Trial · NCT03196973
Efficacy and Safety of DF289 Plus DF277 Otic Solution in the Treatment of Acute Otitis Externa
NCT03196973, Phase 3, Completed, Salvat; results first posted 2021-04-09
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Efficacy and Safety of DF289 Plus DF277 Otic Solution in the Treatment of Acute Otitis Externa. Trials, record NCT03196973. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03196973
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of DF289 Plus DF277 Otic Solution in the Treatment of Acute Otitis Externa
- NCT number
- NCT03196973
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 493 participants, actual
- Lead sponsor
- Salvat
- Conditions
- Acute Otitis Externa
- Interventions
- DF289 plus DF277, DF289, DF277
- First posted
- 2017-06-23
- Last updated
- 2021-04-09
- Results first posted
- 2021-04-09
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Therapeutic Cure (Clinical + Microbiological Cure) | End of Treatment (Day 8+2) | Therapeutic cure will be considered achieved if edema, otalgia and otorrhea are resolved with no further requirement of antimicrobial therapy and bacteriological response is Eradication or Presumed Eradication |
| Secondary | Time to End of Pain | From baseline to End of Study (Day 15+2) | First day on which there is no use of analgesics, the pain score is zero and remains zero until end of study |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Therapeutic Cure (Clinical + Microbiological Cure) | End of Treatment (Day 8+2) | Randomized patients with positive culture for pathogens at baseline | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Time to End of Pain | From baseline to End of Study (Day 15+2) | Randomized patients with positive culture for pathogens at baseline | days | MEDIAN |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Therapeutic Cure (Clinical + Microbiological Cure) | DF289 Plus DF277 | 63 | Participants | ||
| Therapeutic Cure (Clinical + Microbiological Cure) | DF289 | 49 | Participants | ||
| Therapeutic Cure (Clinical + Microbiological Cure) | DF277 | 20 | Participants | ||
| Time to End of Pain | DF289 Plus DF277 | 5.0 | 95% Confidence Interval 4.23 to 6.34 | days | |
| Time to End of Pain | DF289 | 5.9 | 95% Confidence Interval 4.26 to 7.25 | days | |
| Time to End of Pain | DF277 | 7.7 | 95% Confidence Interval 6.74 to 9.00 | days |
Source ClinicalTrials.gov
Participant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | DF289 Plus DF277 | 197 | |
| Overall Study | STARTED | DF289 | 196 | |
| Overall Study | STARTED | DF277 | 100 | |
| Overall Study | COMPLETED | DF289 Plus DF277 | 188 | |
| Overall Study | COMPLETED | DF289 | 184 | |
| Overall Study | COMPLETED | DF277 | 95 | |
| Overall Study | NOT COMPLETED | DF289 Plus DF277 | 9 | |
| Overall Study | NOT COMPLETED | DF289 | 12 | |
| Overall Study | NOT COMPLETED | DF277 | 5 |
Source ClinicalTrials.gov
Adverse events30
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | tachycardia | Cardiac disorders | DF289 Plus DF277 | 1 | 196 | 1 |
| other | tachycardia | Cardiac disorders | DF289 | 0 | 195 | 0 |
| other | tachycardia | Cardiac disorders | DF277 | 1 | 100 | 1 |
| other | ear pain | Ear and labyrinth disorders | DF289 Plus DF277 | 2 | 196 | 2 |
| other | ear pain | Ear and labyrinth disorders | DF289 | 2 | 195 | 2 |
| other | ear pain | Ear and labyrinth disorders | DF277 | 0 | 100 | 0 |
| other | ear pruritus | Ear and labyrinth disorders | DF289 Plus DF277 | 0 | 196 | 0 |
| other | ear pruritus | Ear and labyrinth disorders | DF289 | 2 | 195 | 2 |
| other | ear pruritus | Ear and labyrinth disorders | DF277 | 0 | 100 | 0 |
| other | application site pain | General disorders | DF289 Plus DF277 | 4 | 196 | 4 |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | DF289 Plus DF277 | 0 | 196 |
| Total, all-cause mortality | DF289 | 0 | 195 |
| Total, all-cause mortality | DF277 | 0 | 100 |
| Total, other adverse events | DF289 Plus DF277 | 11 | 196 |
| Total, other adverse events | DF289 | 12 | 195 |
| Total, other adverse events | DF277 | 4 | 100 |
| Total, serious adverse events | DF289 Plus DF277 | 1 | 196 |
| Total, serious adverse events | DF289 | 0 | 195 |
| Total, serious adverse events | DF277 | 0 | 100 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 35834251 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03196973
GET https://conductscience.org/api/trials/v1/NCT03196973/events?page=2