Tramadol OIBD

Phase 1

• Conditions: Opioid induced bowel dysfunction; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: CTIS2022-500108-23-00
• Lead Sponsor: Aalborg University Hospital

Brief Summary

Summary of results - Tramadol_OIBD

Detailed Description

Not available

Study Timeline

• Study Start: 2022-03-04
• Study Completion: 2023-05-15
• Last Update Posted: 21 August 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 20

Inclusion Criteria

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 (who have not taken prescription opioid for one week or longer and at least a year have passed since completion of a previous opioid study.), 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.

Exclusion Criteria

Known hypersensitivity or allergy towards the used pharmaceutical compounds or pharmaceutical compounds similar to those used in the study., 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, Use of nicotine, 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., Use of any analgesic medication within 48 hours before start as well as for the duration of the study, 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).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified