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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This study has been withdrawn prior to enrollment.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:
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
  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
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, 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:

MedlinePlus related topics: Arrhythmia
U.S. FDA Resources

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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 28
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

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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:
Related Info  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: External Affairs, Novartis Biociências S.A
ClinicalTrials.gov Identifier: NCT01026961     History of Changes
Other Study ID Numbers: 381-A-101
Study First Received: December 4, 2009
Last Updated: October 20, 2010
Health Authority: Brazil: Ministry of Health

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

Additional relevant MeSH terms:
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Acetaminophen
Phenylephrine
Oxymetazoline
Dimethindene
Maleic acid
Antipyretics
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
 Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Antipruritics
Dermatologic Agents
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Allergic Agents
Enzyme Inhibitors
Adrenergic alpha-1 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists

ClinicalTrials.gov processed this record on May 23, 2013