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

This study has been withdrawn prior to enrollment.

(Study is no longer required by Brazil health authority.)

Sponsor:

Information provided by:

Novartis

ClinicalTrials.gov Identifier:

NCT01026961

First received: December 4, 2009

Last updated: October 20, 2010

Last verified: October 2010

History of Changes

Tracking Information

First Received Date ^ICMJE

December 4, 2009

Last Updated Date

October 20, 2010

Start Date ^ICMJE

September 2010

Estimated Primary Completion Date

November 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ] [ Designated as safety issue: Yes ]

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

Electrocardiographic (ECG) monitoring and evaluation of heart rhythm following dosing [ Time Frame: 15 days ] [ Designated as safety issue: Yes ]
To report and evaluate adverse events [ Time Frame: 15 days ] [ Designated as safety issue: Yes ]

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
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, 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 Arm (s)

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

Estimated Enrollment ^ICMJE

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

Gender

Both

Ages

18 Years to 50 Years

Accepts Healthy Volunteers

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

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

Information Provided By

Novartis

Verification Date

October 2010

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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