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This study has been withdrawn prior to enrollment.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.)
Information provided by:
Novartis Identifier:
First received: December 4, 2009
Last updated: March 2, 2016
Last verified: March 2016
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
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:

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 ]

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


Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT01026961

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

Additional Information:
Responsible Party: External Affairs, Novartis Biociências S.A Identifier: NCT01026961     History of Changes
Other Study ID Numbers: 381-A-101 
Study First Received: December 4, 2009
Last Updated: March 2, 2016
Health Authority: Brazil: Ministry of Health

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

Additional relevant MeSH terms:
Maleic acid
Adrenergic Agents
Adrenergic Agonists
Adrenergic alpha-1 Receptor Agonists
Adrenergic alpha-Agonists
Analgesics, Non-Narcotic
Anti-Allergic Agents
Autonomic Agents
Cardiotonic Agents
Dermatologic Agents
Enzyme Inhibitors
Histamine Agents
Histamine Antagonists
Histamine H1 Antagonists
Molecular Mechanisms of Pharmacological Action
Nasal Decongestants
Neurotransmitter Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Protective Agents
Respiratory System Agents
Sensory System Agents processed this record on May 30, 2016