Efinaconazole Topical Solution, 10%

2015 ◽  
Vol 105 (5) ◽  
pp. 407-411 ◽  
Author(s):  
Bryan Markinson ◽  
Bryan Caldwell
Keyword(s):  
Potassium Hydroxide ◽  
Tinea Pedis ◽  
Fungal Culture ◽  
Cure Rate ◽  
Double Blind ◽  
Once Daily ◽  
Complete Cure ◽  
Topical Solution ◽  
Cure Rates ◽  
To Receive

Background We sought to evaluate the efficacy of efinaconazole topical solution, 10%, in patients with onychomycosis and coexisting tinea pedis. Methods We analyzed 1,655 patients, aged 18 to 70 years, randomized (3:1) to receive efinaconazole topical solution, 10%, or vehicle from two identical multicenter, double-blind, vehicle-controlled 48-week studies evaluating safety and efficacy. The primary end point was complete cure rate (0% clinical involvement of the target toenail and negative potassium hydroxide examination and fungal culture findings) at week 52. Three groups were compared: patients with onychomycosis and coexisting interdigital tinea pedis on-study (treated or left untreated) and those with no coexisting tinea pedis. Results Treatment with efinaconazole topical solution, 10%, was significantly more effective than vehicle use irrespective of the coexistence of tinea pedis or its treatment. Overall, 352 patients with onychomycosis (21.3%) had coexisting interdigital tinea pedis, with 215 of these patients (61.1%) receiving investigator-approved topical antifungal agents for their tinea pedis in addition to their randomized onychomycosis treatment. At week 52, efinaconazole complete cure rates of 29.4% were reported in patients with onychomycosis when coexisting tinea pedis was treated compared with 16.1% when coexisting tinea pedis was not treated. Both cure rates were significant compared with vehicle (P = .003 and .045, respectively), and in the latter subgroup, no patients treated with vehicle achieved a complete cure. Conclusions Treatment of coexisting tinea pedis in patients with onychomycosis enhances the efficacy of once-daily topical treatment with efinaconazole topical solution, 10%.

Sulphadiazine/Trimethoprim Once Daily in Maxillary Sinusitis: A Randomized Double-Blind Comparison with Sulphamethoxazole/Trimethoprim B.I.D.

1981 ◽  
Vol 9 (6) ◽  
pp. 478-481 ◽  
Author(s):  
Pierre Federspil ◽  
Peter Bamberg
Keyword(s):  
Maxillary Sinusitis ◽  
Favourable Result ◽  
Double Blind Study ◽  
Double Blind ◽  
Once Daily ◽  
Days Of Therapy ◽  
Significant Difference ◽  
Blind Comparison ◽  
Cure Rates

In a randomized double-blind study fifty-four patients suffering from acute maxillary sinusitis were treated for 10 days with daily doses of sulphadiazine/trimethopim (1 g) and sulphamethoxazole/trimethoprim (1.92 g), respectively. The efficacy was evaluated clinically at two follow-up visits. X-ray investigations were performed at admission and after the therapy. Of thirty-nine patients finally evaluated, thirty-seven showed a favourable result. After 6–8 days of therapy there was significant difference in cure rates in favour of sulphadiazine/trimethoprim (p < 0.05) while the outcome as evaluated after treatment was similar for both drugs.

A Parallel-Group Comparison of Astemizole and Loratadine for the Treatment of Perennial Allergic Rhinitis

1997 ◽  
Vol 25 (4) ◽  
pp. 175-181 ◽  
Author(s):  
H Al-Muhaimeed
Keyword(s):  
Allergic Rhinitis ◽  
Statistical Significance ◽  
Double Blind Study ◽  
Perennial Allergic Rhinitis ◽  
Double Blind ◽  
Once Daily ◽  
Runny Nose ◽  
Parallel Group ◽  
The Mean ◽  
To Receive

The efficacy and safety of the two antihistamines, astemizole and loratadine, were compared in a double-blind study of 84 patients with perennial allergic rhinitis. Patients were randomized to receive orally either astemizole 10 mg once daily ( n = 40) or loratadine 10 mg once daily ( n = 44) for 1 week. No other antirhinitis medication was allowed during the study. By day 7 the mean daily symptom scores, recorded on diary cards, were lower in patients receiving astemizole than in those receiving loratadine for runny nose, itchy nose and sneezing, although not for blocked nose, and treatment differences only reached statistical significance for runny nose. After 7 days, 53.75% of patients on astemizole and 38.6% on loratadine were free of symptoms, and 87% of patients on astemizole described the treatment as good or excellent compared with 62% on loratadine. The present results suggest that astemizole may be more effective than loratadine in controlling symptoms of perennial allergic rhinitis.

Comparative Effectiveness of Amoxicillin and Amoxicillin-Clavulanate Potassium in Acute Paranasal Sinus Infections in Children: A Double-Blind, Placebo-Controlled Trial

PEDIATRICS ◽  
1986 ◽  
Vol 77 (6) ◽  
pp. 795-800 ◽  
Author(s):  
Ellen R. Wald ◽  
Darleen Chiponis ◽  
Jocyline Ledesma-Medina
Keyword(s):  
Group A Streptococcus ◽  
Maxillary Sinusitis ◽  
Controlled Trial ◽  
Relative Effectiveness ◽  
Nasal Discharge ◽  
Cure Rate ◽  
Double Blind ◽  
Amoxicillin Clavulanate ◽  
Group A ◽  
To Receive

This study compared the relative effectiveness of two antimicrobial preparations, amoxicillin and amoxicillin-clavulanate potassium (Augmentin), in the treatment of acute maxillary sinusitis in children 2 to 16 years of age. Of 171 children with persistent (ten to 30 days' duration) nasal discharge or daytime cough or both, 136 (80%) had abnormal maxillary sinus radiographs. These children were stratified by age and severity of symptoms and randomly assigned to receive either amoxicillin, amoxicillin-clavulanate potassium, or placebo. After the exclusion of 28 children with throat cultures positive for group A Streptococcus and 15 who did not complete their medication, the remaining 93 children were evaluated: 30 received amoxicillin, 28 received amoxicillin-clavulanate potassium, and 35 received placebo. Clinical assessment was performed at three and ten days. On each occasion, children treated with an antibiotic were more likely to be cured than children receiving placebo (P &lt; .01 at three days, P &lt; .05 at ten days). The overall cure rate was 67% for amoxicillin, 64% for amoxicillin-clavulanate potassium, and 43% for placebo.

scholarly journals Rezafungin versus Caspofungin in a Phase 2, Randomized, Double-Blind Study for the Treatment of Candidemia and Invasive Candidiasis- The STRIVE Trial

2020 ◽  
Author(s):  
George R Thompson ◽  
Alex Soriano ◽  
Athanasios Skoutelis ◽  
Jose A Vazquez ◽  
Patrick M Honore ◽  
...  
Keyword(s):  
Invasive Candidiasis ◽  
Double Blind Study ◽  
Phase 2 ◽  
Double Blind ◽  
Once Daily ◽  
Secondary Endpoints ◽  
Intent To Treat ◽  
Cure Rates ◽  
Treat Population

Abstract Background Rezafungin (RZF) is a novel echinocandin exhibiting distinctive pharmacokinetics/pharmacodynamics. STRIVE was a phase 2, double-blind, randomized trial designed to compare the safety and efficacy of RZF once weekly (QWk) to caspofungin (CAS) once daily for treatment of candidemia and/or invasive candidiasis (IC). Methods Adults with systemic signs and mycological confirmation of candidemia and/or IC were randomized to RZF 400 mg QWk (400 mg), RZF 400 mg on week 1 then 200 mg QWk (400/200 mg), or CAS 70 mg as a loading dose followed by 50 mg daily for ≤ 4 weeks. Efficacy assessments included overall cure (resolution of signs of candidemia/IC + mycological eradication) at day 14 (primary endpoint), investigator-assessed clinical response at day 14, and 30-day all-cause mortality (ACM) (secondary endpoints), and time to negative blood culture. Safety was evaluated by adverse events and ACM through follow-up. Results Of 207 patients enrolled, 183 were in the microbiological intent-to-treat population (~21% IC). Overall cure rates were 60.5% (46/76) for RZF 400 mg, 76.1% (35/46) for RZF 400/200 mg, and 67.2% (41/61) for CAS; investigator-assessed clinical cure rates were 69.7% (53/76), 80.4% (37/46), and 70.5% (43/61), respectively. 30-day ACM was 15.8% for RZF 400 mg, 4.4% for RZF 400/200 mg, and 13.1% for CAS. Candidemia was cleared in 19.5 and 22.8 hours in RZF and CAS patients, respectively. No concerning safety trends were observed; ACM through follow-up was 15.2% (21/138) for RZF and 18.8% (13/69) for CAS. Conclusions RZF was safe and efficacious in the treatment of candidemia and/or IC.

Vandetanib plus mFOLFOX6 in patients with advanced colorectal cancer (CRC): A randomized, double-blind, placebo-controlled phase II study

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 4084-4084
Author(s):  
T. S. Yang ◽  
D. Y. Oh ◽  
R. Guimbaud ◽  
J. Szanto ◽  
T. Salek ◽  
...  
Keyword(s):  
Tyrosine Kinases ◽  
Day Treatment ◽  
Sensory Neuropathy ◽  
Primary Objective ◽  
Double Blind ◽  
Once Daily ◽  
Assessment Visit ◽  
Number Of Patients ◽  
Peripheral Sensory ◽  
To Receive

4084 Background: Vandetanib is a once-daily oral agent that selectively targets key signaling pathways in cancer by inhibiting VEGF, EGF and RET receptor tyrosine kinases. Methods: Eligible patients with advanced CRC and who had previously progressed after an irinotecan- and fluoropyrimidine-containing regimen were randomized 1:1:1 to receive once-daily oral vandetanib (100 or 300 mg) + modified FOLFOX6 (mFOLFOX6) or placebo + mFOLFOX6; mFOLFOX6 was given as standard 14-day treatment cycles (oxaliplatin 85 mg/m2 2-hr and leucovorin 400 mg/m2 2-hr i.v. infusions, followed by 5- fluorouracil [5-FU] 400 mg/mg2 i.v. bolus and 5-FU 2400 mg/m2 46-hr i.v. infusion). The primary objective was to compare the number of patients with a progression event on or before a mandatory tumor assessment visit at data cut-off (∼4 months after last patient randomized). A progression event was defined as the earliest of objective and/or clinical disease progression, or death from any cause. Results: Between March and November 2007, 104 patients (aged 32–81 years) were randomized to receive study treatment ( Table ). At data cut-off on 8 March 2008, there was a greater % of progression events in the vandetanib 100 mg arm compared with placebo (72% [n=23] versus 65% [n=24]; HR=1.21, 2-sided 80% CI 0.82–1.80; 2-sided P=0.53), and also in the vandetanib 300 mg arm compared with placebo (77% [n=27] versus 65% [n=24]; HR=1.41, 2-sided 80% CI 0.96–2.07; 2-sided P=0.25). All except one patient in each group experienced an adverse event (AE) during the study with diarrhea, nausea, thrombocytopenia, and peripheral sensory neuropathy the most commonly reported AEs ( Table ). Neutropenia was the only CTC grade 4 AE to occur in >1 patient in any group (n=2, vandetanib 100 mg arm; n=0, vandetanib 300 mg arm; n=3, placebo arm). Conclusions: In this study of patients with advanced, previously treated CRC, there was no efficacy benefit for vandetanib (100 or 300 mg) + mFOLFOX6 versus placebo + mFOLFOX6. [Table: see text] [Table: see text]

scholarly journals Evaluation of the efficacy and safety of etoricoxib in the treatment of hemophilic arthropathy

Blood ◽  
2006 ◽  
Vol 107 (5) ◽  
pp. 1785-1790 ◽  
Author(s):  
Christos Tsoukas ◽  
M. Elaine Eyster ◽  
Sumiko Shingo ◽  
Saurabh Mukhopadhyay ◽  
Karen M. Giallella ◽  
...  
Keyword(s):  
Global Assessment ◽  
Disease Status ◽  
Controlled Study ◽  
Pain Patient ◽  
Double Blind ◽  
End Points ◽  
Once Daily ◽  
Upper Respiratory Infection ◽  
Hemophilic Arthropathy ◽  
To Receive

This 2-part, double-blind, placebo-controlled study was conducted to determine the safety and efficacy of etoricoxib, a COX-2 selective inhibitor, for the treatment of hemophilic arthropathy. In part 1 (6 weeks), 102 patients (≥ 12 years old) with hemophilic arthropathy were randomized to receive 90 mg etoricoxib once daily or placebo (1:1 ratio). In part 2 (6 months), 51 patients taking placebo in part 1 were randomized to receive 90 mg etoricoxib or 25 mg rofecoxib once daily; patients taking etoricoxib in part 1 continued the same treatment. Efficacy end points included Patient Assessment of Arthropathy Pain, Patient Global Assessment of Arthropathy Disease Status, and Investigator Global Assessment of Arthropathy Disease Status. Safety was evaluated at each study visit. Etoricoxib provided significant improvement in all end points versus placebo (P < .001). Fewer patients taking etoricoxib discontinued due to a lack of efficacy versus placebo (P = .048). During part 2, efficacy was maintained; etoricoxib and rofecoxib demonstrated similar results. The most common adverse experiences were upper respiratory infection and headache. The incidence of joint bleeding during part 1 was similar between etoricoxib (66.7%) and placebo (72.6%) and during part 2 between etoricoxib (77.0%) and rofecoxib (78.9%). We conclude that etoricoxib provided superior efficacy versus placebo for the treatment of hemophilic arthropathy and was generally safe and well tolerated.

scholarly journals A comparative trial between the therapeutic efficacy of topical 2% sertaconazole cream and 1% terbinafine cream in the treatment of tinea cruris/tinea corporis

2017 ◽  
Vol 3 (1) ◽  
pp. 59
Author(s):  
Sumyuktha J. ◽  
Murali Narasimhan ◽  
Parveen Basher Ahamed
Keyword(s):  
Comparative Trial ◽  
Treated Group ◽  
Tinea Corporis ◽  
Fungal Culture ◽  
Tinea Cruris ◽  
Complete Cure ◽  
Group A ◽  
Clinically Significant ◽  
Group B ◽  
Cure Rates

<p class="abstract"><strong>Background:</strong> Skin infections caused by dermatophyte fungi account for 6% of dermatology consultations at our hospital and 3 to 4% worldwide. A variety of antifungal agents are available for topical use. Terbinafine 1% cream is considered the first line topical medication in the treatment of dermatophytosis. Sertaconazole 2% cream is a relatively new drug having antifungal as well as antiflammatory property. In this prospective study we sought to compare the safety and efficacy of topical 2% Sertaconazole and 1% Terbinafine creams in the treatment of localized tinea cruris and/or tinea corporis<span lang="EN-IN">.</span></p><p class="abstract"><strong>Methods:</strong> In this study, 80 patients were randomized into two groups of 40 each. Group A received 2% Sertaconazole cream while group B received Terbinafine 1% cream topical application twice daily for 4 weeks. Patients were followed up at the end of 2<sup>nd</sup> and 4<sup>th</sup> weeks for clinical, mycological (KOH mount and fungal culture) and complete cure (both clinical and mycological).<strong></strong></p><p class="abstract"><strong>Results:</strong> The mean age of the patients studied was 27.97 years. Complete cure was achieved in 59.5% and 80% in group A and 71.4% and 90.9% in group B at the end of 2<sup>nd</sup> and 4<sup>th</sup> weeks respectively. Significant P values were observed if the results were compared within the group, between baseline and 2 weeks, baseline and 4<sup>th</sup> week and also 2<sup>nd</sup> and 4<sup>th</sup> week. Clinically significant side effects were not observed in both the groups<span lang="EN-IN">. </span></p><p class="abstract"><strong>Conclusions:</strong> Although higher cure rates were observed in the Terbinafine treated group, the results were not statistically significant. It can be concluded from our study that Sertaconazole 2% cream is similar in efficacy to Terbinafine 1% cream in the treatment of localized tinea cruris and corporis<span lang="EN-IN">.</span></p>

scholarly journals Novel, Single-Dose Microsphere Formulation of Azithromycin versus 7-Day Levofloxacin Therapy for Treatment of Mild to Moderate Community-Acquired Pneumonia in Adults

2005 ◽  
Vol 49 (10) ◽  
pp. 4035-4041 ◽  
Author(s):  
Joseph D'Ignazio ◽  
Marco A. Camere ◽  
Drew E. Lewis ◽  
Daniel Jorgensen ◽  
Jeanne D. Breen
Keyword(s):  
Single Dose ◽  
Confidence Interval ◽  
Clinical Cure ◽  
Community Acquired Pneumonia ◽  
Double Blind ◽  
Treatment Difference ◽  
Treatment Regimens ◽  
Protocol Population ◽  
Cure Rates ◽  
To Receive

ABSTRACT This randomized, double-blind, noninferiority study was designed to demonstrate that a single 2.0-g oral dose of a novel microsphere formulation of azithromycin was at least as effective as 7 days of levofloxacin, 500 mg/day, in the treatment of adult patients with mild to moderate community-acquired pneumonia (Fine classes I, II, and III). In total, 427 subjects were randomly assigned to receive either a single 2.0-g dose of azithromycin microspheres (n = 213) or a 7-day regimen of levofloxacin (n = 214). At baseline, 219 of 423 (51.8%) treated subjects had at least one pathogen identified by culture, PCR, or serology. The primary end point was the clinical response (cure or failure) in the “clinical per protocol” population at test of cure (days 13 to 24). Clinical cure rates were 89.7% (156 of 174) for azithromycin microspheres and 93.7% (177 of 189) for levofloxacin (treatment difference, −4.0%; 95% confidence interval, −9.7%, 1.7%). Bacteriologic success at test of cure in the “bacteriologic per protocol” population was 90.7% (97 of 107) for azithromycin microspheres and 92.3% (120 of 130) for levofloxacin (treatment difference, −1.7%; 95% confidence interval, −8.8%, 5.5%). Both treatment regimens were well tolerated; the incidence of treatment-related adverse events was 19.9% and 12.3% for azithromycin and levofloxacin, respectively. A single 2.0-g dose of azithromycin microspheres was at least as effective as a 7-day course of levofloxacin in the treatment of mild to moderate community-acquired pneumonia in adult outpatients.

Optimal combination therapy with tropisetron in 445 patients with incomplete control of chemotherapy-induced nausea and vomiting.

1994 ◽  
Vol 12 (11) ◽  
pp. 2439-2446 ◽  
Author(s):  
F Hulstaert ◽  
S Van Belle ◽  
H Bleiberg ◽  
J L Canon ◽  
M Dewitte ◽  
...  
Keyword(s):  
Combination Therapy ◽  
Response Rate ◽  
Complete Response Rate ◽  
Complete Response ◽  
Moderate Increase ◽  
Open Label ◽  
Double Blind ◽  
Once Daily ◽  
Antiemetic Agent ◽  
To Receive

PURPOSE This study evaluated tropisetron (Navoban; Sandoz Pharma, Basle, Switzerland)-based combination therapy in patients who had incomplete control of chemotherapy-induced nausea or vomiting when using tropisetron as a single antiemetic agent. PATIENTS AND METHODS One thousand seventy-two patients, who were scheduled to receive at least two identical cycles of emetogenic chemotherapy, were treated with 5 mg tropisetron once daily in their first chemotherapy course. A 2 x 2 x 2 factorial design was used to evaluate three additional treatments to the recommended 5 mg once daily (intravenously [i.v.] on day 1; orally on days 2 through 6) tropisetron regimen during course 2 in those patients who had shown incomplete control of nausea and/or vomiting on any day of course 1. Four hundred forty-five patients were centrally randomized to receive, in addition, open-label dexamethasone (day 1, 0.2 mg/kg i.v.; days 2 through 6, 8 mg orally) and/or open-label alizapride (day 1, 100 mg i.v. and 4 x 50 mg orally; days 2 through 6, 4 x 50 mg orally) and/or double-blind tropisetron (ie, doubling the dose to 10 mg once daily) or corresponding placebo. RESULTS Complete response rates (no nausea and no vomiting) were 72% for day 1 and 48% for days 1 through 6 of course 1. During course 2, more complete responders were observed when dexamethasone was added, both for day 1 (76% v 66%, P = .020) and for days 1 through 6 (50% v 34%, P = .0004). A moderate increase in the complete response rate was seen with the addition of conventional-dose alizapride (day 1, 75% v 68%, P = .14; days 1 through 6: 47% v 37%, P = .041). Doubling the dose of tropisetron did not change the complete response rate. CONCLUSION The addition of dexamethasone significantly increases the complete response rate of both acute and delayed emesis in patients who have incomplete disease control with tropisetron alone.

scholarly journals Role of Probiotics in Helicobacter pylori Eradication: Lessons from a Study of Lactobacillus reuteri Strains DSM 17938 and ATCC PTA 6475 (Gastrus®) and a Proton-Pump Inhibitor

2019 ◽  
Vol 2019 ◽  
pp. 1-8 ◽  
Author(s):  
Maria Pina Dore ◽  
Stefano Bibbò ◽  
Giovanni Mario Pes ◽  
Ruggero Francavilla ◽  
David Y. Graham
Keyword(s):  
Helicobacter Pylori ◽  
Lactobacillus Reuteri ◽  
Eradication Therapy ◽  
Cure Rate ◽  
Double Blind ◽  
Antibiotics Use ◽  
Incremental Improvement ◽  
H Pylori ◽  
Meta Analyses ◽  
Cure Rates

Background. Meta-analyses involving >4000 subjects with probiotics added to antimicrobial Helicobacter pylori eradication therapy have reported a mean increase in the eradication rate of 12 to 14%. It is unclear how to translate that result into clinical practice. Aim. To evaluate whether administration of Lactobacillus reuteri plus a PPI without antibiotics would eradicate H. pylori infections. Methods. This was a double-blind placebo-controlled randomized 2-site study of L. reuteri (Gastrus®) at a dose of 2 × 108 CFU, 7 times per day, or matching placebo plus 20 mg pantoprazole b.i.d. for 4 weeks. Cure was defined by negative 13C-UBT, 4 weeks after therapy. Sample size required ≥50% cure rates for using probiotics as a clinically useful monotherapy. Results. Recruitment was halted after 56 subjects because of the low cure rate; there were 8 dropouts; 48 subjects completed therapy (71% women, average age 49 years). The cure rates per protocol were 3/24 (12.5%; 95% CI 2.6–32%) with L. reuteri vs. 1/24 (4.1%) with placebo. Side effects (most often diarrhea) occurred infrequently (in 5/28 vs. 3/28; active vs. placebo therapy) (P=0.53). Conclusion. L. reuteri plus a PPI therapy was unable to provide a clinically important rate of H. pylori eradication. The cure rate albeit low (12.5%) was essentially identical to that achieved when probiotics were added to antibiotic therapy. The incremental improvement was additive and independent of antimicrobial resistance or antibiotics use. Probiotics can reliably increase the cure rate to ≥90% only in regimens achieving cure rates of ∼80%. This trial is registered with NCT03404440.

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