Study Stopped
Study is no longer required by Brazil health authority.
Safety of Phenylephrine Hydrochloride, Acetaminophen, Dimethindene Maleate Compared to Phenylephrine Hydrochloride Alone in Healthy Volunteers
A Randomized, Crossover, Double-Blind Study To Evaluate The Safety Of An Association Of Phenylephrine Hydrochloride 10mg + Acetaminophen 500mg + Dimethindene Maleate 1 Mg Compared To Phenylephrine Hydrochloride 10mg In Healthy Volunteers
1 other identifier
interventional
N/A
1 country
1
Brief Summary
This study will evaluate the safety of phenylephrine hydrochloride 10 mg + acetaminophen 500 mg + dimethindene maleate 1 mg compared to phenylephrine hydrocloride 10 mg alone in healthy volunteers.
Trial Health
Trial Health Score
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1 active site
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 4, 2009
CompletedFirst Posted
Study publicly available on registry
December 7, 2009
CompletedStudy Start
First participant enrolled
September 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2010
CompletedMarch 3, 2016
March 1, 2016
2 months
December 4, 2009
March 2, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To compare the effect of phenylephrine hydrochloride 10mg + acetaminophen 500mg + dimethindene maleate 1mg and phenylephrine hydrochloride 10mg alone on vital signs
15 days
Secondary Outcomes (2)
Electrocardiographic (ECG) monitoring and evaluation of heart rhythm following dosing
15 days
To report and evaluate adverse events
15 days
Study Arms (2)
Phenylephrine HCL/Acetaminophen/Dimethindene Maleate
EXPERIMENTALPhenylephrine HCL/Acetaminophen/Dimethindene Maleate
Phenylephrine hydrochloride
ACTIVE COMPARATORPhenylephrine hydrochloride 10mg
Interventions
Phenylephrine HCL 10mg/Acetaminophen 500mg/Dimethindene Maleate 1mg
Eligibility Criteria
You may qualify if:
- Healthy volunteers between 18 and 50 years;
- Clinical examination without abnormal findings
- Ability to understand the nature and purpose of the study, including the risks and adverse effects
You may not qualify if:
- Any cardiovascular disease, coronary artery disease, circulation problems or history of stroke, peripheral vascular disease or arrhythmia
- History of serious adverse reactions or hypersensitivity any drug
- Hypersensitivity to the drug study drugs or chemically related compounds
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novartislead
Study Sites (1)
Scentryphar Pesquisa Clinica Ltda.
Campinas, São Paulo, Brazil
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Novartis Biociências S.A
Novartis
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
December 4, 2009
First Posted
December 7, 2009
Study Start
September 1, 2010
Primary Completion
November 1, 2010
Last Updated
March 3, 2016
Record last verified: 2016-03