Severe exocrine pancreatic insufficiency MedDRA version: 20.0 Level: LLT Classification code 10033628 Term: Pancreatic insufficiency System Organ Class: 100000004856
Conditions
Interventions
Trade Name: Nortase
Pharmaceutical Form: Capsule
Trade Name: Kreon® 10 000
Pharmaceutical Form: Capsule, hard
Trade Name: Nexium® mups 40 mg
Pharmaceutical Form: Tablet
Sponsors
Repha GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Subjects suffering from a severe exocrine pancreatic insufficiency at screening (visit 1) verified by the medical record of the patient and an elastase-1 ELISA (=65 years) yes F.1.3.1 Number of subjects for this age range 4
Exclusion criteria
Exclusion criteria: - Acute pancreatitis or an acute episode within the course of a chronic pancreatitis 4 weeks before the determined study start or during the study - Chronic inflammatory intestinal disease - Bowel stenoses, which are known complications in subjects suffering from cystic fibrosis - Severe disease of lung, liver or kidney - Former surgeries in the gastrointestinal region with detectable influence on lipid-absorption and altered gastric passage (i.e. Whipple procedure, pancreaticoduodenectomy). Patients with pylorus-preserving pancreatic head resection, right sided pancreas resection, duodenum preserving pancreatic head resection might be included. - Impaired lipid-metabolism requiring optimal pharmaceutical treatment (cholesterol >400 mg/dL, triglycerides >400 mg/dL) - Treatment with antibiotics within 8 days before the breath test - Current concomitant medication with laxatives or medication influencing the intestinal motility 24 hours before a visit - Concomitant PPI intake 7 days before each visit (excluding study medication in preparation of Treatment D) - Any long-term medication that directly influences the pH of the gastrointestinal tract 7 days prior to each of the following visits (except Treatment D). This includes but is not limited to PPI, H2 blocking agents, COX inhibiting agents (NSAIDs) Acute, symptomatic treatment with pH-modulating agents (e.g. Bullrich Salz) or COX-inhibiting agents (e.g. ASS) is allowed until 24 hours prior to each visit (except for treatment D). - Known intolerances/allergies/hypersensitivities: o Lactose intolerance o Known mold-Allergy, incompatibility/allergy/sensitivity against Aspergillus oryzae and/or Rhizopus oryzae o Celiac disease, wheat allergy and wheat sensitivity; sensitivity, allergy or incompatibility to other cereals. o hereditary fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency o known incompatibility/allergy/sensitivity against hazelnuts or soy or any other component of Nutella® o to pork (pork allergy) or cultural rejection of pork ingredients o against one of the components of Nortase®: magnesium-stearate, lactose-monohydrate, hydroxypropylmethyl-cellulose (HPMC), coloring agents: iron oxide red E 172, titanium dioxide E 171 o against one of the components of Kreon®: cetyl alcohol, triethylcitrate, dimeticone 1000, macrogol 4000, hypromellose phthalate, gelatin, sodiummdodecylsulfate, titanium dioxide, iron[III]-oxide, iron[III]-hydroxide, iron[II,III]-oxide o to the active substance esomeprazole in Nexium mups®, to substituted benzimidazoles or to any of the excipients listed: Glycerol monostearate 40-55, hyprolose, hypromellose, iron[III]-oxide (E 172), magnesium stearate (Ph.Eur.), methacrylic acid-ethyl acrylate-copolymer (1:1) (Ph.Eur.), microcrystalline cellulose, hard paraffin, macrogol 6000, polysorbate 80, crospovidone, sodium stearyl fumarate (Ph.Eur.), sugar-starch-pellets (sucrose and maize starch), talcum, titan dioxide (E 171), triethyl Citrate - Concomitant use of the following medicinal products: o nelfinavir o atazanavir o clopidogrel o ketoconazole, itraconazole or voriconazole o erlotinib o citalopram, imipramine or clomipramine o diazepam o cilostazol o cisapride o digoxin o methotrexate o tacrolimus o rifampicin o St. John’s wort (Hypericum perforatum) o phenytoin in epileptic patients o warfarin or other coumarine derivatives. - Participation in another clinical study during the study and within the previou
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Comparison of the total 13CO2-emission values (=calculated as Area Under the Curve (AUC)t=0 240 min) between Nortase and Kreon.;Secondary Objective: Efficacy - Comparison of the total 13CO2-emission data (AUCt=0-240 min) between Nortase and Kreon + Nortase - Comparison of the total 13CO2-emission data (AUCt=0-240 min) between Nortase and Kreon + PPI - Comparison of the total 13CO2-emission data (AUCt=0-240 min) between Kreon and Kreon + PPI - Comparison of the total 13CO2-emission data (AUCt=0-240 min) between Kreon and Kreon + Nortase - Comparison of the total 13CO2-emission data (AUCt=0-240 min) between Kreon + PPI and Kreon + Nortase - Comparison of the time until the first measurable 13CO2-signal (t1) occurs in the respective treatment groups - Comparison of the time to reach the maximum lipase activity (tmax) in the respective treatment groups - Comparison of the maximum lipase activity (vmax) of administered therapy in the respective treatment groups. Safety and Tolerability - Type, frequency and severity of documented AEs and SAEs - Tolerability of the study medication (assessed by the subject);Primary end point(s): The primary objective is the comparison of the total 13CO2-emission values (=calculated as Area Under the Curve (AUC)t=0 240 min) between Nortase (B) and Kreon (A). Treatment A: 4 capsules of Kreon Treatment B: 6 capsules of Nortase;Timepoint(s) of evaluation of this end point: after administration of treatments A and B Treatment A: 4 capsules of Kreon Treatment B: 6 capsules of Nortase | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Efficacy - Comparison of the total 13CO2-emission data (AUCt=0-240 min) between Nortase and Kreon + Nortase (Add-On) - Comparison of the total 13CO2-emission data (AUCt=0-240 min) between Nortase and Kreon + PPI (acid resistance) - Comparison of the total 13CO2-emission data (AUCt=0-240 min) between Kreon and Kreon + PPI (acid resistance) - Comparison of the total 13CO2-emission data (AUCt=0-240 min) between Kreon and Kreon + Nortase (Add-On) - Comparison of the total 13CO2-emission data (AUCt=0-240 min) between Kreon + PPI and Kreon + Nortase - Comparison of the time until the first measurable 13CO2-signal (t1) occurs in the respective treatment groups - Comparison of the time to reach the maximum lipase activity (tmax) in the respective treatment groups - Comparison of the maximum lipase activity (vmax) of each administered therapy in the respective treatment groups. Safety and Tolerability - Type, frequency and severity of documented AEs and SAEs - Tolerability of the study medication (assessed by the subject);Timepoint(s) of evaluation of this end point: These secondary endpoints will be analysed in accordance with the primary endpoint. Safety data will be analysed descriptively. | — |
Countries
Germany
Contacts
Public ContactClinical Research
Mediconomics GmbH
Outcome results
None listed