Clinical studies
Studies with INFAI products
INFAI offers clinical trials to pharmaceutical companies with the following products (Helicobacter Test INFAI, Gastromotal, Pancreo-Lip).
To date, several clinical trials have been performed with INFAI products in various fields with pharmaceutical companies:
Clinical studies with ¹³C-urea breath test – Helicobacter Test INFAI
Eudra CT Number: 2017-001369-25 Start: 2017, Duration/Value: completed
The Sensitivity and Specificity of the Modified Helicobacter Test INFAI Using New Test Meal with ¹³C-Urea Breath Test in Helicobacter pylori Positive and Negative Patients with Dyspepsia and GERD Taking Proton Pump Inhibitors. Sponsor: INFAI
EudraCT Number: 2011-003425-96, Start: 2011-12-15, Duration/Value: ongoing
Helicobacter eradication to prevent ulcer bleeding in aspirin users: a large simple randomised controlled trial. Sponsor: University of Nottingham
EudraCT Number: 2010-019064-36, Start: 2011-07-17, Duration/Value: completed
Efficacy and Safety of PYLERA™ (Bismuth Subcitrate Potassium, Metronidazole, and Tetracycline Hydrochloride) With Omeprazole Given x 10 Days in Subjects Who Failed Treatment for Eradication of Helicobacter pylori. Sponsor: Aptalis Pharma Canada Inc.
EudraCT Number: 2010-021558-21, Start: 2011-02-08, Duration/Value: 2010-2011
A Phase IIa, Multi-Centre, Randomised, Double-Blind, Comparator Controlled, Repeated-Dose Study of 2 Dose Levels of AK106 001616 in Patients with Rheumatoid Arthritis. Sponsor: Asahi Kasei Pharma Cooperation.
EudraCT Number: 2008-008010-39, Start: 2009-04-23, Duration/Value: completed 2009-2013
The Sensitivity and Specificity of the modified Helicobacter Test INFAI using new test meal with ¹³C urea breath test in Helicobacter pylori positive and negative patients with Dyspepsia taking Proton Pump Inhibitors. Sponsor: INFAI GmbH.
EudraCT Number: 2007-007749-11, Start: 2008-08-05, Duration/Value: completed
An open-label, randomized, multicenter, two-arm efficacy and safety study of 14 days treatment with Finafloxacin 400 mg b.i.d. plus Amoxicillin 1000 mg b.i.d. versus Finafloxacin 400 mg b.i.d. plus Esomeprazole 40 mg b.i.d. in patients with Helicobacter pylori infection Finafloxacin in patients with Helicobacter: FLASH study. Sponsor: MerLion Pharmaceuticals GmbH
Study Code: HTSA, Status: completed 2008-2011
Non-Viable Lactobacillus reuteri DSMZ 17648 (Pylopass™) as a New Approach to Helicobacter pylori Control in Humans. Nutrients 2013, 5, 3062-3073. Sponsor: Charité Campus Berlin-Buch, HealthTwist GmbH.
EudraCT Number: 2007-006280-78, Start: 2008-03-28, Duration/Value: completed 2007-2009
Efficacy and Safety of Quadruple Therapy by Bismuth Subcitrate Potassium, Metronidazole, and Tetracycline Given x 10 days With Omeprazole in Eradication of Helicobacter pylori: A Comparison to Omeprazole, Amoxicillin and Clarithromycin Given x 7 days. Sponsor: Axcan Pharma Inc.
EudraCT Number: 2006-005073-2, Start: 2007-01-23, Duration/Value: completed 2006-2008
randomized, double-blind, parallel-group, multicentre, phase III study to assess the effect of esomeprazole 20 and 40 mg od versus placebo on the occurrence of peptic ulcers during 26 weeks in subjects on continuous lowdose acetylsalicylic acid (ASA). Sponsor: AstraZeneca AB
EudraCT Number: 2005-001282-34, Start: 2005-07-30, Duration/Value:
A multicentre, randomized, double-blind, placebo-controlled study of the efficacy and safety of itopride HCl in patients suffering from functional dyspepsia. Sponsor: Axcan Pharma Inc.
EudraCT Number: 2004-001234-17, Start: 2006-06-15, Duration/Value: completed 2007-2008
Double-blind, triple dummy, parallel-group, randomized, six-month study to compare celecoxib (200 mg BID) with diclofenac SR (75 mg BID) plus omeprazole (20 mg QD) for gastrointestinal events in subjects with osteoarthritis and rheumatoid arthritis at high-risk of gastrointestinal adverse events. Sponsor: Pfizer Limited
Clinical studies of Gastromotal for gastric emptying rate
EudraCT Number: 2011-002782-38, Start: 2012
Gastromotal ¹³C-octanoic acid breath test in the diagnosis and evaluation of therapeutic outcome in patients with dyspeptic symptoms and delayed gastric emptying. Sponsor: INFAI GmbH.
EudraCT Number: 2007-004997-23, Start: 2007
An exploratory, double-blind, randomized, stratified, placebo-controlled, repeated dose trial to investigate the efficacy of M0003 on symptoms suggestive for gastroparesis, to assess the pharmacodynamic effects on gastric emptying, and to assess the safety, tolerability and pharmacokinetics of M0003. Sponsor: Movetis NV.
Study Code: AA00/01, Study Period: 2000-2002, Phase of development: III
Validation of the ¹³CO2-octanoic acid breath test for the determination of gastric emptying rate in comparison to radioscintigraphy with 99mTc-albumin colloid. Sponsor: INFAI GmbH.
Study Code: OA99/1/001, Study Period: 1999-2000, Phase of development: III
Validation of the ¹³C-octanoic acid breath test for the determination of gastric emptying rate in comparison to radioscintigraphy with 99mTc-albumin colloid. Sponsor: INFAI GmbH.
Clin. Report No.: S246.1.102.01, Study Period: 1995-1996, Phase of development: I
Single, oral, rising-dose, placebo controlled, double-blind study of KC 11485 to investigate safety, tolerability and pharmacokinetics in healthy male volunteers. Sponsor: Solvay Pharmaceuticals B.V.
Clin. Report No.: S246.1.107.01, Study Period: 1996-1996, Phase of development: I
Single, intravenous, rising-dose, placebo controlled, double-blind study of KC 11485 to investigate safety, tolerability and pharmacokinetics in healthy male volunteers. Sponsor: Solvay Pharmaceuticals B.V.
Clin. Report No.: S246.1.110.01, Study Period: 1996-1996, Phase of development: I
Open, randomized, baseline placebo-controlled, 4-way cross-over study of single oral doses of KC 11458 to investigate the influence of enteric-coating with respect to a corresponding meal on the pharmacodynamics and pharmacokinetics of KC 11458 in healthy male volunteers. Sponsor: Solvay Pharmaceuticals B.V.
Clin. Report No.: S246.1.109.01, Study Period: 1996-1996, Phase of development: I
Intravenous, placebo-controlled, repeated rising-dose, randomized, double-blind study of KC 11458 to investigate safety, tolerability and pharmacokinetics in healthy male volunteers. Sponsor: Solvay Pharmaceuticals B.V.
Clin. Report No.: S246.1.104.01, Study Period: 1996-1996, Phase of development: II
Double-blind, randomized, placebo-controlled, single-dose, 4-way crossover study of 3 doses of KC 11458 to investigate the effect on gastric emptying in diabetic patients suffering from delayed gastric emptying. Sponsor: Solvay Pharmaceuticals B.V.
Clinical studies for severe exocrine pancreatic insufficiency (EPI)
Protocol Number: 2102CLI, Start: 2021
A 3-part Phase 1a/1b, first-in-human , randomized, double-blind, placebo-controlled study to evaluate safety, tolerability, and pharmacokinetics of single and multiple ascending doses of oral CDX 7108 in healthy adult subjects and to evaluate proof-of-concept via pharmacodynamics of a single dose of oral CDX 7108 in subjects with exocrine pancreatic insufficiency. Sponsor: Nestlé Suisse S.A.
Eudra CT Number: 2016-005063-13 Start: 2017, Duration/Value: completed
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. Sponsor: Repha GmbH
Study for urea-cycle-disorder
Study number: CCD07 Start 2009 Duration 2009-2010
Study to Evaluate 13 C Isotope Ratio Measurement for Urea Cycle Capacity Assessment. Sponsor: Cytonet
Clinical study with the Cardio Test INFAI
Study number: LipoNMR 14/D/16 Start 2017 Duration 2018-2019
Bewertung der Effektivität ausgewählter Aphereseverfahren anhand der Veränderungen von Lipoproteinfraktionen und Subfraktionen vor und nach Lipoproteinapherese bei Patienten mit Fettstoffwechselstörung mittels NMR-Spektroskopie sowie des etablierten photometrisch-kinetischen Standardverfahrens. Sponsor: INFAI
Screening study for the Metabo Test INFAI
Study number: IBDNMR09, Start 2009 Duration 2009-2012
Optimisation and validation of a fast screening method in the determination of metabolic diseases in neonates using high resolution NMR spectroscopy of urine. Sponsor: INFAI and Bruker