Investigation of Efficacy, Safety, Acid Resistance and Mode of Action of Lipases in Nortase and Kreon with the Pancreo-Lip 13C breath test in Subjects with Severe Exocrine Pancreatic Insufficiency

Phase 1

• Conditions: Severe exocrine pancreatic insufficiency; MedDRA version: 20.0Level: LLTClassification code 10033628Term: Pancreatic insufficiencySystem Organ Class: 100000004856; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2016-005063-13-DE
• Lead Sponsor: Repha GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-03-09
• Last Update Posted: 12 August 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 24

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 (< 100 µg elastase-1/g stool)
- Discontinuation of PPI treatment 7 days prior to each of the following visits 2 - 6 (exception: study medication in order to prepare treatment D)
- Subjects of both sexes aged = 18 years
- Written informed consent signed by the subject
- The subject is willing and in a constitution to attend to the study over the whole duration, to finish the study and to comply with given instructions during the course of the study.
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) yes
F.1.3.1 Number of subjects for this age range 4

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified