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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
Enrollment 190
Recruitment Details ENT Mexican sites
Pre-assignment Details  
Arm/Group Title G238 Clotrimazole
Hide Arm/Group Description

Five drops into the ear canal twice daily for 14 days

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

Five drops into the ear canal twice daily for 14 days

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

Period Title: Overall Study
Started 95 95
Completed 88 79
Not Completed 7 16
Reason Not Completed
Requested by the patient             6             11
Protocol Violation             0             1
Lost to Follow-up             1             4
Arm/Group Title G238 Clotrimazole Total
Hide Arm/Group Description

Five drops into the ear canal twice daily for 14 days

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

Five drops into the ear canal twice daily for 14 days

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

Total of all reporting groups
Overall Number of Baseline Participants 89 85 174
Hide Baseline Analysis Population Description
ITT population: Randomized patients who had at least one efficacy evaluation after starting treatment
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 89 participants 85 participants 174 participants
41.8  (15.8) 39.8  (13.0) 40.8  (14.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 89 participants 85 participants 174 participants
Female
44
  49.4%
46
  54.1%
90
  51.7%
Male
45
  50.6%
39
  45.9%
84
  48.3%
1.Primary Outcome
Title Proportion of Subjects With a Complete Response to Treatment
Hide Description

Efficacy will be assessed primarily by evaluation of the fungal culture, and the sum of signs and symptom scores (pruritus, otalgia, otorrhea and aural fullness obstruction to be scored as 0=absent; 1= mild; 2=moderate; 3=severe). The primary efficacy variable is the proportion of subjects with a negative culture for fungus, AND a signs and symptom score of 0 on Day 24.

Response to the study treatment was classed according to the following definitions:

  • Complete response: Negative fungal culture or presumed eradication on day 24, and sum score for signs and symptoms = 0 on day 24.
  • Partial response: Negative culture or presumed eradication on day 24, and sum score for signs and symptoms = 1 or 2 on day 24.
  • No response: Positive culture on day 24 or negative culture or presumed eradication and sum score for signs and symptoms > 2 on day 24.
Time Frame Day 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title G238 Clotrimazole
Hide Arm/Group Description:

Five drops into the ear canal twice daily for 14 days

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

Five drops into the ear canal twice daily for 14 days

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

Overall Number of Participants Analyzed 89 85
Measure Type: Number
Unit of Measure: participants
Complete Response 72 66
Partial Response 11 11
No-response 5 2
Missing data 1 6
2.Secondary Outcome
Title Changes in Signs/ Symptoms
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The secondary efficacy variables include:

  • Proportion of subjects with signs and symptoms score of “0” at Day 15
  • Proportion of subjects with signs and symptoms score of “0” at Day 24
  • Proportion of subjects with a negative culture for fungus or presumed eradication (mycological cure) on Day 24.
Time Frame 2 weeks and 4 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title G238 Clotrimazole
Hide Arm/Group Description:

Five drops into the ear canal twice daily for 14 days

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

Five drops into the ear canal twice daily for 14 days

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

Overall Number of Participants Analyzed 89 85
Measure Type: Number
Unit of Measure: percentage of patient
Signs and symptoms score 0 at Day 15 59.55 77.65
Signs and symptoms score 0 at Day 24 85.83 86.08
Mycological cure at Day 24 96.63 97.65
3.Other Pre-specified Outcome
Title Mycological Study
Hide Description [Not Specified]
Time Frame Day 24
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description The safety analysis was conducted on the safety population (SAF), i.e. the population that includes all the randomised subjects who took at least one dose of the trial drug and had a safety evaluation.
 
Arm/Group Title G238 Clotrimazole
Hide Arm/Group Description

Five drops into the ear canal twice daily for 14 days

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

Five drops into the ear canal twice daily for 14 days

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

All-Cause Mortality
G238 Clotrimazole
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
G238 Clotrimazole
Affected / at Risk (%) Affected / at Risk (%)
Total   0/89 (0.00%)   0/85 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
G238 Clotrimazole
Affected / at Risk (%) Affected / at Risk (%)
Total   0/89 (0.00%)   0/85 (0.00%) 
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.
Sponsor does not object to publication by Institution of the results of the Trial based on information collected or generated by Institution, whether or not the results are favorable to the Sponsor Drug. However, to ensure against inadvertent disclosure of Confidential Information or unprotected Inventions, Institution will provide Sponsor an opportunity to review any proposed publication or other type of disclosure before it is submitted or otherwise disclosed.
Results Point of Contact
Name/Title: Enrique Jimenez, Medical Director
Organization: Laboratorios SALVAT
Phone: +39933946470
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