scholarly journals Arthritis prevention in the pre-clinical phase of RA with abatacept (the APIPPRA study): a multi-centre, randomised, double blind, parallel group placebo-controlled clinical trial Protocol

2019 ◽  
Author(s):  
Mariam Al-Laith ◽  
Marianna Jasenecova ◽  
Sonya Abraham ◽  
Aisla Bosworth ◽  
Ian N. Bruce ◽  
...  
Keyword(s):  
At Risk ◽  
Controlled Trial ◽  
Hospital Setting ◽  
Placebo Treatment ◽  
Controlled Clinical Trial ◽  
Care Hospital ◽  
Duration Of Treatment ◽  
Double Blind ◽  
Clinical Phase ◽  
Parallel Group

Abstract Trial design: We present a study protocol for a multi-centre, randomised, double blind, parallel group, placebo-controlled trial that seeks to test the feasibility, acceptability and effectiveness of a 52-week period of treatment with the first-in-class costimulatory blocker abatacept for preventing or delaying the onset of inflammatory arthritis. Methods: The study aimed to recruit 206 male or female subjects from the secondary care hospital setting across the UK and the Netherlands. Participants aged 18 or over who report inflammatory sounding joint pain (clinically suspicious arthralgia) and who are found to be positive for serum autoantibodies associated with RA were eligible for enrolment. All study subjects were randomised to receive weekly injections of investigational medicinal product (IMP), either abatacept or placebo treatment over a 52-week period. Participants were then followed up for a further 52 weeks. The primary endpoint was defined as the time to development of ≥ 3 swollen joints, or to the fulfilment of the 2010 ACR/EULAR classification criteria for RA using swollen but not tender joints, whichever endpoint was met first. In either case, swollen joints were confirmed by ultrasonography. Participants, care givers, and those assessing the outcomes were all blinded to group assignment. Clinical assessors and ultrasonographers were also blinded to each other’s assessments for the duration of the study. Conclusions: There is limited experience of the design and implementation of trials for the prevention of inflammatory joint diseases. We discuss the rationale behind choice and duration of treatment, the challenges associated with defining the “at risk” state, and offer pragmatic solutions in the protocol to enrolling subjects at risk of RA. Trial registration: Current Controlled Trials, ID: ISRCTN46017566. Registered on 04 July 2014.

scholarly journals Arthritis Prevention in the Pre-Clinical Phase of RA with Abatacept (the APIPPRA Study): A Multi-Centre, Randomised, Double Blind, Parallel Group Placebo-Controlled Clinical Trial

2018 ◽  
Author(s):  
Mariam Al-Laith ◽  
Marianna Jasenecova ◽  
Sonya Abraham ◽  
Aisla Bosworth ◽  
Ian N. Bruce ◽  
...  
Keyword(s):  
Clinical Trial ◽  
At Risk ◽  
Joint Pain ◽  
Hospital Setting ◽  
Placebo Treatment ◽  
Controlled Clinical Trial ◽  
Care Hospital ◽  
Duration Of Treatment ◽  
Double Blind ◽  
Parallel Group

Abstract Background: Individuals with joint pain and carrying serum autoantibodies associated with rheumatoid arthritis (RA) are at high risk of developing RA. While there are currently no evidence-based guidelines to inform therapy decisions for such subjects, there are therapies licensed for the treatment of established RA that target pathways implicated in the earliest phase of the disease. Accordingly, we set out to test the feasibility, acceptability and effectiveness of a 52-week period of treatment with the first in class costimulatory blocker abatacept for preventing or delaying the onset of inflammatory arthritis. Methods and Design The APIPPRA study was designed as a randomised, double blind, parallel group placebo-controlled clinical trial, aiming to recruit 206 male or female subjects from the secondary care hospital setting across the UK and the Netherlands. Participants aged 18 or over who report inflammatory sounding joint pain (clinically suspicious arthralgia) and who are found to be positive for serum autoantibodies associated with RA, will be randomised to receive weekly injections of investigational medicinal product (IMP), either abatacept or placebo treatment over a 52-week period. All study subjects consent to a further 52 weeks of follow up to monitor for the primary endpoint, the time to development of ≥ 3 swollen joints, or to the fulfillment of the 2010 ACR/EULAR classification criteria for RA using swollen but not tender joints, whichever endpoint is met first. In either case, swollen joints are confirmed by ultrasonography. Discussion There is limited experience of the design and implementation of trials for the prevention of inflammatory joint diseases. Here, we propose to explore the effects of immunomodulatory therapy at the very earliest detectable phase of disease using an intervention that is already licensed for use in established RA. We discuss the rationale behind choice and duration of treatment, the challenges associated with defining the “at risk” state, and offer pragmatic solutions in the protocol to enrolling subjects at risk of RA. Trial registration Current Controlled Trials, ID: ISRCTN46017566. Registered on 04 July 2014

A Double-Blind, Randomized, Parallel-Group, Placebo-Controlled Trial of O-(β-Hydroxyetnyl)-Rutosides in Chronic Arm Oedema Resulting from Breast Cancer Treatment

1995 ◽  
Vol 10 (2) ◽  
pp. 51-55 ◽  
Author(s):  
P. S. Mortimer ◽  
C. Badger ◽  
I. Clarke ◽  
J. Pallett
Keyword(s):  
Breast Cancer ◽  
Controlled Trial ◽  
Symptom Assessment ◽  
Controlled Clinical Trial ◽  
Point Scale ◽  
Carcinoma Of The Breast ◽  
Double Blind ◽  
Parallel Group ◽  
Royal Marsden Hospital ◽  
The Difference

Objective: To assess the efficacy of O-(β-hydroxyethyl)-rutosides (HR) in the treatment of breast-cancer-related lymphoedema. Design: A double-blind, randomized, parallel-group, placebo-controlled clinical trial. Setting: Lymphoedema clinic, Royal Marsden Hospital, London, UK. Patients: Forty-six females with unilateral lymphoedema of the arm secondary to therapy for carcinoma of the breast. Main outcome measures: Arm volume, symptom assessment on a five-point scale. Results: The difference in arm volumes was significantly better for HR than placebo at 6 months, but not at 1–5 months. Conclusion: HR appears to stabilize the patients' condition against increasing lymphoedema in the placebo group.

A Double-Blind, Comparative Study of Zolpidem and Placebo in the Treatment of Insomnia in Elderly Psychiatric In-Patients

1992 ◽  
Vol 20 (2) ◽  
pp. 150-161 ◽  
Author(s):  
S H Shaw ◽  
H Curson ◽  
J P Coquelin
Keyword(s):  
Psychiatric Patients ◽  
Controlled Trial ◽  
Total Duration ◽  
Placebo Treatment ◽  
Daytime Drowsiness ◽  
Double Blind ◽  
Patients Âgés ◽  
Parallel Group ◽  
Sleep Parameters ◽  
Troubles Psychiatriques

The efficacy and tolerability of the imidazopyridine hypnotic, zolpidem, were investigated in 119 elderly psychiatric inpatients complaining of insomnia in a double-blind, parallel-group, placebo-controlled trial. After a 7-day placebo washout period, patients were randomized to receive 10 or 20 mg/day zolpidem, or placebo for 21 days; thereafter, all patients received placebo for 7 days. Sleep was assessed by patient observation on days 0, 1, 7, 14, 21, 22 and 28. Compared with placebo, 20 mg/day zolpidem significantly improved total duration of sleep between day 0 and day 21, and this was maintained at day 28. After 10 or 20 mg/day zolpidem, there was also a trend towards improvement in all other sleep parameters, which remained above baseline at day 28. Zolpidem was well tolerated with no withdrawal symptoms during the second 7-day placebo treatment period. Daytime drowsiness was reported in three patients receiving 20 mg/day zolpidem and in one receiving 10 mg/day zolpidem, but there was no significant increase in daytime drowsiness between days 0 and 21. Ataxia occurred in two, one and one patient, respectively, treated with 20 mg/day zolpidem, 10 mg/day zolpidem and placebo. The incidences of other adverse events or effects on clinical and laboratory parameters were minimal and similar in all three treatment groups. It is concluded that, in elderly psychiatric patients, 10 mg/day zolpidem can be used to treat insomnia and can be safely added to concomitant psychotropic treatment without inducing daytime drowsiness. L'efficacité et la tolérabilité du zolpidem, hypnotique de la classe des imidazopyridines ont été étudiées chez 119 patients âgés hospitalisés souffrant de troubles psychiatriques et se plaignant d'insomnie dans une étude en double aveugle à groupes parallèles, contrôlée par placebo. Après une période de washout par placebo de 7 jours, les patients ont été randomisés de manière à recevoir d'abord 10 ou 20 mg par jour de zolpidem ou du placebo pendant 21 jours; puis tous les patients recevèrent du placebo pendant 7 jours. Le sommeil a pu être évalué par l'observation des patients aux jours 0, 1, 7,14, 21, 22 et 28. Comparé au placebo, le zolpidem à la dose de 20 mg par jour a significativement augmenté la durée totale du sommeil entre le 1er et le 21ème jour, et cet effet était toujours présent au 28ème jour. Après 10 ou 20 mg par jour de zolpidem, on a également relevé une tendance à l'amélioration de tous les autres paramètres du sommeil, qui étaient toujours au-dessus de leurs valeurs de base au 28ème jour. Le zolpidem a été bien toléré et on n'a pas observé de syndrome de manque sevrage lors de la seconde période de traitement de 7 jours par placebo. Une somnolence diurne a été observée chez trois patients recevant 20 mg par jour de zolpidem, et chez un patient recevant 10 mg par jour, mais il n'y pas eu d'augmentation significante de la somnolence diurne entre jour 0 et jour 28. Une ataxie est apparue chez duex patients traité par 20 mg par jour de zolpidem, un patient traiteá par 10 mg par jour de zolpidem, et un patient traité par placebo. Les incidences des autres effets secondaires ou l'action sur les paramètres cliniques ou biologiques s'est révélée minime et similaire pour les trois groupes de patients. L'étude a conclu que, chez les patients âgés souffrant de troubles psychiatriques, un traitement par 10 mg par jour de zolpidem pouvait être utilisé pour traiter l'insomnie et peut être adjoint en toute sécurité à un traitement psychotrope concomitant sans induire de somnolence diurne.

scholarly journals Double-blind, placebo-controlled trial of mifepristone on cognition and depression in alcohol dependence

Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Kim Donoghue ◽  
Abigail Rose ◽  
Simon Coulton ◽  
Rachel Coleman ◽  
Joanna Milward ◽  
...  
Keyword(s):  
Alcohol Dependence ◽  
Cognitive Deficits ◽  
Controlled Trial ◽  
Neuropsychological Test ◽  
Placebo Treatment ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
Symptoms Of Depression ◽  
To Receive ◽  
Alcohol Dependent

Abstract Background Alcohol dependence is a significant issue contributing to disease burden. Changes in cortisol concentrations during alcohol withdrawal are associated with cognitive deficits and symptoms of depression. Current treatments are only successful for a small proportion of people and do not target cognitive deficits and symptoms of depression experienced by those who are alcohol dependent. The aim of this research is to determine the potential efficacy of mifepristone, a type II glucocorticoid receptor antagonist, to prevent symptoms of depression and cognitive deficits following alcohol detoxification. Methods This was a phase 2 therapeutic use trial. It was a double-blind randomised controlled clinical trial of mifepristone versus inactive placebo treatment. The trial aimed to recruit 120 participants who met the inclusion criteria: (1) male, (2) aged 18–60 years inclusive, and (3) alcohol dependent for 5 or more years. Participants were randomised to 600 mg a day mifepristone (200 mg morning, afternoon, and evening) for 7 days and 400 mg for the subsequent 7 days (200 mg morning and evening) or the equivalent number of placebo tablets for 14 days. Primary outcome measures were cognitive function (measured using the Cambridge Neuropsychological Test Automated Battery (CANTAB)) and symptoms of depression (measured using the Beck Depression Inventory (BDI)) at 4 weeks post-randomisation. Results Difficulties recruiting participants due to significant changes in the provision of inpatient care for alcohol dependence resulted in only 27 participants recruited to the trial, with data available for 21 participants. Fourteen participants were randomised to receive mifepristone and 13 to receive placebo. Conclusion Larger trials would be needed to draw conclusions about the efficacy of mifepristone. Trial registration ISRCTN registry ISRCTN54001953. Registered on 29 September 2011.

scholarly journals Evaluation on immediate analgesic efficacy and safety of Kai-Hou-Jian spray (children’s type) in treating sore throat caused by acute pharyngitis and tonsillitis in children: study protocol for a randomized controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Yan-ning Ma ◽  
Cheng-liang Zhong ◽  
Si-yuan Hu ◽  
Qiu-han Cai ◽  
Sheng-xuan Guo
Keyword(s):  
Clinical Trial ◽  
Sore Throat ◽  
Controlled Trial ◽  
Analgesic Efficacy ◽  
Effective Rate ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Acute Pharyngitis ◽  
Randomized Controlled ◽  
Parallel Group

Abstract Background Acute pharyngitis and tonsillitis are common respiratory diseases for which children seek medical care. Their main clinical manifestation is sore throat which interferes with patients’ quality of life. However, there is no proven effective or safe method to treat it. It is necessary to find an excellent strategy to reduce sore throat and reduce the burden of acute illness. We designed the randomized controlled trial with the characteristics of traditional Chinese medicine (TCM) to determine the clinical positioning of Kai-Hou-Jian spray (children’s type) (KHJS) through evidence-based research. This trial aims to evaluate the immediate analgesic efficacy of KHJS on sore throat caused by acute pharyngitis and tonsillitis (wind-heat syndrome/heat exuberance in lung and stomach syndrome) in children and to observe its safety. Methods/design This is a prospective, multicenter, randomized, double-blind, parallel-group, placebo-controlled trial. It will include 240 children with acute pharyngitis/tonsillitis from 7 study sites across China. All participants are randomly assigned to two parallel treatment groups, one with KHJS and the other with placebo sprays, for 5 consecutive days. The primary outcome is the time of analgesic onset. Secondary outcomes include duration of analgesic effect, area under time curve of 0–3 h Wong-Baker FACES Pain Rating Scale (WBS) score (AUC0-3 h), rate of analgesic onset, rate of disappearance of sore throat, changes of WBS score (in days), effective rate of pharyngeal signs, and effective rate of TCM syndrome. The incidence of adverse events during the trial is the primary safety outcome. In addition, vital signs and laboratory tests before and after medication are monitored. Discussion To our knowledge, this will be the first clinical trial to explore the immediate analgesic efficacy of a Chinese patent medicine spray for acute pharyngitis/tonsillitis induced sore throat in children in a multicenter, randomized, double-blinded, parallel-group, placebo-controlled manner. Not only might it prove the efficacy and safety of KHJS in the treatment of sore throat caused by acute pharyngitis/tonsillitis in children, but it might also provide evidence for the treatment of acute sore throat with Chinese herbal medicine. Trial registration A multicenter, randomized, double-blind, very low-dose, parallel controlled trial for the immediate analgesic effect and safety of Kai-Hou- Jian spray (children's type) in the treatment of sore throat caused by acute pharyngitis and tonsillitis in children. Chinese Clinical Trial Registry ChiCTR2000031599. Registered on 5 April 2020

scholarly journals Standard induction with basiliximab versus no induction in low immunological risk kidney transplant recipients: study protocol for a randomized controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Aziza Ajlan ◽  
Hassan Aleid ◽  
Tariq Zulfiquar Ali ◽  
Hala Joharji ◽  
Khalid Almeshari ◽  
...  
Keyword(s):  
Kidney Transplant ◽  
De Novo ◽  
Controlled Trial ◽  
Controlled Clinical Trial ◽  
First Year ◽  
Transplant Recipients ◽  
Kidney Transplant Recipients ◽  
Double Blind ◽  
Donor Specific Antibodies

Abstract Background Induction therapy with IL-2 receptor antagonist (IL2-RA) is recommended as a first-line agent in low immunological risk kidney transplant recipients. However, the role of IL2-RA in the setting of tacrolimus-based immunosuppression has not been fully investigated. Aims To compare different induction therapeutic strategies with 2 doses of basiliximab vs. no induction in low immunologic risk kidney transplant recipients as per KFSHRC protocol. Methods Prospective, randomized, double blind, non-inferiority, controlled clinical trial Expected outcomes 1. Primary outcomes: Biopsy-proven acute rejection within first year following transplant 2. Secondary outcomes: a. Patient and graft survival at 1 year b. eGFR at 6 months and at 12 months c. Emergence of de novo donor-specific antibodies (DSAs) Trial registration The study has been prospectively registered at clinicaltrials.gov (NTC: 04404127). Registered on 27 May 2020.

Clinical and attentional effects of acute nicotine treatment in Tourette’s syndrome

2004 ◽  
Vol 19 (2) ◽  
pp. 102-112 ◽  
Author(s):  
Anne L. Howson ◽  
Sue Batth ◽  
Vadim Ilivitsky ◽  
Armand Boisjoli ◽  
Martine Jaworski ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Event Related Potentials ◽  
Placebo Treatment ◽  
Tourette's Syndrome ◽  
Tourette’S Syndrome ◽  
Continuous Performance Task ◽  
Open Label ◽  
Double Blind ◽  
Nicotine Treatment ◽  
Related Potentials

AbstractEvidence from pre-clinical infrahuman investigations, open-label clinical trials, and a single controlled trial found acute nicotine treatment potentiated up to 4 weeks neuroleptic-induced reductions of dyskinetic symptoms characterizing Tourette’s syndrome (TS). Given the attentional disturbances associated with this syndrome, and the improvements in attentional processes reported with nicotine, this randomized, double-blind, placebo-controlled trial examined the acute (4 h) and sustained (2 weeks) effects of a single dose of transdermal nicotine on clinical (i.e., tics), attentional (continuous performance task, event-related potentials, patient and parental reports) and behavioral symptoms in 23 children and adolescents with TS receiving neuroleptic treatment. In the 14 evaluable patients with complete primary efficacy data, nicotine (compared to placebo) failed to alter symptoms at 4 h but counteracted ERP-P300 signs of diminished attention seen 2 weeks following placebo treatment. Secondary efficacy measures, including patient self-reports and parental ratings, found nicotine to reduce complex tics and improve behaviors related to inattention. Additional work with intermittent dosing schedules is required to characterize optimal clinical and cognitive effects with nicotine treatment.

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