2023-507744-36-00招募中2 期
The effect of naldemedine on opioid-induced bowel dysfunction
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- • Total GI transit time (MTS-2)
研究概览
简要总结
The main obejctive is to investigate the effect of naldemedine on opioid (tramadol) induced bowel dysfunction, using an objective design to explore gastrointestinal transit, motility pattern, secretion and colonic volume.
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy (assessed by a study-affiliated medical doctor)
- •Signed informed consent
- •Able to read and understand Danish
- •Male (to avoid influence of menstrual cycles)
- •Northern European descent (to minimize genetic variance influences on drug metabolism)
- •The researcher believes that the participant understands the study details, is compliant and is expected to complete the study
- •Opioid naïve
- •Between 20 and 40 years of age
- •A STAI score in the range of 20-37 i.e., classified as “no or low anxiety” at inclusion
排除标准
- •Known hypersensitivity or allergy towards the used pharmaceutical compounds or pharmaceutical compounds similar to those used in the study
- •Daily alcohol consumption
- •Participation motivated by “wrongful” reasons such as poor economy or psychosocial issues e.g., problems in the family, loneliness, sadness. People with such problems may be more likely to develop substance dependence
- •Intake of alcohol within 48 hours before start of study period or any alcohol consumption during each study period. If consumption takes place during the study the participant will be excluded
- •Use of any analgesic medication within 48 hours before start as well as for the duration of the study
- •Nicotine use
- •Less than three spontaneous bowel movements per week
- •Participation in other studies within 14 days prior to first visit
- •Expected need of medical/surgical treatment during the study
- •Any diagnosed disease, which investigator concludes will affect the trial (including all contraindicated complications: severe chronic obstructive pulmonary disease, pulmonary heart disease, severe bronchial asthma, paralytic ileus, hypercapnia, serious respiratory depression with hypoxia, moderate to severe decreased liver function, gastrointestinal obstruction or perforation, acute surgical abdominal complications such as appendicitis, Mb. Crohn’s, ulcerative colitis, and toxic mega colon)
- •History of substance abuse (alcohol, THC, benzodiazepine, central stimulants and/or opioids, urine drug test will be performed prior to treatment start)
- •History of major mental disorders (e.g., major anxiety, major depression or treatment with psychoactive medications etc.)
- •Metal implants or pacemaker
- •Daily use of prescription only medicine
结局指标
主要结局
• Total GI transit time (MTS-2)
• Total GI transit time (MTS-2)
• Colorectal transit time (MTS-2)
• Colorectal transit time (MTS-2)
次要结局
- • Subjective assessments of constipation (PAC-SYM, BSFS, GSRS, BFI)
- • Diagnostic evaluation of opioid-induced constipation (Rome IV C6)
- • Subjective assessment of opiate withdrawal (SOWS)
- • Segmental transit time of the stomach, small intestine, and colonic segments (assessed with MTS-2)
- • Detailed colonic motility (assessed with 3D-Transit)
- • Colon volume (assessed with MRI)
- • Water content in the colon (assessed with MRI)
- • Rear-front pressures and defecation indices (measured by Fecobionics)
研究者
Asbjørn Mohr Drewes
Scientific
Aalborg University Hospital
研究点 (1)
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