Comparison Between Oxomemazine, Guaifenesin and Potassium... | NCT01257243

Studies
Comparison Between Oxomemazine, Guaifenesin and Potassium Iodate Versus Guaifenesin Monotherapy in Acute Cough Treatment

NCT01257243

Sponsor

EMS

Status

Completed

Last Update Posted

Apr 17, 2019Actual

Enrollment

260Actual

Phase

Phase 3

Conditions

Cough

Interventions

Syrup of oxomemazine, guaifenesin and potassium iodate
Syrup of guaifenesin

Countries

Brazil

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1, 2012Actual

Primary Completion Date

Sep 30, 2013Actual

Completion Date

Oct 25, 2013Actual

First Submitted Date

Dec 8, 2010

First Submission Date that Met QC Criteria

Dec 8, 2010

First Posted Date

Dec 9, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 15, 2019

Last Update Posted Date

Apr 17, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is evaluate if efficacy of a combination dose of oxomemazine, guaifenesin and potassium iodate is superior than guaifenesin monotherapy in acute cough treatment.

Detailed Description

STUDY DESIGN

Open-label, superiority, prospective, parallel group, intent to treat trial
Experiment duration: 7 days
3 visits (days 1, 2 and 7)
Reduction cough symptoms
Adverse events evaluation

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

260Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
DRUG 1	Experimental	Syrup of oxomemazine, guaifenesin and potassium iodate	Drug: Syrup of oxomemazine, guaifenesin and potassium iodate
DRUG 2	Active Comparator	Syrup of guaifenesin	Drug: Syrup of guaifenesin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Syrup of oxomemazine, guaifenesin and potassium iodate	Drug	5ml each 4 hours	DRUG 1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Reduction/improvement of cough symptoms	The reduction of cough symptoms will be evaluated by comparative score index basal and final score	DAY 7

Secondary Outcomes

Measure	Description	Time Frame
Tolerance	Adverse events will be collected and followed in order to evaluate safety and tolerability	DAY 7

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients must be able to understand the study procedures agree to participate and give written consent.
Patients with productive cough as result an acute URTI (i.e., cold or flu) or allergic cough in the last 10 day.
Cough score superior to 3.

Exclusion Criteria:

Pregnancy or risk of pregnancy.
Lactation.
Fever above 38º C.
Patients with bacterial infections of the upper respiratory tract.
Any pathology or past medical condition that can interfere with this protocol.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Felipe Pinho, MD	EMS	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Beneficência Nipo Brasileira de São Paulo - Hospital Nipo Brasileiro		São Paulo		02189-000	Brazil

Condition Browse Module

MeSH Terms

ID	Term
D003371	Cough
D003139	Common Cold
D007251	Influenza, Human

Ancestor Terms

ID	Term
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases
D012818	Signs and Symptoms, Respiratory
D012816	Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D006140	Guaifenesin
C039693	potassium iodate

Ancestor Terms

ID	Term
D006139	Guaiacol
D008738	Methyl Ethers
D004987	Ethers
D009930	Organic Chemicals
D010647

Browse Leaves

Not provided

Browse Branches

Not provided