BridgeMD
Naldemedine OIBD
EU CTIS ID: 2023-507744-36-00
What this study is testing
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.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- • Healthy (assessed by a study-affiliated medical doctor)
- • Negative pregnancy test at screening and before each treatment visit (female participants only)
- • Agreed to use highly effective contraception during the entire study (female participants only)
- • Signed informed consent
- • Able to read and understand Danish
- • Male or female
You likely can't join if
- • Known hypersensitivity or allergy towards the used pharmaceutical compounds or pharmaceutical compounds similar to those used in 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
See the full eligibility criteria
- • Healthy (assessed by a study-affiliated medical doctor)
- • Negative pregnancy test at screening and before each treatment visit (female participants only)
- • Agreed to use highly effective contraception during the entire study (female participants only)
- • Signed informed consent
- • Able to read and understand Danish
- • Male or female
- • 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 60 years of age
- • A STAI score in the range of 20-37 i.e., classified as “no or low anxiety” at inclusion
- • Known hypersensitivity or allergy towards the used pharmaceutical compounds or pharmaceutical compounds similar to those used in 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
- • Lactating
- • 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.