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

• Sponsor: Salvat (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01993823
• Collaborator: (none)
• Enrollment: 190
• Location: 1
• Arms: 2
• Duration (Months): 18
• Patients Per Site Per Month: 10.5

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of G238 for the treatment of otomycosis

Condition or Disease	Intervention/Treatment	Phase
Otomycosis	Drug: G238; Drug: Clotrimazole	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 190 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Phase III, Multicenter, Randomized, Double-blind, Parallel Group, Active Treatment-controlled Study Assessing the Safety and Efficacy of G238 Compared to Clotrimazole 1% Otic Solution in Patients With Otomycosis
• Study Start Date: May 1, 2013
• Actual Primary Completion Date: Nov 1, 2014
• Actual Study Completion Date: Nov 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: G238 Five drops into the ear canal twice daily for 14 days	Drug: G238; Five drops into the ear canal twice daily for 14 days
Active Comparator: Clotrimazole Five drops into the ear canal twice daily for 14 days	Drug: Clotrimazole; Five drops into the ear canal twice daily for 14 days

Outcome Measures

Primary Outcome Measures

1. Proportion of Subjects With a Complete Response to Treatment [Day 24]

   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.

Secondary Outcome Measures

1. Changes in Signs/ Symptoms [2 weeks and 4 weeks]

   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.

Other Outcome Measures

1. Mycological Study [Day 24]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 18 years or older.

• Clinical diagnosis of otomycosis where topical treatment is indicated.

Exclusion Criteria:

• Other ear diseases.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Laboratorios SALVAT, S.A.	Esplugues de Llobregat	Barcelona	Spain	08950

Sponsors and Collaborators

• Salvat

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Salvat
• ClinicalTrials.gov Identifier: NCT01993823
• Other Study ID Numbers: G238OTIII/11IA01
• First Posted: Nov 25, 2013
• Last Update Posted: Apr 4, 2017
• Last Verified: Mar 1, 2017

• Additional relevant MeSH terms: Otomycosis; Clotrimazole; Miconazole

Study Results

Participant Flow

Recruitment Details	ENT Mexican sites

Arm/Group Title	G238	Clotrimazole
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

Baseline Characteristics

Arm/Group Title	G238	Clotrimazole	Total
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 Participants	89	85	174
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	41.8 (15.8)	39.8 (13.0)	40.8 (14.5)
Sex: Female, Male (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 Outcome

Title	Proportion of Subjects With a Complete Response to Treatment
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

Outcome Measure Data

Analysis Population Description

ITT

Arm/Group Title	G238	Clotrimazole
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
Measure Participants	89	85
Complete Response	72 80.9%	66 77.6%
Partial Response	11 12.4%	11 12.9%
No-response	5 5.6%	2 2.4%
Missing data	1 1.1%	6 7.1%

2. Secondary Outcome

Title	Changes in Signs/ Symptoms
Description	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

Outcome Measure Data

Analysis Population Description

ITT

Arm/Group Title	G238	Clotrimazole
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
Measure Participants	89	85
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
Time Frame	Day 24

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

Adverse Events

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
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 (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	G238		Clotrimazole
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/89 (0%)		0/85 (0%)
Other (Not Including Serious) Adverse Events
	G238		Clotrimazole
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/89 (0%)		0/85 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.