Safety of Phenylephrine Hydrochloride, Acetaminophen, Dimethindene Maleate Compared to Phenylephrine Hydrochloride Alone in Healthy Volunteers

Tracking Information
First Submitted Date ICMJE	December 4, 2009
First Posted Date ICMJE	December 7, 2009
Last Update Posted Date	March 3, 2016
Study Start Date ICMJE	September 2010
Estimated Primary Completion Date	November 2010 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: December 4, 2009)	To compare the effect of phenylephrine hydrochloride 10mg + acetaminophen 500mg + dimethindene maleate 1mg and phenylephrine hydrochloride 10mg alone on vital signs [ Time Frame: 15 days ]
Original Primary Outcome Measures ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01026961 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: December 4, 2009)	Electrocardiographic (ECG) monitoring and evaluation of heart rhythm following dosing [ Time Frame: 15 days ]; To report and evaluate adverse events [ Time Frame: 15 days ]
Original Secondary Outcome Measures ICMJE	Same as current
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Safety of Phenylephrine Hydrochloride, Acetaminophen, Dimethindene Maleate Compared to Phenylephrine Hydrochloride Alone in Healthy Volunteers
Official Title ICMJE	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
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.
Detailed Description	Not Provided
Study Type ICMJE	Interventional
Study Phase	Phase 1; Phase 2
Study Design ICMJE	Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Triple (Participant, Care Provider, Investigator)
Condition ICMJE	Heart Rate; Blood Pressure; Arrhythmias
Intervention ICMJE	Drug: Phenylephrine HCL Phenylephrine HCL 10mg; Drug: Phenylephrine HCL/Acetaminophen/Dimethindene Maleate Phenylephrine HCL 10mg/Acetaminophen 500mg/Dimethindene Maleate 1mg
Study Arms	Experimental: Phenylephrine HCL/Acetaminophen/Dimethindene Maleate Phenylephrine HCL/Acetaminophen/Dimethindene Maleate Intervention: Drug: Phenylephrine HCL/Acetaminophen/Dimethindene Maleate; Active Comparator: Phenylephrine hydrochloride Phenylephrine hydrochloride 10mg Intervention: Drug: Phenylephrine HCL
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Withdrawn
Actual Enrollment ICMJE; (submitted: March 2, 2016)	0
Original Estimated Enrollment ICMJE; (submitted: December 4, 2009)	28
Study Completion Date	Not Provided
Estimated Primary Completion Date	November 2010 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	Inclusion Criteria: 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 Exclusion Criteria: 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
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years to 50 Years (Adult)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	Brazil
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT01026961
Other Study ID Numbers ICMJE	381-A-101
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	External Affairs, Novartis Biociências S.A
Study Sponsor ICMJE	Novartis
Collaborators ICMJE	Not Provided
Investigators ICMJE	Study Director: Novartis Biociências S.A Novartis
PRS Account	Novartis
Verification Date	March 2016
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP