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Trial registered on ANZCTR
Registration number
ACTRN12618001817235
Ethics application status
Approved
Date submitted
3/11/2018
Date registered
7/11/2018
Date last updated
16/07/2019
Date data sharing statement initially provided
7/11/2018
Type of registration
Prospectively registered
Titles & IDs
Public title
The extent and rate of atropine sulfate absorption when administered under the tongue in humans
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Scientific title
Pharmacokinetics of atropine after sublingual and oral administration in healthy and clozapine-treated adults
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Secondary ID [1]
296509
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None
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Universal Trial Number (UTN)
U1111-1223-2206
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Hypersalivation
310290
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Drooling
310291
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Condition category
Condition code
Mental Health
309025
309025
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0
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Schizophrenia
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
The study will involve the administration of 0.6mg atropine sulfate solution under the tongue (sublingual) on day 1, 0.6mg atropine sulfate oral (swallowed) tablet at least 4 days after day 1, then 1.2mg atropine sulfate solution under the tongue at least 4 days after day 2.
All participants will have the study medications at this sequence of administration.
The extent and rate of atropine sulfate absorption after sublingual administration will be compared to that after the tablet oral administration.
The study will involve the administration of each dose once only.
Participants will be observed over the first one hour after the medication administration. Participants will be remaining in the Charles Perkins Unit clinics area over the study period (10 hours) on each of the study days.
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Intervention code [1]
312824
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Treatment: Drugs
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Comparator / control treatment
The pharmacokinetics of the 0.6mg sublingual dose will be compared to that of the 0.6mg oral tablet and to the 1.2mg atropine sulfate oral tablet
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Control group
Active
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Outcomes
Primary outcome [1]
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Time needed for the atropine sulfate to be detected in the venous blood as assessed by serial blood collection.
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Assessment method [1]
307986
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Timepoint [1]
307986
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Immediately prior to the administration of the study medication then 5, 10, 20, 30, 40, and 60 minutes and at 2, 3, 6, 8, 9, 10 hours post administration
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Secondary outcome [1]
353572
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Pulse rate as assessed by sphygnamometer
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Assessment method [1]
353572
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Timepoint [1]
353572
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The pulse rate will be checked at baselines and then every 15 minutes over the first one hour then every 30 minutes over following one hour after the administration of the study medication.
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Secondary outcome [2]
353573
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Amount of saliva secreted over 5 minutes. Cotton rolls and saliva pads will be used to measure the saliva amount secreted.
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Assessment method [2]
353573
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Timepoint [2]
353573
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Saliva secretion will be measured at baselines and 2 hours after the administration of the study medication
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Eligibility
Key inclusion criteria
Healthy Participants:
1. Age: between 18 and 50 year old
2. Non pregnant or breast feeding
3. Able to consent for participation in the study
4. Healthy as per the pathology test results, ECG, and medical history.
Clozapine-treated patients:
1. Age: between 18 and 50 year old
2. Non pregnant or breast feeding
3. Able to consent for participation in the study
4. Treated with clozapine.
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Minimum age
18
Years
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Maximum age
50
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
Healthy Participants:
1. Known allergy to atropine
2. Over the last 3 months found to have a serum bilirubin, albumin, or INR outside the normal range.
3. Over the last 3 months found to have an eGFR less than 90mL/min/1.73m2
4. Known to have or found upon screening to have high blood pressure ( more than 140/90), postural hypotension, angina, or cardiac arrhythmia.
5. Known to have glaucoma, myasthenia gravis, prostatic hypertrophy, bladder obstruction, GI obstructive disease such as ileus, or other medical illness that may be seriously adversely affected by atropine, tachycardia secondary to cardiac insufficiency or thyrotoxicosis, fever, or pregnancy induced hypertension.
6. Have dry mouth, hypersalivation or drooling.
7. Treated with an anticoagulants, antiarrhythmics, depolarising and non-depolarising muscle relaxants, or neuromuscular blocking agents.
8. Treated with a medication that has an anticholinergic effects such as: olanzapine, quetiapine, chlorpromazine, hyoscine, benztropine, ipratropium bromide, oxybutynin, solifenacin, darifenacin, sedating antihistamines such as promethazine, benzhexol, tricyclic or tetracyclic antidepressants. Inhalation medications with anticholinergic effect are exempted.
9. Treated with a medication with a cholinergic effect such as Anticholinesterases used in the treatment of dementia such as donepezil.
Clozapine treated participants:
Known to have any of the following conditions:
1. Known allergy to atropine
2. Females during the menstrual period
3. Over the last 3 months found to have a serum bilirubin, albumin, or INR outside the normal range.
4. Over the last 3 months found to have an eGFR less than 90mL/min/1.73m2
5. Known to have or found upon screening to have high blood pressure (more than 140/90), postural hypotension, angina, or cardiac arrhythmia.
6. Known to have glaucoma, myasthenia gravis, prostatic hypertrophy, bladder obstruction, GI obstructive disease such as ileus, or other medical illness that may be seriously adversely affected by atropine, tachycardia secondary to cardiac insufficiency or thyrotoxicosis, fever, or pregnancy induced hypertension.
7. Have severe constipation or diarrhoea.
8. Have dry mouth, hypersalivation or drooling.
9. Wearing dental braces
10. Treated with an anticoagulants, antiarrhythmics, depolarising and non-depolarising muscle relaxants, or neuromuscular blocking agents.
11. Is treated with any medication other than clozapine that is known to have a significant anticholinergic effects such as: olanzapine, quetiapine, chlorpromazine, hyoscine, benztropine, ipratropium bromide, oxybutynin, solifenacin, darifenacin, sedating antihistamines such as promethazine, benzhexol, tricyclic or tetracyclic antidepressants. Inhalation medications with anticholinergic effect are exempted.
12. Treated with a medication with a cholinergic effect such as Anticholinesterases used in the treatment of dementia such as donepezil.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Not applicable
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
The 1.2mg sublingual atropine dose will be on the third study day for all participants
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Phase
Phase 1 / Phase 2
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Type of endpoint/s
Pharmacokinetics
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
19/08/2019
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Actual
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Date of last participant enrolment
Anticipated
1/04/2020
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Actual
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Date of last data collection
Anticipated
1/05/2020
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Actual
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Sample size
Target
20
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Accrual to date
0
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Final
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
12355
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Royal Prince Alfred Hospital - Camperdown
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Recruitment hospital [2]
12356
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Concord Repatriation Hospital - Concord
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Recruitment postcode(s) [1]
24596
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2050 - Camperdown
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Recruitment postcode(s) [2]
24597
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2139 - Concord
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Funding & Sponsors
Funding source category [1]
301097
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Government body
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Name [1]
301097
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Sydney Local Health District
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Address [1]
301097
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Level 11 KGV Building, Missenden Rd, Camperdown, NSW 2050
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Country [1]
301097
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Australia
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Primary sponsor type
Government body
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Name
Sydney Local Health District
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Address
Level 11 KGV Building, Missenden Rd, Camperdown, NSW 2050
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Country
Australia
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Secondary sponsor category [1]
300707
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Individual
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Name [1]
300707
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Professor Tim Lambert
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Address [1]
300707
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Concord Repatriation and General Hospital, Hospital Rd, Concord West, NSW 2139
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Country [1]
300707
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Australia
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Secondary sponsor category [2]
300717
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University
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Name [2]
300717
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The University of Sydney
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Address [2]
300717
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Level 6, Janes Foss Russell Building, Darlington NSW 2006
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Country [2]
300717
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Australia
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Secondary sponsor category [3]
300726
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Individual
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Name [3]
300726
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Omar Mubaslat
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Address [3]
300726
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Department of Pharmacy, Royal Prince Alfred Hospital. Missenden Rd, NSW 2050
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Country [3]
300726
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
301846
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Sydney Local Health District Ethics Review Committee (RPAH Zone)
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Ethics committee address [1]
301846
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Research Ethics and Governance Office (REGO), Royal Prince Alfred Hospital, Missenden Road, CAMPERDOWN NSW 2050
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Ethics committee country [1]
301846
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Australia
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Date submitted for ethics approval [1]
301846
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09/11/2018
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Approval date [1]
301846
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01/02/2019
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Ethics approval number [1]
301846
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HREC/18/RPAH/687
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Summary
Brief summary
Atropine sulfate 1% is commonly prescribed to treat excess saliva secretion and drooling in patients treated with clozapine. Clozapine is used for the treatment of schizophrenia.
In this study we aim to measure the amount of atropine that is absorbed when the atropine is administered under the tongue
We will be enrolling healthy adults and clozapine treated adults so we can compare the absorption between the two types of people.
We will also compare the amount of atropine absorbed after under the tongue administration to that after oral (swallowing) administration
The effect of atropine on pulse rate and saliva secretion will be monitored and compared between the sublingual and oral administration.
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Trial website
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Trial related presentations / publications
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Public notes
Serial blood samples collection will be performed are Charles Perkins Center for healthy participants and clozapine treated participants who are residing in the community. One participant will be studied on any one day.
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Contacts
Principal investigator
Name
88310
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Mr Omar Mubaslat
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Address
88310
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The Department of Pharmacy, Royal Prince Alfred Hospital, Missenden Rd, 2050 NSW, Australia
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Country
88310
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Australia
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Phone
88310
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+61 2 9515 8145
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Fax
88310
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+61 2 9515 8400
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Email
88310
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[email protected]
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Contact person for public queries
Name
88311
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Mr Omar Mubaslat
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Address
88311
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The Department of Pharmacy, Royal Prince Alfred Hospital, Missenden Rd, 2050 NSW, Australia
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Country
88311
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Australia
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Phone
88311
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+61 2 9515 8145
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Fax
88311
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+61 2 9515 8400
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Email
88311
0
[email protected]
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Contact person for scientific queries
Name
88312
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Mr Omar Mubaslat
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Address
88312
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The Department of Pharmacy, Royal Prince Alfred Hospital, Missenden Rd, 2050 NSW, Australia
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Country
88312
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Australia
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Phone
88312
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+61 2 9515 8145
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Fax
88312
0
+61 2 9515 8400
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Email
88312
0
[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
No benefit from sharing data is anticipated
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
Source
Title
Year of Publication
DOI
Embase
Pharmacokinetics and Effects on Saliva Flow of Sublingual and Oral Atropine in Clozapine-Treated and Healthy Adults: An Interventional Cross-Over Study.
2022
https://dx.doi.org/10.5152/pcp.2022.21221
N.B. These documents automatically identified may not have been verified by the study sponsor.
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