Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000080224
Ethics application status
Approved
Date submitted
9/12/2008
Date registered
3/02/2009
Date last updated
7/04/2009
Type of registration
Prospectively registered

Titles & IDs
Public title
Desmopressin for the Treatment of Orthostatic Hypotension and Excessive Nighttime Urination in Parkinson’s Disease
Scientific title
A Double-Blind, Placebo-controlled Crossover Clinical Trial of Desmopressin for the Treatment of Orthostatic Hypotension and Nocturia in Parkinson’s Disease
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Nocturia 4107 0
Parkinson's Disease 4108 0
Orthostatic Hypotension 4109 0
Condition category
Condition code
Neurological 4301 4301 0 0
Other neurological disorders
Renal and Urogenital 4302 4302 0 0
Other renal and urogenital disorders
Neurological 4303 4303 0 0
Parkinson's disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Subjects will start with either nightly placebo or oral desmopressin for three weeks. After a washout period of one week of no medication, they will then switch to the therapy they have not tried for another three weeks.

Subjects taking desmopressin will begin with a 100 mcg nightly dose. If this is tolerated, after one week they will increase to 200 mcg nightly, which they will take for two weeks.
Intervention code [1] 3819 0
Treatment: Drugs
Comparator / control treatment
Oral microcellulose capsule taken nightly for three weeks
Control group
Placebo

Outcomes
Primary outcome [1] 5193 0
Improvement of at least 2 points on the COMPASS-OD survey, which assesses for symptoms of low blood pressure.
Timepoint [1] 5193 0
Assessed at day 21 and 49
Primary outcome [2] 5194 0
Number of nocturnal bladder voids as measured by a diary
Timepoint [2] 5194 0
Assessed at day 21 and 49
Secondary outcome [1] 8745 0
Improvement in sleep as measured by a survey (Epworth Sleepiness Scale)
Timepoint [1] 8745 0
Assessed at day 21 and 49

Eligibility
Key inclusion criteria
Parkinson's disease
Orthostatic hypotension (blood pressure drop with standing)
A need to empty the bladder 2 or more times at night
Minimum age
30 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
History of renal failure, congestive heart failure, or cirrhosis
A history of low blood sodium
Dementia

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Subjects will be enrolled by a convenience sample through our clinic. Treatment allocation will be done using numbered containers, with numbers assigned by a person otherwise uninvolved in the trial.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a randomization table created by a computer software.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
6/04/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 4269 0
Hospital
Name [1] 4269 0
Royal Brisbane & Women's Hospital
Country [1] 4269 0
Australia
Primary sponsor type
Individual
Name
John O'Sullivan
Address
RBWH, Butterfield St., Herston, QLD, 4029
Country
Australia
Secondary sponsor category [1] 3841 0
Individual
Name [1] 3841 0
Melinda Burnett
Address [1] 3841 0
RBWH, Butterfield St., Herston, QLD, 4029
Country [1] 3841 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6321 0
Royal Brisbane & Women's Hospital Human Research Ethics Committee
Ethics committee address [1] 6321 0
RBWH, Butterfield St., Herston, QLD, 4029
Ethics committee country [1] 6321 0
Australia
Date submitted for ethics approval [1] 6321 0
01/10/2008
Approval date [1] 6321 0
Ethics approval number [1] 6321 0
2008/103

Summary
Brief summary
We plan to study 20 patients with idiopathic Parkinson's disease with complications of orthostatic hypotension and nocturia. In an 8 week double-blinded, crossover study design, we will study the effects of oral desmopressin (or matching placebo) on orthostatic hypotension, nocturia, and sleep.
Trial website
Trial related presentations / publications
Schoffer, K.L., Henderson, R. D., O'Maley, K. O'Sullivan, J. D. Nonpharmacological treatment, fludrocortisone, and domperidone for orthostatic hypotension in Parkinson's disease. Mov Disord, 2007. 22(11): p. 1543-9.
Public notes

Contacts
Principal investigator
Name 35026 0
Address 35026 0
Country 35026 0
Phone 35026 0
Fax 35026 0
Email 35026 0
Contact person for public queries
Name 12373 0
Melinda Burnett
Address 12373 0
RBWH, Butterfield St., Herston, QLD, 4029
Country 12373 0
Australia
Phone 12373 0
+61 7 3636 8111
Fax 12373 0
Email 12373 0
[email protected]
Contact person for scientific queries
Name 3301 0
Melinda Burnett
Address 3301 0
RBWH, Butterfield St., Herston, QLD, 4029
Country 3301 0
Australia
Phone 3301 0
+61 7 3636 8111
Fax 3301 0
Email 3301 0
[email protected]

No information has been provided regarding IPD availability


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
No additional documents have been identified.