- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01026961
Safety of Phenylephrine Hydrochloride, Acetaminophen, Dimethindene Maleate Compared to Phenylephrine Hydrochloride Alone in Healthy Volunteers
March 2, 2016 updated by: Novartis
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.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
São Paulo
-
Campinas, São Paulo, Brazil
- Scentryphar Pesquisa Clinica Ltda.
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Phenylephrine HCL/Acetaminophen/Dimethindene Maleate
|
Phenylephrine HCL 10mg/Acetaminophen 500mg/Dimethindene Maleate 1mg
|
Active Comparator: Phenylephrine hydrochloride
Phenylephrine hydrochloride 10mg
|
Phenylephrine HCL 10mg
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
15 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Electrocardiographic (ECG) monitoring and evaluation of heart rhythm following dosing
Time Frame: 15 days
|
15 days
|
To report and evaluate adverse events
Time Frame: 15 days
|
15 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Novartis Biociências S.A, Novartis
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2010
Primary Completion (Anticipated)
November 1, 2010
Study Registration Dates
First Submitted
December 4, 2009
First Submitted That Met QC Criteria
December 4, 2009
First Posted (Estimate)
December 7, 2009
Study Record Updates
Last Update Posted (Estimate)
March 3, 2016
Last Update Submitted That Met QC Criteria
March 2, 2016
Last Verified
March 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Heart Diseases
- Cardiovascular Diseases
- Arrhythmias, Cardiac
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Analgesics, Non-Narcotic
- Antipyretics
- Protective Agents
- Adrenergic alpha-Agonists
- Adrenergic Agonists
- Cardiotonic Agents
- Dermatologic Agents
- Respiratory System Agents
- Anti-Allergic Agents
- Histamine H1 Antagonists
- Histamine Antagonists
- Histamine Agents
- Antipruritics
- Sympathomimetics
- Vasoconstrictor Agents
- Mydriatics
- Nasal Decongestants
- Adrenergic alpha-1 Receptor Agonists
- Acetaminophen
- Phenylephrine
- Oxymetazoline
- Dimethindene
Other Study ID Numbers
- 381-A-101
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Blood Pressure
-
SE HealthCentre for Aging and Brain Health InnovationCompletedHypertension | Blood Pressure | Hypotension | High Blood Pressure | Low Blood PressureCanada
-
DongGuk UniversityActive, not recruitingHypertension | Blood Pressure | Ambulatory Blood Pressure | Home Blood Pressure MeasurementKorea, Republic of
-
University of JordanCompletedBlood Pressure | Heart Rate | Airway PressureJordan
-
ROX Medical, Inc.CompletedHypertension | Blood Pressure, High | Blood Pressure, Resistant | Blood Pressure, UncontrolledUnited Kingdom, Netherlands, Belgium
-
Istituto Auxologico ItalianoRecruitingArterial Hypertension | Ambulatory Blood Pressure Monitoring | Blood Pressure Determination | Home Blood Pressure MonitoringItaly
-
RadiRad Co., Ltd.Hualien Tzu Chi General HospitalNot yet recruitingBlood Pressure
-
Riphah International UniversityRecruiting
-
The George InstituteUniversity of Abuja Teaching HospitalNot yet recruiting
-
GE HealthcareNot yet recruiting
-
Guangdong Provincial People's HospitalRecruiting
Clinical Trials on Phenylephrine HCL/Acetaminophen/Dimethindene Maleate
-
NovartisCompletedNasal Congestion | Rhinorrhea | Sneezing | Upper Respiratory Tract InfectionBrazil
-
Janssen Korea, Ltd., KoreaCompleted
-
University of MinnesotaCompletedEpstein-Barr Virus Infections | Cytomegalovirus Infections | Transplantation InfectionUnited States
-
Johnson & Johnson Consumer Inc. (J&JCI)Terminated
-
Janssen Korea, Ltd., KoreaCompleted
-
GlaxoSmithKlineWithdrawnInfections, Respiratory Tract
-
AllerganCompletedOcular Hypertension | Open-Angle GlaucomaCanada
-
BayerCompletedSeasonal Allergic Rhinitis | Vasomotor Rhinitis
-
Bp Consulting, IncAllerganCompletedOcular Hypertension | Open-Angle GlaucomaCanada