scholarly journals Paracetamol (acetaminophen) route in palliative care (PC) patients: Intravenous versus subcutaneous route pharmacokinetics study protocol for a randomized trial = ParaSCIVPallia

2019 ◽  
Author(s):  
Marine Vernant ◽  
Marie Lepoupet ◽  
Christian Creveuil ◽  
Antoine Alix ◽  
Charlotte Gourio ◽  
...  
Keyword(s):  
Palliative Care ◽  
Adverse Events ◽  
Crossover Study ◽  
Drug Safety ◽  
Spontaneous Pain ◽  
Subcutaneous Route ◽  
Trial Register ◽  
Open Crossover ◽  
Primary Endpoints ◽  
Pain Rate

Abstract Background: Among palliative care (PC) patients who are administered paracetamol, the subcutaneous (SC) route is often an alternative to the intravenous (IV) route. Yet pharmacological and clinical data are lacking. Many French palliative teams are now empirically using paracetamol by the SC route, but there are no data to support this practice.Aim: Compare pharmacokinetic (PK) parameters between the IV and SC routes for PC patients.Design: A randomized, open, crossover study in two PC centers. The primary endpoints are AUC0-t, AUC0-, Cmax, and Vd et t1/2. All adverse events will be reported for a safety analysis.Setting/participants: 20 adult PC patients with an IV device, having spontaneous pain, not related to care, with a numeric pain rate scale > 3/10, or having a systematic prescription of paracetamol in the usual treatment. They also have to meet all eligibility criteria.Conclusion: First study comparing PK parameters for IV paracetamol versus SC paracetamol.Trial registration:Clinical trial register number NCT03944044, 2019-06-04https://clinicaltrials.gov/ct2/show/NCT03944044Committee for the protection of persons (CPP) 18.09.05.58206 approval 2018/10/4National Drug Safety Agency (ANSM: Agence Nationale de Sécurité Médicament) MEDAECNAT-2018-09-00009 approval 2018/11/29

scholarly journals Paracetamol (acetaminophen) route in palliative care (PC) patients: Intravenous versus subcutaneous route pharmacokinetics study protocol for a randomized pilot trial = ParaSCIVPallia

2019 ◽  
Author(s):  
Marine Vernant ◽  
Marie Lepoupet ◽  
Christian Creveuil ◽  
Antoine Alix ◽  
Charlotte Gourio ◽  
...  
Keyword(s):  
Palliative Care ◽  
Pilot Trial ◽  
Pharmacokinetic Parameters ◽  
Intravenous Route ◽  
Spontaneous Pain ◽  
Subcutaneous Route ◽  
Eligibility Criteria ◽  
Open Crossover ◽  
Primary Endpoints ◽  
Pain Rate

Abstract Background :Among palliative care patients, the subcutaneous route is often an alternative to the intravenous route, yet pharmacological and clinical data are lacking. Many French palliative teams are now empirically using paracetamol by the subcutaneous route, but there are no data to support this practice. Aim :Compare pharmacokinetic parameters between the intravenous and subcutaneous routes for PC patients. Design : A randomized, open, crossover study in two palliative care centres. The primary endpoints are AUC0-t, AUC0-∞, Cmax, and Vd et t1/2. All adverse events will be reported for a safety analysis. Setting/participants 20 adult palliative care patients with an IV device, having spontaneous pain, not related to care, with a numeric pain rate scale > 3/10, or having a systematic prescription of paracetamol in the usual treatment. They also have to meet all eligibility criteria. Conclusion : First pilot study comparing paracetamol intravenous versus subcutaneous route pharmacokinetics.

scholarly journals Modeling Diagnostic Strategies to Manage Toxic Adverse Events following Cancer Immunotherapy

2021 ◽  
pp. 0272989X2110027
Author(s):  
Frederik van Delft ◽  
Mirte Muller ◽  
Rom Langerak ◽  
Hendrik Koffijberg ◽  
Valesca Retèl ◽  
...  
Keyword(s):  
Palliative Care ◽  
Adverse Events ◽  
Scenario Analysis ◽  
Real World ◽  
Model Calibration ◽  
Positive Test ◽  
Test Accuracy ◽  
Test Sensitivity ◽  
False Positive Test ◽  
Test Outcomes

Background Although immunotherapy (IMT) provides significant survival benefits in selected patients, approximately 10% of patients experience (serious) immune-related adverse events (irAEs). The early detection of adverse events will prevent irAEs from progressing to severe stages, and routine testing for irAEs has become common practice. Because a positive test outcome might indicate a clinically manifesting irAE that requires treatment to (temporarily) discontinue, the occurrence of false-positive test outcomes is expected to negatively affect treatment outcomes. This study explores how the UPPAAL modeling environment can be used to assess the impact of test accuracy (i.e., test sensitivity and specificity), on the probability of patients entering palliative care within 11 IMT cycles. Methods A timed automata-based model was constructed using real-world data and expert consultation. Model calibration was performed using data from 248 non–small-cell lung cancer patients treated with nivolumab. A scenario analysis was performed to evaluate the effect of changes in test accuracy on the probability of patients transitioning to palliative care. Results The constructed model was used to estimate the cumulative probabilities for the patients’ transition to palliative care, which were found to match real-world clinical observations after model calibration. The scenario analysis showed that the specificity of laboratory tests for routine monitoring has a strong effect on the probability of patients transitioning to palliative care, whereas the effect of test sensitivity was limited. Conclusion We have obtained interesting insights by simulating a care pathway and disease progression using UPPAAL. The scenario analysis indicates that an increase in test specificity results in decreased discontinuation of treatment due to suspicion of irAEs, through a reduction of false-positive test outcomes.

A Randomized Phase 1 Safety Study of Repeated Doses of Intranasal OP0201 Metered Dose Inhaler Compared to Placebo in Healthy Adults: A Potential Treatment for Otitis Media

2020 ◽  
Author(s):  
Mai D. Sirimanne ◽  
Janak A. Patel ◽  
Martin Kankam ◽  
Bradley D. Vince ◽  
Catherine C. Turkel
Keyword(s):  
Adverse Events ◽  
Otitis Media ◽  
Phase 1 ◽  
Healthy Adults ◽  
Dose Inhaler ◽  
Metered Dose Inhaler ◽  
Maximum Serum ◽  
Median Tmax ◽  
Primary Endpoints ◽  
Metered Dose

Abstract Background OP0201 Nasal Aerosol is a novel drug-device surfactant product being developed for treatment and prevention of otitis media. The active ingredients in OP0201, dipalmitoylphosphatidylcholine (DPPC) and cholesteryl palmitate (CP), are endogenous to the human nasal and respiratory systems. This phase 1 study evaluated the safety and tolerability of OP0201 in healthy adults. Methods This was a randomized, double-blind, placebo-controlled, parallel-group study with a dose-escalation cohort design to evaluate 30 mg/day (Cohort A) and 60 mg/day (Cohort B) of OP0201. Subjects were randomized 4:1 to receive either OP0201 or placebo 3 times per day for 14 consecutive days. Treatment was administered via a metered dose inhaler and sprayed directly backwards into each nostril. Primary endpoints were adverse events, otoscopy, tympanometry, nasal and epipharynx endoscopy, University of Pennsylvania Smell Identification Test (UPSIT), audiology pure-tone hearing test, 12-lead electrocardiography, physical examination, vital signs, and clinical laboratory tests. Exploratory endpoints included baseline-adjusted maximum serum concentration (Cmax) and time to maximum concentration (tmax) of DPPC and CP on Day 14 in Cohort B. Results 101 participants were screened, and 30 were randomized (15 per cohort; n=12 OP0201, n=3 placebo). No deaths, serious adverse events, or treatment-emergent adverse events leading to study discontinuation were reported. No clinically significant deviations from baseline were found in any of the primary endpoints. Serum DPPC and CP concentrations on Day 14 were comparable to baseline in the OP0201 group and numerically higher in the placebo group. Mean baseline-corrected serum DPPC Cmax on Day 14 was 0.82 µg/mL with OP0201 and 4.51 µg/mL with placebo, with a median tmax observed at 0.05 hours for both groups. Mean baseline-corrected serum CP Cmax on Day 14 was 14.89 µM with OP0201 and 89.50 µM with placebo, with a median tmax observed at 0.05 and 0.22 hours for OP0201 and placebo, respectively. Conclusions OP0201 was safe and well tolerated in healthy adults. There were no supraphysiologic systemic concentrations of DPPC or CP after local intranasal administration of a 60 mg/day dose of OP0201. These outcomes support continued development of OP0201 with future studies in a patient population.

Safety and Efficacy of Fremanezumab for the Prevention of Migraine: a Meta-analysis from Random Clinical Trails

2020 ◽  
Author(s):  
Bixi Gao ◽  
Nan Sun ◽  
Yanbo Yang ◽  
Yue Sun ◽  
Mingjia Chen ◽  
...  
Keyword(s):  
Adverse Events ◽  
Neurological Diseases ◽  
Meta Analysis ◽  
Cochrane Library ◽  
Serious Adverse Events ◽  
Safety And Efficacy ◽  
Therapeutic Drugs ◽  
Primary Endpoints ◽  
Calcitonin Gene ◽  
Clinical Trails

Abstract Background Fremanezumab (TEV-48125) is a fully humanized immunoglobulin G isotype 2a selective monoclonal antibody that potently binds to calcitonin gene-related peptide (CGRP). It is one of novel therapeutic drugs for the prevention of migraine, which is one of the most common neurological diseases worldwide. Several clinical trails have been conducted to investigate the safety and efficacy of fremanezumab, but there is no systematic review of existing literature has been performed. Hence, we performed a meta-analysis to investigate the efficacy and safety of fremanezumab for prevention of migraine. Method Pubmed (MEDLINE), Embase, and Cochrane Library were searched from January 2001 to August 2019 for randomized controlled trials (RCTs). Five RCTs with 3379 patients were finally included in our study. Result We pooled 3379 patients from 5 RCTs, the primary endpoints were mean monthly migraine and headache days, baseline to week 12. We found that fremanezumab led to a significant reduction in migraine days (P < 0.0001) and headache days (P < 0.0001) during 12 weeks compared with placebo. In addition, after using fremanezumab, the risk of at least one adverse event (P=0.001) or related to the trail regimen (P=0.0005) significantly increase compared with placebo. Conclusions Fremanezumab has good efficacy for the prevention of migraine. The administration of fremanezumab can cause some mild adverse events but not serious adverse events.

Automated Needle Targeting (ANT) Device-Assisted Renal Access during Percutaneous Nephrolithotripsy (PCNL) Puncture: A Pilot Study to Assess the Safety and Efficacy of a Novel Technique

2020 ◽  
Author(s):  
Chu Ann Chai ◽  
W.S Yeoh ◽  
A.N Fadzli ◽  
T.A Ong ◽  
S Kuppusamy ◽  
...  
Keyword(s):  
Adverse Events ◽  
Radiation Exposure ◽  
Renal Stones ◽  
Open Label ◽  
Primary Endpoints ◽  
Ethical Approval ◽  
The Mean ◽  
Set Up ◽  
Surgical Duration ◽  
Mean Time

Abstract Background: To explore the use of an automated needle targeting (ANT) device as an assistive intraoperative navigation modality during PCNL for the treatment of large renal stones, with the aim of reducing surgical durations and radiation exposure.Methods: This open-label, single-surgeon clinical trial included patients with a diagnosis of renal stones for whom PCNL using the ANT device via the percutaneous access technique was indicated. Ethical approval was obtained from the UMMC ethics review board (Ref. 20118105-6740). The ANT was assembled after an initial motor calibration, and the image calibration was performed using the patient’s fluoroscopic images. Subsequently, the ANT software calculated a bullseye alignment before percutaneous puncture. Accurate renal access was confirmed by the efflux of urine in the Chiba biopsy needle, as well as by imaging with the C-arm intensifier at different angles. The primary endpoints were the time to successful renal access (from ANT set-up to urine efflux) and adverse events.Results: In all cases, successful renal access was achieved with a single attempt. The mean time to renal access was 6 minutes, 8 seconds. The mean fluoroscopy duration was 101 seconds, with a mean radiation dose of 23.46 mGy. No adverse events were documented.Conclusion: The ANT device enabled successful, safe and efficient renal access for PCNL in this study. Further research is needed to justify the effectiveness of this device in terms of enabling accurate renal access while reducing the surgical duration and radiation exposure to both surgeons and patients.

The Clinical Efficacy of a Multi-Lamellar Emulsion Containing Pseudoceramide in Childhood Atopic Dermatitis: An Open Crossover Study

2003 ◽  
Vol 15 (4) ◽  
pp. 133 ◽  
Author(s):  
Eun Ju Lee ◽  
Ki Beom Suhr ◽  
Jeung Hoon Lee ◽  
Jang Kyu Park ◽  
Chun Yu Jin ◽  
...  
Keyword(s):  
Atopic Dermatitis ◽  
Crossover Study ◽  
Clinical Efficacy ◽  
Open Crossover

Administration of label and off-label drugs by the subcutaneous route in palliative care: an observational cohort study

2020 ◽  
pp. bmjspcare-2020-002185
Author(s):  
Jesper Jørgen Jensen ◽  
Per Sjøgren
Keyword(s):  
Palliative Care ◽  
Drug Administration ◽  
Subcutaneous Administration ◽  
Drug Discontinuation ◽  
Subcutaneous Route ◽  
Scientific Publications ◽  
Prospective Data ◽  
Off Label ◽  
Injectable Drugs ◽  
Observational Cohort

BackgroundThe marketing authorisation for many injectable drugs used in palliative care does not cover the frequently preferred subcutaneous route. Consequently, subcutaneous off-label drug administration is often practised.AimTo assess the use, safety and tolerability of subcutaneous label and subcutaneous off-label drug administration in a Danish hospice.Material and methodsRetrospective data from hospice inpatient records registered with subcutaneous drug administration. Prospective data of subcutaneous drug administration registered to hospice inpatients over a period of 2 months.ResultsDrugs were administered subcutaneously to 90% of patients in both studied cohorts. Thirty different drugs were administered subcutaneously. Ten (33%) drugs were authorised for subcutaneous administration, 14 (47%) for intramuscular and 6 (20%) for intravenous administration only. A search in major palliative literature and scientific publications revealed that 11 of the 20 subcutaneous off-labelled drugs were administered with little to no support from these sources. In seven patients, 11 adverse drug reactions (ADRs) were registered. ADRs were all minor local reactions and led to drug discontinuation in two patients only.ConclusionSubcutaneous drug administration was frequently used in the hospice. Two-thirds of the drugs were administered subcutaneously off-label. The findings of only a few and minor ADRs indicate that the drugs identified in this study, although often subcutaneously off-label and with little support from palliative literature, were administered with acceptable safety and tolerability. Off-label treatment practised in the clinic should be identified, reported and serve as inspiration for future scientific research and incentives for extension of marketing authorisations.

Supportive care organization: Patients and oncologist national survey comparison.

2014 ◽  
Vol 32 (31_suppl) ◽  
pp. 202-202
Author(s):  
Florian Scotte ◽  
Christian Herve ◽  
Jean Marc Tourani ◽  
Roland Bugat ◽  
Fadila Farsi ◽  
...  
Keyword(s):  
Palliative Care ◽  
Adverse Events ◽  
Supportive Care ◽  
National Survey ◽  
Care Organization ◽  
Analgesic Treatment ◽  
Face To Face ◽  
French Speaking ◽  
Professional Resources

202 Background: The medical doctor's (MD) perspective of supportive care in cancer (SCC) in France was previously assessed on a national survey. However, the opinion of patients (P) has never been evaluated nor compared to MD’s perception.Wepromoted and compared P and MD awareness via national surveys to monitor implementation and information delivered to patients on SCC. Methods: The French Speaking Association for SCC (AFSOS) conducted two observational studies, analyzed with a Chi2 test: S1: a 30 points questionnaire sent to 2,263 physicians caring for cancer P (oncologists, radiotherapists, haematologists, gastroenterologists); and S2: a 40 points questionnaire performed by physicians to P, using a face-to-face method. Results: 711 MDs returned S1 and S2 was conducted with 1,562 P. In S1, MDs declared relying on SCC organization (81%) but 19% of P declared they were offered to benefit from an organization called SCC (54% at diagnosis, 35% after complication). The name SCC was known by 34% of P, most frequently described as complementary care to specific treatments (55%). Palliative Care word had been previously heard by 80% P, mostly considered as care to improve quality of life during cancer treatment for 59%. In S2, professional resources identified outside the hospital were: general practitioners (84%), nurses (58%), pharmacists (52%). According to P, the top 3 supportive care consultations proposed were psychology (61%), nutrition (55%) and announcement organization (55%), while MDs mentioned palliative care (98%), psychological care (98%), social care (98%), S2 showed that supportive treatment was prescribed to 63% of P, mostly by their oncologist (74%), and 64% of those P received information on side-effects. Epoetin was prescribed to 25% and analgesics to 73%, with discussion on adverse events respectively for 38% and 53%. MDs declared delivering information on adverse events to 49% of P receiving epoetin and to 74% of P running for analgesic treatment. Conclusions: Oncologist is the cornerstone of SCC organization. Information as well as treatment must be developed to further enhance SCC and patient quality of care.

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