Methodological Aspects of Prophylactic Drug Trials in Migraine

Cephalalgia ◽  
1981 ◽  
Vol 1 (3) ◽  
pp. 127-141 ◽  
Author(s):  
Jes Olesen ◽  
Annette Æbelholt Krabbe ◽  
Peer Tfelt-Hansen
Keyword(s):  
Crossover Design ◽  
Drug Trials ◽  
Duration Of Treatment ◽  
Time Effects ◽  
Sufficient Power ◽  
Number Of Patients ◽  
Prophylactic Drug ◽  
Headache Diary ◽  
Methodological Aspects ◽  
Clinical Problems

The purpose of this paper is to analyse methodological aspects of prophylactic drug trials in migraine. A study of ferrum quartz in 33 patients provided the necessary data base. Migraine definitions, relation between interval headache and migraine, and a number of other clinical problems are discussed. A headache diary is presented which to a certain extent allows a separation of interval headache and migraine attacks. Virtually all patients with frequent migraine attacks have interval headaches. A statistical model which allows a separation of time effects and treatment effects is presented. The inter-patient variability was much greater than intra-patient variability. This indicates that it will be difficult to obtain sufficient power with a non-crossover design. The relation between duration of treatment periods and the recessary number of patients is shown to be inversely related.

scholarly journals Patients’ expectations on medicines information

2020 ◽  
Vol 30 (Supplement_5) ◽  
Author(s):  
A Sevikyan ◽  
I Kazaryan
Keyword(s):  
Storage Conditions ◽  
Community Pharmacies ◽  
Duration Of Treatment ◽  
Pharmacy Staff ◽  
Medicine Price ◽  
Expiry Date ◽  
Face To Face ◽  
Medicines Information ◽  
Number Of Patients ◽  
Effective Use

Abstract Background Medicines information is important for patients as it assists them in achieving more safe and effective use of pharmaceuticals. Many patients seek information from community pharmacies' staff. The objectives of this study were to identify specific topics of medicines information which patients expect to receive at community pharmacies. Methods Face-to-face interviews were conducted with 1059 visitors of community pharmacies in Armenia. Previously developed questionnaire was used for interviewing patients. Data were analysed with the SPSS statistical software. Results Most of participants acknowledged importance of receiving from community pharmacies' staff information on therapeutic indications of medicines (91.1%), dosage and method of administration (90.8%), the duration of treatment (86.3%), expiry date (85.7%), adverse reactions (85.0%), contraindications (84.6%), storage conditions (77.5%) and type of activity (76.0%). Importance of receiving information on some specific topics depends on patients' age. Participants' acknowledgement of information on interaction with other medicines, certain categories of users, and potential effects on the ability to drive is decreasing with patients' age increasing (p < 0.001). The opposite trend was observed with attitude to receiving information on medicine price that was mostly valued by elderly patients (p = 0.046). The number of patients who trust the information provided was higher among those who more often received comprehensive responses from pharmacists and pharmacy assistants (p < 0.001). Conclusions Receiving medicines information from the staff of community pharmacies is important for patients, and the majority of them trust to information received. Patients are mainly provided with comprehensive responses to their questions about medicines, and there was dependence between a frequency of receiving comprehensive responses and a level of patients' trust the information provided by pharmacy staff. Key messages Increasing patients’ awareness on their right to get medicines information can be beneficial. Comprehensive responses increase patients trust medicines information provided by pharmacists.

Evaluating the reporting of adverse events in controlled clinical trials conducted in 2010–2015 on migraine drug treatments

Cephalalgia ◽  
2018 ◽  
Vol 38 (12) ◽  
pp. 1885-1895
Author(s):  
Peer Tfelt-Hansen ◽  
Janus Kaufmann Lindqvist ◽  
Thien Phu Do
Keyword(s):  
Adverse Events ◽  
Randomized Controlled Trials ◽  
International Headache Society ◽  
Controlled Trial ◽  
Migraine Treatment ◽  
Controlled Trials ◽  
Acute Administration ◽  
Drug Trials ◽  
Randomized Controlled ◽  
Number Of Patients

Background In 2008, the International Headache Society published guidelines on the “evaluation and registration of adverse events in clinical drug trials on migraine”. They listed seven recommendations for reporting adverse events in randomized controlled trials on migraine. The present study aimed to evaluate adherence to these recommendations, and based on the results, to recommend improvements. Methods We searched the PubMed/MEDLINE database to identify controlled trials on migraine drugs published from 2010 to 2015. For each trial, we noted whether five of the recommended parameters were presented. In addition, we noted whether adverse events were reported in abstracts. Results We identified 73 trials; 51 studied acutely administered drugs and 22 studied prophylactic drugs for migraine. The number of patients with any adverse events were reported in 74% of acute-administration and 86% of prophylactic drug trials. Only 30 (41%) of the 73 studies reported adverse events with data in the abstracts, and 27 (37%) abstracts did not mention adverse events. Conclusion Adverse events, both frequency and symptoms, should be reported to allow a fair judgement of benefit/tolerability ratio when randomized controlled trials in migraine treatment are published. Clinically significant adverse events should be included in the abstract of every randomized controlled trial in migraine treatment.

scholarly journals CLINICAL EVALUATION OF AYURVEDIC FORMULATION OF COLICARMIN PLUS SYRUP ON COLIC, GRIPING PAIN, INDIGESTION, NAUSEA, VOMITING, AND OTHER DIGESTIVE DISORDERS IN PAEDIATRICS AND GERIATRICS PATIENTS.

2016 ◽  
pp. 114
Author(s):  
Devendra Mishra ◽  
Girish H Patel ◽  
Rupali Gathani
Keyword(s):  
Side Effects ◽  
Geriatric Patients ◽  
Total Duration ◽  
Nausea And Vomiting ◽  
Duration Of Treatment ◽  
Open Label ◽  
Open Label Study ◽  
Label Study ◽  
Number Of Patients ◽  
Digestive Disorders

<p>ABSTRACT<br />Objective: An open label study to assess the effect of colicarmin plus syrup on colic and griping pain, indigestion, nausea and vomiting in children,<br />and geriatric patients.<br />Methods: (a) A study was conducted on 75 number of patients to evaluate the effect of colicarmin plus syrup on colic and griping pain, indigestion,<br />nausea and vomiting in children, and adults, (b) mostly these children were selected from different classes of families, (c) all the patients were checked<br />on the 1<br />st<br />, 2<br />nd<br />, and 3<br />rd<br /> week after starting the therapeutic dose.<br />Dosage schedule: (a) Children: 1 Teaspoonful thrice a day after meals, (b) adults: 2 Teaspoonful twice to thrice a day after meals.<br />Results: (a) Colic and griping pain: In the total duration of treatment, no of patients recovering were 23-on 1<br />st<br /> week, 4-on 2<br /> week,<br />overall result is 93.54%, (b) indigestion: In the total duration of treatment, no of patients recovering were 26-on 1<br />st<br />nd<br /> week, and 3-on 3<br /> week, 3-on 2<br /> week, and 1-on<br />3<br />rd<br /> week, the overall result is 93.75%, (c) nausea and vomiting: In the total duration of treatment, no of patients recovering were 8-on 1<br /> week, 2-on<br />2<br />nd<br /> week, and 1-on 3<br />rd<br /> week, the overall result is 91.33%.<br />Conclusion: Based on the study, we can conclude that colicarmin plus syrup is an Ayurvedic formulation with benefits such as digestive, carminative,<br />anthelmintic, antiflatulent, antispasmodic, and devoid of side effects.<br />Keywords: Digestive, Carminative, Anthelmintic, Antiflatulent and Antispasmodic.<br />nd</p><p>st</p><p>rd</p>

scholarly journals Some Peculiarities of Silica Modification Under High Reagent Pressure. I. Methodological Aspects

1995 ◽  
Vol 12 (3) ◽  
pp. 231-238 ◽  
Author(s):  
V.V. Sidorchuk ◽  
V.A. Tertykh ◽  
R. Leboda ◽  
Z. Hubicki
Keyword(s):  
Thermal Analysis ◽  
Surface Reaction ◽  
Silica Surface ◽  
Porous Silica ◽  
Physicochemical Characteristics ◽  
Geometrical Parameters ◽  
Duration Of Treatment ◽  
Preparation Conditions ◽  
Modification Process ◽  
Methodological Aspects

The effect of the following factors on the chemical and geometrical modification of aerosilogel (prepared from aerosil) was studied: the physicochemical characteristics of the modifying reagent pressures, the preparation conditions for the silica surface, the reaction temperature, the reagent pressures, the duration of treatment and the method employed for the modification process. The course of the surface reaction was followed by IR spectroscopy, differential thermal analysis and adsorption. During high-pressure modification, the geometrical parameters of the porous silica structure may be changed.

Dasatinib 50 mg or 70 mg BID compared to 100 mg or 140 mg QD in patients with CML in chronic phase (CP) who are resistant or intolerant to imatinib: One-year results of CA180034

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 7004-7004 ◽  
Author(s):  
N. P. Shah ◽  
D. W. Kim ◽  
H. M. Kantarjian ◽  
P. Rousselot ◽  
P. E. Dorlhiac-Llacer ◽  
...  
Keyword(s):  
Kinase Inhibitor ◽  
Chronic Phase ◽  
Progression Free Survival ◽  
Response Rates ◽  
Primary Objective ◽  
Molecular Response ◽  
Duration Of Treatment ◽  
Open Label ◽  
Number Of Patients ◽  
One Year

7004 Background: Previous data with dasatinib (SPRYCEL®), a short-acting oral multitargeted kinase inhibitor of BCR-ABL and SRC family kinases, have shown the safety and efficacy of the 70 mg BID dose in CP-CML patients. Surprisingly, phase-I data (NEJM 2006;354:2531) demonstrated complete hematologic (CHR) and major cytogenetic responses (MCyR) among CP-CML patients at total daily doses (TDD) of 100 mg and 140 mg in both the BID and QD schedule, despite the achievement of only transient inhibition of BCR-ABL by dasatinib when administered once daily. Methods: Patients with CP-CML resistant or intolerant to imatinib were randomized to one of 4 dasatinib arms: 1) 100 mg QD; 2) 50 mg BID; 3) 140 mg QD; 4) 70 mg BID. In this randomized, prospective, open-label trial, the primary objective compared the CyR rate among the BID and QD arms. Secondary objectives included comparison of the CyR rate between TTDs of 100 and 140 mg and the safety among the 4 arms. Results: 662 patients were randomized from July 2005 to March 2006 and received treatment. Response rates, with a median duration of treatment of 8 months, are shown below. Duration of CyR and progression-free survival were similar across all 4 arms. There was significantly less grade (Gr) 3–4 neutropenia (P=0.035), thrombocytopenia (P=0.001), anemia (P=0.032), and pleural effusions (P=0.028) in the 100-mg QD arm compared to the other 3 arms combined. No differences were seen across the 4 arms in the rates of other adverse events. There were fewer interruptions and reductions and the least number of patients discontinuing treatment for drug-related toxicity in the 100-mg QD arm. Conclusions: Dasatinib 100 mg QD offers the most favorable benefit-risk ratio in CP-CML. This trial provides the first evidence that intermittent kinase inhibition can achieve deep clinical remissions and is associated with an improved safety profile. One-year follow-up on all subjects, molecular response rates, and BCR-ABL mutation data will be presented. [Table: see text] [Table: see text]

Efficacy and toxicity of q 2 weeks docetaxel versus weekly versus q 3 weeks in metastatic castration-resistant prostate cancer (CRPC).

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. e16087-e16087
Author(s):  
Akshiv Malhotra ◽  
Paula Rosenbaum ◽  
Bernard J. Poiesz
Keyword(s):  
Specific Antigen ◽  
Progression Free Survival ◽  
Response Rates ◽  
Test Results ◽  
Castration Resistant Prostate Cancer ◽  
Duration Of Treatment ◽  
Free Survival ◽  
Castration Resistant ◽  
Significant Toxicity ◽  
Number Of Patients

e16087 Background: Standard treatment for metastatic CRPC is docetaxel 75 mg/m2q3weeks. Methods: We retrospectively studied patients treated with q 1, 2, or 3 weeks docetaxel regimens at 30, 60 and 75 mg/m2, respectively. The choice of regimen and duration of treatment was decided by their oncologist. Patients who had been in a clinical trial previously, or treated with any other chemotherapy before docetaxel were excluded. On this basis 41 patients were studied. Prostate specific antigen (PSA) was used as the primary method to assess response and progression. Response was a decline of >/=50% from baseline value with no clinical or radiographic evidence of disease progression. For patients whose PSA did not decrease, progression was a >/= 25% increase from baseline. If the PSA decreased without reaching response criteria, progression was a >/= 25% increase from nadir. In those who responded, progression was a >/= 50% increase from nadir. The increase had to be at least 5ng/ml. Toxicity was graded on the basis of CTCAE version 4.0. Response rate and toxicity in the 3 arms was compared using a two by two square t-test. Results: There were 12, 14 and 15 patients in the q1w, q2w and q3w arms, respectively. Response rates, mean progression free survival (PFS), median PFS, mean overall survival (OS), median OS, mean cumulative dose (MCD) and toxicity are shown in table 1. Toxicity was similar in the q1w, q2w and q3w arms, except grade 1/2 neuropathy was higher in the q2w arm vs. the q1w arm (p=0.005). Conclusions: The MCD, response rates, PFS and OS in the q1w and q3w arms were similar to previously published reports. Patients in the q2w arm received a statistically significant higher MCD. Our data suggest a better outcome in the q2w arm as compared to the q1w and q3w arms. However, given the small number of patients studied, the results are not statistically significant. Toxicity was similar save for grade1/2 neuropathy. [Table: see text]

scholarly journals Management of Alarming Hemangiomas with Oral Prednisolone in Infants

2017 ◽  
Vol 7 (1) ◽  
pp. 7-11
Author(s):  
Kamal M Choudhury ◽  
Shafiqul Hoque
Keyword(s):  
Oral Prednisolone ◽  
Single Mode ◽  
Duration Of Treatment ◽  
College Hospital ◽  
Vast Number ◽  
Prednisolone Therapy ◽  
Medical College ◽  
Number Of Patients ◽  
Study Population ◽  
Medical University

Background: Treatment of hemangiomas remains a contentious and difficult issue for the physicians as well as for the surgeons. The numerous modality of treatment for hemangiomas testifies that no single mode of treatment is entirely satisfactory in their management. However, for alarming hemangiomas oral prednisolone had been used for long with encouraging resultsMethods: From a vast number of patients with hemangiomas attending the out-patient departments (OPDs) of Bangabandhu Sheikh Mujib Medical University (BSMMU), Dhaka Shishu Hospital (DSH), Rajshahi Medical College Hospital (RMCH) and BIRDEM General Hospital between 1999 through 2014, we had selected consecutively 462 infants with alarming hemangiomas. The whole study population (462 infants with alarming hemangiomas) received oral prednisolone at a dose of 2-4 mg/kg/day, and the results were observed sequentially in serial follow-ups.Results: About 71% patients showed substantial regression of the hemangiomas with oral prednisolone therapy after a mean duration of treatment of 6 months. Few adverse effects were associated with oral prednisolone but these were mostly transient and reversible.Conclusion: The authors assert that the management of alarming hemangiomas with oral prednisolone therapy is safe and effective.Birdem Med J 2017; 7(1): 7-11

Infectious diseases and tropical medicine

2016 ◽  
Keyword(s):  
Clinical Trials ◽  
Clinical Practice ◽  
Statistical Analysis ◽  
Infectious Diseases ◽  
Clinical Evidence ◽  
Critical Evaluation ◽  
Duration Of Treatment ◽  
The Uk ◽  
Clinical Problems ◽  
Key Questions

Some of the earliest clinical trials were conducted in infectious diseases. In the 1940s, the development of the first antibiotics for treating tuberculosis coincided with the recognition that rigorous clinical trials were required to determine optimum drug combinations and duration of treatment. The joint efforts of bacteriologists, clinicians, and statisticians promoted the development of clinical trials, acknowledging that clinically valid endpoints and careful statistical analysis are vital for trials to provide evidence of sufficient quality to guide clinical practice. This chapter covers key questions in this field addressed by good-quality trials. It covers clinical evidence important to practitioners both overseas and in the UK. It focuses on trials that have generated key data, while also covering trials which address clinical problems that are important worldwide and less commonly seen in the UK where critical evaluation of current trials might be difficult.

Methodological Aspects of Drug Trials in Migraine. pp 216–226

1985 ◽  
Vol 4 (4) ◽  
pp. 216-226
Author(s):  
Peer Tfelt-Hansen ◽  
Jes Olesen
Keyword(s):  
Drug Trials ◽  
Methodological Aspects

Differences in the exposure to sunitinib in the immediate and deferred cytoreductive nephrectomy (CN) arms of the randomized controlled trial SURTIME.

2020 ◽  
Vol 38 (6_suppl) ◽  
pp. 703-703
Author(s):  
Yasmin Abu-Ghanem ◽  
Johannes V. Van Thienen ◽  
Christian U. Blank ◽  
Thomas Powles ◽  
Bertrand F. TOMBAL ◽  
...  
Keyword(s):  
Systemic Therapy ◽  
Drug Exposure ◽  
Controlled Trial ◽  
Dose Intensity ◽  
Duration Of Treatment ◽  
Intention To Treat ◽  
Number Of Patients ◽  
Metastatic Sites ◽  
Post Hoc ◽  
Treat Analysis

703 Background: SURTIME compared immediate CN followed by sunitinib 50mg/day (4/2 weeks on-off) 4 weeks after surgery (n=50) versus 3 cycles sunitinib followed by CN in the absence of progression and continued sunitinib 4 weeks after surgery (n=49). In the intention to treat analysis, the hazard ratio of the secondary endpoint overall survival (OS) favored deferred CN [0.57 (CI: 0.34–0.95, p=0.032)] with a median OS of 32.4 (CI: 14.5-65.3) versus only 15.0 months (CI: 9.3–29.5), following immediate CN. We investigated differences in exposure to systemic therapy between the two arms. Methods: Post-hoc exploratory analysis of number of patients receiving sunitinib, overall response rate (ORR) by RECIST 1.1, length of drug exposure and dose intensity in the immediate and deferred arm. Descriptive methods and 95% confidence intervals (CI) were used. Results: In the deferred arm, 97.7% (CI: 89.3-99.6; n=48) received sunitinib versus only 80% (CI: 66.9-88.7, n=40) in the immediate arm. Following immediate CN, 19.6% had confirmed progression at an interval CT scan 4 weeks after CN compared to baseline and 25% started with sunitinib > 4 weeks after surgery. At week 16, 46.0% had progressed at metastatic sites in the immediate CN arm versus 32.7% in the deferred arm, who had a per-protocol recommendation against nephrectomy. In the deferred arm, 83% completed 3 cycles sunitinib with 77.1% at >90%-120% relative dose intensity and an ORR of 29%, reducing the median sum of target lesions from 162 to 127 mm prior to planned CN.Of the patients who started with sunitinib in the immediate (n=40) or continued in the deferred arm after CN (n=29) median duration of treatment was 140 versus 351 days. Conclusions: With immediate CN fewer patients receive systemic therapy, which is administered later and shorter compared to the deferred approach. Starting systemic therapy with sunitinib leads to early and more profound control of the disease and identification of progression prior to planned CN which may translate into the observed survival benefit. Clinical trial information: NCT01099423.

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