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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This study has been withdrawn prior to enrollment.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:
ClinicalTrials.gov Identifier:
NCT01026961
First Posted: December 7, 2009
Last Update Posted: March 3, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Novartis
  Purpose
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.

Condition Intervention Phase
Heart Rate Blood Pressure Arrhythmias Drug: Phenylephrine HCL Drug: Phenylephrine HCL/Acetaminophen/Dimethindene Maleate Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Electrocardiographic (ECG) monitoring and evaluation of heart rhythm following dosing [ Time Frame: 15 days ]
  • To report and evaluate adverse events [ Time Frame: 15 days ]

Enrollment: 0
Study Start Date: September 2010
Estimated Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Phenylephrine HCL/Acetaminophen/Dimethindene Maleate
Phenylephrine HCL/Acetaminophen/Dimethindene Maleate
Drug: Phenylephrine HCL/Acetaminophen/Dimethindene Maleate
Phenylephrine HCL 10mg/Acetaminophen 500mg/Dimethindene Maleate 1mg
Active Comparator: Phenylephrine hydrochloride
Phenylephrine hydrochloride 10mg
Drug: Phenylephrine HCL
Phenylephrine HCL 10mg

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01026961


Locations
Brazil
Scentryphar Pesquisa Clinica Ltda.
Campinas, São Paulo, Brazil
Sponsors and Collaborators
Novartis
Investigators
Study Director: Novartis Biociências S.A Novartis
  More Information

Additional Information:
Responsible Party: External Affairs, Novartis Biociências S.A
ClinicalTrials.gov Identifier: NCT01026961     History of Changes
Other Study ID Numbers: 381-A-101
First Submitted: December 4, 2009
First Posted: December 7, 2009
Last Update Posted: March 3, 2016
Last Verified: March 2016

Keywords provided by Novartis:
Safety
heart rate
systolic and diastolic blood pressure
arrhythmias

Additional relevant MeSH terms:
Acetaminophen
Phenylephrine
Oxymetazoline
Maleic acid
Dimethindene
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cardiotonic Agents
Mydriatics
Autonomic Agents
Sympathomimetics
Vasoconstrictor Agents
Nasal Decongestants
Respiratory System Agents
Adrenergic alpha-1 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Protective Agents
Antipruritics
Dermatologic Agents
Histamine H1 Antagonists
Histamine Antagonists