louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00784797: Misopristol Versus Pitocin for Second Trimester Abortion
Official title: Comparison Between Misopristol and Pitocin After Mifepristone Preparation for Second Trimeter Abortion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Abortion, Missed
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2008-11-04
Enrollment: 145
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Second trimester abortion can be done surgically or medically. Medical abortion with mifepristone and misopristol is one of the common protocol, but misopristol have high rate side effect. The investigators recent study proved the efficacy of pitocin after mifepristone in second trimester abortion with minimal side effects.

Working hypothesis and aims: To compare misopristol and pitocin after mifepristone preparation in second trimester in seccess rate, interval to abortion, side effects and patient satisfaction.


Eligibility criteria: Inclusion Criteria:

* midtrimester late abortion
* midtrimester induced abortion

Exclusion Criteria:

* placenta previa
* infected abortion
* rupture of membranes
* s/p cesarean section \*2 or more

Primary outcomes:
measure: Success rate of abortion
timeFrame: 24 hours
measure: Interval to abortion
timeFrame: 24 hours
Secondary outcomes:
measure: Side effects
timeFrame: 24 hours
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization
Study officials:
affiliation: Hadassah Medical Organization
name: Assaf Ben-Meir, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ghosh J, Papadopoulou A, Devall AJ, Jeffery HC, Beeson LE, Do V, Price MJ, Tobias A, Tuncalp O, Lavelanet A, Gulmezoglu AM, Coomarasamy A, Gallos ID. Methods for managing miscarriage: a network meta-analysis. Cochrane Database Syst Rev. 2021 Jun 1;6(6):CD012602. doi: 10.1002/14651858.CD012602.pub2.
citation: Freeman MD, Porat N, Rojansky N, Elami-Suzin M, Winograd O, Ben-Meir A. Physical symptoms and emotional responses among women undergoing induced abortion protocols during the second trimester. Int J Gynaecol Obstet. 2016 Nov;135(2):154-157. doi: 10.1016/j.ijgo.2016.05.008. Epub 2016 Aug 15.
citation: Elami-Suzin M, Freeman MD, Porat N, Rojansky N, Laufer N, Ben-Meir A. Mifepristone followed by misoprostol or oxytocin for second-trimester abortion: a randomized controlled trial. Obstet Gynecol. 2013 Oct;122(4):815-820. doi: 10.1097/AOG.0b013e3182a2dcb7.
Clinical trial NCT03776097: Long-term Follow-up Observation After Surgical Treatment of Peri-implantitis in Multicenter Post Market Clinical Study
Official title: Non-interventional Long-term Follow-up Observation After Surgical Treatment of Peri-implantitis in Multicenter Post Market Clinical Follow-up (PMCF) Study 13.530.231
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Peri-implantitis
Lead sponsor: Geistlich Pharma AG
Sponsor class: INDUSTRY
First posted: 2018-12-14
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients from a previous study

Brief summary: The objective of this non-interventional long-term follow-up observation is to evaluate the long-term sustainability of two surgical treatments of peri-implantitis with and without Geistlich Bio-Oss® and Geistlich Bio-Gide® from a previous study

Detailed description: The study is a non-interventional long-term follow-up observation without any study specific procedure outside normal clinical routine. Patients from a previous study are selected to participate in this study within a standard maintenance Programm. Primary and secondary oucomes refer to the previous study

Eligibility criteria: Inclusion Criteria:

* Implant survival at the treated site from the previous study
* Written informed consent

Exclusion Criteria:

* Implant failure at the treated site
* Severe trauma to implant site causing removal of the implant since the last visit of previous study

Primary outcomes:
measure: Defect fill
timeFrame: 2 years after the start of the study
Secondary outcomes:
Other outcomes:
Locations:
city: Kristianstad
country: Sweden
facility: Kristianstad University
Study officials:
affiliation: Geistlich Pharma
name: Silvia Rasi, PhD
role: STUDY_DIRECTOR
affiliation: Kristianstadt University
name: Stefan Renvert
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00944697: A Study to Demonstrate the Analgesic Efficacy of Oxycodone/Naloxone Prolonged Release Tablets in Addition to Pregabalin Compared to Pregabalin Alone in Opioid-naïve Subjects Treated With Pregabalin Suffering From Moderate to Severe Pain Due to Diabetic Polyneuropathy
Official title: An Exploratory, Randomised, Double-blind, Single-dummy, Placebo Controlled, Parallel Group Study to Demonstrate the Analgesic Efficacy of Oxycodone/Naloxone Prolonged Release Tablets in Addition to Pregabalin Compared to Pregabalin Alone in Opioid-naïve Subjects Treated With Pregabalin Suffering From Moderate to Severe Pain Due to Diabetic Polyneuropathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Moderate to Severe Pain Due to Diabetic Polyneuropathy
Lead sponsor: Mundipharma Research GmbH & Co KG
Sponsor class: INDUSTRY
First posted: 2009-07-23
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: To show superior analgesic efficacy of OXN PR in addition to a patient's current dose of pregabalin compared to pregabalin alone.

Detailed description: Study OXN2502 is a pilot, exploratory, randomised, placebo-controlled, double-blind, single-dummy, parallel group study to assess efficacy and safety of OXN PR in addition to a patient's current dose of pregabalin compared to pregabalin alone in opioid-naïve subjects treated with pregabalin suffering from moderate to severe pain due to diabetic polyneuropathy.

Eligibility criteria: Inclusion criteria:

* Moderate to severe pain due diabetic polyneuropathy
* Opioid-naive subjects

Exclusion criteria:

* Females who are pregnant or lactating
* Subjects with evidence of significant structural abnormalities of the gastrointestinal tract
* Subjects with evidence of impaired liver/kidney function upon entry into the study

Primary outcomes:
measure: Short Form McGill Pain Score.
timeFrame: Visit 2 (randomisation) and Visit 10 (end of study (12 weeks) or withdrawal)
Secondary outcomes:
Other outcomes:
Locations:
city: Ludwigshafen
country: Germany
facility: Dr Oliver Emrich
Study officials:
References:
Clinical trial NCT01009697: Dose Linearity Study of Codeine Sulfate Under Fasted Conditions
Official title: A Single Dose, 3-Period, 3-Treatment, 6-Sequence, 3-Way Crossover Study of the Dose Linearity of Codeine Sulfate Tablets Under Fasting Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pain
Lead sponsor: West-Ward Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2009-11-09
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The objective of this study was to examine the dose linearity of Roxane Laboratories' 15 mg, 30 mg, and 60 mg codeine sulfate tablets under fasted conditions


Eligibility criteria: Inclusion Criteria:

* No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening.

Exclusion Criteria:

* Positive test for HIV, Hepatitis B, or Hepatitis C.
* Treatment with known enzyme altering drugs.
* History of allergic or adverse response to Codeine Sulfate or any comparable or similar product.

Primary outcomes:
measure: bioequivalence determined by statistical comparison Cmax
timeFrame: 21 Days
Secondary outcomes:
Other outcomes:
Locations:
city: Austin
country: United States
facility: CEDRA Clinical Research
state: Texas
Study officials:
affiliation: CEDRA Clinical Research
name: Fredrick Bieberdorf, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01985997: Postmarketing Safety Study of Q/LAIV in Subjects 2 Through 49 Years of Age
Official title: Postmarketing Safety Study of Q/LAIV in Subjects 2 Through 49 Years of Age
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Observation Safety
Keywords: FluMist, Quadrivalent, Vaccine
Lead sponsor: MedImmune LLC
Sponsor class: INDUSTRY
First posted: 2013-11-18
Enrollment: 95000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children and adults 2 to 49 years of age vaccinated with Q/LAIV, TIV or no vaccine at Kaiser Permenente Northern California sites.

Brief summary: This is an observational post-marketing study conducted in children and adults immunized with Q/LAIV as part of routine clinical practice at Kaiser Permanente Northern California (NCKP) sites.

Detailed description: Children and adults will be immunized with Q/LAIV as part of routine clinical practice at Kaiser Permanente Northern California (NCKP) sites. Using existing data on healthcare utilization, rates of medically attended events (MAEs) of interest will be evaluated in all eligible Q/LAIV recipients who are vaccinated in the Kaiser Permanente (KP) Northern California Health Care Plan during the 2013-2014 influenza season. Enrollment must include a minimum of 10,000 children 2 through 8 years of age; based on previous utilization of FluMist at NCKP, enrollment is expected to include approximately 80,000 children and adults 2 to 49 years of age.

Eligibility criteria: Inclusion Criteria:

1. . Age 2 through 49 years at the time of vaccination (or index date for unvaccinated controls)
2. . Membership in the KP Health Care Plan for at least 12 months prior to vaccination/index date
3. . Continuous enrollment in KP Health Care Plan through 6 months following vaccination/index date.

Exclusion Criteria:

NONE

Primary outcomes:
measure: Rates of medically attended events: hypersensitivity, seizures/convulsions
timeFrame: From 0-3 days
measure: Rates of medically attended events: lower respiratory tract infection, wheezing, Guillain-Barré syndrome, Bell's palsy, encephalitis, neuritis, vasculitis, any hospitalization and respiratory hospitalizations
timeFrame: From 1 to 42 days
measure: Rates of medically attended events: narcolepsy/cataplexy
timeFrame: From 1 to 180 days
Secondary outcomes:
Other outcomes:
Locations:
city: Oakland
country: United States
facility: Research Site
state: California
Study officials:
affiliation: MedImmune LLC
name: Herve Caspard, MD
role: STUDY_DIRECTOR
References:
citation: Baxter R, Eaton A, Hansen J, Aukes L, Caspard H, Ambrose CS. Safety of quadrivalent live attenuated influenza vaccine in subjects aged 2-49years. Vaccine. 2017 Mar 1;35(9):1254-1258. doi: 10.1016/j.vaccine.2017.01.062. Epub 2017 Feb 2.
Clinical trial NCT06528197: Construction of Clinical Model of Primary Sjogren's Syndrome Combined Traditional Chinese and Western Medicine
Official title: Construction of Clinical Model of Primary Sjogren's Syndrome Combined Traditional Chinese Medicine and Western Medicine Based on Multi-omics
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Primary Sjögren Syndrome
Lead sponsor: China-Japan Friendship Hospital
Sponsor class: OTHER
Collaborators: name: Xiyuan Hospital of China Academy of Chinese Medical Sciences
name: Beijing Hospital of Traditional Chinese Medicine
name: Shunyi Hospital, Beijing Traditional Chinese Medicine Hospital
First posted: 2024-07-30
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with primary Sjögren's syndrome

Brief summary: This study aims to establish a large sample cohort of patients with primary sjogren's syndrome, collect multi-omics information of patients with primary sjogren's syndrome, and construct disease diagnosis model and disease prognosis prediction model.


Eligibility criteria: Inclusion Criteria:

* Meets the 2002 AECG or 2016 ACR/EULAR classification criteria of primary Sjögren's syndrome.

Exclusion Criteria:

* Comorbid connective tissue disease other than the disease under research.
* Women who are pregnant or breastfeeding.
* Combined severe cardiovascular or cerebrovascular disease, hepatic or renal failure, or severe malignant tumors.
* Other conditions (e.g., cognitive impairment) that the investigators consider ineligible for enrollment.

Primary outcomes:
measure: Number of participants with system involvement
timeFrame: Baseline , 6 months follow-up
Secondary outcomes:
measure: Mortality
timeFrame: Baseline , 6 months follow-up
measure: Number of participants with tumor
timeFrame: Baseline , 6 months follow-up
measure: Number of participants with connective tissue disease
timeFrame: Baseline , 6 months follow-up
Other outcomes:
Locations:
city: Beijing
country: China
facility: Jiaqi Chen
state: Beijing
Study officials:
References:
Clinical trial NCT03120897: Rainbow Acoustic Monitoring (RAM) Clinical Engineering Data Collection
Official title: Rainbow Acoustic Monitoring (RAM) Clinical Engineering Data Collection
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Sleep Apnea
Lead sponsor: Masimo Corporation
Sponsor class: INDUSTRY
First posted: 2017-04-19
Enrollment: 78
Sex: ALL
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: To capture high resolution waveform data and numerical data from investigational and FDA-released RAM sensors in the neonatal, infant, pediatric, and adult patient population


Eligibility criteria: Inclusion Criteria:

* Male or Female subjects that are between 0 to 70 years old.
* Neonate, Infant, Pediatric, Adult, and Pregnant subjects with fully developed skin.

Exclusion Criteria:

* Patients with skin abnormalities at the planned application sites that would interfere with sensor, cannula or electrode applications.
* Patients with pre-existing conditions and/or co-morbidities that would prohibit them from participating in the study due to unacceptable risks to their health and well-being, as determined by the Principal Investigator (PI).
* Patients who the PI deems ineligible at the PI's discretion

Primary outcomes:
measure: Number of subjects in which respiratory rate is collected
timeFrame: Duration of surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University Medical Center
state: California
Study officials:
References:
Clinical trial NCT00431197: Steady-State Feedback Actions of Testosterone on Luteinizing Hormone Secretion in Young and Older Men
Official title: Steady-State Feedback Actions of Testosterone on Luteinizing Hormone Secretion in Young and Older Men
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hypogonadism
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2007-02-05
Enrollment: 40
Sex: MALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: This study is being done to learn how the male hormone , testosterone, affects pituitary hormones in younger and older men. The pituitary is a gland in the brain that secretes hormones, some of which normally control growth and fertility.

Detailed description: Concentrations of bioavailable testosterone decline by 1.0-1.5% annually as men age. Reduced systemic testosterone availability is associated with decreased muscle mass, strength and aerobic capacity, decreased bone-mineral density and increased risk of hip fracture, waning sexual interest, inpaired spatial cognition and increased risk of visceral obesity, impaired glucose tolerance and coronary artery disease. Luteinizing hormone (LH) secretion often fails in healthy older individuals. In addition, aging is marked by an acceleration of LH pulse frequency, loss of high-amplitude LH pulses and disorderly release of LH and testosterone, as measured by the approximate entropy statistic. The mechanisms that underlie such complex adaptations are not known, but appear to involve multiple loci of regulatory failure.

Eligibility criteria: * Healthy Men Ages 18-80
* All ethnicities eligible
* Men with indeterminate erectile dysfunction eligible with normal serum gonadotropin, total testosterone, prolactin and TSH concentrations and documented integrity of the neurovascular, cardiovascular, hepatorenal systems

Primary outcomes:
measure: LH and Testosterone levels will be evaluated after 4 study visits
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic and Foundation
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Johannes D. Veldhuis, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00211497: Safety and Efficacy of MBI 226 1.25% and 2.5% Topical Acne Solutions in the Treatment of Acne
Official title: A Phase II, Randomized, Vehicle-Controlled, Double-Blind, Multi-Center Study to Evaluate Safety and Efficacy of MBI 226 1.25% and 2.5% Acne Solutions Applied Topically for 12 Weeks to Subjects With Acne Vulgaris
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acne Vulgaris
Acne
Propionibacterium Acnes
Keywords: acne vulgaris
acne
Propionibacterium acnes
topical
inflammatory
non-inflammatory
lesion counts
lesions
Lead sponsor: BioWest Therapeutics Inc
Sponsor class: INDUSTRY
First posted: 2005-09-21
Enrollment: 255
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a Phase II, randomized, vehicle-controlled, double-blind, multi center study to evaluate the efficacy and safety of topically applied MBI 226 1.25% and 2.5% Acne Solutions as anti-acne preparations in human subjects with facial acne vulgaris.


Eligibility criteria: Inclusion Criteria:

* Males and females 12 years and older
* Presence of inflammatory and non-inflammatory lesions

Exclusion Criteria:

* Acne conglobata, acne fulminans, or secondary acne (chloracne, drug-induced acne, etc.)
* Active facial cysts or any nodulocystic lesions

Primary outcomes:
measure: - percent change from Baseline to Week 12 in inflammatory acne lesion counts
Secondary outcomes:
measure: Single continuous endpoints:
measure: • Percent change from Baseline to Week 6 and Week 12 in non inflammatory acne lesion counts
measure: • The percent change from Baseline to Week 6 and Week 12 in total acne lesion counts
measure: Multiple continuous endpoints:
measure: • Percent change from Baseline to Weeks 3, 6, 9 and 12 in inflammatory acne lesion counts
measure: • Percent change from Baseline to Weeks 3, 6, 9 and 12 in non-inflammatory acne lesion counts
measure: • Percent change from Baseline to Weeks 3, 6, 9 and 12 in total acne lesion counts
measure: Categorical endpoints:
measure: • Dichotomized Physicians Global Severity Assessment scores at Week 6 and Week 12
measure: • PGSA absolute scores at Week 6 and Week 12
measure: • PGSA absolute scores over Baseline, Week 6 and Week 12
Other outcomes:
Locations:
Study officials:
affiliation: BioWest Therapeutics Inc
name: Jim Pankovich
role: STUDY_DIRECTOR
References:
Clinical trial NCT01666197: Efficacy and Safety of Diclofenac Potassium 25 mg Tablet Taken Three Times Daily in Subjects With Acute Joint Pain
Official title: A Randomized, Double-blind, Multi-center, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Diclofenac Potassium 25 mg Tablet Taken Three Times Daily in Subjects With Acute Joint Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Ankle Sprain
Keywords: Acute Joint Pain
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2012-08-16
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy of diclofenac potassium 25 mg tablet compared with placebo taken three times a day in subjects with acute ankle sprains under 'in-use' conditions, in particular with regard to pain relief.


Eligibility criteria: Inclusion Criteria:

* Male or female aged 18 years and over.
* Acute sprain of the lateral ankle, Grade I-II, meeting baseline pain intensity level.
* Injury within past 12 hours.

Exclusion Criteria:

* Pain medication was taken within the 6 hours that precede randomization.
* During the past 3 months: Grade I-III sprain of the same ankle.
* During the past 6 months: Grade II-III sprain, any other significant injury (such as fracture or torn ligament), or surgery (except for skin or nails) of the same ankle or foot.
* Pain or instability in the same ankle attributable to previous ankle sprain or any other trauma.
* Ankle sprain attributable to a known disease affecting the ligaments, such as ligament hyperlaxity due to connective tissue disease (e.g., Marfan's syndrome, Down's syndrome, Ehlers-Danlos syndrome).

Primary outcomes:
measure: Pain on Movement
timeFrame: 48 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Brühl
country: Germany
facility: Investigator
city: Essen
country: Germany
facility: Investigator
city: Gilching
country: Germany
facility: Investigator
city: Köln
country: Germany
facility: Investigator
Study officials:
References:
Clinical trial NCT03686397: SVT-15652 Otic Solution for the Treatment of Otomycosis.
Official title: A Phase III, Multicenter, Randomized, Double-Blind Clinical Trial to Assess the Efficacy and Safety of SVT-15652 Otic Solution Compared to Placebo for the Treatment of Fungal Otitis Externa (Otomycosis).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Otomycosis
Lead sponsor: Salvat
Sponsor class: INDUSTRY
First posted: 2018-09-26
Enrollment: 194
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Multicenter, randomized, 2-arm parallel-group, double blind, placebo-controlled study in patients suffering from Otomycosis. This study will compare the efficacy and safety of SVT-15652 otic solution to that of Placebo, when administering one vial twice daily during 14 days.


Eligibility criteria: Main Inclusion Criteria:

* At least 18 years of age
* Clinical diagnosis of otomycosis in one or both ears, where topical treatment is indicated.
* Signs/symptoms of pruritus, otalgia and ear fullness.
* Debris or drainage clinically consistent with fungal infection.

Main Exclusion Criteria:

* Known bacterial otitis externa or malignant otitis externa.
* Tympanic perforation, tympanostomy tubes inserted and post mastoid surgery.
* Structural ear anomalies which may difficult the evaluation of the therapeutic response.
* Uncontrolled diabetes mellitus.
* Any infection requiring systemic antimicrobial or systemic antifungal therapy.
* Concomitant medicines that may interfere with the study evaluations.

Primary outcomes:
measure: Therapeutic Cure (Clinical and Mycological Cure)
timeFrame: Test of cure on day 24
Secondary outcomes:
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Clinic
Study officials:
References: