Otitis ExternaPhase 3NCT00980876
A Comparative Study Between Two Formulations of the Ciprofloxacin Hydrochloride + Hydrocortisone Otic Suspension
A Phase 3 study testing Cipro HC and Ciprofloxacin HCl and Hydrocortisone in people with Otitis Externa, run by Farmoquimica S.A. at 1 site in Brazil.
Trial summary
The objective of this study is to compare the efficacy and safety profiles of the test product containing 2 mg/mL ciprofloxacin hydrochloride associated with 10 mg/mL of hydrocortisone with the reference product Cipro HC®, in patients with acute otitis externa. Read more about this study
- Who is it for?
- Ages 1 year to 70 years
- Conditions the study is for
- Otitis Externa
- What is being tested?
- Cipro HC and Ciprofloxacin HCl and Hydrocortisone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 224 participants
- Where
- 1 siteBrazil
- Study dates
- Apr 2012to Jan 2015
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Informed of the nature of the study and given written informed consent;
- Patients with acute otitis externa;
- Intact tympanic membrane.
Who cannot join
- Known allergy or sensitivity to Ciprofloxacin Hydrochloride and Hydrocortisone;
- Patient has the tympanic membrane not intact;
- Diabetes
- Bilateral Acute Otitis Externa;
- Pregnant or lactating patients;
- Overt fungal Acute Otitis Externa;
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- Other diseases of the ear
- Current Infection requiring systemic antimicrobial therapy.
- Current enrollment in an investigational drug or device study or participation in such a study within 30 days of entry into this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multicentric, Double Blind, Randomized, Parallel Comparative Study Between Ciprofloxacin HCl 2 mg/mL + Hydrocortisone 10 mg/mL Ear Suspension and Cipro HC®, for the Assessment of Efficacy and Safety in Patients With Otitis Externa.
The objective of this study is to compare the efficacy and safety profiles of the test product containing 2 mg/mL ciprofloxacin hydrochloride associated with 10 mg/mL of hydrocortisone with the reference product Cipro HC®, in patients with acute otitis externa.
Read the detailed description
Phase III, non inferiority, multicentric, controlled, single blind, parallel-group, randomized study.
Population: 224 patients with external otitis , men and women aged between 1 - 70 years.
Primary endpoint: The primary endpoint of this study is the elimination of pain, swelling and otorrhea (cure).
Secondary endpoint: The endpoint will be the identification of the side effects of medication use.
- Conditions
- Otitis Externa
- Being tested
- Cipro HC, Ciprofloxacin HCl and Hydrocortisone
- Medical subject headings
- Otitis Externa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cipro HCDrug
Cipro HC (Ciprofloxacin HCl and Hydrocortisone)
Ciprofloxacin HCl and HydrocortisoneDrug
Also called Otociriax
Ciprofloxacin Hydrochloride and Hydrocortisone
| Study group | Role | What they receive |
|---|---|---|
| Cipro HC | Active comparator | Reference product Receives: Drug: Cipro HC |
| Ciprofloxacin HCl and Hydrocortisone | Experimental | Test product Receives: Drug: Ciprofloxacin HCl and Hydrocortisone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cure (reduced pain, swelling and otorrhea)
Measured: 7 days
Secondary outcomes (1)
Identification of possible side effects
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2009 (estimated)
- Study startApr 2012
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Otitis ExternaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 224 participants (actual)
Sponsor and investigators
- Lead sponsor
- Farmoquimica S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Pharmagenix Projetos em Medicina Farmacêutica Ltda.
- Responsible party
- Sponsor
- Investigators
- Agricio N. Crespo, Phd, Principal investigator, Clínica Quiron
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00980876
- Sponsor's protocol ID
- STPh 09/08
- Status last verified
- Mar 2012
- First submitted
- 18 Sep 2009
- Last updated
- 17 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentric, Double Blind, Randomized, Parallel Comparative Study Between Ciprofloxacin HCl 2 mg/mL + Hydrocortisone 10 mg/mL Ear Suspension and Cipro HC®, for the Assessment of Efficacy and Safety in Patients With Otitis Externa.
- ClinicalTrials.gov ID
- NCT00980876
- Acronym / sponsor ID
- STPh 09/08
- Conditions
- Otitis Externa
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 224 participants (actual)
- Lead sponsor
- Farmoquimica S.A.Industry (pharma, biotech, devices)
- Collaborators
- Pharmagenix Projetos em Medicina Farmacêutica Ltda.
- Study start
- Apr 2012
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 21 Sep 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to compare the efficacy and safety profiles of the test product containing 2 mg/mL ciprofloxacin hydrochloride associated with 10 mg/mL of hydrocortisone with the reference product Cipro HC®, in patients with acute otitis externa.
Detailed description
Phase III, non inferiority, multicentric, controlled, single blind, parallel-group, randomized study.
Population: 224 patients with external otitis , men and women aged between 1 - 70 years.
Primary endpoint: The primary endpoint of this study is the elimination of pain, swelling and otorrhea (cure).
Secondary endpoint: The endpoint will be the identification of the side effects of medication use.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cipro HC | Active comparator | Drug: Cipro HCReference product |
| Ciprofloxacin HCl and Hydrocortisone | Experimental | Drug: Ciprofloxacin HCl and HydrocortisoneTest product |
Who may qualify
- Ages
- 1 year to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Informed of the nature of the study and given written informed consent;
- Patients with acute otitis externa;
- Intact tympanic membrane.
Key exclusion criteria (9 listed)
- Known allergy or sensitivity to Ciprofloxacin Hydrochloride and Hydrocortisone;
- Patient has the tympanic membrane not intact;
- Diabetes
- Bilateral Acute Otitis Externa;
- Pregnant or lactating patients;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cipro HCCipro HC (Ciprofloxacin HCl and Hydrocortisone) | Drug | Cipro HC |
| Ciprofloxacin HCl and HydrocortisoneAlso: OtociriaxCiprofloxacin Hydrochloride and Hydrocortisone | Drug | Ciprofloxacin HCl and Hydrocortisone |
Primary outcome
Cure (reduced pain, swelling and otorrhea)
Time frame: 7 days
1 secondary outcome
Identification of possible side effects
Time frame: 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Agricio N. Crespo, Phd principal investigator
Clínica Quiron
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cipro HC and Ciprofloxacin HCl and Hydrocortisone in people with Otitis Externa, run by Farmoquimica S.A. at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cure (reduced pain, swelling and otorrhea) (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2015.