ID

32367

Beschreibung

Safety and Efficacy Study of NH004 Films for Relief of Sialorrhea Symptoms in Parkinson's Disease Patients; ODM derived from: https://clinicaltrials.gov/show/NCT00761137

Link

https://clinicaltrials.gov/show/NCT00761137

Stichworte

Versionen (2)
  1. 28.10.18 28.10.18 -
  2. 28.10.18 28.10.18 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

28. Oktober 2018

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Sialorrhea Secondary to Parkinson's Disease NCT00761137

Englisch

Eligibility Sialorrhea Secondary to Parkinson's Disease NCT00761137

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. patients with idiopathic parkinson's disease, according to the uk brain bank criteria.
Beschreibung

Parkinson Disease

Datentyp

boolean

Alias
UMLS CUI [1]
C0030567
2. patients complaining of drooling, with a score of at least 3 in the fleni sialorrhea scale.
Beschreibung

Drooling | Sialorrhea Rating scale

Datentyp

boolean

Alias
UMLS CUI [1]
C0013132
UMLS CUI [2,1]
C0037036
UMLS CUI [2,2]
C0681889
3. patient is between 50 and 80 years of age, inclusive.
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
4. male or non-pregnant female. females of child-bearing potential will be required to have undergone a pregnancy test with negative results prior to entry to the study and agree to use contraceptive measures for the duration of the study.
Beschreibung

Gender | Gender Pregnancy Absent | Childbearing Potential Pregnancy test negative | Childbearing Potential Contraceptive methods

Datentyp

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2,1]
C0079399
UMLS CUI [2,2]
C0032961
UMLS CUI [2,3]
C0332197
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0427780
UMLS CUI [4,1]
C3831118
UMLS CUI [4,2]
C0700589
5. patients must have used the same medication and dose for pd for the last month. no changes in the medication for pd are expected during the study.
Beschreibung

Pharmaceutical Preparations Same Parkinson Disease | Pharmaceutical Preparations Dosage Same Parkinson Disease

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0445247
UMLS CUI [1,3]
C0030567
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C0445247
UMLS CUI [2,4]
C0030567
6. patients who can reasonable be expected to be on "on-state" for the duration of the testing procedures.
Beschreibung

Patient state | Testing

Datentyp

boolean

Alias
UMLS CUI [1]
C0683521
UMLS CUI [2]
C0039593
7. patients who have a stable response to levodopa for pd.
Beschreibung

Levodopa Parkinson Disease | Response Stable

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0023570
UMLS CUI [1,2]
C0030567
UMLS CUI [2,1]
C1704632
UMLS CUI [2,2]
C0205360
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. pregnant women or women who may become pregnant.
Beschreibung

Pregnancy | Pregnancy possible

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0425965
2. patients with a diagnosis of depression, schizophrenia or with obvious symptoms of these diseases.
Beschreibung

Depressive disorder | Schizophrenia | Symptoms Depressive disorder | Symptoms Schizophrenia

Datentyp

boolean

Alias
UMLS CUI [1]
C0011581
UMLS CUI [2]
C0036341
UMLS CUI [3,1]
C1457887
UMLS CUI [3,2]
C0011581
UMLS CUI [4,1]
C1457887
UMLS CUI [4,2]
C0036341
3. patients with mmse score equal to or lower than 26.
Beschreibung

Mini-mental state examination

Datentyp

boolean

Alias
UMLS CUI [1]
C0451306
4. patients who are receiving the following drugs: tricyclic antidepressants, maoi's, neuroleptics (antipsychotics), or anticholinergics.
Beschreibung

Tricyclic Antidepressive Agents | Monoamine Oxidase Inhibitors | Antipsychotic Agents | Anticholinergic Agents

Datentyp

boolean

Alias
UMLS CUI [1]
C0003290
UMLS CUI [2]
C0026457
UMLS CUI [3]
C0040615
UMLS CUI [4]
C0242896
5. patients who have taken any of the drugs mentioned in exclusion criteria number 4 within the last week.
Beschreibung

Pharmaceutical Preparations Excluded

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0332196
6. patients with hypersensitivity to atropine or other anticholinergic drugs.
Beschreibung

Atropine allergy | Anticholinergic allergy

Datentyp

boolean

Alias
UMLS CUI [1]
C0570993
UMLS CUI [2]
C0570982
7. patients who have experienced adverse effects as a result of taking anticholinergic drugs.
Beschreibung

Adverse effects Due to Anticholinergic Agents

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0879626
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C0242896
8. patients taking hypnotic or other sleep inducing drugs.
Beschreibung

Hypnotics | Sleep Inducing Drugs

Datentyp

boolean

Alias
UMLS CUI [1]
C0020591
UMLS CUI [2]
C0871377
9. patients with severe urinary or gastrointestinal symptoms.
Beschreibung

Urinary symptoms Severe | Gastrointestinal symptoms Severe

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0426359
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C0426576
UMLS CUI [2,2]
C0205082
10. patients with significant dental/oral pathology.
Beschreibung

Dental Diseases | Mouth Diseases

Datentyp

boolean

Alias
UMLS CUI [1]
C1704330
UMLS CUI [2]
C0026636
11. patients with severe dysautonomia.
Beschreibung

Dysautonomia Severe

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0013363
UMLS CUI [1,2]
C0205082
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Ähnliche Modelle

Eligibility Sialorrhea Secondary to Parkinson's Disease NCT00761137

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Parkinson Disease
Item
1. patients with idiopathic parkinson's disease, according to the uk brain bank criteria.
boolean
C0030567 (UMLS CUI [1])
Drooling | Sialorrhea Rating scale
Item
2. patients complaining of drooling, with a score of at least 3 in the fleni sialorrhea scale.
boolean
C0013132 (UMLS CUI [1])
C0037036 (UMLS CUI [2,1])
C0681889 (UMLS CUI [2,2])
Age
Item
3. patient is between 50 and 80 years of age, inclusive.
boolean
C0001779 (UMLS CUI [1])
Gender | Gender Pregnancy Absent | Childbearing Potential Pregnancy test negative | Childbearing Potential Contraceptive methods
Item
4. male or non-pregnant female. females of child-bearing potential will be required to have undergone a pregnancy test with negative results prior to entry to the study and agree to use contraceptive measures for the duration of the study.
boolean
C0079399 (UMLS CUI [1])
C0079399 (UMLS CUI [2,1])
C0032961 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
C3831118 (UMLS CUI [3,1])
C0427780 (UMLS CUI [3,2])
C3831118 (UMLS CUI [4,1])
C0700589 (UMLS CUI [4,2])
Pharmaceutical Preparations Same Parkinson Disease | Pharmaceutical Preparations Dosage Same Parkinson Disease
Item
5. patients must have used the same medication and dose for pd for the last month. no changes in the medication for pd are expected during the study.
boolean
C0013227 (UMLS CUI [1,1])
C0445247 (UMLS CUI [1,2])
C0030567 (UMLS CUI [1,3])
C0013227 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0445247 (UMLS CUI [2,3])
C0030567 (UMLS CUI [2,4])
Patient state | Testing
Item
6. patients who can reasonable be expected to be on "on-state" for the duration of the testing procedures.
boolean
C0683521 (UMLS CUI [1])
C0039593 (UMLS CUI [2])
Levodopa Parkinson Disease | Response Stable
Item
7. patients who have a stable response to levodopa for pd.
boolean
C0023570 (UMLS CUI [1,1])
C0030567 (UMLS CUI [1,2])
C1704632 (UMLS CUI [2,1])
C0205360 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Pregnancy possible
Item
1. pregnant women or women who may become pregnant.
boolean
C0032961 (UMLS CUI [1])
C0425965 (UMLS CUI [2])
Depressive disorder | Schizophrenia | Symptoms Depressive disorder | Symptoms Schizophrenia
Item
2. patients with a diagnosis of depression, schizophrenia or with obvious symptoms of these diseases.
boolean
C0011581 (UMLS CUI [1])
C0036341 (UMLS CUI [2])
C1457887 (UMLS CUI [3,1])
C0011581 (UMLS CUI [3,2])
C1457887 (UMLS CUI [4,1])
C0036341 (UMLS CUI [4,2])
Mini-mental state examination
Item
3. patients with mmse score equal to or lower than 26.
boolean
C0451306 (UMLS CUI [1])
Tricyclic Antidepressive Agents | Monoamine Oxidase Inhibitors | Antipsychotic Agents | Anticholinergic Agents
Item
4. patients who are receiving the following drugs: tricyclic antidepressants, maoi's, neuroleptics (antipsychotics), or anticholinergics.
boolean
C0003290 (UMLS CUI [1])
C0026457 (UMLS CUI [2])
C0040615 (UMLS CUI [3])
C0242896 (UMLS CUI [4])
Pharmaceutical Preparations Excluded
Item
5. patients who have taken any of the drugs mentioned in exclusion criteria number 4 within the last week.
boolean
C0013227 (UMLS CUI [1,1])
C0332196 (UMLS CUI [1,2])
Atropine allergy | Anticholinergic allergy
Item
6. patients with hypersensitivity to atropine or other anticholinergic drugs.
boolean
C0570993 (UMLS CUI [1])
C0570982 (UMLS CUI [2])
Adverse effects Due to Anticholinergic Agents
Item
7. patients who have experienced adverse effects as a result of taking anticholinergic drugs.
boolean
C0879626 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C0242896 (UMLS CUI [1,3])
Hypnotics | Sleep Inducing Drugs
Item
8. patients taking hypnotic or other sleep inducing drugs.
boolean
C0020591 (UMLS CUI [1])
C0871377 (UMLS CUI [2])
Urinary symptoms Severe | Gastrointestinal symptoms Severe
Item
9. patients with severe urinary or gastrointestinal symptoms.
boolean
C0426359 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0426576 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
Dental Diseases | Mouth Diseases
Item
10. patients with significant dental/oral pathology.
boolean
C1704330 (UMLS CUI [1])
C0026636 (UMLS CUI [2])
Dysautonomia Severe
Item
11. patients with severe dysautonomia.
boolean
C0013363 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
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