Effect of Propranolol on the Autonomic Nervous System and Muscle Pain
NCT ID: NCT01333150
Last Updated: 2012-03-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
16 participants
INTERVENTIONAL
2011-08-31
2012-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
DOUBLE
Study Groups
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Propranolol
Propranololhydrochlorid
One single dose of Propranolol tablet of 40 mg randomized in one of the two sessions
Placebo
Placebo
One single dose of placebo
Interventions
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Propranololhydrochlorid
One single dose of Propranolol tablet of 40 mg randomized in one of the two sessions
Placebo
One single dose of placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Characteristic Pain Intensity (CPI) more than or equal to 20 (Axe II, RDC/TMD questionnaire)
* Women of childbearing potential must use adequate contraception
* Signed consent statement
Exclusion Criteria
* Recognized existing malignancy or within last 5 years
* Known HIV
* Abuse of drugs including alcohol
* Recognized Raynaud's syndrome
* Former sympathectomy
* Known cardiovascular disease including abnormal EKG and blood pressure (ECG-12 is recorded before the first trial session and assessed by the physician)
* Recognized lung insufficience, including bronchial asthma
* Known severe hepatic or renal dysfunction
* Known diabetes mellitus
* Known severe depression
* Pregnancy (tests performed in both sessions 1 and 2 before the start of a session)
* Fertility Treatment
* Lactation
* Post-menopausal
* Previous adverse reaction when taking beta-blocker, including hypersensitivity to propranolol or to any of the excipients
* Patients who can not read and understand the written information
* Patients who can not follow the protocol
* Patients who do not agree to comply with the requirements for participation in both studies regarding food intake, physical activity, etc.
18 Years
60 Years
FEMALE
No
Sponsors
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Aarhus University Hospital
OTHER
University of Aarhus
OTHER
Responsible Party
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Principal Investigators
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Peter Svensson, DDS, PhD, Dr.Odont
Role: PRINCIPAL_INVESTIGATOR
University of Aarhus
Locations
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Section of Clinical Oral Physiology,Department of Dentistry,HEALTH. Aarhus University
Aarhus, , Denmark
Section of Clinical Oral Physiology, Aarhus University
Aarhus C, , Denmark
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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M-20090062
Identifier Type: -
Identifier Source: org_study_id
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