Search results for "Placebo"
showing 10 items of 704 documents
Alpha-dihydroergocryptine in the treatment of de novo parkinsonian patients: results ofa multicentre, randomized, double-blind, placebo-controlled st…
2000
INTRODUCTION A multicentre, randomized, double-blind, placebo-controlled, parallel group study was carried out in 123 patients suffering from never treated (de novo) idiopathic Parkinson's disease (PD). The aim of the study was to confirm the efficiency and safety of alpha-dihydroergocryptine (alpha-DHEC) given as monotherapy in the symptomatic treatment of PD. The total score of the Unified Parkinson's Disease Rating Scale (UPDRS) was identified as the efficacy target variable. PATIENTS AND METHODS Sixty-two patients (32 males, 30 females, mean age +/- SD 64 +/- 10) were randomized to alpha-dihydroergocryptine and 61 (30 males, 31 females, mean age 63.8 +/- 9.1) to placebo. According to th…
A Dose-Dependent Improvement in Exercise Tolerance in Patients With Stable Angina Treated With Mildronate: A Clinical Trial “MILSS I”
2011
Objective. To assess the efficacy of various doses of Mildronate in combination with standard therapy for the exercise tolerance of patients with stable angina pectoris. The primary efficacy variable was the change in exercise time in bicycle ergometry from the baseline to 12 weeks of treatment. The secondary endpoints were the changes in maximum achieved load and time to the onset of angina from the baseline to week 12. Material and Methods. A total of 512 patients with chronic coronary heart disease who had ischemia as the limiting factor in the exercise test from 72 study centers in 4 countries were enrolled in this prospective, randomized, double-blind, placebo controlled phase 2 study.…
Late Breaking Abstract - Predictive value of FeNO in patients with non-specific respiratory symptoms: a randomised controlled trial
2017
Background: Fractional exhaled nitric oxide (FeNO) can predict treatment response in asthma, but little is known of its utility in patients with non-specific respiratory symptoms (NSRS). Aims and objectives: To evaluate the association between baseline FeNO and response to treatment with inhaled corticosteroids (ICS) in patients with NSRS. Methods: This was a multi-centre randomised, placebo-controlled trial, carried out in UK and Singapore. It consisted of a 2-week assessment period to establish baseline measurements and a 4-week treatment period with either extrafine ICS (200 µ beclomethasone bid) or placebo. NIOX VERO (Circassia) was used to measure baseline FeNO. The primary endpoint wa…
Pioneer: A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of Avapritinib in Patients with Indolent or Smoldering Systemic Mastocytosis w…
2019
Background: The gain-of function mutation KIT D816V plays a central role in the pathogenesis of systemic mastocytosis (SM). Among subtypes of SM, indolent SM (ISM) is the most frequent and is associated with normal/near-normal life expectancy; smoldering SM (SSM) is a subtype with a relatively higher burden of mast cells and may be associated with an increased risk of progression to advanced mastocytosis. However, both ISM and SSM patients may experience severe symptoms associated with mast cell mediator release, such as pruritus, diarrhea, anaphylaxis, and bone pain, which can be severely debilitating and have a profoundly negative impact on quality of life. Symptomatic treatments (eg, ant…
Photobiomodulation and myofascial temporomandibular disorder: Systematic review and meta-analysis followed by cost-effectiveness analysis
2021
Background Photobiomodulation (PBM) is a non-invasive and non-pharmacological treatment, which, has shown beneficial results in the treatment of temporomandibular disorders (TMD) related pain. This systematic review and meta-analysis study aimed to evaluate the efficacy of photobiomodulation in the treatment of myofascial pain associated with (TMD by analyzing randomized clinical trials published from 2007 to February 2019. The secondary objective of the study was to perform a cost-effectiveness analysis of TMD treatment with photobiomodulation in patients with myofascial pain. Material and methods International databases were used: Pubmed, Medline and Web of Science; the initial search rai…
Mirabegron in overactive bladder: A review of efficacy, safety, and tolerability
2013
Aims Mirabegron, the first β3-adrenoceptor agonist to enter clinical practice, has a different mechanism of action from antimuscarinic agents. This review presents data on the efficacy, safety, and tolerability of mirabegron in studies conducted to date. Methods All clinical data on mirabegron that are currently in the public domain are included, including some in-press manuscripts. Results In Phase III clinical trials in patients with overactive bladder (OAB), mirabegron at daily doses of 25, 50, and 100 mg demonstrated significant efficacy in treating the symptoms of OAB, including micturition frequency, urgency incontinence, and urgency. Significant improvements in micturition frequency,…
Long-term safety, tolerability and efficacy of flexible-dose fesoterodine in elderly patients with overactive bladder: Open-label extension of the SO…
2013
Aims To assess the long-term safety, tolerability, and efficacy of flexible-dose fesoterodine in elderly patients with OAB. Methods Patients aged ≥65 years who completed a 12-week, randomized, double-blind, placebo-controlled trial were eligible for the 12-week, open-label (OL) extension phase. Patients who received double-blind placebo started on fesoterodine 4 mg and could increase to 8 mg after 4 or 8 weeks of OL treatment, while fesoterodine-treated patients continued on their double-blind dose; only one dose escalation or de-escalation was permitted. Discontinuations and adverse events (AEs) were monitored, and patients completed 3-day bladder diaries and patient-reported outcomes at t…
A double blind placebo-controlled study on the rectal administration of morphine as a premedication in abdominal hysterectomy
2000
Abstract Benzodiazepines are now commonly used as anxiolytic premedication prior to surgery. However, the role of opioids, as a premedication, has diminished over the last decades and they are no longer routinely used for premedication. Rather, opioids are generally used to treat severe pain in the postoperative period. Studies have shown that both NSAIDs and opioids improve analgesia in the early postoperative period. Until now, there have been no studies investigating the effect of morphine as a rectal premedication in adults in combination with blood levels of morphine. The effect of a rectal premedication with 30 mg of morphine sulphate, on postoperative pain levels and opioid consumpti…
Efficacy of subcutaneous and sublingual immunotherapy with grass allergens for seasonal allergic rhinitis: a meta-analysis–based comparison
2012
Background: Subcutaneous (SCIT) and sublingual (SLIT) immunotherapy are the 2 most prescribed routes for administering allergen-specific immunotherapy. They were shown to be effective in control of symptoms and in reducing rescue medication use in patients with allergic diseases, but their effectiveness has to be balanced against side effects. In recent years, SLIT has been increasingly prescribed, instead of SCIT, because of improved safety and easy administration. Objective: We assessed which route is the most effective in the treatment of patients with seasonal allergic rhinitis to grass pollen. Methods: An indirect meta-analysis–based comparison between SCIT and SLIT was performed. Trea…
Platelet glycoprotein IIb/IIIa blockers during percutaneous coronary intervention and as the initial medical treatment of non-ST segment elevation ac…
2010
BACKGROUND During percutaneous coronary intervention (PCI), and in non-ST segment elevation acute coronary syndromes (NSTEACS), the risk of acute vessel occlusion by thrombosis is high. Glycoprotein IIb/IIIa blockers strongly inhibit platelet aggregation and may prevent mortality and myocardial infarction. This is an update of a Cochrane review first published in 2001, and previously updated in 2007 and 2010. OBJECTIVES To assess the efficacy and safety effects of glycoprotein IIb/IIIa blockers when administered during PCI, and as initial medical treatment in patients with NSTEACS. SEARCH METHODS We updated the searches of the Cochrane Central Register of Controlled Trials (CENTRAL) on The …