Drug Release and Absorption from Controlled Release Formulations in Patients with Gastrointestinal Dysfunctions.
- Conditions
- MedDRA version: 20.0 Level: LLT Classification code 10012594 Term: Diabetes System Organ Class: 100000004861MedDRA version: 20.0 Level: LLT Classification code 10048516 Term: Gastrointestinal disorder (NOS) System Organ Class: 100000004856Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Healthy (pain) and patients (pain).MedDRA version: 20.0 Level: LLT Classification code 10050554 Term: Gastric bypass NOS System Organ Class: 100000004865MedDRA version: 20.1 Level: LLT Classification code 10009093 Term: Chronic pancreatitis System Organ Class: 100000004856
- Registration Number
- EUCTR2017-000732-34-DK
- Lead Sponsor
- Mech-Sense, Dept. Gastroenterology & Hepatology, Aalborg University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 135
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
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method