A randomized, double-blind, placebo-controlled trial for prevention of oxaliplatin-induced neuropathy symptoms with pregabalin.

2011 ◽  
Vol 29 (4_suppl) ◽  
pp. 553-553
Author(s):  
M. Karthaus ◽  
C. S. Karapetis ◽  
M. Brown ◽  
N. Pavlakis ◽  
T. Trarbach ◽  
...  
Keyword(s):  
Neuropathic Pain ◽  
Interim Analysis ◽  
Controlled Trial ◽  
Unmet Need ◽  
Persistent Pain ◽  
Controlled Study ◽  
Double Blind ◽  
Treatment Groups ◽  
Persistent Symptoms

553 Background: Sensorial peripheral neuropathy (PNP) is a major limitation for pts receiving oxaliplatin-based ctx for CRC. Pregabalin is widely used for treatment of oxaliplatin-induced PNP. We evaluated the efficacy of pregabalin vs. placebo for the prevention of paresthesia from the onset of oxaliplatin-based ctx over each cycle. Methods: Rd, db, placebo-controlled study in adult CRC pts with ECOG 0-2 to undergo a new oxaliplatin/5-FU/FA-based ctx. Pts were excluded if they had neuropathic pain or other of painful paresthesia prior to baseline. Paresthesia, dysesthesia, and pain were rated on a numerical scale (NRS 0-10) every day. Primary endpoint was the time of onset of persistent symptoms (NRS >4). Results: Of the 69 screened pts, 64 were randomized and 61 received study medication (32 pregabalin vs. 29 placebo). Pts were balanced in both arms regarding age, sex, stage, and ctx. There were no differences between both treatment groups for all PNP parameters at any cycle. One pt in both arms developed paresthesia (5.3%) after 9 cycles of ctx, 1 pt had persistent pain (placebo arm). During the follow-up period persistent paresthesic, dysesthesic, and persistent pain developed in 2 vs. 1, 2 vs. 2, and 0 vs. 2 pts, respectively. The study was terminated after a blinded data review found that there were very few events of persistent symptoms, which was then confirmed an interim analysis. Nausea and anorexia were the most frequently reported AE in both groups. Conclusions: The results of this study, which was terminated early at interim analysis, is that too few patients developed persistent symptoms to allow any meaningful treatment difference for prevention of neuropathic pain related to oxaliplatin by pregabalin. There remains an unmet need for oxaliplatin-induced PNP with new trial design issues in this field urgently needed. No significant financial relationships to disclose.

scholarly journals One Year Follow-up of a Randomized, Double-Blind, Placebo-Controlled Trial of Percutaneous Peripheral Nerve Stimulation for Chronic Neuropathic Pain Following Amputation

Neurosurgery ◽  
2019 ◽  
Vol 66 (Supplement_1) ◽  
Author(s):  
Joshua M Rosenow ◽  
Christopher Gilmore ◽  
Brian M Ilfeld ◽  
Sean Li ◽  
Mehul J Desai ◽  
...  
Keyword(s):  
Neuropathic Pain ◽  
Pain Relief ◽  
Peripheral Nerve ◽  
Nerve Stimulation ◽  
Peripheral Nerve Stimulation ◽  
Pain Interference ◽  
Controlled Study ◽  
Double Blind ◽  
Double Blind Placebo

Abstract INTRODUCTION Over 85% of patients experience residual limb (RLP) and/or phantom limb (PLP) pain following amputation. Peripheral nerve stimulation (PNS) is a non-opioid approach to relieve postamputation neuropathic pain. A recent multicenter, randomized, double-blind, placebo-controlled study using a novel percutaneous PNS system demonstrated clinically and statistically significant improvements in pain and pain interference with PNS compared to placebo (Gilmore et al, 2019). This work presents prospective 1-yr follow-up to assess durability of pain relief and functional improvements. METHODS Over 85% of patients experience residual limb (RLP) and/or phantom limb (PLP) pain following amputation. Peripheral nerve stimulation (PNS) is a non-opioid approach to relieve post-amputation neuropathic pain. A recent multicenter, randomized, double-blind, placebo-controlled study using a novel percutaneous PNS system demonstrated clinically and statistically significant improvements in pain and pain interference with PNS compared to placebo (Gilmore et al, 2019). This work presents prospective one-year follow-up to assess durability of pain relief and functional improvements. RESULTS A significantly greater proportion of subjects who completed the 12-mo visit reported = 50% pain relief on the BPI-SF (5/8, 63%; average pain relief = 73% among responders) compared to the placebo group at the time of crossover (0/14, 0%, P = .003; average pain relief = 23%). A majority of subjects also reported = 50% reductions in pain interference at 12 mo (5/8, 63%). Two of 13 (15%) subjects in the placebo group reported sustained improvements in pain interference (P = .06). Average reduction in pain interference among responders in the PNS group was 87%. CONCLUSION This work suggests that PNS delivered over 60 d may provide clinically significant and enduring pain relief, enabling improved function and potentially reducing the need for a permanently implanted system.

Randomized, Controlled Trial of Transdermal Clonidine for Smoking Cessation

1993 ◽  
Vol 27 (9) ◽  
pp. 1025-1028 ◽  
Author(s):  
Daniel E. Hilleman ◽  
Syed M. Mohiuddin ◽  
Michael G. Delcore ◽  
B. Daniel Lucas
Keyword(s):  
Smoking Cessation ◽  
Behavior Modification ◽  
Potential Role ◽  
Controlled Trial ◽  
Care Facility ◽  
Double Blind ◽  
Cancer Society ◽  
Treatment Groups ◽  
Women Smokers

OBJECTIVE: To determine the efficacy and safety of clonidine versus placebo in smoking cessation. DESIGN: Single-center, randomized, double-blind, parallel-design comparison of transdermal clonidine with behavior modification, transdermal clonidine without behavior modification, placebo with behavior modification, and placebo without behavior modification. SETTING: Outpatient, university-based ambulatory care facility. PATIENTS: One hundred fifty generally healthy, highly nicotine-dependent cigarette smokers. INTERVENTION: Clonidine was given as the transdermal patch initiated 72 hours prior to smoking-cessation attempts and continued for six weeks thereafter. Clonidine was given at a dose of 0.2 mg/d for patients weighing more than 150 pounds (>67.5 kg) and at a dose of 0.1 mg/d for patients weighing less than 150 pounds (<67.5 kg). Behavior modification consisted of a total of 12 one-hour structured group training sessions. Patients not receiving behavior modification received printed material, which included the “Help Quit Kit” and the “I Quit Kit” from the American Cancer Society. MAIN OUTCOME MEASURES: Smoking-cessation rates were assessed at 6, 12, 24, and 52 weeks of follow-up. In addition, adverse reactions to clonidine or placebo were evaluated. RESULTS: Clonidine with behavior modification was statistically superior to the other three treatment groups but only at 6 weeks of follow-up. There were no differences in smoking-cessation rates among any of the treatment groups at any other follow-up intervals. Patients receiving behavior modification, regardless of whether they received clonidine, had better quit rates than patients not receiving behavior modification at all follow-up times except 52 weeks. Women receiving clonidine had significantly better quit rates than men receiving clonidine at all follow-up visits. Clonidine was associated with a significantly higher incidence of adverse effects than placebo (52 vs. 11 percent). However, the number of smokers withdrawing from the study was not greater with clonidine compared with placebo (9 vs. 7 percent, respectively). CONCLUSIONS: Clonidine is probably not effective as a pharmacologic adjunct to behavior modification in smoking cessation. It may have a potential role in women smokers who do-not respond to or cannot tolerate more traditional smoking-cessation therapies.

Abstract P090: The Effect of Bupropion on Symptoms of Depression Among Patients Attempting to Quit Smoking Post-Myocardial Infarction: The ZESCA Trial

Circulation ◽  
2012 ◽  
Vol 125 (suppl_10) ◽  
Author(s):  
Kristian B Filion ◽  
Sonia M Grandi ◽  
Lawrence Joseph ◽  
Jennifer O'Loughlin ◽  
Gilles Paradis ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Smoking Cessation ◽  
Depressive Symptomatology ◽  
Controlled Trial ◽  
Double Blind ◽  
Treatment Groups ◽  
Symptoms Of Depression ◽  
Quit Smoking ◽  
The Mean

Background: Bupropion is a smoking cessation drug that can be prescribed immediately following a myocardial infarction (MI). Depression is prevalent during this period, and bupropion, which can also be prescribed as an anti-depressant, may improve symptoms of depression in this population. Methods: The ZESCA Trial is a randomized, double-blind, placebo-controlled trial that examined the efficacy of bupropion as a smoking cessation therapy in 392 hospitalized MI patients. Treatment duration was 9 weeks, and follow-up was 12 months. Depressive symptomatology was defined by a Beck Depression Inventory-II (BDI-II) score > 14. A total of 4 patients were missing baseline BDI-II scores and were excluded from this analysis. Differences in changes in depressive symptomatology from baseline were examined overall and in those with symptoms of depression at baseline. Results: The mean age was 53.9 years (standard deviation [SD] = 10.3), and 84% were male. A total of 20% of patients had depressive symptomatology at baseline. The median BDI-II score was 6.0 (inter-quartile range [IQR] = 2.0, 12.0) overall and 19.0 (16.0, 25.0) among those with depressive symptomatology at baseline. The mean BDI-II score was similar between treatment groups throughout the follow-up period (Figure). Similarly, there were no differences in BDI-II score between treatment groups at baseline or 9 weeks when restricted to those with depressive symptomatology at baseline. In this group, patients randomized to bupropion had a higher BDI-II score at 12 months (bupropion - placebo = 5.98, 95% confidence interval = 0.92, 11.04); the difference is likely due to differential participation at 12 months. At all follow-up visits, there were no differences in change in BDI-II score between treatment groups, both in the overall study population and in those with depressive symptomatology at baseline. Conclusions: Our results suggest that bupropion does not improve symptoms of depression in patients who are attempting to quit smoking post-MI.

scholarly journals A randomized, double-blind, placebo-controlled study to assess the effect of an aqueous extract of Triticum aestivum on canine outer ear inflammation

2017 ◽  
Vol 37 (11) ◽  
pp. 1270-1274 ◽  
Author(s):  
Ciciane P.M. Fernandes ◽  
Alana Hijano ◽  
Charles S. Lima ◽  
Eduardo G. Fontoura ◽  
Renata C. Schramm ◽  
...  
Keyword(s):  
Aqueous Extract ◽  
Bacterial Infections ◽  
Elevated Temperatures ◽  
Controlled Trial ◽  
External Otitis ◽  
Controlled Study ◽  
Double Blind ◽  
Fungal Isolation ◽  
Double Blind Placebo ◽  
Treatment Groups

ABSTRACT: Outer ear otitis is a multifactorial acute or chronic inflammation of the ear canal, and treatment is often hampered by growing antibiotic resistance. Pre-clinical assessments have shown that an aqueous extract of Triticum aestiveum (wheat) can effectively reduce the symptoms associated with the disease. The purpose of this study was to assess, through a randomized, double-blind, placebo-controlled trial, the use of T. aestivum extract on canine external otitis. Thirty dogs (60 ears) met the criteria to be included in this study, and were randomly assigned a treatment group: placebo, extract, or positive control (C+). Ears were treated every day for seven days, and assessed before treatment (day zero), after treatment (day 7), and again on reassessment (day 14). Clinical assessment included: type of otitis; pinna conformation; presence or absence of itchiness, foul odor, and pain; presence of stenosis, erythema and cerumen. Furthermore, the evaluators assessed the temperature in each ear and the pH of the cerumen, and swabs were collected for bacterial and fungal isolation. All veterinarians treating and assessing the animals were blinded regarding the treatment groups. Results showed little difference in the treatment groups regarding clinical parameters. By day 7 ears treated with the C+ had elevated temperatures, when compared to the others (P<0.05), this was still true on day 14. Bacterial isolation had completely died out by day 7, however, on day fourteen the placebo group had six ears with bacterial infections, unlike the other two groups (P<0.05). The results generated herein show that a 25% wheat extract solution is effective in the reduction of clinical and microbiological parameters of external otitis, with better results when compared to a placebo, and similar results to the traditional, antibiotic/anti-inflammatory treatment.

Double-blind placebo-controlled trial of etanercept in the prevention of work disability in ankylosing spondylitis: Table 1

2010 ◽  
Vol 69 (11) ◽  
pp. 1926-1928 ◽  
Author(s):  
Nick Barkham ◽  
Laura C Coates ◽  
Helen Keen ◽  
Elizabeth Hensor ◽  
Alexander Fraser ◽  
...  
Keyword(s):  
Placebo Group ◽  
Ankylosing Spondylitis ◽  
Clinical Outcomes ◽  
Job Loss ◽  
Controlled Trial ◽  
Controlled Study ◽  
Double Blind ◽  
Treatment Groups ◽  
Gait Parameters ◽  
Significant Difference

ObjectivesEtanercept has been shown to be rapidly effective in suppressing disease activity in ankylosing spondylitis (AS). The aim of this study was to determine whether etanercept improves work instability as measured by the Ankylosing Spondylitis Work Instability Scale (AS-WIS).MethodForty patients with active AS who were in work but were work unstable were recruited. Patients were randomised to receive 25 mg etanercept or placebo twice weekly for 12 weeks. The primary outcome was change in AS-WIS at week 12. The AS-WIS is a patient-derived outcome measure which allows stratification of the risk of job loss. Secondary outcomes included clinical outcomes and gait parameters.ResultsThe mean improvement in AS-WIS score at week 12 was 2.75 in the etanercept group and 0.68 in the placebo group (p=0.125). The risk of job loss decreased for 11 (55%) of the etanercept group compared with 7 (35%) in the placebo group. Conversely, the risk of job loss increased in 3 (15%) of the placebo group compared with 1 (5%) in the etanercept group. There was no statistically significant difference between treatment groups in change in WIS categories (Mann–Whitney U test=0.153, p=0.160). Significant improvement with etanercept was seen at week 12 in clinical outcomes and gait parameters. Etanercept was well tolerated, with no dropouts due to adverse events.ConclusionThis small study confirms the efficacy of etanercept on clinical outcome measures in patients with AS and suggests an effect on work instability which needs to be replicated in a larger controlled study.

scholarly journals Study protocol of the global Effisayil 1 Phase II, multicentre, randomised, double-blind, placebo-controlled trial of spesolimab in patients with generalized pustular psoriasis presenting with an acute flare

BMJ Open ◽  
2021 ◽  
Vol 11 (3) ◽  
pp. e043666
Author(s):  
Siew Eng Choon ◽  
Mark G Lebwohl ◽  
Slaheddine Marrakchi ◽  
A David Burden ◽  
Tsen-Fang Tsai ◽  
...  
Keyword(s):  
Phase Ii ◽  
Controlled Trial ◽  
Unmet Need ◽  
Intravenous Dose ◽  
Pustular Psoriasis ◽  
Controlled Study ◽  
Supplementary File ◽  
Physician Global Assessment ◽  
Double Blind ◽  
Generalized Pustular Psoriasis

IntroductionGeneralized pustular psoriasis (GPP) is a rare, potentially life-threatening disease characterised by recurrent flares of widespread neutrophilic aseptic skin pustular eruption. Despite the availability of approved biologics for GPP in Japan, Taiwan and Thailand, associated evidence is largely based on uncontrolled studies in which acute flares were not directly assessed. Therefore, there is a high unmet need to investigate new rapid-acting effective treatments that resolve symptoms associated with acute GPP flares. A prior Phase I proof-of-concept study showed rapid improvements in skin and pustule clearance with a single intravenous dose of spesolimab, a novel anti-interleukin-36 receptor antibody, in patients presenting with an acute GPP flare. Here, we present the design and rationale of Effisayil 1, a global, Phase II, placebo-controlled study to evaluate the efficacy, safety and tolerability of spesolimab in patients presenting with an acute GPP flare.Methods and analysisAt least 51 patients with an acute GPP flare will be randomised 2:1 to receive a single 900 mg intravenous dose of spesolimab or placebo and followed for up to 28 weeks. The primary endpoint is a Generalized Pustular Psoriasis Physician Global Assessment (GPPGA) pustulation subscore of 0 (pustule clearance) at Week 1. The key secondary endpoint is a GPPGA score of 0 or 1 (clear or almost clear) at Week 1. Safety will be assessed over the study duration by the occurrence of treatment-emergent adverse events. Blood and skin biopsies will be collected to assess biomarkers. Superiority of spesolimab over placebo in the proportion of patients achieving the primary and key secondary endpoints will be evaluated.Ethics and disseminationThe study complies with the ethical principles of the Declaration of Helsinki, the International Council for Harmonisation’s Good Clinical Practice and local regulations. Ethics committee approvals have been obtained for each centre from all participating countries and are listed in online supplementary file 1. Primary results will be published in a peer-reviewed journal.Trial registration detailsClinicalTrials.gov identifier: NCT03782792; Pre-results.

Placebo-Controlled Trial of Intravaginal Clindamycin 2% Cream for the Treatment of Bacterial Vaginosis

1993 ◽  
Vol 27 (11) ◽  
pp. 1343-1345 ◽  
Author(s):  
Gary E. Stein ◽  
Sharon L. Christensen ◽  
Nancy L. Mummaw ◽  
David E. Soper
Keyword(s):  
Bacterial Vaginosis ◽  
Clinical Success ◽  
Controlled Trial ◽  
Signs And Symptoms ◽  
Controlled Clinical Trial ◽  
Success Rates ◽  
Double Blind ◽  
Treatment Groups ◽  
Vaginal Cream

OBJECTIVE: To compare the safety and efficacy of intravaginal clindamycin 2% cream with placebo in nonpregnant women with bacterial vaginosis. DESIGN: A randomized, double-blind, placebo-controlled clinical trial. SETTING: Ambulatory patients in the general community. PATIENTS: Two hundred fifteen nonpregnant outpatients with a diagnosis of bacterial vaginosis were entered into this study. Of the 134 evaluable patients, 65 received clindamycin and 69 placebo. Demographic parameters were comparable between the two treatment groups. INTERVENTION: Study subjects were equally randomized to receive either 5 g of clindamycin 2% vaginal cream or placebo cream for seven nights. MAIN OUTCOME MEASURES: Clinical and microbiologic follow-up evaluations were scheduled for 5–10 days and 25–39 days posttreatment. Patients were interviewed about signs and symptoms, adverse events, and compliance. Diagnostic examinations were performed. RESULTS: Clinical success rates (cure and improvement) occurred in 50 of 65 patients who received clindamycin (77 percent) and 17 of 69 patients who received placebo (25 percent) by the first posttreatment visit (p<0.001). Microbiologic cures or improvement were observed in 59 of the 65 patients treated with clindamycin (91 percent) compared with 20 of 69 placebo-treated patients (29 percent) (p<0.001). At the end of the study, clinical and microbiologic cures or improvement were evident in 45 of 57 (79 percent) and 37 of 57 clindamycin-treated patients (65 percent), respectively, and 18 of 51 (35 percent) and 14 of 51 (28 percent) of the placebo-treated patients, respectively. The success rates with clindamycin 2% cream were statistically higher than those with placebo. The adverse-effect profiles in the two groups were similar and no serious adverse effects were reported. Patients who received clindamycin had a statistically higher incidence of nonbacterial vaginitis/cervicitis (18.5 vs. 7.5 percent, p=0.003). CONCLUSIONS: Intravaginal clindamycin 2% cream appears to be an effective and safe treatment of symptomatic bacterial vaginosis in nonpregnant women.

scholarly journals Emergence and Persistence of Macrolide Resistance in Oropharyngeal Flora and Elimination of Nasal Carriage of Staphylococcus aureus after Therapy with Slow-Release Clarithromycin: a Randomized, Double-Blind, Placebo-Controlled Study

2004 ◽  
Vol 48 (11) ◽  
pp. 4183-4188 ◽  
Author(s):  
Hans F. Berg ◽  
Jeroen H. T. Tjhie ◽  
Gert-Jan Scheffer ◽  
Marcel F. Peeters ◽  
Peter H. J. van Keulen ◽  
...  
Keyword(s):  
Staphylococcus Aureus ◽  
Pathogenic Bacteria ◽  
Slow Release ◽  
Controlled Trial ◽  
Nasal Carriage ◽  
Controlled Study ◽  
Double Blind ◽  
Treatment Groups ◽  
Development Of Resistance ◽  
Oropharyngeal Flora

ABSTRACT To investigate the effect of slow-release (SR) clarithromycin on colonization and the development of resistance in oropharyngeal and nasal flora, a double-blind, randomized, placebo-controlled trial was performed with 8 weeks of follow-up. A total of 296 patients with documented coronary artery disease were randomized in the preoperative outpatient clinic to receive a daily dose of SR clarithromycin (500 mg) (CL group) or placebo tablets (PB group) until the day of surgery. Nose and throat swabs were taken before the start of therapy, directly after the end of therapy, and 8 weeks later. The presence of potential pathogenic bacteria was determined, and if they were isolated, MIC testing was performed. Quantitative culture on media with and without macrolides was performed for the indigenous oropharyngeal flora. In addition, analysis of the mechanism of resistance was performed with the macrolide-resistant indigenous flora. Basic patient characteristics were comparable in the two treatment groups. The average number of tablets taken was 15 (standard deviation = 6.4). From the throat swabs, Haemophilus parainfluenzae was isolated and carriage was not affected in either of the treatment groups. Nasal carriage of Staphylococcus aureus, however, was significantly reduced in the CL group (from 35.3 to 4.3%) compared to the PB group (from 32.4 to 30.3%) (P < 0.0001; relative risk [RR], 7.0; 95% confidence interval [CI], 3.1 to 16.0). Resistance to clarithromycin was present significantly more frequently in H. parainfluenzae in the CL group after treatment (P = 0.007; RR, 1.6; 95% CI, 1.1 to 2.3); also, the percentage of patients with resistance to macrolides in the indigenous flora after treatment was significantly higher in the CL group (31 to 69%) (P < 0.0001; RR, 1.9; 95% CI, 1.4 to 2.5). This persisted for at least 8 weeks. This study shows that besides the effective elimination of nasal carriage of S. aureus, treatment with SR clarithromycin for approximately 2 weeks has a marked and sustained effect on the development of resistance in the oropharyngeal flora for at least 8 weeks.

scholarly journals Efficacy of Chuanxiong Ding Tong Herbal Formula Granule in the Treatment and Prophylactic of Migraine Patients: A Randomized, Double-Blind, Multicenter, Placebo-Controlled Trial

2012 ◽  
Vol 2012 ◽  
pp. 1-9 ◽  
Author(s):  
Caihong Fu ◽  
Lihua Yu ◽  
Yihuai Zou ◽  
Kegang Cao ◽  
Jianjun Zhao ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Blood Stasis ◽  
Controlled Study ◽  
Herbal Formula ◽  
Double Blind ◽  
Chinese Herbal ◽  
Significant Difference ◽  
Vas Scores ◽  
To Receive

Objective.To evaluate the efficacy of traditional Chinese herbal ChuanXiong Ding Tong herbal formula granule (CXDT-HFG) for migraine patients with “the Syndrome of Liver Wind and Blood Stasis.”Methods.150 migraine patients were recruited and assigned randomly in a double-blind, placebo-controlled study to receive CXDT-HFG (n=99) plus necessary analgesics, or placebo (n=51) plus necessary analgesics for 16 weeks (12 weeks’ intervention and 4 weeks’ follow up). Outcome measures included migraine days, frequency of migraine attacks, analgesics consumption for acute treatment, and the proportion of responders as well as the visual analogue scale (VAS) scores and intensity for pain.Results.Compared with the placebo group, the CXDT-HFG group showed significant reduction in migraine days and attacks frequency at week 12 and follow-up period (P<0.05) as well as in the reduction of VAS scores at follow-up period.There was significant difference in the proportion of responders between the two groups at follow-up period (P=0.014). However there were no significant differences between the two groups in analgesics consumption (P>0.05). Conclusion.CXDT-HFG was more effective than placebo in decreasing days of migraine attacks, frequency, VAS scores, and relieving pain intensity for migraine patients.

Sign in / Sign up

Export Citation Format

Share Document