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Trial record 14 of 40 for:    Clotrimazole

Clinical Study to Assess the Efficacy and Safety of G238 Compared to Clotrimazole Otic Solution in the Treatment of Otomycosis

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ClinicalTrials.gov Identifier: NCT01993823
Recruitment Status : Completed
First Posted : November 25, 2013
Results First Posted : February 13, 2017
Last Update Posted : April 4, 2017
Sponsor:
Information provided by (Responsible Party):
Salvat

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition: Otomycosis
Interventions: Drug: G238
Drug: Clotrimazole

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
ENT Mexican sites

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
G238

Five drops into the ear canal twice daily for 14 days

G238: Five drops into the ear canal twice daily for 14 days

Clotrimazole

Five drops into the ear canal twice daily for 14 days

Clotrimazole: Five drops into the ear canal twice daily for 14 days


Participant Flow:   Overall Study
    G238   Clotrimazole
STARTED   95   95 
COMPLETED   88   79 
NOT COMPLETED   7   16 
Requested by the patient                6                11 
Protocol Violation                0                1 
Lost to Follow-up                1                4 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
ITT population: Randomized patients who had at least one efficacy evaluation after starting treatment

Reporting Groups
  Description
G238

Five drops into the ear canal twice daily for 14 days

G238: Five drops into the ear canal twice daily for 14 days

Clotrimazole

Five drops into the ear canal twice daily for 14 days

Clotrimazole: Five drops into the ear canal twice daily for 14 days

Total Total of all reporting groups

Baseline Measures
   G238   Clotrimazole   Total 
Overall Participants Analyzed 
[Units: Participants]
 89   85   174 
Age 
[Units: Years]
Mean (Standard Deviation)
 41.8  (15.8)   39.8  (13.0)   40.8  (14.5) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      44  49.4%      46  54.1%      90  51.7% 
Male      45  50.6%      39  45.9%      84  48.3% 


  Outcome Measures

1.  Primary:   Proportion of Subjects With a Complete Response to Treatment   [ Time Frame: Day 24 ]

2.  Secondary:   Changes in Signs/ Symptoms   [ Time Frame: 2 weeks and 4 weeks ]

3.  Other Pre-specified:   Mycological Study   [ Time Frame: Day 24 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Enrique Jimenez, Medical Director
Organization: Laboratorios SALVAT
phone: +39933946470
e-mail: ejimenezv@salvatbiotech.com



Responsible Party: Salvat
ClinicalTrials.gov Identifier: NCT01993823     History of Changes
Other Study ID Numbers: G238OTIII/11IA01
First Submitted: October 9, 2013
First Posted: November 25, 2013
Results First Submitted: December 21, 2016
Results First Posted: February 13, 2017
Last Update Posted: April 4, 2017