임상 시험 Nct 페이지

Summary
EudraCT Number:2006-004323-10
Sponsor's Protocol Code Number:ESAMOX
National Competent Authority:Germany - BfArM
Clinical Trial Type:EEA CTA
Trial Status:Completed
Date on which this record was first entered in the EudraCT database:2007-01-19
Trial results View results
Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL
A. Protocol Information
A.1Member State ConcernedGermany - BfArM
A.2EudraCT number2006-004323-10
A.3Full title of the trial
Effektivität und Verträglichkeit von Esomeprazol, Moxifloxacin und Amoxicillin in der Reservetherapie der Helicobacter pylori Infektion.
A.4.1Sponsor's protocol code numberESAMOX
A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
A.8EMA Decision number of Paediatric Investigation Plan
B. Sponsor Information
B.Sponsor: 1
B.1.1Name of SponsorTechnische Universität Dresden
B.1.3.4CountryGermany
B.3.1 and B.3.2Status of the sponsorNon-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1Name of organisation providing support
B.4.2Country
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1Name of organisation
B.5.2Functional name of contact point
D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3IMP RoleTest
D.2 Status of the IMP to be used in the clinical trial
D.2.1IMP to be used in the trial has a marketing authorisation Yes
D.2.1.1.1Trade name Nexium mups 20 mg
D.2.1.1.2Name of the Marketing Authorisation holderAstraZeneca
D.2.1.2Country which granted the Marketing AuthorisationGermany
D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
D.2.5.1Orphan drug designation number
D.3 Description of the IMP
D.3.1Product nameEsomeprazol gastro-resistant tablets 20 mg
D.3.2Product code Esomeprazol
D.3.4Pharmaceutical form Film-coated tablet
D.3.4.1Specific paediatric formulation Information not present in EudraCT
D.3.7Routes of administration for this IMPOral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8INN - Proposed INNEsomeprazol
D.3.10 Strength
D.3.10.1Concentration unit mg milligram(s)
D.3.10.2Concentration typeequal
D.3.10.3Concentration number20
D.3.11 The IMP contains an:
D.3.11.1Active substance of chemical origin Yes
D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
The IMP is a:
D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
D.3.11.3.1Somatic cell therapy medicinal product No
D.3.11.3.2Gene therapy medical product No
D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
D.3.11.5Radiopharmaceutical medicinal product No
D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
D.3.11.7Plasma derived medicinal product No
D.3.11.8Extractive medicinal product No
D.3.11.9Recombinant medicinal product Information not present in EudraCT
D.3.11.10Medicinal product containing genetically modified organisms No
D.3.11.11Herbal medicinal product No
D.3.11.12Homeopathic medicinal product No
D.3.11.13Another type of medicinal product No
D.IMP: 2
D.1.2 and D.1.3IMP RoleTest
D.2 Status of the IMP to be used in the clinical trial
D.2.1IMP to be used in the trial has a marketing authorisation Yes
D.2.1.1.1Trade name Avalox
D.2.1.1.2Name of the Marketing Authorisation holderBayer Vital GmbH
D.2.1.2Country which granted the Marketing AuthorisationGermany
D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
D.2.5.1Orphan drug designation number
D.3 Description of the IMP
D.3.1Product nameMoxifloxacin tablets 400 mg
D.3.2Product code Moxifloxacin
D.3.4Pharmaceutical form Film-coated tablet
D.3.4.1Specific paediatric formulation Information not present in EudraCT
D.3.7Routes of administration for this IMPOral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8INN - Proposed INNMoxifloxacin
D.3.10 Strength
D.3.10.1Concentration unit mg milligram(s)
D.3.10.2Concentration typeequal
D.3.10.3Concentration number400
D.3.11 The IMP contains an:
D.3.11.1Active substance of chemical origin Yes
D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
The IMP is a:
D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
D.3.11.3.1Somatic cell therapy medicinal product No
D.3.11.3.2Gene therapy medical product No
D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
D.3.11.5Radiopharmaceutical medicinal product No
D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
D.3.11.7Plasma derived medicinal product No
D.3.11.8Extractive medicinal product No
D.3.11.9Recombinant medicinal product Information not present in EudraCT
D.3.11.10Medicinal product containing genetically modified organisms No
D.3.11.11Herbal medicinal product No
D.3.11.12Homeopathic medicinal product No
D.3.11.13Another type of medicinal product No
D.IMP: 3
D.1.2 and D.1.3IMP RoleTest
D.2 Status of the IMP to be used in the clinical trial
D.2.1IMP to be used in the trial has a marketing authorisation Yes
D.2.1.1.1Trade name Amoxicillin-ratiopharm 1000 mg
D.2.1.1.2Name of the Marketing Authorisation holderRatiopharm GmbH
D.2.1.2Country which granted the Marketing AuthorisationGermany
D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
D.2.5.1Orphan drug designation number
D.3 Description of the IMP
D.3.1Product nameAmoxicillin tablets 1000 mg
D.3.2Product code Amoxicillin
D.3.4Pharmaceutical form Film-coated tablet
D.3.4.1Specific paediatric formulation Information not present in EudraCT
D.3.7Routes of administration for this IMPOral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8INN - Proposed INNAmoxicillin
D.3.10 Strength
D.3.10.1Concentration unit mg milligram(s)
D.3.10.2Concentration typeequal
D.3.10.3Concentration number1000
D.3.11 The IMP contains an:
D.3.11.1Active substance of chemical origin Yes
D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
The IMP is a:
D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
D.3.11.3.1Somatic cell therapy medicinal product No
D.3.11.3.2Gene therapy medical product No
D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
D.3.11.5Radiopharmaceutical medicinal product No
D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
D.3.11.7Plasma derived medicinal product No
D.3.11.8Extractive medicinal product No
D.3.11.9Recombinant medicinal product Information not present in EudraCT
D.3.11.10Medicinal product containing genetically modified organisms No
D.3.11.11Herbal medicinal product No
D.3.11.12Homeopathic medicinal product No
D.3.11.13Another type of medicinal product No
D.8 Information on Placebo
E. General Information on the Trial
E.1 Medical condition or disease under investigation
E.1.1Medical condition(s) being investigated
Reserve Therapie der Helicobacter pylori Infection
MedDRA Classification
E.1.2 Medical condition or disease under investigation
E.1.2Version 8.1
E.1.2Level LLT
E.1.2Classification code 10054263
E.1.2Term Helicobacter infection
E.1.3Condition being studied is a rare disease No
E.2 Objective of the trial
E.2.1Main objective of the trial
Das primäre Studienziel ist die Effektivität eine Tripeltherapie bestehend aus Esomeprazol, Moxifloxacin und Amoxicillin in der Reservetherapie der Helicobacter pylori Infektion (Hauptzielkriterium: Eradikationsrate 4 Wochen nach Abschluß der Therapie). Die Studie prüft auf Überlegenheit einer 14-tägigen Therapiedauer im Vergleich zu einer 7-tägigen Therapiedauer.
E.2.2Secondary objectives of the trial
• Verträglichkeit
• posttherapeutische Antibiotikaresistenz
• Einfluß von Pathogenitätsfaktoren des Helicobacter pylori (cagA, vacA u.a.)
• Einfluß vom Metabolisierer-Status des Patienten (CYP2C19)
E.2.3Trial contains a sub-study No
E.3Principal inclusion criteria
- männliche und weibliche Patienten 18 Jahre oder älter
- Helicobacter pylori Infektion nachgewiesen durch Kultur und Histologie
- Indikation zur Therapie gemäß den Maastricht-2 Konsensus-Empfehlungen (6)
- mindestens eine vorangegangene erfolglose Standardtherapie
- prätherapeutisches Antibiogramm
- schriftliche Einwilligung nach erfolgter Aufklärung des Patienten
E.4Principal exclusion criteria
- in-vitro Resistenz gegen Moxifloxacin und/oder Amoxicillin
- aktuelles kompliziertes Ulkus (Blutung, Stenose, Perforation)
- tägliche Einnahme nicht-steroidaler Antirheumatika
- begleitende Therapie mit Medikamenten, für die mögliche Wechselwirkungen der
Studienmedikation beschrieben wurden
- bekannte Unverträglichkeit gegen die Studienmedikation
- Magenteilresektion, Vagotomie
- Chronische Hepatitis B oder C, Leberzirrhose Child B und C, andere chronische
Lebererkrankungen
- Transaminasenerhöhung auf > 5-fach des oberen Normwertes
- Medikamentös behandelte Depression oder früherer Suizidversuch
- bekannte Herzrhythmusstörungen, Verlängerung der QT-Zeit, Neigung zu
Kammertachykardien
- Gleichzeitige Anwendung von anderen Arzneimitteln, die das QT-Intervall
verlängern
- Bradykardie (klinisch relevant)
- Herzinsuffizienz (klinisch relevant) mit reduzierter linksventrikulärer Auswurffraktion
oder symptomatischen Herzrythmusstörungen
- Überempfindlichkeit gegen andere Chinolone (als Avalox)
- Sehnenerkrankungen/-schäden infolge einer Anwendung von Chinolonen in der
Anamnese
- Störung des Elektrolythaushaltes, insbesondere bei unkorrigierter Hyperkaliämie
- Heriditäre Glactoseintoleranz
- Lactasemangel oder Glucose-Galactose-Malabsorption
- Therapie mit Antibiotika oder Wismut zwischen Endoskopie (Screening) und
Studieneinschluß (Visite 1)
- bekanntes Malignom
- schwere Begleiterkrankungen (Karnovsky-Index < 60)
- Fehlende Kontrazeption
- Schwangerschaft, Stillzeit: weibliche Prüfungsteilnehmer mit „fehlender
Kontrazeption“ werden von dieser Studie ausgeschlossen. Gebärfähige Frauen
müssen während der Teilnahme an der Studie eine zuverlässige und medizinisch
akzeptierte Methode der Schwangerschaftsverhütung praktizieren (z. B.
Antikonzeptiva, Verhütungsstäbchen, Hormonspirale, Vaginalring,
Verhütungspflaster, Dreimonatsspritze)
- Teilnahme an einer anderen klinischen Prüfung innerhalb von 30 Tagen vor Beginn
dieser Therapie
E.5 End points
E.5.1Primary end point(s)
Definierter Studienendpunkt ist der C13-Harnstoff-Atemtest 4 Wochen nach Therapieende. Bei positivem Ergebnis des C13-Atemtest (Therapieversager) soll zusätzlich innerhalb von 2 Wochen eine Endoskopie mit Helicobacter pylori Kultur und Antibiogramm durchgeführt werden.
E.6 and E.7 Scope of the trial
E.6Scope of the trial
E.6.1Diagnosis No
E.6.2Prophylaxis No
E.6.3Therapy Yes
E.6.4Safety No
E.6.5Efficacy Yes
E.6.6Pharmacokinetic No
E.6.7Pharmacodynamic No
E.6.8Bioequivalence No
E.6.9Dose response No
E.6.10Pharmacogenetic No
E.6.11Pharmacogenomic No
E.6.12Pharmacoeconomic No
E.6.13Others No
E.7Trial type and phase
E.7.1Human pharmacology (Phase I) No
E.7.1.1First administration to humans No
E.7.1.2Bioequivalence study No
E.7.1.3Other No
E.7.1.3.1Other trial type description
E.7.2Therapeutic exploratory (Phase II) No
E.7.3Therapeutic confirmatory (Phase III) Yes
E.7.4Therapeutic use (Phase IV) No
E.8 Design of the trial
E.8.1Controlled Yes
E.8.1.1Randomised Yes
E.8.1.2Open Yes
E.8.1.3Single blind No
E.8.1.4Double blind No
E.8.1.5Parallel group No
E.8.1.6Cross over No
E.8.1.7Other No
E.8.2 Comparator of controlled trial
E.8.2.1Other medicinal product(s) No
E.8.2.2Placebo No
E.8.2.3Other Yes
E.8.2.3.1Comparator description
kürzere Therapiedauer (7-tägig)
E.8.3 The trial involves single site in the Member State concerned No
E.8.4 The trial involves multiple sites in the Member State concerned Yes
E.8.4.1Number of sites anticipated in Member State concerned11
E.8.5The trial involves multiple Member States No
E.8.6 Trial involving sites outside the EEA
E.8.6.1Trial being conducted both within and outside the EEA No
E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
E.8.7Trial has a data monitoring committee No
E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
E.8.9 Initial estimate of the duration of the trial
E.8.9.1In the Member State concerned years5
E.8.9.1In the Member State concerned months8
E.8.9.1In the Member State concerned days
F. Population of Trial Subjects
F.1 Age Range
F.1.1Trial has subjects under 18 No
F.1.1.1In Utero Information not present in EudraCT
F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
F.1.1.3Newborns (0-27 days) Information not present in EudraCT
F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
F.1.1.5Children (2-11years) Information not present in EudraCT
F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
F.1.2Adults (18-64 years) Yes
F.1.3Elderly (>=65 years) Yes
F.2 Gender
F.2.1Female Yes
F.2.2Male Yes
F.3 Group of trial subjects
F.3.1Healthy volunteers No
F.3.2Patients Yes
F.3.3Specific vulnerable populations Yes
F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2007-01-19. Yes
F.3.3.2Women of child-bearing potential using contraception Yes
F.3.3.3Pregnant women No
F.3.3.4Nursing women No
F.3.3.5Emergency situation No
F.3.3.6Subjects incapable of giving consent personally No
F.3.3.7Others No
F.4 Planned number of subjects to be included
F.4.1In the member state130
F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
Nach Beendigung der Studienteilnahme liegt die Weiterbehandlung des Patienten im Ermessen des Prüfers.
G. Investigator Networks to be involved in the Trial
N. Review by the Competent Authority or Ethics Committee in the country concerned
N.Competent Authority Decision Authorised
N.Date of Competent Authority Decision2006-11-10
N.Ethics Committee Opinion of the trial applicationFavourable
N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
N.Date of Ethics Committee Opinion
P. End of Trial
P.End of Trial StatusCompleted
P.Date of the global end of the trial2010-09-19

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