“Adverse reactions to aspartame: Double-blind challenge in patients from a vulnerable population” by Walton et al

1994 ◽  
Vol 36 (3) ◽  
pp. 206-207 ◽  
Author(s):  
Harriett H. Butchko
Keyword(s):  
Adverse Reactions ◽  
Vulnerable Population ◽  
Double Blind ◽  
Blind Challenge

Adverse reactions to aspartame: Double-blind challenge in patients from a vulnerable population

1993 ◽  
Vol 34 (1-2) ◽  
pp. 13-17 ◽  
Author(s):  
Ralph G. Walton ◽  
Robert Hudak ◽  
Ruth J. Green-Waite
Keyword(s):  
Adverse Reactions ◽  
Vulnerable Population ◽  
Double Blind ◽  
Blind Challenge

489 Pivotal Phase 3 Study of FT218, a Once-Nightly Sodium Oxybate Formulation, in Patients With Narcolepsy: REST-ON Primary Results

SLEEP ◽  
2021 ◽  
Vol 44 (Supplement_2) ◽  
pp. A193-A193
Author(s):  
Clete Kushida ◽  
Colin Shapiro ◽  
Thomas Roth ◽  
Michael Thorpy ◽  
Russell Rosenberg ◽  
...  
Keyword(s):  
Adverse Reactions ◽  
Sleep Latency ◽  
Sodium Oxybate ◽  
Mean Difference ◽  
Pivotal Phase ◽  
Double Blind ◽  
Old Patients ◽  
Maintenance Of Wakefulness Test ◽  
To Receive ◽  
Clinical Global Impression Improvement

Abstract Introduction Sodium oxybate (SO) is an effective treatment for patients with narcolepsy; however, currently available SO formulations require twice-nightly dosing. The purpose of this study was to evaluate efficacy and safety of FT218, an investigational once-nightly controlled-release SO formulation, for the treatment of excessive daytime sleepiness and cataplexy in patients with narcolepsy types 1 (NT1) and 2 (NT2). Methods This was a randomized, double-blind, placebo-controlled, multicenter study in patients with narcolepsy ≥16 years old. Patients were randomized 1:1 to receive FT218 or matching placebo: 4.5 g/night for 1 week, 6.0 g/night for 2 weeks, 7.5 g/night for 5 weeks, and 9.0 g/night for 5 weeks (maximum treatment duration, 13 weeks). Coprimary endpoints were mean sleep latency (minutes) on maintenance of wakefulness test (MWT), Clinical Global Impression-Improvement (CGI-I) of sleepiness, and weekly number of cataplexy attacks (NCAs; NT1 only). Results A total of 212 patients were randomized and received study treatment (FT218, n=107; placebo, n=105). FT218 showed significant (P<0.001) improvement vs placebo in mean sleep latency on MWT for all evaluated doses; LS mean difference (minutes) between FT218 and placebo was 6.13 at 9.0 g (week 13), 6.21 at 7.5 g (week 8), and 4.98 at 6.0 g (week 3). A higher proportion of patients receiving FT218 were much/very much improved on CGI-I vs placebo (72% vs 31.6% at 9.0 g; 62.6% vs 22.8% at 7.5 g; and 40.1% vs 6.1% at 6.0 g; all P<0.001). LS mean difference between FT218 and placebo in mean weekly NCAs was significant (P<0.001) for all doses: −6.65 at 9.0 g, −6.27 at 7.5 g, and −4.83 at 6.0 g. The most common adverse reactions were nausea, vomiting, headache, dizziness, enuresis, and decreased appetite. Conclusion All evaluated doses of FT218 showed significant improvement vs placebo in mean sleep latency on MWT, CGI-I, and weekly NCAs. FT218 was generally well tolerated and the most common adverse events were consistent with known side effects of SO. Support (if any) Avadel Pharmaceuticals.

Hypoallergenic Infant Formulas

PEDIATRICS ◽  
1989 ◽  
Vol 83 (6) ◽  
pp. 1068-1069
Author(s):  
Keyword(s):  
Adverse Reactions ◽  
Villous Atrophy ◽  
Young Infant ◽  
Specific Antigen ◽  
Double Blind ◽  
Parental History ◽  
Pulmonary Hemosiderosis ◽  
Immune Mediated ◽  
Dietary Antigens

Antigenic constituents of human milk or of alternative feedings for infants may be responsible for adverse reactions in a subset of infants with milk protein intolerance. These reactions include those commonly associated with atopy, such as angioedema, urticaria, wheezing, vomiting, and eczema. Pulmonary hemosiderosis, malabsorption with villous atrophy, and eosinophilic enterocolitis, perhaps mediated by immune complexes or T cells, have also been associated with the ingestion of cow's milk proteins and/or soy proteins in infant feedings. Colic, sleeplessness, and irritability are symptoms seen in almost all infants at some time during infancy, including those few infants with immune-mediated reactions to dietary antigens. Determining that adverse reactions are, in fact, immune mediated is often difficult and is accomplished by an in vivo challenge with the potential offending antigen, together with in vitro confirmation of immunoreactivity to the challenge antigen. Double-blind challenge with purified dietary antigens is useful in relating symptoms to a specific antigen, but the results may be difficult to interpret if the appearance of symptoms is delayed beyond several hours in a young infant. In vitro testing is compromised by the presence of some form of immunoreactivity, such as hemagglutinating antibodies, to dietary antigens in a large percentage of infants without symptoms and by lack of standardization of clinical tests for cell-mediated reactions to dietary antigens. Much effort also has been devoted to predicting in which infants immune-mediated reactions to dietary proteins will develop in advance of their introduction into the diet. Increased cord blood IgE concentrations and parental history of atopy place an infant at highest risk for atopic disease during infancy and early childhood.

Adverse reactions to foods in adulthood assessed by double-blind placebo-controlled food challenges

2002 ◽  
Vol 109 (1) ◽  
pp. S92-S92 ◽  
Author(s):  
Julia Rodriguez ◽  
Gemma Izquierdo ◽  
Paloma Poza-Guedes ◽  
Paloma Campo ◽  
Pilar Daroca ◽  
...  
Keyword(s):  
Adverse Reactions ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Food Challenges

Prevention of Recurrent Urinary Tract Infections in Girls

PEDIATRICS ◽  
1977 ◽  
Vol 59 (4) ◽  
pp. 562-565
Author(s):  
Jacob A. Lohr ◽  
Donna H. Nunley ◽  
Stuart S. Howards ◽  
Raymond F. Ford
Keyword(s):  
Urinary Tract ◽  
Adverse Reactions ◽  
Low Dose ◽  
Double Blind ◽  
Urinary Tract Abnormality ◽  
History Of ◽  
The Difference ◽  
Tract Infections ◽  
Blind Crossover Study ◽  
Double Blind Crossover Study

Eighteen girls between the ages of 3 and 13 years—with a history of at least three culture-documented episodes of bacteriuria in the previous year, but without radiologic evidence of major urinary tract abnormality—were placed on a double-blind, crossover study comparing the effectiveness of nitrofurantoin macrocrystals against a placebo in preventing the recurrence of bacteriuria. Each child was placed on a daily low dose of nitrofurantoin (1.2 to 2.4 mg/kg/day) or an identical-appearing placebo for six months. Each child was then placed on the opposite capsule for a similar period. There were 35 episodes of bacteriuria (4.2 episodes/patient/yr) in the patients taking the placebo, which compared with a rate of 3.8 episodes/patient/yr during the year prior to the study. Only two episodes (0.2 episodes/patient/yr) occurred in the patients taking the drug. The difference in the rate of recurrent bacteriuria between the girls on placebo and on medication is significant at the 0.01 level using the Wilcoxin matched-pairs test. There were no adverse reactions to the drug. Nitrofurantoin macrocrystals in a single daily low dose appear to be a safe, effective method of preventing recurrent bacteriuria in girls at high risk.

scholarly journals P60 Efficacy of switching to infliximab biosimilar (Remsima®) in paediatric inflammatory bowel disease (PIBD): a 2-Year retrospective evaluation

2020 ◽  
Vol 105 (9) ◽  
pp. e37.2-e38
Author(s):  
Fatima Yaqub ◽  
Joanne Crook ◽  
John Fell
Keyword(s):  
Inflammatory Bowel Disease ◽  
Treatment Failure ◽  
Disease Activity ◽  
Patient Outcomes ◽  
Bowel Disease ◽  
Adverse Reactions ◽  
Double Blind ◽  
Time Points ◽  
Parallel Group ◽  
Inflammatory Bowel

AimTo evaluate patient outcomes 2 years post switching Infliximab therapy from Infliximab originator molecule Remicade® to biosimilar Remsima®.MethodsPatients with PIBD who experienced induction with Remicade® therapy, were <18 years old at last follow-up and were receiving active treatment with Remsima® 2 years post switching were selected to be included for evaluation. Outcome measures included monitoring disease activity and treatment failure at baseline (before switching) and at selected time points up to 2 years post-switch. Disease activity was assessed looking at a range of parameters: disease activity scores; trough infliximab levels; haematological markers (HGB, platelets, WBC); LFTs (bilirubin, ALT, ALP); inflammatory markers (ESR, CRP) and faecal calprotectin levels. Patients who failed therapy were assessed for adverse reactions and infliximab antibody formation. Data was analysed with the Cochran Q test, repeated measures ANOVA test and Friedman test; with post-hoc Bonferroni and Wilcoxon Signed-Ranks tests if appropriate.ResultsData was available for 18 patients after exclusion criteria were applied. There was a significant increase in trough infliximab levels by the end of the period from an average of 5 ug/L to 12 ug/L at 2 years. The average dose/kg increased over 2 years by 1.5 mg/kg. Disease activity markers showed no changes between time points except a decrease in ALP levels from baseline to 1 year, but values remained within normal ranges. Four patients were discontinued from Remsima® due to side effects or loss of efficacy. The average time to treatment failure on Remsima® was 38 months (~19/20 doses). Three out of four patients developed infliximab antibodies, 2 of these patients went on to suffer adverse reactions; 1 exhibited joint pain which settled weeks after each infusion and the other developed an immediate infusion reaction in the form of a rash with urticaria on the 3rd infusion of Remsima®.ConclusionInfliximab biosimilars, such as Remsima®, were approved for use in PIBD by the EMA after studies in adult populations with rheumatic diseases.1 2 Induction studies have shown efficacy in PIBD but data on switching is limited and short-term.3 4 Our data shows no significant differences in clinical patient outcomes over a 2-year period in a cohort switched from Remicade® to Remsima®. In fact, a significant increase in trough infliximab levels in patients remaining on Remsima® suggests efficacy in producing therapeutic levels in PIBD patients. Increased levels may be explained by dose intensification used by the PIBD multi-disciplinary team (MDT), reflecting careful dose optimisation strategies used at this trust throughout the time period. Patients losing response were not unexpected and are likely not due to the biosimilar switch but rather due to the length of time the patients were on treatment. The small sample size and retrospective nature of this study mean larger cohort studies are required over prolonged time periods to confirm these findings. PIBD MDTs should continue to monitor patients for adverse reactions, particularly in those who develop infliximab antibodies.ReferencesPark W, Hrycaj P, Jeka S, et al. A randomised, double-blind, multicentre, parallel-group, prospective study comparing the pharmacokinetics, safety, and efficacy of CT-P13 and innovator infliximab in patients with ankylosing spondylitis: the PLANETAS study. Ann Rheum Dis 2013;72:1605–1612.Yoo DH, Hrycaj P, Miranda P, et al. Extended report: a randomised, double-blind, parallel-group study to demonstrate equivalence in efficacy and safety of CT-P13 compared with innovator infliximab when co-administered with methotrexate in patients with active rheumatoid arthritis: the PLANETRA study. Ann Rheum Dis 2013;72:1613.Sieczkowska J, Jarzębicka D, Banaszkiewicz A, et al. Switching Between Infliximab Originator and Biosimilar in Paediatric Patients with Inflammatory Bowel Disease. Preliminary Observations. J Crohn’s Colitis 2016;10:127–132.Sieczkowska J, Jarzębicka D, Meglicka M, et al. Experience with biosimilar infliximab (CT-P13) in paediatric patients with inflammatory bowel diseases. Therap Adv Gastroenterol 2016;9:729–735.

scholarly journals Efficacy of a herbal toothpaste on patients with established gingivitis: a randomized controlled trial

2006 ◽  
Vol 20 (2) ◽  
pp. 172-177 ◽  
Author(s):  
Fabiana Ozaki ◽  
Claudio Mendes Pannuti ◽  
Ana Vitória Imbronito ◽  
Wellington Pessotti ◽  
Luciana Saraiva ◽  
...  
Keyword(s):  
Adverse Reactions ◽  
Controlled Trial ◽  
Test Group ◽  
Experimental Period ◽  
Positive Control ◽  
Control Group ◽  
Control Groups ◽  
Double Blind ◽  
Significant Difference ◽  
And Control

The aim of this randomised, double blind controlled trial was to verify the efficacy of a herbal dentifrice on the reduction of plaque and gingivitis. Forty eight volunteers with established gingivitis were randomly assigned to either a test group (herbal dentifrice) or positive control group (dentifrice with triclosan and fluoride). The dentifrices were distributed in plain white tubes by an independent pharmacy, which revealed the contents of each tube only after the experimental period. Plaque and gingivitis assessments were carried out on baseline and after 28 days of product use. All examinations were conducted by the same calibrated investigator. Subjects were instructed to brush their teeth three times daily using their assigned dentifrice for 28 days. There was a significant reduction in plaque levels in both the test and control groups. However, there was no significant difference between the groups. A significant reduction in gingivitis was observed in both groups, although there was no significant difference between them. No adverse reactions were reported. The authors concluded that both dentifrices were effective in reducing plaque and gingivitis in subjects with established gingivitis.

scholarly journals Etiology of Cervicitis and Treatment with Minocycline

1993 ◽  
Vol 4 (2) ◽  
pp. 95-100 ◽  
Author(s):  
William R Bowie ◽  
Val Willetts ◽  
Bernard A Binns ◽  
Robert C Brunham
Keyword(s):  
Dose Regimen ◽  
Polymorphonuclear Leukocytes ◽  
Adverse Reactions ◽  
Transmitted Disease ◽  
Cervical Mucus ◽  
Double Blind Study ◽  
Double Blind ◽  
Yellow Colour ◽  
Sexually Transmitted ◽  
Major Teaching Hospital

Objective: To evaluate the etiology of cervicitis using the recommended Canadian definition, and to evaluate the efficacy and tolerability of seven days of minocycline treatment, 100 versus 200 mg at bedtime.Design: Randomized double-blind study with initial microbiological evaluation, and intended follow-up through 12 weeks.Setting: Women attending the major sexually transmitted disease clinic in Vancouver and the major teaching hospital in Winnipeg.Population Studied: Women with cervicitis (inclusion criteria were an off-white or yellow colour of cervical mucus when viewed on a white-tipped swab, and a mean of 10 or more polymorphonuclear leukocytes per oil immersion [× 1000] field on Gram stain of cervical mucus). Fourty-four women were enrolled but two were excluded because of contaminated cultures.Interventions: Treatment with two identical appearing capsules of 50 mg (100 mg dose) or 100 mg (200 mg dose) of minocycline taken at bedtime with water for seven days.Main Results: Of the 42 evaluable women,Chlamydia trachomatiswas initially isolated from 19 (45%) andNeisseria gonorrhoeaefrom four (10%). The study was prematurely terminated because of an unacceptable and significantly higher frequency of adverse reactions on the higher dose regimen of minocycline – severe reactions in one (4%) on 100 mg compared with six (30%) on 200 mg (P=0.05). Major reactions were dizziness, mood alterations and nausea. Clinical parameters, but not numbers of polymorphonuclear leukocytes, improved significantly irrespective of initial microbiology or the regimen received. Cultures became and stayed negative forC trachomatisin seven of eight on minocycline 100 mg and five of six on minocycline 200 mg. Both ‘failures’ had an intervening negative culture and were re-exposed to untreated sexual partners.Conclusions: Although not a definitive study in terms of proving efficacy of lower dose regimens, the results are consistent with efficacy and demonstrate the significant advantage of the lower dose regimen in terms of adverse reactions.

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