EUCTR2017-000732-34-DK进行中（未招募）1 期
Oral Controlled Release Formulations to Patients with Gastrointestinal Dysfunction – Is the Release of Drug and the Absorption Impaired? - ABOXY
Mech-Sense, Dept. Gastroenterology & Hepatology, Aalborg University Hospital0 个研究点目标入组 135 人开始时间: 2017年4月25日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 135
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
入选标准
- •General inclusion criteria:
- •Signed informed consent.
- •Able to read and understand Danish.
- •Northern European descent (in order to minimize genetic variance influences on pain perception and drug metabolism).
- •The researcher believes that the participant understands the study details, is compliant and is expected to complete the study.
- •25-80 years of age
- •The investigator will ensure that fertile female participants use a safe contraception method during the study and for at least 32,5 hours after termination of the last treatment visit. The following methods are considered as safe contraception methods: the pill, spiral, injection of controlled release progestogen, subdermal implantation, hormonal vaginal ring or transdermal patches.
- •The investigator will ensure that fertile female participants have a negativ pregnancy test before each treatment visit.
- •Specific inclusion criteria for healthy volunteers
- •Opioid naïve*
- •BMI between 18,5-29,9 kg/m2
- •eGFR, ALAT, bilirubin, hemglobin and HbA1c levels are all normal or non-clinical significant (Assessed by a medical doctor)
- •Healthy (Assessed by a medical doctor)
- •Specific inclusion criteria for the diabetic patients
- •Diagnosed with diabetes mellitus
- •GI symptoms (eg. nausea, abdominal pain)
- •Oxycodone naïve (has not taken oxycodone for at least 1 week)
- •Specific inclusion criteria for the chronic pancreatitis patients
- •Diagnosed with chronic pancreatitis and exocrine insufficiency (f-elastase below 100 µg/g stool)
- •Oxycodone naïve (has not taken oxycodone for at least 1 week)
- •Specific inclusion criteria for the gastric bypass patients
- •Have undergone a gastric bypass surgery at least one year ago or longer
- •Oxycodone naïve (has not taken oxycodone for at least 1 week)
- •Specific inclusion criteria for the short bowel patients
- •Has a stoma
- •Resection occurred at least one year ago or longer
- •Has at least 150 cm small intestine
- •Oxycodone naïve (has not taken oxycodone for at least 1 week)
- •Specific inclusion criteria for the short bowel patients (pilot study)
- •Has a stoma
- •Has less than 150 cm small intestine
- •Has not taken oxycodone for at least 48 hours
- •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 90
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 45
排除标准
- •General exclusion criteria for all participants
- •Known hypersensitivity or allergy towards the pharmaceutical compounds used in the study or pharmaceutical compounds similar to those used in the study
- •Participation in other intervention studies within 14 days prior to first visit
- •Expected need of new medication or surgical treatment during the course of the study
- •Any diagnosed disease, which investigator concludes will affect the trial
- •Daily alcohol consumption
- •Intake of alcohol 48 hours prior or during the study days
- •Consumption of grapefruit juice or juice from Seville oranges (strong CYP3A4 inhibitors) 48 hours prior or during the study days
- •(Daily) use of any prescription, non-prescription and/or herbal medicines that may influence the study results (eg. strong inhibitors or inducers of CYP3A4, oxycodone)
- •Any contraindications related to the investigational drugs (severe respiratory depression, severe heart disease, chronic obstructive pulmonary disease or acute severe asthma and paralytic ileus)
- •Female participants who are lactating
- •Intake of non-opioids 24 hours prior or during the study days
- •Known allergy towards any of the Smartbar content
- •Specifik exclusion criteria for healthy volunteers
- •Has persistent pain.
- •Daily nicotine comsumption (e.g. cigarette smoking, nicotine patch etc.)
- •History of substance abuse
- •Family history of substance abuse
研究者
相似试验
已完成
不适用
Influence of rituals on open-label placebo effect in healthy volunteersegative emotional statesPoor sleep qualityLow perceived well-beingPerceived fatigueNegative emotional statesAlternative and Complementary Medicine - Other alternative and complementary medicineMental Health - Studies of normal psychology, cognitive function and behaviourACTRN12620000305921Dr Kate Faasse101
已完成
不适用
Are pills enough? The influence of information on open-label placebo effects in healthy volunteersegative emotional statePositive mental wellbeingPhysical symptomsSleep qualityACTRN12617001092381Dr Kate Faasse90
已完成
4 期
Bioavailability study of Vitamin K2CTRI/2017/09/009660Synergia Lifesciences PvtLtd16
进行中（未招募）
不适用
A Study to Investigate the Pharmacokinetics, Safety and Tolerability of Voriconazole in ChildreSystemic fungal infectionMedDRA version: 18.0Level: LLTClassification code 10042941Term: Systemic fungal infection NOSSystem Organ Class: 100000004862EUCTR2014-004184-21-Outside-EU/EEAPfizer, Inc.48
进行中（未招募）
1 期
Extended-release Pharmacotherapy for Opioid Use Disorder (EXPO)MedDRA version: 20.0Level: SOCClassification code 10037175Term: Psychiatric disordersSystem Organ Class: 10037175 - Psychiatric disordersMedDRA version: 23.1Level: LLTClassification code 10013658Term: Drug addictionSystem Organ Class: 10037175 - Psychiatric disordersOpiod addictionEUCTR2018-004460-63-GBSouth London and Maudsley NHS Foundation Trust600