scholarly journals The Effect of Bovine Colostrum on the Absolute Neutrophil Counts of Pediatric Patients with Acute Lymphocytic Leukemia Undergoing Chemotherapy: A Double Blind Randomized Placebo Controlled Study

2019 ◽  
Vol 4 (3) ◽  
Keyword(s):  
Lymphoblastic Leukemia ◽  
Chemotherapeutic Agents ◽  
Bovine Colostrum ◽  
Lymphocytic Leukemia ◽  
Controlled Study ◽  
Double Blind ◽  
Treatment Groups ◽  
Therapeutic Outcomes ◽  
The Absolute ◽  
To Receive

Background: Changes in the blood counts mainly leukopenia and neutropenia in patients with Acute Lymphoblastic Leukemia (ALL) are common adverse events following chemotherapy. These commonly delays further administration of chemotherapeutic agents thereby potentially affecting therapeutic outcomes. Bovine colostrum has shown some promises in different fields of medicine and one claim is its use in prevention of neutropenia. However, there are no studies to support such claim Objective: The general objective of this study is to determine the efficacy of bovine colostrum in preventing neutropenia among patients with ALL receiving chemotherapy. Methodology: This is a randomized, double blind, placebo controlled study involving the use of bovine colostrum for 1 week against placebo in preventing neutropenia among patientsundergoing chemotherapy. Participants were randomly assigned to receive the test products which were given orally 2x a day for 7 days starting simultaneously with the chemotherapy before the outcome measures were evaluated. Results: A total of 21 subjects were enrolled, 10 of them received the placebo while 11 received the bovine colostrum. Results showed that there was significant increase in the Absolute Neutrophil Count (ANC) of patients given bovine colostrum as compared to the placebo group. There was also significant increase in the WBC and platelet counts among those who were given Bovine Colostrum. No incidence of infection or untoward effects on both treatment groups. Conclusion: Bovine Colostrum is effective and safe in increasing the absolute neutrophil counts of ALL patients undergoing chemotherapy

scholarly journals From clinical guidelines to practice. Clinical experience in treatment of patients with allergic rhinitis

2021 ◽  
pp. 62-67
Author(s):  
A. Y. Ovchinnikov ◽  
N. A. Miroshnichenko ◽  
E. M. Khon ◽  
N. P. Jimsheleishvili ◽  
V. A. Simsovа ◽  
...  
Keyword(s):  
Allergic Rhinitis ◽  
Seasonal Allergic Rhinitis ◽  
Inflammatory Diseases ◽  
Nasal Congestion ◽  
Controlled Study ◽  
Double Blind ◽  
Entire Treatment Period ◽  
Treatment Groups ◽  
Histamine H1 Receptors ◽  
To Receive

Introduction. Antihistamines are the most commonly prescribed class of medications for the treatment of allergic rhinitis (AR). However, they are also widely used in the treatment of inflammatory diseases of the ENT organs. One such drug is levocytirizine, (R) an enantiomer of cetirizine, which is a selective antagonist of peripheral histamine H1-receptors. This article analyzes the properties of levocytirizine in terms of safety and efficacy in allergic rhinitis.Aim of the study is to assess the efficacy of levocetirizine in patients with seasonal allergic rhinitis (SAR) and perennial allergic rhinitis (PAR) versus placebo, and safety for patients with allergic rhinitis.Materials and methods. In this, double-blind, placebo-controlled study, 52 patients with year-round allergic rhinitis and 28 patients with seasonal allergic rhinitis were randomized to receive levocetirizine 5 mg/day once or placebo. Mean overall measures of five symptoms (nasal congestion, nasal itching, itchy eyes, rhinorrhea, and sneezing) were compared between treatment groups at 1, 2, and 4 weeks. All individual symptom scores were also examined.Results. Levocetirizine showed a significant improvement in the condition of patients with CAR and SAR over the entire treatment period compared to placebo. Assessment of individual symptoms showed statistically significant differences in favor of levocetirizine. Conclusion. Levocetirizine is an effective, safe, and well-tolerated drug for the treatment of allergic rhinitis.

scholarly journals A randomised, placebo-controlled study of RIPK1 inhibitor GSK2982772 in patients with active ulcerative colitis

2021 ◽  
Vol 8 (1) ◽  
pp. e000680
Author(s):  
Kathy Weisel ◽  
Nicola Scott ◽  
Scott Berger ◽  
Susanne Wang ◽  
Kurt Brown ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Ulcerative Colitis ◽  
Disease Activity ◽  
Controlled Study ◽  
Experimental Medicine ◽  
Open Label ◽  
Double Blind ◽  
Treatment Groups ◽  
To Receive

ObjectiveTumour necrosis factor signalling via the receptor-interacting protein kinase 1 (RIPK1) pathway regulates colonic inflammation suggesting that RIPK1 inhibition may be a potential therapeutic target in ulcerative colitis (UC). This phase IIa, randomised, double-blind experimental medicine study investigated the safety, pharmacokinetics (PK), pharmacodynamics (PD) and preliminary efficacy of the RIPK1 inhibitor GSK2982772 in patients with active UC.DesignIn part A, prior to a protocol amendment, one patient was randomised to receive GSK2982772 60 mg twice daily for 42 days. After the amendment, patients were randomised 2:1 to receive GSK2982772 60 mg or placebo three times daily for 42 days. In part B, all patients switched to open-label GSK2982772 60 mg three times daily for 42 days. Safety, PK, PD biomarkers, histological disease activity, clinical efficacy and quality of life were assessed at days 43 and 85.ResultsThirty-six patients were randomised (n=12, placebo/open-label GSK2982772; n=24, GSK2982772/open-label GSK2982772). Most adverse events were mild, with headache reported the most frequently across groups (placebo/open-label GSK2982772, n=2 (17%); GSK2982772/open-label GSK2982772, n=8 (33%)). GSK2982772 was well distributed into colonic tissue, with generally higher concentrations in colonic biopsy samples versus plasma. No apparent differences between treatment groups were observed for PD, histological disease activity, clinical disease activity or quality-of-life measures. At screening, all patients had Mayo endoscopic scores of 2 or 3. At day 43, no patients in the placebo/open-label GSK2982772 group achieved Mayo endoscopic scores of 0 or 1 vs 3/24 (13%) for GSK2982772/open-label GSK2982772. At day 85, 1/9 (11%) achieved scores of 0 or one for placebo/open-label GSK2982772 vs 3/22 (14%) for GSK2982772/open-label GSK2982772.ConclusionGSK2982772 was generally well tolerated, with no treatment-related safety concerns identified. However, no significant differences in efficacy were observed between treatment groups, suggesting that GSK2982772 as monotherapy is not a promising treatment for patients with active UC.Trial registration numberNCT02903966.

Elsiglutide in the primary prevention of chemotherapy (CT)-induced diarrhea in patients with colorectal cancer (CRC) receiving 5-fluorouracil (5-FU)-based CT: A multinational, randomized, double-blind, placebo-controlled study.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. 10101-10101
Author(s):  
Meinolf Karthaus ◽  
Mikhail Fedyanin ◽  
Igor Bondarenko ◽  
Salvatore Chessari ◽  
Riccardo Spezia ◽  
...  
Keyword(s):  
Primary Prevention ◽  
Dose Intensity ◽  
Controlled Study ◽  
Double Blind ◽  
Treatment Groups ◽  
Ct Dose ◽  
Injection Site Reactions ◽  
Alpha Level ◽  
To Receive ◽  
Clinical Trial Information

10101 Background: Diarrhea is a burdensome toxicity of 5-FU-based regimens and may lead to CT dose intensity reduction. We investigated the efficacy of 3 subcutaneous (s.c.) doses of elsiglutide (a GLP-2 analog) vs. placebo and vs. each other, in the primary prevention of CT induced diarrhea in patients (pts) with CRC receiving FOLFOX or FOLFIRI. Methods: Pts were randomized equally to receive placebo or elsiglutide 10, 20, or 40 mg s.c. on days (d)1–4 of the first 2 CT cycles and were followed up in cycle 3 for safety only. Stratification factors were CT regimen and country. Primary endpoint was the proportion of pts with diarrhea of CTC grade ≥2 in cycle 1. Changes in plasma levels of citrulline, a marker of intestinal mass, from baseline to d5 and d14 of each cycle were analyzed. With 480 pts randomized, the study had 85% power to detect a 15% difference vs. placebo for each dose at an alpha level of 0.1, assuming a 20% frequency of diarrhea CTC grade ≥2 in the placebo arm. Results: Treatment groups were comparable for the 484 pts (142 receiving FOLFIRI) who were randomized to receive placebo (n = 123), elsiglutide 10 mg (n = 120), 20 mg (n = 121), or 40 mg (n = 120), respectively. The proportion of pts with diarrhea CTC grade ≥2 was higher with placebo (10%) than with elsiglutide 10 mg (3%), 20 mg (5%) and 40 mg (6%); differences were not statistically significant. A similar pattern was observed in cycle 2. Differences in diarrhea frequency between placebo and elsiglutide groups were pronounced in the FOLFIRI subgroup (cycle 1: 18% with placebo, 6% with 10 mg and 20 mg; 3% with 40 mg elsiglutide). Reduction of citrulline levels was smaller with elsiglutide compared with placebo. The safety profile of all elsiglutide doses was acceptable with few related injection site reactions, mostly at the highest dose. Conclusions: Although a lower frequency of diarrhea CTC grade ≥2 was observed with elsiglutide, this difference was not statistically significant in pts receiving FOLFOX or FOLFIRI for CRC. Interpretation must consider the unexpectedly low reported frequency of diarrhea of grade ≥2, particularly with FOLFOX regimens. Clinical trial information: 2014-000998-39.

Benzodiazepine Premedication 

1999 ◽  
Vol 90 (3) ◽  
pp. 740-747 ◽  
Author(s):  
Janet M. van Vlymen ◽  
Monica M. Sa Rego ◽  
Paul F. White
Keyword(s):  
Operating Room ◽  
Breast Biopsy ◽  
Saline Group ◽  
Patient Comfort ◽  
Controlled Study ◽  
Double Blind ◽  
Needle Localization ◽  
Treatment Groups ◽  
Anxiety Levels ◽  
To Receive

Background Women awaiting needle-guided breast biopsy procedures may experience high anxiety levels. A randomized, double-blind, placebo-controlled study was designed to evaluate the ability of midazolam and diazepam (in a lipid emulsion [Dizac]) to improve patient comfort during needle localization and breast biopsy procedures. Methods Ninety women received two consecutive doses of a study medication, one before the mammographic needle localization and a second before entering the operating room. Patients were assigned randomly to receive saline, 2.0 ml intravenously, at the two time points; midazolam, 1.0 mg intravenously and 2.0 mg intravenously; or diazepam emulsion, 2.0 mg intravenously and 5.0 mg intravenously, respectively. Patients assessed their anxiety levels before the needle localization, before entering the operating room, and on arrival in the operating room. Patients completed a questionnaire evaluating their perioperative experience at the time of discharge. Results Patient satisfaction during needle localization was significantly improved in both benzodiazepine treatment groups (vs. saline). The incidence of moderate-to-severe discomfort during needle localization was lower in the midazolam (20%) and diazepam emulsion (6%) groups compared with the saline group (70%) (P<0.05). The preoperative visual analogue scale anxiety scores were similar in all three groups. In the operating room, however, anxiety scores were 55% and 68% lower after midazolam (21+/-19) and diazepam emulsion (15+/-14) compared with saline (46+/-28). Finally, there was no difference in the time to achieve home-readiness or actual discharge time among the three groups. Conclusions Premedication with midazolam or diazepam emulsion improved patients' comfort during needle localization procedures and significantly reduced intraoperative anxiety levels before breast biopsy procedures without prolonging discharge times. Use of diazepam emulsion may be an effective alternative to midazolam in this population.

Safety and Efficacy of a Topical Anesthetic for Neonatal Circumcision

PEDIATRICS ◽  
1993 ◽  
Vol 92 (5) ◽  
pp. 710-714 ◽  
Author(s):  
Kathleen B. Weatherstone ◽  
Lynn B. Rasmussen ◽  
Allen Erenberg ◽  
Emily M. Jackson ◽  
Katherine S. Claflin ◽  
...  
Keyword(s):  
Vital Signs ◽  
Behavioral Changes ◽  
Controlled Study ◽  
Topical Anesthetic ◽  
Double Blind ◽  
Safety And Efficacy ◽  
Exact Test ◽  
Treatment Groups ◽  
Topical Lidocaine ◽  
Postoperative Serum

Objective. Circumcision is a common neonatal surgical procedure routinely performed without the use of anesthesia. The purpose of this study was to evaluate the safety and efficacy of topical lidocaine cream as an anesthetic for circumcision. Methods. Thirty newborns were studied in a randomized, double-blind, placebo-controlled study; 15 received a topical 30% lidocaine cream and 15 received the cream base alone. Vital signs were recorded, and preoperative and postoperative serum β-endorphin and lidocaine concentrations were measured. A videotape of the newborn was used to score behavioral changes. Results. Comparisions of the vital signs precircumcision and postcircumcision showed no differences between the placebo and treatment groups, with the exception of mean systolic blood pressure, which significantly increased in the placebo-treated newborns (P < .05). Serum β-endorphin concentrations increased postoperatively in 11 of 15 subjects receiving placebo, but decreased or remained unchanged in 10 of 15 subjects receiving lidocaine (P = .03, Fisher's exact test). When stress-related behaviors in the precircumcision and post-circumcision periods were compared, the mean increase in their occurrence was greater in the placebo than in the treatment group. There was no significant absorption of lidocaine as measured in the serum. Conclusion. Topical application of a 30% lidocaine cream as used in this study may be a safe and efficacious anesthetic for circumcision.

scholarly journals Efficacy and tolerability of the investigational topical cream SD-101 (6% allantoin) in patients with epidermolysis bullosa: a phase 3, randomized, double-blind, vehicle-controlled trial (ESSENCE study)

2020 ◽  
Vol 15 (1) ◽  
Author(s):  
Amy S. Paller ◽  
◽  
John Browning ◽  
Milos Nikolic ◽  
Christine Bodemer ◽  
...  
Keyword(s):  
Epidermolysis Bullosa ◽  
Wound Closure ◽  
Trial Registration ◽  
Controlled Study ◽  
Phase 3 ◽  
Double Blind ◽  
Treatment Groups ◽  
Topical Cream ◽  
Link Type ◽  
Total Body

Abstract Background Epidermolysis bullosa (EB) is a rare genetic disorder that manifests as blistering and/or skin erosion. There is no approved treatment for EB; current standard of care consists of wound and pain management. SD-101 6% is a topical cream containing 6% allantoin that was developed for treating skin lesions in patients with EB. The aim of this phase 3, multicenter, randomized, double-blind, vehicle-controlled study was to assess the efficacy and safety of SD-101 6% cream versus vehicle (0% allantoin) on lesions in patients with EB. Methods Eligible patients were ≥1 month old, had a diagnosis of EB (simplex, recessive dystrophic, or intermediate junctional) and a target wound 10–50 cm2 in size that was present for ≥21 days. Patients were randomly assigned to SD-101 6% cream or vehicle, which was applied topically once a day to the entire body for 3 months. Primary efficacy endpoints were time to complete target wound closure within 3 months and the proportion of patients who experienced complete target wound closure within 3 months. Post hoc subgroup analyses were conducted by patient age and in those with body surface area index of total body wound burden ≥5% at baseline. Results In total, 169 patients were enrolled and randomly assigned to SD-101 6% (n = 82) or vehicle (n = 87). Baseline demographics and disease characteristics were similar between treatment groups. There were no statistically significant differences between treatment groups in time to target wound closure (hazard ratio, 1.004; 95% confidence interval [CI] 0.651, 1.549; P = 0.985) or proportion of patients with complete target wound closure within 3 months (odds ratio [95% CI], 0.733 [0.365, 1.474]; nominal P = 0.390). A positive trend toward faster wound closure with SD-101 6% versus vehicle was observed in patients aged 2 to <12 years and those with total body wound burden ≥5% at baseline. SD-101 6% cream was well tolerated. Conclusions SD-101 6% cream for treatment of EB-associated lesions was not more effective than vehicle in shortening the time to complete target wound closure or achieving complete target wound closure within 3 months. Trial registration ClinicalTrials.gov, NCT02384460; Date of trial registration, February 13, 2015; First participant enrolled, March 11, 2015.

Palliation of pain associated with metastatic bone cancer using samarium-153 lexidronam: a double-blind placebo-controlled clinical trial.

1998 ◽  
Vol 16 (4) ◽  
pp. 1574-1581 ◽  
Author(s):  
A N Serafini ◽  
S J Houston ◽  
I Resche ◽  
D P Quick ◽  
F M Grund ◽  
...  
Keyword(s):  
Pain Relief ◽  
Bone Metastases ◽  
Active Drug ◽  
Opioid Analgesic ◽  
Controlled Study ◽  
Controlled Clinical Trial ◽  
Complete Relief ◽  
Double Blind ◽  
Double Blind Placebo ◽  
To Receive

PURPOSE To evaluate the effectiveness and safety of samarium-153 (153Sm) lexidronam (EDTMP) in a double-blind, placebo-controlled study. PATIENTS AND METHODS Patients with painful bone metastases secondary to a variety of primary malignancies were randomized to receive 153Sm-EDTMP 0.5 or 1.0 mCi/kg, or placebo. Treatment was unblinded for patients who did not respond by week 4, with those who had received placebo eligible to receive 1.0 mCi/kg of active drug in an open-label manner. Patient and physician evaluations were used to assess pain relief, as was concurrent change in opioid analgesia. RESULTS One hundred eighteen patients were enrolled onto the study. Patients who received 1.0 mCi/kg of active drug had significant reductions in pain during each of the first 4 weeks in both patient-rated and physician-rated evaluations. Pain relief was observed in 62% to 72% of those who received the 1.O-mCi/kg dose during the first 4 weeks, with marked or complete relief noted in 31% by week 4. Persistence of pain relief was seen through week 16 in 43% of patients who received 1.0 mCi/kg, of active drug. A significant correlation (P = .01) was observed between reductions in opioid analgesic use and pain scores only for those patients who received 1.0 mCi/kg 153Sm-EDTMP. Bone marrow suppression was mild, reversible, and not associated with grade 4 toxicity. CONCLUSION A single dose of 1.0 mCi/kg of 153Sm-EDTMP provided relief from pain associated with bone metastases. Pain relief was observed within 1 week of administration and persisted until at least week 16 in the majority of patients who responded.

Paroxetine in the Treatment of Panic Disorder a Randomised, Double-Blind, Placebo-Controlled Study

1995 ◽  
Vol 167 (3) ◽  
pp. 374-379 ◽  
Author(s):  
S. Oehrberg ◽  
P. E. Christiansen ◽  
K. Behnke ◽  
A. L. Borup ◽  
B. Severin ◽  
...  
Keyword(s):  
Panic Disorder ◽  
Cognitive Therapy ◽  
Panic Attacks ◽  
Controlled Study ◽  
Positive Trend ◽  
Double Blind ◽  
Treatment Groups ◽  
Efficacy Measures ◽  
The Mean ◽  
Primary Measure

BackgroundThis study compared the efficacy and tolerability of paroxetine with placebo in the treatment of panic disorder.MethodAfter three weeks of placebo, patients received 12 weeks of treatment with paroxetine (20, 40, or 60 mg) or placebo, and finally two weeks of placebo. Dosages were adjusted according to efficacy and tolerability. Standardised cognitive therapy was given to all patients. The primary measure of outcome was reduction in the number of panic attacks.ResultsAnalysis of the results showed statistically significant differences in favour of paroxetine between the two treatment groups in two out of the three primary measures of outcome, i.e. 50% reduction in total number of panic attacks and number of panic attacks reduced to one or zero over the study period. For the third measure of outcome, the mean change in the total number of attacks from baseline, there was a positive trend in favour of paroxetine. The results of the primary measures of outcome were strongly supported by the results of the secondary efficacy measures of outcome. In addition, paroxetine, at all doses, was very well tolerated.ConclusionParoxetine plus cognitive therapy was significantly more effective than placebo plus cognitive therapy in the treatment of panic disorder.

scholarly journals Safety, immunogenicity and efficacy after switching from reference infliximab to biosimilar SB2 compared with continuing reference infliximab and SB2 in patients with rheumatoid arthritis: results of a randomised, double-blind, phase III transition study

2017 ◽  
Vol 77 (2) ◽  
pp. 234-240 ◽  
Author(s):  
Josef S Smolen ◽  
Jung-Yoon Choe ◽  
Nenad Prodanovic ◽  
Jaroslaw Niebrzydowski ◽  
Ivan Staykov ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Transition Period ◽  
Phase Iii ◽  
Double Blind ◽  
Treatment Groups ◽  
American College Of Rheumatology ◽  
Registration Number ◽  
Phase Iii Study ◽  
Transition Study ◽  
To Receive

ObjectivesEfficacy, safety and immunogenicity results from the phase III study of SB2, a biosimilar of reference infliximab (INF), were previously reported through 54 weeks. This transition period compared results in patients with rheumatoid arthritis (RA) who switched from INF to SB2 with those in patients who maintained treatment with INF or SB2.MethodsPatients with moderate to severe RA despite methotrexate treatment were randomised (1:1) to receive SB2 or INF at weeks 0, 2 and 6 and every 8 weeks thereafter until week 46. At week 54, patients previously receiving INF were rerandomised (1:1) to switch to SB2 (INF/SB2 (n=94)) or to continue on INF (INF/INF (n=101)) up to week 70. Patients previously receiving SB2 continued on SB2 (SB2/SB2 (n=201)) up to week 70. Efficacy, safety and immunogenicity were assessed up to week 78.ResultsEfficacy was sustained and comparable across treatment groups. American College of Rheumatology (ACR) 20 responses between weeks 54 and 78 ranged from 63.5% to 72.3% with INF/SB2, 66.3%%–69.4% with INF/INF and 65.6%–68.3% with SB2/SB2. Treatment-emergent adverse events during this time occurred in 36.2%, 35.6% and 40.3%, respectively, and infusion-related reactions in 3.2%, 2.0% and 3.5%. Among patients who were negative for antidrug antibodies (ADA) up to week 54, newly developed ADAs were reported in 14.6%, 14.9% and 14.1% of the INF/SB2, INF/INF and SB2/SB2 groups, respectively.ConclusionsThe efficacy, safety and immunogenicity profiles remained comparable among the INF/SB2, INF/INF and SB2/SB2 groups up to week 78, with no treatment-emergent issues or clinically relevant immunogenicity after switching from INF to SB2.Trial registration numberNCT01936181; EudraCT number: 2012-005733-37.

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