Effect of Desmopressin on the Nocturnal Micturition Frequ... | NCT00806468

Studies
Effect of Desmopressin on the Nocturnal Micturition Frequency in Patients With Parkinson Disease

NCT00806468

Sponsor

Johannes Gutenberg University Mainz

Status

Terminated

Last Update Posted

Dec 20, 2010Estimated

Enrollment

1Actual

Phase

Phase 4

Conditions

Parkinson Disease

Interventions

Desmotabs

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2010

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

lack of recruitment

Expanded Access Info

Start Date

Feb 2009

Primary Completion Date

Dec 2010Estimated

Completion Date

Feb 2011Estimated

First Submitted Date

Dec 9, 2008

First Submission Date that Met QC Criteria

Dec 9, 2008

First Posted Date

Dec 10, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 17, 2010

Last Update Posted Date

Dec 20, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

1Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Desmopressin	Experimental	Desmopressin 0,2 mg once daily and Desmopressin 0,2 mg bid for one week each.	Drug: Desmotabs

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Desmotabs	Drug	Desmotabs encapsulated, 0,2 mg once daily for one week, 0,2 mg bid for one week	Desmopressin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
average nocturnal micturition frequency within the 2 weeks treatment phase each		6 weeks

Secondary Outcomes

Measure	Description	Time Frame
safety and efficacy on nocturnal micturition frequency of Desmopressin in patients with Parkinson syndrome		8 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male patients with idiopathic Parkinson Syndrome
18 to 85 years
Nocturnal Pollakisuria > 2 mictions /night (documented in Screening phase )
Na+ i.S > 135 mmol/l
Patient is able to understand all aspects and individual consequences of the clinical trial
An informed consent signed and dated by the patient is available prior to any study specific treatment
The study is consistent with the patients´ request for an appropriate treatment

Exclusion Criteria:

Intake of the following concomitant medication: Carbamazepin, Oxcarbazepine, diuretics (Furosemide, Torasemide), non steroidal antiphlogistics, Loperamide, antidiuretic hormone analoga (besides study medication), drugs for treatment of bladder disfunction, in particular anticholinergics
Central Diabetes insipidus
Known heart insufficiency (NYHA Stad. III und IV)
clinical relevant kidney insufficiency
Habitual and psychogenic Polydipsia
Hypersensitivity or allergy against the trial medication or any other ingredient of the trial medication
Participation in another clinical trial during or within 6 months prior to this clinical trial
Medical or psychological condition, which might endanger the proper conduction of the clinical trial
Known drug or alcohol abuse

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Thomas Vogt, MD	Johannes Gutenberg University Mainz, Department of Neurology	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Klinikum der Johannes Gutenberg-Universität Mainz, Studienzentrum Neurologie, Langenbeckstr. 1, 55131 Mainz		Mainz		55131	Germany

Condition Browse Module

MeSH Terms

ID	Term
D010300	Parkinson Disease
D053158	Nocturia

Ancestor Terms

ID	Term
D020734	Parkinsonian Disorders
D001480	Basal Ganglia Diseases
D001927	Brain Diseases
D002493	Central Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D003894	Deamino Arginine Vasopressin

Ancestor Terms

ID	Term
D001127	Arginine Vasopressin
D014667	Vasopressins
D010909	Pituitary Hormones, Posterior
D010907	Pituitary Hormones

Browse Leaves

Not provided

Browse Branches

Not provided