Chronic diarrhea - The effect of opium tincture on the gastrointestinal function MedDRA version: 20.1 Level: LLT Classification code 10066556 Term: Chronic diarrhea System Organ Class: 100000004856
Conditions
Interventions
Trade Name: Dropizol
Product Name: Dropizol
Pharmaceutical Form: Oral drops, liquid
Pharmaceutical form of the placebo: Oral drops, liquid
Route of administration of the placebo: Oral use
Sponsors
Mech-Sense, Aalborg University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Signed informed consent before any study specific procedures • Able to read and understand Danish • Male or female with an age of 20 years or more • The researcher believes that the participant understands what the study entails, are capable of following instructions, can attend when needed, and are expected to complete the study. • The investigator will ensure that fertile female participants have a negative pregnancy test before each treatment visit and use contraception during the entity of the study. • Opioid naïve* • Healthy (assessed by a study-affiliated medical doctor) 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 20 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Known allergy towards pharmaceutical compounds similar to Dropizol. • Participation in other studies within 14 days of first visit (1 year if opioids involved). • Expected need of medical/surgical treatment during the study • History of psychiatric illness (e.g. mental retardation, schizophrenia, affective disorders (depression), personality disorders or treatment with psychoactive medications) • History of substance abuse (e.g. alcohol, nicotine, THC, benzodiazepine, central stimulants and/or opioids) • Family history of substance abuse • Increased intracranial pressure • Known major stenosis of the intestines • Planned MRI within the next 3 months • Metal implants or pacemaker • Severe decreased renal function (defined as eGFR below 45) • Severe decreased hepatic function (defined as Child-Pugh class B or higher) • Treatment with MAO- inhibitors during the entity of the study • Severe COPD or acute severe asthma (defined as FEV1 below 50 % or acute ongoing exacerbation) • Cor pulmonale • Female participants that are lactating • Medicine known to affect gastrointestinal motility must not be initiated during the entity of the study • Use of any analgesic medication within 48 hours before start as well as for the duration of the study (urine drug test will be performed prior to treatment start). • Intake of alcohol within 48 hours before start of study period as well as for the duration of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Main objective of the trial is to describe the efficacy and safety of opium tincture (Dropizol (R), Pharmanovia A/S, Denmark) against chronic diarrhea;Secondary Objective: Not applicable;Primary end point(s): Primary endpoint: To evaluate change in transit time with 3D transit (main segments);Timepoint(s) of evaluation of this end point: At baseline and during treatment with Dropizol | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Change in the following MRI parameters for all segments (stomach, small and large intestine): Motility index. Parameter C, secretion volume. • Change in bowel questionnaires • Change in side effects • Tachyphylaxis between the different gut segments • Change in quantitative sensory testing (QST) • Change in resting EEG • Change in pupil diameter • Change in Continuous reaction time (CRT) ;Timepoint(s) of evaluation of this end point: 1. at baseline and at end of treatment 2. at baseline and at end of treatment 3. at baseline, during treatment, and at the end of treatment 4. at baseline and at end of treatment 5. at baseline and at end of treatment 6. at baseline and at end of treatment 7. at baseline and at end of treatment 8. at baseline and at end of treatment | — |
Countries
Denmark
Contacts
Public ContactTina Okdahl
Mech-Sense, Aalborg University Hospital
Outcome results
None listed