Safety of Phenylephrine Hydrochloride, Acetaminophen, Dimethindene Maleate Compared to Phenylephrine Hydrochloride Alone in Healthy Volunteers

Blood Pressure Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01026961
• Other study ID #: 381-A-101
• Status: Withdrawn
• Phase: Phase 1/Phase 2
• First received: December 4, 2009
• Last updated: March 2, 2016
• Start date: September 2010

Study information

• Verified date: March 2016
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator)

Related Conditions & MeSH terms

• Arrhythmias
• Blood Pressure
• Heart Rate

Intervention

Drug:
• Phenylephrine HCL
Phenylephrine HCL 10mg
• Phenylephrine HCL/Acetaminophen/Dimethindene Maleate
Phenylephrine HCL 10mg/Acetaminophen 500mg/Dimethindene Maleate 1mg

Locations

Country	Name	City	State
Brazil	Scentryphar Pesquisa Clinica Ltda.	Campinas	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To compare the effect of phenylephrine hydrochloride 10mg + acetaminophen 500mg + dimethindene maleate 1mg and phenylephrine hydrochloride 10mg alone on vital signs		15 days	Yes
Secondary	Electrocardiographic (ECG) monitoring and evaluation of heart rhythm following dosing		15 days	Yes
Secondary	To report and evaluate adverse events		15 days	Yes

External Links

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