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This study has been withdrawn prior to enrollment.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

December 4, 2009
October 20, 2010
September 2010
November 2010   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01026961 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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

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.

Not Provided
Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
  • Heart Rate
  • Blood Pressure
  • Arrhythmias
  • Drug: Phenylephrine HCL
    Phenylephrine HCL 10mg
  • Drug: Phenylephrine HCL/Acetaminophen/Dimethindene Maleate
    Phenylephrine HCL 10mg/Acetaminophen 500mg/Dimethindene Maleate 1mg
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
28
Not Provided
November 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 50 Years
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT01026961
381-A-101
No
External Affairs, Novartis Biociências S.A
Novartis
Not Provided
Study Director: Novartis Biociências S.A Novartis
Novartis
October 2010

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