ES2655505T3 - Producto y procedimiento para el tratamiento de la diarrea - Google Patents

Producto y procedimiento para el tratamiento de la diarrea Download PDF

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Publication number
ES2655505T3
ES2655505T3 ES14722445.5T ES14722445T ES2655505T3 ES 2655505 T3 ES2655505 T3 ES 2655505T3 ES 14722445 T ES14722445 T ES 14722445T ES 2655505 T3 ES2655505 T3 ES 2655505T3
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treatment
patients
diarrhea
group
procedure
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Reed B. Hogan Ii
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MAREGADE RX LLC
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MAREGADE RX LLC
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/335Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
    • A61K31/34Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having five-membered rings with one oxygen as the only ring hetero atom, e.g. isosorbide
    • A61K31/341Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having five-membered rings with one oxygen as the only ring hetero atom, e.g. isosorbide not condensed with another ring, e.g. ranitidine, furosemide, bufetolol, muscarine
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/41Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
    • A61K31/41641,3-Diazoles
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/41Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
    • A61K31/425Thiazoles
    • A61K31/4261,3-Thiazoles
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0053Mouth and digestive tract, i.e. intraoral and peroral administration
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/12Antidiarrhoeals
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2300/00Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y02TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
    • Y02ATECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
    • Y02A50/00TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
    • Y02A50/30Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

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  • Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Organic Chemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)
  • Investigating Or Analysing Biological Materials (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)

Abstract

Antagonista del receptor H1 y antagonista del receptor H2 para utilizar en el tratamiento de la diarrea en un paciente, en el que el paciente presenta diarrea inducida por quimioterapia, y el antagonista del receptor H1 comprende cetirizina, levocetirizina o mezclas de las mismas.

Description

imagen1
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deposiciones
6
0%
0
10-25%
1
28-45%
1
50-65%
0
66-85%
0
> 86%
Ejemplo 8: Estudio del Tratamiento de la diarrea crónica (no es parte de la invención)
La edad de la población del estudio fue de 21 a 70, con pacientes con diagnóstico de diarrea crónica, que dieron su
5 consentimiento para el tratamiento. Se excluyeron los pacientes si había una sensibilidad o alergia a los antagonistas del receptor H1 o antagonistas del receptor H2, insuficiencia renal o historial de insuficiencia renal, un diagnóstico de enfermedad inflamatoria del intestino (enfermedad de Crohn o colitis ulcerosa), una infección activa conocida del colon (tal como Clostridium difficile, giardia o Salmonella), colitis microscópica demostrada por biopsia (colitis colagenosa o linfocítica), o una incapacidad para suspender otros agentes anti-diarreicos durante el estudio. Los pacientes también
10 fueron excluidos si eran mujeres embarazadas o en periodo de lactancia, o si el paciente estaba tomando atazanavir, itraconazol o ketoconazol. El estudio fue iniciado después de la aprobación del IRB.
El estudio fue un ensayo comparativo, doble ciego, de distribución aleatoria, durante 4 semanas, con cruzamiento. Después de obtener el consentimiento informado, los pacientes fueron asignados aleatoriamente a uno de los dos grupos 15 (activo o placebo), sin saber los pacientes ni los médicos a qué grupo fue asignado cada paciente. A cada paciente se le proporcionó el procedimiento de tratamiento que le fue asignado al azar y se le dio un diario para documentar los síntomas. Después de 7 días de tratamiento, los individuos participaron en una entrevista telefónica con un miembro del equipo de investigación que desconocía el tratamiento. Se permitió el cruzamiento después de una semana de tratamiento para quienes no tuvieron respuesta. Al final del estudio de 28 días, los pacientes completaron un cuestionario detallado. La
20 calidad de las heces se evaluó utilizando la Escala de heces de Bristol de 7 puntos.
El grupo "activo" recibió famotidina (24 mg) y cetirizina (9 mg), una vez por día, con ambos fármacos combinados en forma de una sola cápsula. El grupo "placebo" recibió una cápsula una vez al día, que no contenía principios activos.
25 Los resultados del estudio se muestran en la Tabla 6. La tabla muestra los resultados de 27 pacientes, 12 en el grupo placebo y 15 en el grupo activo. El valor promedio del porcentaje de cambio de heces por día (HPD) fue 25,08 para el grupo placebo, mientras que el valor promedio para un cambio de porcentaje en HPD fue 46,00 para el grupo activo. Sólo 3 de los pacientes del grupo activo aceptaron el cruzamiento, mientras que 9 de los pacientes del grupo placebo acordaron el cruzamiento. Los datos demuestran una significación clínica entre el grupo placebo y el grupo activo, y demuestran una
30 mejora significativa en la calidad de vida de los pacientes en el grupo activo.
Tabla 6: Resultados del Estudio del tratamiento de Diarrea crónica
Grupo
Número de pacientes Promedio Δ% HPD
Placebo
12 25.08
Activo
15 46.00
35 REFERENCIAS
Schiller LR, "Secretory Diarrhea" Current Gastroenterology Reports (1999) 1: 389-397.
Schiller, LR, Hogan RB, Morawski, SG, Santa Ana, CA, Bern MJ, Nogaard, RP, Bo-Linn, GW, Fordtran JS, "Studies of the 40 Prevalence and Significance of Radiolabeled Rice Acid Malabsorption in a Group of Patients with Idiopathic Chronic Diarrhea" Gastroenterology (1997) 92:151-160.
Fordtran JS, Santa Ana CA, Morawski SG, et al. "Pathophysiology of chronic diarrhea: insights derived from intestinal perfusion studies in 31 patients" Gastroenterol Clin North Am (1986) 15:477-490.
45
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Claims (1)

  1. imagen1
ES14722445.5T 2013-03-14 2014-03-14 Producto y procedimiento para el tratamiento de la diarrea Active ES2655505T3 (es)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201361782608P 2013-03-14 2013-03-14
US201361782608P 2013-03-14
PCT/US2014/027323 WO2014152420A2 (en) 2013-03-14 2014-03-14 Product and method for treating diarrhea

Publications (1)

Publication Number Publication Date
ES2655505T3 true ES2655505T3 (es) 2018-02-20

Family

ID=50680150

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ES17189072T Active ES2743604T3 (es) 2013-03-14 2014-03-14 Producto y procedimiento para el tratamiento de la diarrea

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US (4) US9717726B2 (es)
EP (3) EP2968205B1 (es)
JP (4) JP6313417B2 (es)
KR (4) KR20180088514A (es)
CN (2) CN108939076A (es)
AU (3) AU2014239878B2 (es)
BR (2) BR122017004716A2 (es)
CA (1) CA2906005C (es)
DK (1) DK2968205T3 (es)
ES (2) ES2655505T3 (es)
HK (1) HK1247557B (es)
HU (1) HUE035201T2 (es)
IL (3) IL273377B2 (es)
MX (2) MX350814B (es)
MY (1) MY175326A (es)
PL (1) PL2968205T3 (es)
PT (1) PT2968205T (es)
RU (1) RU2015143475A (es)
WO (1) WO2014152420A2 (es)
ZA (1) ZA201708539B (es)

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* Cited by examiner, † Cited by third party
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US9717726B2 (en) * 2013-03-14 2017-08-01 Maregade Rx, LLC Product and method for treating diarrhea
WO2015073573A1 (en) * 2013-11-14 2015-05-21 Jacobs Michael M Compositions and methods for the prevention and treatment of alcohol-induced hangover syndrome
EP3558296B1 (en) 2016-12-23 2023-06-28 Maregade RX, LLC Low dose product and method for treating diarrhea
IT201900012645A1 (it) * 2019-07-23 2021-01-23 Eros Zanotti Una composizione farmaceutica per l'uso nel trattamento delle chinetosi
CN117293008A (zh) * 2019-08-05 2023-12-26 株式会社日立高新技术 等离子处理装置
US20220408780A1 (en) * 2020-02-11 2022-12-29 The E. Wolfson Medical Center A method effective for treating ulcerative colitis
KR102936883B1 (ko) 2021-08-23 2026-03-11 주식회사 히타치하이테크 플라스마 처리 장치 및 플라스마 처리 방법
EP4408414A4 (en) * 2021-09-22 2025-10-22 Hista Rx Llc COMPOSITIONS AND METHODS FOR THE TREATMENT AND PREVENTION OF INTERSTITIAL CYSTITIS

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BR112015022513A2 (pt) 2017-07-18
WO2014152420A2 (en) 2014-09-25
JP2018135340A (ja) 2018-08-30
JP2016513692A (ja) 2016-05-16
IL273377B1 (en) 2023-06-01
IL241372A0 (en) 2015-11-30
BR122017004716A2 (pt) 2019-07-30
PL2968205T3 (pl) 2018-03-30
US20170049770A1 (en) 2017-02-23
JP2021046400A (ja) 2021-03-25
US20140275116A1 (en) 2014-09-18
JP6790140B2 (ja) 2020-11-25
JP6313417B2 (ja) 2018-04-18
IL241372B (en) 2018-06-28
US20190038619A1 (en) 2019-02-07
MX350814B (es) 2017-09-21
EP3581205A3 (en) 2020-03-25
JP6473254B2 (ja) 2019-02-20
EP3269364A1 (en) 2018-01-17
PT2968205T (pt) 2018-01-05
HUE035201T2 (hu) 2018-05-02
AU2017251701A1 (en) 2017-11-09
US11058681B2 (en) 2021-07-13
WO2014152420A3 (en) 2014-11-20
US9717726B2 (en) 2017-08-01
US10034875B2 (en) 2018-07-31
CN105324112A (zh) 2016-02-10
EP2968205B1 (en) 2017-10-11
CA2906005C (en) 2021-12-28
CN108939076A (zh) 2018-12-07
KR20210021606A (ko) 2021-02-26
KR20200100211A (ko) 2020-08-25
CA2906005A1 (en) 2014-09-25
KR101884506B1 (ko) 2018-08-01
CN105324112B (zh) 2018-08-17
EP3269364B1 (en) 2019-05-29
ES2743604T3 (es) 2020-02-20
MX366329B (es) 2019-07-05
AU2014239878B2 (en) 2017-08-24
ZA201708539B (en) 2019-05-29
MX2015011885A (es) 2016-05-16
KR20180088514A (ko) 2018-08-03
KR20150139535A (ko) 2015-12-11
IL273377B2 (en) 2023-10-01
RU2015143475A (ru) 2017-04-20
IL273377A (en) 2020-05-31
AU2019201412A1 (en) 2019-03-21
EP3581205A2 (en) 2019-12-18
IL256300A (en) 2018-02-28
DK2968205T3 (da) 2017-11-27
HK1213205A1 (en) 2016-06-30
AU2017251701B2 (en) 2019-03-14
IL256300B (en) 2020-04-30
KR102449977B1 (ko) 2022-09-30
HK1247557B (en) 2020-07-03
MY175326A (en) 2020-06-19
AU2014239878A1 (en) 2015-10-15
US20220047583A1 (en) 2022-02-17
EP2968205A2 (en) 2016-01-20
JP2019089796A (ja) 2019-06-13

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