Bioequivalence of a New Pediatric Paracetamol Oral Suspension Compared With a Marketed Formulation in Healthy Adults: A Randomized, Open-Label Study.

Background: A new oral paracetamol formulation with the same paracetamol quantity (24 mg/mL) as a marketed formulation but with finer active ingredient particle size and lower amounts of maltitol (5.85 g/dose in the test formulation vs 7.25 g/dose in the reference formulation) and sorbitol (2.

Efficacy of an experimental toothpaste containing sodium bicarbonate, sodium hyaluronate and sodium fluoride on gingivitis.

Background: Gingivitis is driven by plaque accumulation and, if left untreated, can progress to irreversible periodontitis. For many, the mechanical action of toothbrushing does not achieve adequate plaque control. The aim of this study was to investigate whether twice-daily use of a toothpaste containing 0.

Patient Factors in the Dose Selection of Oral Sumatriptan for Acute Migraine: A Post Hoc Analysis of Two Randomized Controlled Studies.

Introduction: Patients are seeking greater involvement in their healthcare. It therefore may be beneficial to provide guidance on initial oral sumatriptan dose selection for the treatment of acute migraine in nontraditional settings, such as telehealth and other remote forms of medical care. We sought to determine whether clinical or demographic factors are predictive of oral sumatriptan dose preference.

Randomized, double-blind, noninferiority study of diclofenac diethylamine 2.32% gel applied twice daily versus diclofenac diethylamine 1.16% gel applied four times daily in patients with acute ankle sprain.

Background: Diclofenac diethylamine (DDEA) gel has demonstrated efficacy for treatment of ankle sprains in both the 1.16% four-times-daily (QID) and 2.32% twice-daily (BID) formulations.

Pharmacokinetic Characterization of a Prototype Mini Nicotine Lozenge.

Introduction: Cigarette smoking remains a substantial public health problem. Nicotine replacement therapy (NRT) is an effective treatment that increases the success of a quit attempt. There are different NRT formats with no difference in efficacy, but their pharmaceutical form or route of administration may translate into individual preferences.

Stain control with two experimental dentin hypersensitivity toothpastes containing spherical silica: a randomised, early-phase development study.

Aims: To determine in human participants whether toothpastes containing small quantities of a novel spherical silica, added to provide enhanced cleaning properties, could achieve similar or greater extrinsic dental stain removal compared to toothpastes containing standard dental abrasive silica concentrations.

Materials And Methods: One hundred and twenty-three adults with extrinsic dental stain were randomised to one of four parallel groups for 8 weeks' twice-daily brushing with an experimental toothpaste containing either 0.5% or 1% spherical silica (with relative dentin abrasivity [RDA] of ~38 and ~58, respectively), or marketed toothpastes containing either 6% (RDA ~ 36) or 16% (RDA ~ 166) standard abrasive silica.

A method development randomised clinical study investigating efficacy of an experimental oral rinse in providing long-term relief from dentinal hypersensitivity.

Objectives: To evaluate and compare clinical efficacy of a 1.5% dipotassium oxalate monohydrate (KOX)-containing oral rinse ('Test') for the relief of dentinal hypersensitivity (DH) against Negative Control and Placebo oral rinses, adjunctive to twice-daily brushing with a standard fluoride dentifrice, after 8 weeks.

Methods: This was a randomised, examiner blind, parallel-group, method development study in participants with DH, assessed at baseline and after 4 and 8 weeks by response to an evaporative (air) stimulus (evaluated by Schiff sensitivity score and a 10-point visual rating scale [VRS]) and a tactile stimulus (Yeaple probe).

The prospective course of rapid-cycling bipolar disorder: findings from the STEP-BD.

Objective: In a naturalistic follow-up of adult bipolar patients, the authors examined the contributions of demographic, phenomenological, and clinical variables, including antidepressant use, to prospectively observed mood episode frequency.

Method: For 1,742 bipolar I and II patients in the Systematic Treatment Enhancement Program for Bipolar Disorder (STEP-BD), episodes of mood disorders were evaluated for up to 1 year of treatment.

Results: At entry, 32% of the patients met the DSM-IV criteria for rapid cycling in the prestudy year.

Intensive psychosocial intervention enhances functioning in patients with bipolar depression: results from a 9-month randomized controlled trial.

Objective: Psychosocial interventions are effective adjuncts to pharmacotherapy in delaying recurrences of bipolar disorder; however, to date their effects on life functioning have been given little attention. In a randomized trial, the authors examined the impact of intensive psychosocial treatment plus pharmacotherapy on the functional outcomes of patients with bipolar disorder over the 9 months following a depressive episode.

Method: Participants were 152 depressed outpatients with bipolar I or bipolar II disorder in the multisite Systematic Treatment Enhancement Program for Bipolar Disorder (STEP-BD) study.

Psychosocial treatments for bipolar depression: a 1-year randomized trial from the Systematic Treatment Enhancement Program.

Context: Psychosocial interventions have been shown to enhance pharmacotherapy outcomes in bipolar disorder.

Objective: To examine the benefits of 4 disorder-specific psychotherapies in conjunction with pharmacotherapy on time to recovery and the likelihood of remaining well after an episode of bipolar depression.

Design: Randomized controlled trial.

Treatment characteristics and illness burden among European Americans, African Americans, and Latinos in the first 2,000 patients of the systematic treatment enhancement program for bipolar disorder.

Objective: Across ethnicity/race, prevalence rates of bipolar disorder are similar. However, African Americans and Latinos may receive less specialty mental health treatment and different medications, and may be less adherent to treatment regimens than European American patients. This study compared illness characteristics, treatment history, and overall functioning in a sample of European American, African American, and Latino patients with bipolar disorder.

Psychotherapy, symptom outcomes, and role functioning over one year among patients with bipolar disorder.

Objective: Randomized trials indicate that psychosocial interventions effective adjuncts to pharmacotherapy in bipolar disorder (1,2). A one-year naturalistic-prospective design was used to examine the association between psychotherapy use and the symptomatic and functional outcomes of patients with bipolar disorder.

Methods: Patients with bipolar disorder in a depressed phase (N=248) were drawn from the first 1,000 enrollees (November 1999 to April 2002) in the Systematic Treatment Enhancement Program (STEP-BD), a study of patients with bipolar disorder receiving best-practice pharmacotherapy.