Symptoms suggestive for gastroparesis MedDRA version: 9.1 Level: LLT Classification code 10018043 Term: Gastroparesis
Conditions
Interventions
Product Name: M0003
Pharmaceutical Form: Tablet
INN or Proposed INN: N/A
CAS Number: N/A
Current Sponsor code: M0003
Other descriptive name: R149402 (J&JPRDR-n°), refer to protocol page 8
Concentratio
Sponsors
Movetis NV
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Written informed consent form (ICF) signed voluntarily before the first trial related activity. 2. Aged between 18 and 70 years, extremes included. 3. Female subjects of childbearing potential should have a negative urine pregnancy test at screening and at baseline and have to use an efficient method of birth control during the duration of the clinical trial and until the first menses after a 30 days period following the last dose of trial medication. Females must be on a stable regimen, for at least one month, of oral contraceptives, contraceptive implant or depot injection, contraceptive patch, IUD, condom and spermicidal agent or diaphragm and spermicidal agent and willing to continue this contraception. 4. History of at least 3 months chronic upper abdominal discomfort during the previous 6 months prior to screening. 5. Weight as defined by a Quetelet index (Body Mass Index [BMI], weight in kg divided by the square of height in meters) between 18 and 35 kg/m² (extremes included). Only applicable for subjects with diabetes mellitus (Type I or II): 6. Documentation on medical record of diagnosis of diabetes mellitus. Subjects should be on stable treatment for diabetes for at least one month. 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Positive screening test for alcohol, barbiturate, amphetamine or narcotics at screening. 2. Haemoglobin (Hb)A1c > 10% at screening. 3. Subjects with severe diabetes resulting in severe neuropathic symptoms, nephropathy or proliferative retinopathy. 4. History of cardiac arrhythmias, bronchospastic disease, cardiovascular disease (e.g., history of ischaemic heart disease or cerebrovascular accident), thyrotoxicosis, parkinsonism, drug allergy. 5. Presence of prolonged QTc (Bazett and Fridericia) on ECG at screening (QTc = 450 msec for males and QTc = 470 msec for females). For diabetic patients, QTc = 480 msec. 6. Subjects with a history of upper abdominal surgery (less than 6 months ago) or GI cancer (less than 5 years ago). 7. Cholecystectomy less than 6 months ago. 8. Delayed gastric emptying due to organic cause. 9. Stomach ulcus less than 3 months ago. 10. Displaying hepatitis symptoms 11. Use of drugs known to prolong QT interval and/or to induce torsades de pointes. 12. Use of potent CYP3A4 inhibitors 7 days before the start of treatment. 13. Use of prokinetics 7 days before the start of treatment. 14. Use of anti-cholinergic drugs 7 days before start of treatment. 15. Any condition that in the opinion of the investigator(s) would complicate or compromise the trial or the well being of the subject or evidence of clinically relevant pathology that could interfere with the trial results or put the subject’s safety at risk 16. Participation in an investigational drug trial in 30 days prior to enrollment into this trial. 17. Pregnant or breastfeeding subjects. 18. Malignant desease of any kind during the previous 5 years except for successfully treated skin (basal or squamous cell) cancer. 19. Subjects who are expected to be non-compliant and/or not co-operative. 20. Subjects who are employees at the investigational site (in the case of hospital, at the same department), relatives or spouse of the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: n.a. due to the exploratory character of the study.;Secondary Objective: · To explore the efficacy of 4 weeks dosing of M0003 on symptom severity (as measured by the gastroparesis cardinal symptoms index [GCSI], subject assessment of upper gastro-intestinal symptom severity index [PAGI-SYM] and diary), in comparison to placebo; · To explore the pharmacodynamic (PD) effect and the dose-relationship of 4 weeks dosing of M0003 on gastric emptying parameters (as measured in the 13C-octanoic acid breath test) and on meal related symptoms, in comparison to placebo; · To assess the safety, tolerability, and plasma concentrations of a repeated dose of M0003 in subjects with upper GI tract motility disturbances suggestive for nondiabetic or diabetic gastroparesis.;Primary end point(s): n.a. due to the exploratory character of the study. | — |
Countries
Belgium, Germany, Lithuania, Netherlands
Outcome results
None listed