Trial Outcomes & Findings for Clinical Study to Assess the Efficacy and Safety of G238 Compared to Clotrimazole Otic Solution in the Treatment of Otomycosis (NCT NCT01993823)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

190 participants

Primary outcome timeframe

Day 24

Results posted on

2017-04-04

Participant Flow

ENT Mexican sites

Participant milestones

Participant milestones
Measure	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
Overall Study STARTED	95	95
Overall Study COMPLETED	88	79
Overall Study NOT COMPLETED	7	16

Reasons for withdrawal

Reasons for withdrawal
Measure	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
Overall Study Requested by the patient	6	11
Overall Study Protocol Violation	0	1
Overall Study Lost to Follow-up	1	4

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	G238 n=89 Participants Five drops into the ear canal twice daily for 14 days G238: Five drops into the ear canal twice daily for 14 days	Clotrimazole n=85 Participants Five drops into the ear canal twice daily for 14 days Clotrimazole: Five drops into the ear canal twice daily for 14 days	Total n=174 Participants Total of all reporting groups
Age, Continuous	41.8 years STANDARD_DEVIATION 15.8 • n=99 Participants	39.8 years STANDARD_DEVIATION 13.0 • n=107 Participants	40.8 years STANDARD_DEVIATION 14.5 • n=206 Participants
Sex: Female, Male Female	44 Participants n=99 Participants	46 Participants n=107 Participants	90 Participants n=206 Participants
Sex: Female, Male Male	45 Participants n=99 Participants	39 Participants n=107 Participants	84 Participants n=206 Participants

PRIMARY outcome

Timeframe: Day 24

Population: ITT

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.

Outcome measures

Outcome measures
Measure	G238 n=89 Participants Five drops into the ear canal twice daily for 14 days G238: Five drops into the ear canal twice daily for 14 days	Clotrimazole n=85 Participants Five drops into the ear canal twice daily for 14 days Clotrimazole: Five drops into the ear canal twice daily for 14 days
Proportion of Subjects With a Complete Response to Treatment Complete Response	72 participants	66 participants
Proportion of Subjects With a Complete Response to Treatment Partial Response	11 participants	11 participants
Proportion of Subjects With a Complete Response to Treatment No-response	5 participants	2 participants
Proportion of Subjects With a Complete Response to Treatment Missing data	1 participants	6 participants

SECONDARY outcome

Timeframe: 2 weeks and 4 weeks

Population: ITT

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.

Outcome measures

Outcome measures
Measure	G238 n=89 Participants Five drops into the ear canal twice daily for 14 days G238: Five drops into the ear canal twice daily for 14 days	Clotrimazole n=85 Participants Five drops into the ear canal twice daily for 14 days Clotrimazole: Five drops into the ear canal twice daily for 14 days
Changes in Signs/ Symptoms Signs and symptoms score 0 at Day 15	59.55 percentage of patient	77.65 percentage of patient
Changes in Signs/ Symptoms Signs and symptoms score 0 at Day 24	85.83 percentage of patient	86.08 percentage of patient
Changes in Signs/ Symptoms Mycological cure at Day 24	96.63 percentage of patient	97.65 percentage of patient

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 24

Outcome measures

Outcome data not reported

Adverse Events

G238

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Clotrimazole

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Enrique Jimenez, Medical Director

Laboratorios SALVAT

Phone: +39933946470

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER