EUCTR2016-005063-13-DE进行中（未招募）1 期
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 - NORTPANK
Repha GmbH0 个研究点目标入组 24 人开始时间: 2017年3月9日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 24
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •-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
排除标准
- •- 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 cilostazol
- •o cisapride
- •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
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