scholarly journals Efficacy of Diosmectite (Smecta)®in the Treatment of Acute Watery Diarrhoea in Adults: A Multicentre, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study

2011 ◽  
Vol 2011 ◽  
pp. 1-8 ◽  
Author(s):  
Faouzi Khediri ◽  
Abdennebi Ilhem Mrad ◽  
Moussadek Azzouz ◽  
Hedi Doughi ◽  
Taoufik Najjar ◽  
...  
Keyword(s):  
Median Time ◽  
Primary Endpoint ◽  
Acute Diarrhoea ◽  
Watery Diarrhoea ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Intention To Treat ◽  
Parallel Group ◽  
Diarrhoea Episode ◽  
Treat Population

Background. Although diosmectite has demonstrated efficacy in the treatment of acute watery diarrhoea in children, its efficacy in adults still needs to be assessed. The objective of this study was therefore to assess the efficacy of diosmectite on the time to recovery in adults with acute diarrhoea.Methods. A total of 346 adults with at least three watery stools per day over a period of less than 48 hours were prospectively randomized to diosmectite (6 g tid) or placebo during four days. The primary endpoint was time to diarrhoea recovery.Results. In the intention-to-treat population, median time to recovery was 53.8 hours (range [3.7–167.3]) with diosmectite (n=166) versus 69.0 hours [2.2–165.2] with placebo, (n=163;P=.029), which corresponds to a difference of 15.2 hours. Diosmectite was well tolerated.Conclusion. Diosmectite at 6 g tid was well tolerated and reduced the time to recovery of acute watery diarrhoea episode in a clinically relevant manner.

scholarly journals A placebo-controlled double blind trial of hydroxychloroquine in mild-to-moderate COVID-19

2020 ◽  
Author(s):  
Vincent Dubée ◽  
Pierre-Marie Roy ◽  
Bruno Vielle ◽  
Elsa Parot-Schinkel ◽  
Odile Blanchet ◽  
...  
Keyword(s):  
Primary Endpoint ◽  
Controlled Trial ◽  
Supplemental Oxygen ◽  
Double Blind ◽  
Intention To Treat ◽  
Viral Shedding ◽  
Virological Outcomes ◽  
Secondary Endpoints ◽  
To Receive ◽  
Treat Population

AbstractBackgroundThe efficacy of hydroxychloroquine in coronavirus disease 2019 (COVID-19) remains controversial.MethodsWe conducted a multicentre randomized double-blind placebo-controlled trial evaluating hydroxychloroquine in COVID-19 patients with at least one of the following risk factors for worsening: age ≥75 years, age between 60 and 74 years, and presence of at least one comorbidity, or need for supplemental oxygen (≤3 L/min). Eligible patients were randomized in a 1:1 ratio to receive either 800mg hydroxychloroquine on Day 0 followed by 400mg per day for 8 days or a placebo. The primary endpoint was a composite of death or tracheal intubation within 14 days following randomization. Secondary endpoints included mortality and clinical evolution at Day 14 and 28, viral shedding at Day 5 and 10.ResultsThe trial was stopped after 250 patients were included due to a slowdown of the pandemic in France. The intention-to-treat population comprised 123 and 124 patients in the placebo and hydroxychloroquine groups, respectively. The median age was 77 years and 151 patients required oxygen therapy. The primary endpoint occurred in nine patients in the hydroxychloroquine group and eight patients in the placebo group (relative risk 1.12; 95% confidence interval 0.45– 2.80; P=0.82). No difference was observed between the two groups in any of the secondary endpoints.ConclusionIn this trial involving mainly older patients with mild-to-moderate COVID-19, patients treated with hydroxychloroquine did not experience better clinical or virological outcomes than those receiving the placebo.

scholarly journals GO-DACT: a phase 3b randomised, double-blind, placebo-controlled trial of GOlimumab plus methotrexate (MTX) versus placebo plus MTX in improving DACTylitis in MTX-naive patients with psoriatic arthritis

2020 ◽  
Vol 79 (4) ◽  
pp. 490-498 ◽  
Author(s):  
Elsa Vieira-Sousa ◽  
Pedro Alves ◽  
Ana M Rodrigues ◽  
Filipa Teixeira ◽  
Jose Tavares-Costa ◽  
...  
Keyword(s):  
Psoriatic Arthritis ◽  
Primary Endpoint ◽  
Controlled Trial ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Intention To Treat ◽  
Score Analysis ◽  
Registration Number ◽  
Secondary Endpoints ◽  
Median Change

ObjectivesTo assess the efficacy of golimumab in combination with methotrexate (MTX) versus MTX monotherapy in psoriatic arthritis (PsA) dactylitis.MethodsMulticentre, investigator-initiated, randomised, double-blind, placebo-controlled, parallel-design phase 3b trial in 11 Portuguese rheumatology centres. Patients with PsA along with active dactylitis and naive to MTX and biologic disease-modifying antirheumatic drugs (bDMARDs) were randomly assigned to golimumab or placebo, both in combination with MTX. The primary endpoint was Dactylitis Severity Score (DSS) change from baseline to week 24. Key secondary endpoints included DSS and Leeds Dactylitis Index (LDI) response, and changes from baseline in the LDI and MRI dactylitis score. Analysis was by intention-to-treat for the primary endpoint.ResultsTwenty-one patients received golimumab plus MTX and 23 MTX monotherapy for 24 weeks. One patient from each arm discontinued. Patient inclusion was halted at 50% planned recruitment due to a favourable interim analysis. Median baseline DSS was 6 in both arms. By week 24, patients treated with golimumab plus MTX exhibited significantly greater improvements in DSS relative to MTX monotherapy (median change of 5 vs 2 points, respectively; p=0.026). In the golimumab plus MTX arm, significantly higher proportions of patients achieved at least 50% or 70% improvement in DSS and 20%, 50% or 70% improvement in LDI in comparison to MTX monotherapy.ConclusionsThe combination of golimumab and MTX as first-line bDMARD therapy is superior to MTX monotherapy for the treatment of PsA dactylitis.Trial registration numberNCT02065713

scholarly journals Eptinezumab in episodic migraine: A randomized, double-blind, placebo-controlled study (PROMISE-1)

Cephalalgia ◽  
2020 ◽  
Vol 40 (3) ◽  
pp. 241-254 ◽  
Author(s):  
Messoud Ashina ◽  
Joel Saper ◽  
Roger Cady ◽  
Barbara A Schaeffler ◽  
David M Biondi ◽  
...  
Keyword(s):  
Adverse Events ◽  
Primary Endpoint ◽  
Preventive Treatment ◽  
Episodic Migraine ◽  
Controlled Study ◽  
Upper Respiratory Tract ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Parallel Group ◽  
Study Sites

Objective To evaluate the efficacy and safety of eptinezumab, a humanized anti-calcitonin gene-related peptide monoclonal antibody, in the preventive treatment of episodic migraine. Methods The PRevention Of Migraine via Intravenous ALD403 Safety and Efficacy-1 (PROMISE-1) study was a phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group study. Adults with episodic migraine were randomized to eptinezumab 30 mg, 100 mg, 300 mg, or placebo for up to four intravenous (IV) doses administered every 12 weeks. The primary endpoint was change from baseline in monthly migraine days (MMDs) over weeks 1–12. Results A total of 888 patients received treatment across 84 study sites. Mean MMDs at baseline was ∼8.6 across treatment groups. Eptinezumab 100 mg and 300 mg met the primary endpoint, significantly reducing MMDs across weeks 1–12 compared with placebo (30 mg, −4.0; 100 mg, −3.9, p = 0.0182; 300 mg, −4.3; placebo, −3.2, p = 0.0001). Treatment-emergent adverse events were reported by 58.4% (30 mg), 63.2% (100 mg), 57.6% (300 mg), and 59.5% (placebo) of patients. Treatment-emergent adverse events reported by ≥2% of eptinezumab-treated patients at an incidence greater than placebo included: upper respiratory tract infection (30 mg, 11.4%; 100 mg, 9.9%; 300 mg, 10.3%; placebo, 7.2%), and fatigue (30 mg, 2.3%; 100 mg, 3.6%; 300 mg, 3.6%; placebo, <1%). Conclusion Eptinezumab (100 mg or 300 mg) significantly reduced migraine frequency, was well tolerated, and had an acceptable safety profile when used for the preventive treatment of migraine in adults with episodic migraine. ClinicalTrials.gov identifier: NCT02559895

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