ID

23481

Beschreibung

Responsible Party: Hevert-Arzneimittel GmbH & Co. KG ClinicalTrials.gov Identifier: NCT02296814 History of Changes Other Study ID Numbers: SHDE-1 2014-000907-29 ( EudraCT Number ) DRKS00006877 ( Registry Identifier: DRKS ) Study First Received: November 7, 2014 Last Updated: July 16, 2015 Efficacy and Safety of Sinusitis Hevert SL Tablets Compared to Placebo in Adult Patients With Acute, Uncomplicated Rhinosinusitis (CESAR) ODM derived from: https://clinicaltrials.gov/ct2/show/NCT02296814

Link

https://clinicaltrials.gov/ct2/show/NCT02296814

Stichworte

Versionen (1)
  1. 07.07.17 07.07.17 -
Hochgeladen am

7. Juli 2017

DOI

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Eligibility Rhinosinusitis NCT02296814 DRKS00006877

Englisch

Eligibility Rhinosinusitis NCT02296814 DRKS00006877

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI-1
C1512693
1. Signed informed consent
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
2. Male and female outpatients, aged ≥ 18 and ≤ 75 years
Beschreibung

Outpatient, Age

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0029921
UMLS CUI [1,2]
C0001779
3. Diagnosis of acute, uncomplicated (or recurrent acute) rhinosinusitis - characterized by Major Rhinosinusitis Symptom Score (MRSSinv) ≥ 8 and ≤ 15 points - individual score for facial pain/pressure (on bending) ≥ 1 (mild) and ≤ 2 (moderate) - with presence of symptoms ≤ 3 days prior to inclusion Out of the 5 main rhinosinusitis symptoms, at least 3 must be present. Among these, the presence of nasal congestion and facial pain / pressure (on bending) is mandatory.
Beschreibung

Rhinosinusitis

Datentyp

boolean

Alias
UMLS CUI [1]
C0948780
4. Women of childbearing potential: willingness to use contraception methods
Beschreibung

Contraceptive Methods

Datentyp

boolean

Alias
UMLS CUI [1]
C0700589
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI-1
C0680251
Medical History: Diseases 1. Chronic rhinosinusitis (i.e. all forms and causes of persistent chronic rhinosinusitis)
Beschreibung

Chronic rhinosinusitis

Datentyp

boolean

Alias
UMLS CUI [1]
C0149516
Medical History: Diseases 2. Polyposis nasi, recent history
Beschreibung

Nasal Polyps

Datentyp

boolean

Alias
UMLS CUI [1]
C0027430
Medical History: Diseases 3. Infection of dental origin in the maxilla
Beschreibung

Maxilla Infection

Datentyp

boolean

Alias
UMLS CUI [1]
C1400602
Medical History: Diseases 4. Cystic fibrosis, recent history
Beschreibung

Cystic fibrosis

Datentyp

boolean

Alias
UMLS CUI [1]
C0010674
Medical History: Diseases 5. Anatomical deviations of the nasal septum that significantly impair nasal and paranasal ventilation / air flow
Beschreibung

Deviated nasal septum

Datentyp

boolean

Alias
UMLS CUI [1]
C0549397
Medical History: Diseases 6. Acute symptoms of a known allergic rhinitis
Beschreibung

Allergic Rhinitis

Datentyp

boolean

Alias
UMLS CUI [1]
C2607914
Medical History: Diseases 7. History of smoking within the last two years prior to study enrolment or current smoking habits
Beschreibung

Smoking Status

Datentyp

boolean

Alias
UMLS CUI [1]
C1519386
Medical History: Diseases 8. Patients with asthma
Beschreibung

Asthma

Datentyp

boolean

Alias
UMLS CUI [1]
C0004096
Medical History: Diseases 9. Known hypersensitivity to study medication or excipients (asteraceae, lactose, allergy to bee venom, etc.)
Beschreibung

Hypersensitivity to Study Drug

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0304229
Medical History: Diseases 10. Underlying diseases leading to a significant immune deficiency
Beschreibung

Immune Deficiency

Datentyp

boolean

Alias
UMLS CUI [1]
C1855771
Medical History: Diseases 11. Signs or symptoms of bacterial sinusitis requiring antibiotic treatment (e.g. fever >38.3°C, orbital complications, severe unilateral frontal headache or toothache)
Beschreibung

Bacterial Sinusitis

Datentyp

boolean

Alias
UMLS CUI [1]
C1262006
Medical History: Diseases 12. atients with progressive auto-immune diseases, tuberculosis, leukemia or leukemia-like diseases, multiple sclerosis, inflammatory diseases of the connective tissues, rheumatoid arthritis, Lupus erythematodes, HIV infection or other chronic viral diseases
Beschreibung

Comorbidity

Datentyp

boolean

Alias
UMLS CUI [1]
C0009488
Medical History: Diseases 13. Patients with untreated/unstable thyroid gland disorder (treatment should not include iodine supplementation)
Beschreibung

Thyroid Diseases

Datentyp

boolean

Alias
UMLS CUI [1]
C0040128
Medical History: Diseases 14. Pre-menopausal women (last menstruation ≤ 1 year prior to informed consent) who: - are nursing or pregnant, - or are of child-bearing potential and are not practicing an acceptable method of birth control, or do not plan to continue using this method throughout the study. Acceptable methods of birth control include transdermal patch, intra uterine devices/systems (IUDs/IUSs), oral, implantable or injectable contraceptives, double barrier methods, sexual abstinence and vasectomised partner.
Beschreibung

Gynaecological Status

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0700589
Medical History: Diseases 15. Severe diseases of liver or kidney
Beschreibung

Liver or Kidney Disease

Datentyp

boolean

Alias
UMLS CUI [1]
C0023895
UMLS CUI [2]
C0022658
Medical History: Diseases 16. Severe somatopathic, neurological and / or psychiatric diseases
Beschreibung

Neurological or Mental Disorder

Datentyp

boolean

Alias
UMLS CUI [1]
C0027765
UMLS CUI [2]
C0004936
Medical History: Diseases 17. Patients with malignant growth processes or cancer treatment within the last two years prior to study inclusion.
Beschreibung

Malignant Neoplasms

Datentyp

boolean

Alias
UMLS CUI [1]
C0006826
Medical History: Diseases 18. History of alcohol or drug abuse
Beschreibung

Substance Use Disorder

Datentyp

boolean

Alias
UMLS CUI [1]
C0038586
Medical History: Medication 1. Treatment with systemic or nasal antibiotics or nasal or systemic corticosteroids within the last 4 weeks prior to study inclusion
Beschreibung

Antibiotics, Corticosteroids

Datentyp

boolean

Alias
UMLS CUI [1]
C0003232
UMLS CUI [2]
C0001617
Medical History: Medication 2. Treatment with alternative medicine preparations (homeopathic and phytotherapeutical drugs) for treatment of common cold like symptoms or with immunomodulating properties (such as Echinacea), within the last 7 days prior to study inclusion
Beschreibung

Alternative medicine

Datentyp

boolean

Alias
UMLS CUI [1]
C0002346
Medical History: Medication 3. Treatment with decongestant (α-sympathomimetics on the day of study inclusion within 5 hours prior to screening and during the study)
Beschreibung

Decongestants

Datentyp

boolean

Alias
UMLS CUI [1]
C0282374
Medical History: Medication 4. Chronic use of decongestant remedies
Beschreibung

Chronic Use of Decongestants

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0282374
UMLS CUI [1,2]
C0205191
Medical History: Medication 5. Treatment with immunosuppressive medication 8 weeks prior to study inclusion and during the study for any condition
Beschreibung

Immunosuppression

Datentyp

boolean

Alias
UMLS CUI [1]
C0021079
Medical History: Medication 6. Systemic antiviral treatment such as aciclovir; zanamivir, or oseltamivir within 30 days prior to study inclusion
Beschreibung

Antiviral Treatment

Datentyp

boolean

Alias
UMLS CUI [1]
C2363964
Medical History: Medication 7. Patients requiring antibiotic treatment for any condition at study entry
Beschreibung

Requiring Antibiotics

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0003232
UMLS CUI [1,2]
C0027552
Medical History: General 1. Parallel participation in any other clinical study or participation in another study within less than 6 weeks prior to study inclusion, or previous participation in this same study
Beschreibung

Study Participation Status

Datentyp

boolean

Alias
UMLS CUI [1]
C2348568
Medical History: General 2. Legal incapacity and / or other circumstances rendering the patient unable to understand the nature, scope and possible impact of the study
Beschreibung

Understanding Ability

Datentyp

boolean

Alias
UMLS CUI [1]
C0582778
Medical History: General 3. Patients in custody by juridical or official order
Beschreibung

Custody

Datentyp

boolean

Alias
UMLS CUI [1]
C0680610
Medical History: General 4. Patients who have difficulties in understanding the language (German) in which the patient information is given
Beschreibung

Language Ability

Datentyp

boolean

Alias
UMLS CUI [1]
C1145677
Medical History: General 5. Patients who are employees of a trial center, the CRO, the sponsor or its authorised representatives or are relatives either of the study site staff, the CRO staff; the sponsor staff or its authorised representatives
Beschreibung

Relationship

Datentyp

boolean

Alias
UMLS CUI [1]
C0439849
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Ähnliche Modelle

Eligibility Rhinosinusitis NCT02296814 DRKS00006877

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Inclusion Criteria
C1512693 (UMLS CUI-1)
Informed Consent
Item
1. Signed informed consent
boolean
C0021430 (UMLS CUI [1])
Outpatient, Age
Item
2. Male and female outpatients, aged ≥ 18 and ≤ 75 years
boolean
C0029921 (UMLS CUI [1,1])
C0001779 (UMLS CUI [1,2])
Rhinosinusitis
Item
3. Diagnosis of acute, uncomplicated (or recurrent acute) rhinosinusitis - characterized by Major Rhinosinusitis Symptom Score (MRSSinv) ≥ 8 and ≤ 15 points - individual score for facial pain/pressure (on bending) ≥ 1 (mild) and ≤ 2 (moderate) - with presence of symptoms ≤ 3 days prior to inclusion Out of the 5 main rhinosinusitis symptoms, at least 3 must be present. Among these, the presence of nasal congestion and facial pain / pressure (on bending) is mandatory.
boolean
C0948780 (UMLS CUI [1])
Contraceptive Methods
Item
4. Women of childbearing potential: willingness to use contraception methods
boolean
C0700589 (UMLS CUI [1])
Item Group
Exclusion Criteria
C0680251 (UMLS CUI-1)
Chronic rhinosinusitis
Item
Medical History: Diseases 1. Chronic rhinosinusitis (i.e. all forms and causes of persistent chronic rhinosinusitis)
boolean
C0149516 (UMLS CUI [1])
Nasal Polyps
Item
Medical History: Diseases 2. Polyposis nasi, recent history
boolean
C0027430 (UMLS CUI [1])
Maxilla Infection
Item
Medical History: Diseases 3. Infection of dental origin in the maxilla
boolean
C1400602 (UMLS CUI [1])
Cystic fibrosis
Item
Medical History: Diseases 4. Cystic fibrosis, recent history
boolean
C0010674 (UMLS CUI [1])
Deviated nasal septum
Item
Medical History: Diseases 5. Anatomical deviations of the nasal septum that significantly impair nasal and paranasal ventilation / air flow
boolean
C0549397 (UMLS CUI [1])
Allergic Rhinitis
Item
Medical History: Diseases 6. Acute symptoms of a known allergic rhinitis
boolean
C2607914 (UMLS CUI [1])
Smoking Status
Item
Medical History: Diseases 7. History of smoking within the last two years prior to study enrolment or current smoking habits
boolean
C1519386 (UMLS CUI [1])
Asthma
Item
Medical History: Diseases 8. Patients with asthma
boolean
C0004096 (UMLS CUI [1])
Hypersensitivity to Study Drug
Item
Medical History: Diseases 9. Known hypersensitivity to study medication or excipients (asteraceae, lactose, allergy to bee venom, etc.)
boolean
C0020517 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
Immune Deficiency
Item
Medical History: Diseases 10. Underlying diseases leading to a significant immune deficiency
boolean
C1855771 (UMLS CUI [1])
Bacterial Sinusitis
Item
Medical History: Diseases 11. Signs or symptoms of bacterial sinusitis requiring antibiotic treatment (e.g. fever >38.3°C, orbital complications, severe unilateral frontal headache or toothache)
boolean
C1262006 (UMLS CUI [1])
Comorbidity
Item
Medical History: Diseases 12. atients with progressive auto-immune diseases, tuberculosis, leukemia or leukemia-like diseases, multiple sclerosis, inflammatory diseases of the connective tissues, rheumatoid arthritis, Lupus erythematodes, HIV infection or other chronic viral diseases
boolean
C0009488 (UMLS CUI [1])
Thyroid Diseases
Item
Medical History: Diseases 13. Patients with untreated/unstable thyroid gland disorder (treatment should not include iodine supplementation)
boolean
C0040128 (UMLS CUI [1])
Gynaecological Status
Item
Medical History: Diseases 14. Pre-menopausal women (last menstruation ≤ 1 year prior to informed consent) who: - are nursing or pregnant, - or are of child-bearing potential and are not practicing an acceptable method of birth control, or do not plan to continue using this method throughout the study. Acceptable methods of birth control include transdermal patch, intra uterine devices/systems (IUDs/IUSs), oral, implantable or injectable contraceptives, double barrier methods, sexual abstinence and vasectomised partner.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0700589 (UMLS CUI [3])
Liver or Kidney Disease
Item
Medical History: Diseases 15. Severe diseases of liver or kidney
boolean
C0023895 (UMLS CUI [1])
C0022658 (UMLS CUI [2])
Neurological or Mental Disorder
Item
Medical History: Diseases 16. Severe somatopathic, neurological and / or psychiatric diseases
boolean
C0027765 (UMLS CUI [1])
C0004936 (UMLS CUI [2])
Malignant Neoplasms
Item
Medical History: Diseases 17. Patients with malignant growth processes or cancer treatment within the last two years prior to study inclusion.
boolean
C0006826 (UMLS CUI [1])
Substance Use Disorder
Item
Medical History: Diseases 18. History of alcohol or drug abuse
boolean
C0038586 (UMLS CUI [1])
Antibiotics, Corticosteroids
Item
Medical History: Medication 1. Treatment with systemic or nasal antibiotics or nasal or systemic corticosteroids within the last 4 weeks prior to study inclusion
boolean
C0003232 (UMLS CUI [1])
C0001617 (UMLS CUI [2])
Alternative medicine
Item
Medical History: Medication 2. Treatment with alternative medicine preparations (homeopathic and phytotherapeutical drugs) for treatment of common cold like symptoms or with immunomodulating properties (such as Echinacea), within the last 7 days prior to study inclusion
boolean
C0002346 (UMLS CUI [1])
Decongestants
Item
Medical History: Medication 3. Treatment with decongestant (α-sympathomimetics on the day of study inclusion within 5 hours prior to screening and during the study)
boolean
C0282374 (UMLS CUI [1])
Chronic Use of Decongestants
Item
Medical History: Medication 4. Chronic use of decongestant remedies
boolean
C0282374 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
Immunosuppression
Item
Medical History: Medication 5. Treatment with immunosuppressive medication 8 weeks prior to study inclusion and during the study for any condition
boolean
C0021079 (UMLS CUI [1])
Antiviral Treatment
Item
Medical History: Medication 6. Systemic antiviral treatment such as aciclovir; zanamivir, or oseltamivir within 30 days prior to study inclusion
boolean
C2363964 (UMLS CUI [1])
Requiring Antibiotics
Item
Medical History: Medication 7. Patients requiring antibiotic treatment for any condition at study entry
boolean
C0003232 (UMLS CUI [1,1])
C0027552 (UMLS CUI [1,2])
Study Participation Status
Item
Medical History: General 1. Parallel participation in any other clinical study or participation in another study within less than 6 weeks prior to study inclusion, or previous participation in this same study
boolean
C2348568 (UMLS CUI [1])
Understanding Ability
Item
Medical History: General 2. Legal incapacity and / or other circumstances rendering the patient unable to understand the nature, scope and possible impact of the study
boolean
C0582778 (UMLS CUI [1])
Custody
Item
Medical History: General 3. Patients in custody by juridical or official order
boolean
C0680610 (UMLS CUI [1])
Language Ability
Item
Medical History: General 4. Patients who have difficulties in understanding the language (German) in which the patient information is given
boolean
C1145677 (UMLS CUI [1])
Relationship
Item
Medical History: General 5. Patients who are employees of a trial center, the CRO, the sponsor or its authorised representatives or are relatives either of the study site staff, the CRO staff; the sponsor staff or its authorised representatives
boolean
C0439849 (UMLS CUI [1])
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