Dosing Colistimethate Every 8 h Results in Higher Plasma Concentrations of Active Colistin Than Every 12-Hourly Dosing without Increase in Nephrotoxicity: A Phase 1 Pharmacokinetics Trial in Healthy Adult Volunteers.

Despite its use for decades, pharmacokinetic (PK) and safety studies on colistin are limited. We conducted a phase l, open-label trial to evaluate the safety and PK of multiple doses of intravenous (IV) and aerosolized colistimethate sodium (CMS) administered separately and in combination. In total, 31 healthy adults were enrolled into three cohorts of 9, 10, and 12 participants, respectively.

Characterization of Polybacterial versus Monobacterial Conjunctivitis Infections in Pediatric Subjects Across Multiple Studies and Microbiological Outcomes with Besifloxacin Ophthalmic Suspension 0.6.

Introduction: The choice of empiric therapy for bacterial conjunctivitis should be guided by an awareness of typical causative pathogen distributions. Bacterial conjunctivitis can be polybacterial, although pediatric-specific data are lacking.

Methods: This was a post-hoc analysis of data in pediatric subjects (1-17 years) from five bacterial conjunctivitis trials evaluating besifloxacin ophthalmic solution 0.

Clinical Performance of Samfilcon A, a Unique Silicone Hydrogel Lens, on a 7-Day Extended Wear Basis.

Purpose: The objective of this study was to evaluate and compare the clinical performance of samfilcon A, a unique, polyvinylpyrrolidone (PVP)-containing, silicone hydrogel contact lens with that of the balafilcon A silicone hydrogel contact lens when worn on a 7-day extended wear basis.

Subjects And Methods: A total of 669 subjects completed this 12-month, controlled, parallel group, masked, randomized study; of these, 340 wore samfilcon A lenses and 329 balafilcon A lenses. Subjects wore their respective assigned lenses bilaterally on a 7-day extended wear basis.

Characterization of baseline polybacterial versus monobacterial infections in three randomized controlled bacterial conjunctivitis trials and microbial outcomes with besifloxacin ophthalmic suspension 0.6.

Background/purpose: To date, studies examining polymicrobial infections in ocular disease have mostly been limited to keratitis or endophthalmitis. We characterized polybacterial infections compared to monobacterial infections in prior clinical studies evaluating besifloxacin ophthalmic suspension 0.6% for the treatment of bacterial conjunctivitis and report on associated microbiological outcomes.

Single-Dose Intraventricular Nimodipine Microparticles Versus Oral Nimodipine for Aneurysmal Subarachnoid Hemorrhage.

Background and Purpose- EG-1962 is a sustained release formulation of nimodipine administered via external ventricular drain in patients with aneurysmal subarachnoid hemorrhage. A randomized, open-label, phase 1/2a, dose-escalation study provided impetus for this study to evaluate efficacy and safety of a single intraventricular 600 mg dose of EG-1962 to patients with aneurysmal subarachnoid hemorrhage, compared with standard of care oral nimodipine. Methods- Subjects were World Federation of Neurological Surgeons grades 2-4, modified Fisher grades 2-4 and had an external ventricular drain inserted as part of standard of care.

A two-part phase 1 study to establish and compare the safety and local tolerability of two nasal formulations of XF-73 for decolonisation of Staphylococcus aureus: A previously investigated 0.5mg/g viscosified gel formulation versus a modified formulation.

Objectives: Successful decolonisation of nasal Staphylococcus aureus (SA) carriage by mupirocin is limited by increasing drug resistance. This randomised, open-label, phase 1 study compared the safety and local tolerability of two nasal formulations of XF-73, a novel porphyrinic antibacterial with rapid intrinsic activity against SA.

Methods: The study was performed in 60 healthy adults.

Effects of Rifamycin Coadministration on Bedaquiline Desmethylation in Healthy Adult Volunteers.

There is an urgent need to identify safe and effective combination treatments for multidrug-resistant (MDR) Mycobacterium tuberculosis infection (TB). Bedaquiline, a new diarylquinoline, is approved for the treatment of MDR pulmonary TB in combination with other drugs, which could include rifabutin, which is also used to treat drug-resistant TB. Both rifabutin and bedaquiline are metabolized via cytochrome P450 3A4, and rifabutin is an inducer of this enzyme.

An induced extrinsic tooth stain prevention model to investigate whitening potential of sugar-free chewing gums.

Purpose: To establish an accelerated clinical test method to evaluate the effectiveness of sugar-free gums in prevention of the formation of extrinsic stains when chewed over a 2-week period in conjunction with daily tooth brushing. A secondary objective was to compare three methods for measuring extrinsic stain.

Methods: 25 healthy adult volunteers were enrolled in a single center, examiner blind, randomized 4-way crossover clinical study.

Impact of Rifabutin or Rifampin on Bedaquiline Safety, Tolerability, and Pharmacokinetics Assessed in a Randomized Clinical Trial with Healthy Adult Volunteers.

Bedaquiline is a diarylquinoline that specifically inhibits mycobacterial ATP synthase. Bedaquiline has been used to effectively treat tuberculosis (TB) caused by drug-susceptible and drug-resistant Rifamycins are a cornerstone of combination drug regimens for the treatment of TB. This phase 1, open-label, randomized, controlled trial evaluated the effect of steady-state dosing of rifabutin or rifampin on the safety, tolerability, and pharmacokinetics of bedaquiline given as a single dose.

Comparison of Rectal and Esophageal Sensitivity in Women With Functional Heartburn.

This study tested the primary hypothesis that there is a correlation of maximum pain threshold (MPT) in the esophagus and rectum in persons with functional heartburn. Secondary aims evaluated correlations with initial perception threshold (IPT) and pain threshold (PT). This study explored objective sensory endpoints of IPT, PT, and MPT in the esophagus and rectum of 14 females with functional heartburn to determine whether visceral hypersensitivity is generalized or organ-specific.

Subjective Assessment of Enamelon® Preventive Treatment Gel in a Self-Reported Dry-Mouth Population.

Background: The efficacy of stannous fluoride toothpastes is well established for reducing caries, plaque, and gingivitis and relieving the discomfort of dentin hypersensitivity. Management of dry mouth may include relief remedies in addition to usual oral hygiene methods to maintain oral health and improve quality of life. This 6-week, single-blind, randomized, two-period crossover clinical study was designed to evaluate the oral tolerance and potential of Enamelon® Preventive Treatment Gel (EPTG), with 0.

A 6-month clinical investigation of custom tray application of peroxide gel with or without doxycycline as adjuncts to scaling and root planing for treatment of periodontitis.

Purpose: To evaluate the 6-month clinical effects of one scaling and root planing (SRP) procedure alone or combined with local administration of hydrogen peroxide gel (with or without inclusion of doxycycline for 2 weeks) using periodontal medicament carriers in the form of customized prescription trays for treatment of subjects with chronic periodontitis.

Methods: Using a randomized controlled design, 61 subjects with moderate to advanced periodontitis were assigned to three parallel treatment groups: 1) SRP combined with prescription-tray (Perio Tray) application of 1.7% hydrogen peroxide gel (Perio Gel) and, for the first 2 weeks, doxycycline, 2) SRP combined with prescription-tray application of peroxide gel, and 3) SRP alone.

Crossover clinical investigation of a whitening chewing gum for inhibiting dental stain formation in conjunction with tooth brushing.

Objective: The purpose of this clinical investigation was to evaluate the effectiveness of a marketed whitening chewing gum compared to a no-gum control in preventing the formation of extrinsic stains on the teeth of stain-forming subjects when chewed over a 12-week period of regular unsupervised use in conjunction with daily tooth brushing.

Methods: This was a single-center, examiner-blind, randomized, 12-week crossover clinical trial. Stain-forming (after smoking or drinking coffee or tea) adults, starting with a stain-free baseline, either chewed the test gum (Orbit White) unsupervised four times per day, 15 minutes/chew, or used no gum along with daily brushing with a commercially available toothbrush and dentifrice for 12 weeks.

Effectiveness of a calcium sodium phosphosilicate-containing prophylaxis paste in reducing dentine hypersensitivity immediately and 4 weeks after a single application: a double-blind randomized controlled trial.

Aims: The aim of this single-site, randomized, controlled, double-blind, 3-arm parallel study was to determine the effectiveness of a prophylaxis paste containing 15% calcium sodium phosphosilicate (CSPS; NovaMin(®) ) with and without fluoride in reducing dentine hypersensitivity immediately after a single application and 28 days following dental scaling and root planing.

Materials & Methods: Overall, 151 subjects were enrolled in this study. All subjects received a scaling and root planing procedure followed by a final prophylaxis step using one of three different prophylaxis pastes: Test-A (15% NovaMin(®) and NaF), Test-B (15% NovaMin(®) ) and a control.

Custom tray application of peroxide gel as an adjunct to scaling and root planing in the treatment of periodontitis: results of a randomized controlled trial after six months.

Objective: Scaling and root planing (SRP) is the primary non-surgical treatment for periodontitis, but its effectiveness is limited. Consequently, various adjunctive therapies have been investigated to improve clinical outcome. This study evaluated the clinical effects of one SRP procedure alone or combined with local administration of hydrogen peroxide gel using customized trays for the treatment of subjects with chronic periodontitis over a period of six months.

NUPRO sensodyne prophylaxis paste with NovaMin for the treatment of dentin hypersensitivity: a 4-week clinical study.

Purpose: The primary objective of this study was to compare the effectiveness of NUPRO Sensodyne Prophylaxis Paste with NovaMin, with and without fluoride, to a standard prophylaxis paste without fluoride (control) in reducing dentin hypersensitivity immediately after a single application following dental scaling and root planing. The secondary objective was to compare the duration of sensitivity relief up to 28 days after a single application of the NUPRO pastes with NovaMin compared to the control paste.

Methods: This was a randomized, single-center, controlled, three-treatment, parallel-group study conducted at Salus Research in Fort Wayne, Indiana.

Custom tray application of peroxide gel as an adjunct to scaling and root planing in the treatment of periodontitis: a randomized, controlled three-month clinical trial.

Objective: Periodontitis is an inflammatory condition of the supporting dental tissues that is normally treated by mechanical removal of the subgingival biofilm. This mechanical treatment, generally known as scaling and root planing (SRP), is not entirely effective, and various adjunctive therapies have been investigated to improve the clinical outcome. This study evaluated the clinical effects of SRP alone or combined with local administration of hydrogen peroxide gel using customized trays in the treatment of subjects with chronic periodontitis.

Comparative investigation of a dentifrice containing triclosan/copolymer/sodium fluoride and specially-designed silica and a dentifrice containing 0.243% sodium fluoride in a silica base for the control of established supra-gingival plaque and gingivitis: a 6-month clinical study.

Purpose: To investigate the efficacy of a dentifrice containing 0.3% triclosan, 2.0% PVM/MA copolymer, 0.

Assessment of hypersensitivity reduction of a dentifrice containing 0.3% triclosan, 2.0% PVM/MA copolymer, 0.243% NaF and specially-designed silica as compared to a dentifrice containing 0.454% stannous fluoride, sodium hexametaphosphate and zinc lactate and to a dentifrice containing 0.243% NaF on dentin hypersensitivity reduction: an 8-week study.

Purpose: To evaluate the 8-week dentin hypersensitivity efficacy of three toothpastes: (1) a dentifrice containing 0.3% triclosan, 2.0% PVM/MA copolymer, 0.

Immune responses associated with perioperative exposure and reexposure to topical bovine thrombin do not impair hemostasis.

Topical bovine thrombin has been associated with immune responses and anecdotal reports of coagulopathy. This open-label study assessed the impact on clinical hemostasis of human antibodies to bovine thrombin (aBT) or factor V/Va (aBV/Va) in response to topical bovine thrombin (THROMBIN-JMI) in patients both with and without preexisting anti-bovine antibodies. Noninferiority analysis assessed primary endpoint for mean shift from baseline activated partial thromboplastin time (aPTT) at 48 hours postsurgery; secondary endpoints included changes from baseline antibodies/titers and coagulation parameters through 8 weeks postsurgery.

Comparative investigation of the efficacy of triclosan/copolymer/sodium fluoride and stannous fluoride/sodium hexametaphosphate/zinc lactate dentifrices for the control of established supragingival plaque and gingivitis in a six-month clinical study.

Objective: This double-blind clinical study, conducted at the University of Puerto Rico, San Juan, Puerto Rico, was designed to compare the efficacy of two commercially available dentifrices for the control of supragingival plaque and gingivitis.

Methods: Qualifying adult male and female subjects from the San Juan, Puerto Rico area were randomly assigned to one of two treatment groups: 1) a commercially available dentifrice containing 0.3% triclosan, 2.

A comparison of the efficacy of a triclosan/copolymer/sodium fluoride dentifrice, a stannous fluoride/sodium hexametaphosphate/zinc lactate dentifrice, and a sodium fluoride dentifrice for the control of established supragingival plaque and gingivitis: a six-week clinical study.

Objective: To compare the efficacy ofa dentifrice containing 0.3% triclosan, 2.0% PVM/MA copolymer, and 0.

A clinical investigation of the efficacy of three commercially available dentifrices for controlling established gingivitis and supragingival plaque.

Objective: To assess the efficacy ofa dentifrice containing 0.3% triclosan/2.0% PVM/MA copolymer/0.

A clinical investigation of the efficacy of a commercial mouthrinse containing 0.05% cetylpyridinium chloride to control established dental plaque and gingivitis.

Objective: The objective of this independent, double-blind, parallel, six-week clinical study was to assess the efficacy of a commercially available mouthrinse containing 0.05% cetylpyridinium chloride (CPC) for controlling established dental plaque and gingivitis relative to that of a control mouthrinse without CPC.

Methods: Adult male and female subjects from the Maceió, Brazil area reported to the clinical facility, after having refrained from any oral hygiene procedures for 12 hours, and from eating, drinking, and smoking for four hours, for an assessment of the oral soft and hard tissues, and for a baseline gingivitis and dental plaque evaluation.

Clinical investigation of the efficacy of a commercial mouthrinse containing 0.05% cetylpyridinium chloride in preventing dental plaque.

Objective: The objective of this independent, double-blind, seven-day clinical study was to assess the efficacy of a commercially available mouthrinse containing 0.05% cetylpyridinium chloride (CPC) in preventing dental plaque build-up relative to that of a control mouthrinse without 0.05% CPC.