approved hormonal implants or topical patches, intrauterine devices; barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository; true abstinence (true abstinence: when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence e.g., calendar, ovulation, symptothermal, post-ovulation methods and withdrawal are not acceptable methods of contraception. Should the subject become sexually active while participating in the study, she and her partner must agree to use a double barrier method or condoms/diaphragms with spermicidal foam/gel/film/cream/ suppository). Subjects are to be informed verbally that a female condom and male condom should not be used;
- •Subjects to whom any of the following conditions apply must be excluded:
- •1)Those with a history of gastro-oesophageal reflux disease, or reflux symptoms typically requiring self medication with over the counter or prescription medication more than twice a week on an ongoing basis.
- •2)Those who have a history of active gastrointestinal disease (gastroduodenal ulcer, gastrointestinal haemorrhage, mechanical obstruction or perforation) within the last year.
- •3)Those who show clinically significant allergic, pulmonary, neurological, renal, hepatic, cardiovascular, psychiatric, metabolic, endocrine, or haematological disease.
- •4)Those who are observed at screening to have a hiatus hernia with a diameter which exceeds 3cm.
- •5)Those who have a history of basal skull facture or who have undergone trans-sphenoidal surgery.
- •6)Those who have been hospitalised within the previous three months for major surgery or medical illness.
- •7)Those who have had a clinically significant illness within the previous four weeks.
- •8)Those who have taken any prescription medication or non-prescription medication (other than hormonal contraceptives) within seven days, prior to the screening visit, which the Principal Investigator considers may interfere with the study.
- •9)Those who have taken H2 antagonists or motility stimulants in the two weeks prior to enrolment in the study and during the study.
- •10)Those who have taken proton pump inhibitors 4 weeks prior to enrolment into the study and during the study.
- •11)Any previous history of allergy or known intolerance to any of the study drugs or the following formulation constituents.
- •12)Those who have a current or recent (one year) history of alcohol abuse or abuse of any legal or illegal drugs, substances, solvents.
- •13)Those who consume abnormal quantities of coffee, tea or cola (e.g. more than six cups) according to the Principal Investigator’s judgement.
- •14)Those who have taken part in any clinical study within the previous three months, or have taken part in a total of four or more studies in the last 12 months.
- •15)Those who are unable to communicate well with the Investigator (i.e. language problem, poor mental development or impaired cerebral function) in the opinion of the Investigator.
- •16)Those who have evidence of columnar lined oesophagus, or any other significant abnormality in the opinion of the endoscopist and Investigator (as determined during the endoscopy procedure to place the catheter).
- •17)Woman of childbearing potential, who are pregnant or lactating, seeking pregnancy or failing to take adequate contraceptive precautions. Adequate contraceptive precautions include oral or injectable contraceptives, approved hormonal implants or topical patches, intrauterine devices; barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository; true abstinence (true abstinence: when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence e.g., calendar, ovulation, symptothermal, post-ovulation methods and withdrawal are not acceptable methods of contraception. Should the subject become sexually active while participating in the study, she and her partner must agree to use a double barrier method or condoms/diaphragms with spermicidal foam/gel/film/cream/ suppository). Subjects are to be informed verbally that a female condom and male condom should not be used
研究者
相似试验
已完成
不适用
A randomised, single centre, phase IV crossover study to assess the acceptability of once daily Zindaclin® used for one week compared to three other marketed topical antibiotics in patients with mild to moderate acneAcneMild to moderate acne vulgaris.Skin and Connective Tissue DiseasesISRCTN43187439ProStrakan Pharmaceuticals (UK)65
进行中（未招募）
1 期
Gaviscon Double Action pH monitoring study.This study is to demonstrate the antacid action of Gaviscon Double Action Mint versus a matched placebo using a pH catheter.EUCTR2012-004131-23-GBReckitt Benckiser Healthcare (UK) Ltd25
已完成
不适用
A randomized, single center, 2-way crossover, comparator controlled Phase I trial to evaluate the effect of a new analgesic on ventilation in healthy subjectspijnnociceptive painpainNL-OMON32792Grunenthal12
已完成
1 期
A study in healthy volunteers to assess how the body takes up different recipes of the test medicine (alectinib)CancerISRCTN74516835Chugai Pharmaceutical Co., Ltd.29
已完成
不适用
clinical trial to investigate pharmacokinetic interaction between HGP0904, HGP0608 and HGP1405Diseases of the circulatory systemKCT0001693Hanmi Pharm28