NCT01257243

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
260

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Oct 2012

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 8, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 9, 2010

Completed
1.8 years until next milestone

Study Start

First participant enrolled

October 1, 2012

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2013

Completed
25 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 25, 2013

Completed
Last Updated

April 17, 2019

Status Verified

April 1, 2019

Enrollment Period

12 months

First QC Date

December 8, 2010

Last Update Submit

April 15, 2019

Conditions

Cough

Keywords

coughsymptomscoldflu

Outcome Measures

Primary Outcomes (1)

  • 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 (1)

  • Tolerance

    DAY 7

Study Arms (2)

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

Syrup of oxomemazine, guaifenesin and potassium iodateDRUG

5ml each 4 hours

DRUG 1
Syrup of guaifenesinDRUG

5ml each 4 hours

DRUG 2

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beneficência Nipo Brasileira de São Paulo - Hospital Nipo Brasileiro

São Paulo, 02189-000, Brazil

Location

MeSH Terms

Conditions

CoughCommon ColdInfluenza, Human

Interventions

Guaifenesinpotassium iodate

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and SymptomsRespiratory Tract InfectionsInfectionsPicornaviridae InfectionsRNA Virus InfectionsVirus DiseasesOrthomyxoviridae Infections

Intervention Hierarchy (Ancestors)

GuaiacolMethyl EthersEthersOrganic ChemicalsPhenyl EthersCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbons

Study Officials

  • Felipe Pinho, MD

    EMS

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 8, 2010

First Posted

December 9, 2010

Study Start

October 1, 2012

Primary Completion

September 30, 2013

Study Completion

October 25, 2013

Last Updated

April 17, 2019

Record last verified: 2019-04

Locations

BR(1)