Healthy (pain) and patients (pain). MedDRA version: 20.1 Level: LLT Classification code 10009093 Term: Chronic pancreatitis System Organ Class: 100000004856 MedDRA version: 20.0 Level: LLT Classification code 10012594 Term: Diabetes System Organ Class: 100000004861 MedDRA version: 20.0 Level: LLT
Conditions
Interventions
Trade Name: Oxynorm
Product Name: Oxynorm
Pharmaceutical Form: Oral solution
INN or Proposed INN: Oxycodone
CAS Number: 124-90-3
Sponsors
Mech-Sense, Dept. Gastroenterology & Hepatology, Aalborg University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective of this study is to investigate the impact of GI-pathophysiology on net absorption of oxycodone administered as immediate release formulations and two different types of CRFs in patients with gastrointestinal disorders and to compare results obtained in healthy volunteers. ;Secondary Objective: Secondary objectives are to investigate if the pharmacodynamic effect of oxycodone is different depending on the formulation both within patients groups and when compared to healthy volunteers. ;Primary end point(s): The primary endpoints are the pharmacokinetic parameters defined as Cmax (maximum plasma concentration), Tmax (time at maximum plasma concentration), F (bioavailabilty), ka (rate of absorption) and AUC (area under the plasma concentration curve). These values are all derived from the blood concentrations of oxycodone. ;Timepoint(s) of evaluation of this end point: Eighteen blood samples (9 mL each) will be taken at specified times over a periode of 12 hours. One before drug administration and the rest after. A final blood sample will be taken the next morning (approx. 24 hours after drug administration). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Pharmadynamics parameters defined as o Change in pupil size when given oxycodone. o Pain response to muscle pressure. ; Timepoint(s) of evaluation of this end point: Pupil eye diameter will be recorded 19 times during the day. One time before drug administration and the rest afterwards. Muscle pressure will be applied 9 times during the day. One before drug administration and the rest afterwards. | — |
Countries
Denmark
Contacts
Public ContactLouise Ladebo Rasmussen
Mech-Sense, Dept. Gastroenterology & Hepatology, Aalborg University Hospital
Outcome results
None listed