Salsalate in the Treatment of Rheumatoid Árthritis: A Double-Blind Clinical and Gastroscopic Trial versus Piroxicam. I – Clinical Trial

1989 ◽  
Vol 17 (4) ◽  
pp. 316-319 ◽  
Author(s):  
F. Montrone ◽  
I. Caruso ◽  
M. Cazzola ◽  
G. Bianchi Porro
Keyword(s):  
Rheumatoid Arthritis ◽  
Clinical Trial ◽  
Treatment Period ◽  
Controlled Study ◽  
Evening Meal ◽  
Double Blind ◽  
Treatment Groups ◽  
End Of Treatment ◽  
The Difference ◽  
Equal Efficacy

A double-blind, double-dummy controlled study to compare the clinical efficacy and gastric tolerability of salsalate and piroxicam in the treatment of rheumatoid arthritis was performed. Twenty-three patients were treated with 1.5 g salsalate twice daily and 20 with 20 mg piroxicam (taken after the evening meal) for a period of 4 weeks. Patients were submitted to gastroscopy at the start and end of treatment; only patients who presented a normal baseline gastroscopy were admitted to the trial. At the end of the planned treatment period, a statistically significant improvement of all clinical variables was observed in both treatment groups, the difference between the two drugs not being statistically significant. Seven (37%) patients treated with salsalate complained of tinnitus. The results show that salsalate and piroxicam have equal efficacy in relieving the symptoms of arthritis.

Salsalate in the Treatment of Rheumatoid Arthritis: A Double-Blind Clinical and Gastroscopic Trial versus Piroxicam. II – Endoscopic Evaluation

1989 ◽  
Vol 17 (4) ◽  
pp. 320-323 ◽  
Author(s):  
G. Bianchi Porro ◽  
M. Petrillo ◽  
S. Ardizzone
Keyword(s):  
Rheumatoid Arthritis ◽  
Controlled Study ◽  
Gastric Lesions ◽  
Endoscopic Evaluation ◽  
Double Blind ◽  
Treatment Groups ◽  
End Of Treatment ◽  
Dyspeptic Symptoms ◽  
The Difference ◽  
Equal Efficacy

A double-blind, double-dummy controlled study to compare the clinical efficacy and gastric tolerability of salsalate and piroxicam in the treatment of rheumatoid arthritis was performed. A total of 23 patients were treated with 1.5 g salsalate twice daily and 20 with 20 mg piroxicam (after the evening meal) for 4 weeks. Patients were submitted to gastroscopy at the start and end of treatment; only patients who presented a normal baseline gastroscopy were admitted to the trial. At the end of the planned treatment period, a statistically significant improvement of all clinical variables was observed in both treatment groups, the difference between the two drugs not being statistically significant. Five of 20 (25%) piroxicam treated patients and only 2/19 (11%) salsalate treated patients showed gastric lesions at final endoscopy. No relationship was found between dyspeptic symptoms and endoscopic lesions. The results show that salsalate and piroxicam have equal efficacy in relieving arthritic symptoms, but salsalate causes fewer gastric lesions.

scholarly journals Male Hormonal Contraception: A Double-Blind, Placebo-Controlled Study

2008 ◽  
Vol 93 (7) ◽  
pp. 2572-2580 ◽  
Author(s):  
Ellen Mommers ◽  
Wendy M. Kersemaekers ◽  
Jörg Elliesen ◽  
Marc Kepers ◽  
Dan Apter ◽  
...  
Keyword(s):  
Treatment Period ◽  
Active Treatment ◽  
Hormonal Contraception ◽  
Sperm Concentration ◽  
Controlled Study ◽  
Double Blind ◽  
Testosterone Undecanoate ◽  
Treatment Groups ◽  
High Release ◽  
Mode Of Application

Abstract Background: This study was performed to assess spermatogenesis suppression and safety of a new combination of an etonogestrel (ENG) implant combined with testosterone undecanoate (TU) injections for male contraception. This is the first large placebo-controlled study for male hormonal contraception. Design and Study Subjects: In this double-blind, multicenter study, we randomly assigned 354 healthy men to receive either a low- or high-release ENG implant sc combined with im TU injections (750 mg every 10 or 12 wk or 1000 mg every 12 wk) or placebo implant and injections. Treatment duration was 42 or 44 wk and posttreatment follow-up at least 24 wk. Results: Overall, spermatogenesis was suppressed to 1 million/ml or less at wk 16 in 89% of men, with approximately 94% in two high-release ENG groups. Suppression was maintained up to the end of the treatment period in 91% of men. For all men who completed the treatment period, 3% never achieved 1 million/ml or less. Median recovery time to a sperm concentration above 20 million/ml was 15 wk (mean 17 wk, 95% confidence interval 16–18 wk). Treatment was well tolerated. As compared with the placebo group, more men in the active treatment groups reported adverse events such as weight gain, mood changes, acne, sweating, or libido change. For both spermatogenesis suppression and safety, differences were small between the active treatment groups. Conclusions: The combination of an ENG implant with TU injections is a well-tolerated male hormonal method, providing effective and reversible suppression of spermatogenesis. Although the results are good, there is still room for improvement, possibly by adjusting the dose regimen or changing the mode of application.

scholarly journals Efficacy, safety and immunogenicity of GP2015, an etanercept biosimilar, compared with the reference etanercept in patients with moderate-to-severe rheumatoid arthritis: 24-week results from the comparative phase III, randomised, double-blind EQUIRA study

RMD Open ◽  
2018 ◽  
Vol 4 (2) ◽  
pp. e000757 ◽  
Author(s):  
Marco Matucci-Cerinic ◽  
Yannick Allanore ◽  
Arthur Kavanaugh ◽  
Maya H Buch ◽  
Hendrik Schulze-Koops ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Treatment Period ◽  
Similar Efficacy ◽  
Phase Iii ◽  
Inadequate Response ◽  
Double Blind ◽  
Reactive Protein ◽  
Period 2 ◽  
Equivalent Efficacy ◽  
The Difference

ObjectivesTo demonstrate the equivalent efficacy and compare the safety and immunogenicity of an etanercept biosimilar, GP2015, with reference etanercept (ETN) in patients with moderate-to-severe, active rheumatoid arthritis (RA), characterised by an inadequate response to synthetic or biologic disease-modifying antirheumatic drugs (DMARDs).MethodsIn the EQUIRA study, eligible patients (n=376) were randomised 1: 1 to 50  mg GP2015 or ETN subcutaneously, once weekly, for 24 weeks (treatment period 1). Patients from both groups, with at least moderate European League Against Rheumatism response at week 24, received GP2015 up to week 48 (treatment period 2). All patients continued to receive concomitant methotrexate at a stable dose (10–25  mg/week) until end of the study. The 24-week results are presented here.ResultsEquivalent efficacy between GP2015 and ETN was demonstrated if the 95% CI for the difference in disease activity score 28-joint count C reactive protein (DAS28-CRP) change from baseline to week 24 between treatment arms was contained within the prespecified equivalence margin range of −0.6 to 0.6. The least squares mean difference (GP2015–ETN) in change from baseline in DAS28-CRP up to week 24 was −0.07 (95% CI −0.26 to 0.12 [primary endpoint)]. The incidence of treatment-emergent adverse events was comparable between GP2015 (43.5%) and ETN (49.5%). None of the GP2015-treated patients developed neutralising anti-drug antibodies (NAbs) whereas 1.6% and 0.6% of patients in ETN group were NAb positive at weeks 4 and 12, respectively.ConclusionIn patients with RA who had an inadequate response to DMARDs, GP2015 demonstrated a similar efficacy and a comparable safety and immunogenicity profile with ETN.Trial registrationNCT02638259.

Double-blind evaluation of chemonucleolysis for herniated lumbar discs

1978 ◽  
Vol 49 (6) ◽  
pp. 816-827 ◽  
Author(s):  
Albert N. Martins ◽  
Archimedes Ramirez ◽  
James Johnston ◽  
P. Robert Schwetschenau
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Conservative Management ◽  
Double Blind Study ◽  
Double Blind ◽  
Content Type ◽  
Treatment Groups ◽  
Small Clinical Trial ◽  
The Difference ◽  
Fine Print

✓ Sixty-six patients with symptomatic herniated lumbar discs refractory to the usual conservative management were allocated at random into one of two treatment groups according to a double-blind protocol: 31 received chymopapain intradiscally (chemonucleolysis) and 35 received a placebo intradiscally. Symptoms remained significantly improved 1 year or more after injection for 55% of those treated with chymopapain and for 46% of those treated with placebo. The difference is not statistically significant. However, to discard chemonucleolysis on the basis of this one small clinical trial may be premature. Since continuing controversy has re-established a climate in which another double-blind study of chemonucleolysis is ethically feasible and scientifically desirable, we favor additional clinical trials under a tightly controlled protocol to help resolve the issue.

scholarly journals Comparison of the efficacy and safety of CELBESTA® versus CELEBREX® in patients with rheumatoid arthritis: a 6-week, multicenter, double-blind, double-dummy, active-controlled, randomized, parallel-group, non-inferiority phase 4 clinical trial

2020 ◽  
Vol 48 (6) ◽  
pp. 030006052093132
Author(s):  
Hyun-Sook Kim ◽  
Won-Ho Choi ◽  
Bo Young Kim ◽  
Sung Soo Kim ◽  
Sang-Il Lee ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Clinical Trial ◽  
Renal Toxicity ◽  
Least Square ◽  
Efficacy And Safety ◽  
Generic Equivalent ◽  
Analog Scale ◽  
Double Blind ◽  
Parallel Group ◽  
The Difference

Objectives Celecoxib is a selective cyclooxygenase (COX)-2 inhibitor that is commonly used to reduce the incidence of gastrointestinal (GI) complications in patients with rheumatoid arthritis (RA). CELBESTA® is a generic equivalent to CELEBREX®, a celecoxib preparation. This study compared the efficacy and safety of CELBESTA® and CELEBREX® in patients with RA. Methods This was a multicenter, double-blind, double-dummy, active-controlled, randomized, parallel-group, non-inferiority clinical trial. The primary endpoint was a change from baseline in self-assessed pain intensity determined using a 100-mm visual analog scale after 6 weeks of treatment. Results After a washout period, 119 eligible subjects were randomized to one of two groups (CELBESTA® group, n = 61; CELEBREX® group, n = 58). CELBESTA® was not inferior to CELEBREX® because the upper limit of two-sided 95% confidence interval (CI) for the difference between the two groups (difference in the least square [LS] mean, −8.68 mm; two-sided 95% CI −16.59 mm to −0.77 mm) was less than the non-inferiority margin (10 mm). There were no significant differences in GI complications and renal toxicity. Conclusions CELBESTA® was not inferior to CELEBREX® with regard to the pain relief efficacy in RA patients, and the tolerability and safety profiles were excellent and at similar levels for both preparations.

A Comparative Clinical Trial of Fenbufen and Indomethacin in Patients with Rheumatoid Arthritis

1976 ◽  
Vol 4 (6) ◽  
pp. 418-426 ◽  
Author(s):  
J M Vergara-Castro ◽  
L F Arias ◽  
B P Greenberg
Keyword(s):  
Rheumatoid Arthritis ◽  
Clinical Trial ◽  
Crossover Trial ◽  
Blind Study ◽  
Double Blind Study ◽  
Double Blind ◽  
Treatment Groups ◽  
Physical Measurements ◽  
Rheumatoid Arthritis Activity ◽  
Single Blind

A 12-week double-blind crossover trial compared fenbufen and indomethacin in 40 patients with rheumatoid arthritis. Fenbufen (600-800 mg/day) was significantly superior to indomethacin (75-100 mg/day) in improving the physical measurements of rheumatoid arthritis activity. Twenty-four patients who demonstrated marked or moderate improvement in the double-blind study participated in a 14-week single-blind study. After one week on placebo, patients received either fenbufen once a day at bedtime, fenbufen twice a day, or indomethacin three times a day for 12 weeks, followed by 2 weeks of placebo. All three treatment groups demonstrated significant improvement. The two fenbufen groups were significantly superior to indomethacin in improving the physical measurements of rheumatoid arthritis activity. No significant differences were found between the two fenbufen treatment groups. Drug-related side-effects reported during both studies were significantly ewer with fenbufen than with indomethacin.

scholarly journals Responsiveness of the Scripps Neurologic Rating Scale During a Multiple Sclerosis Clinical Trial

1999 ◽  
Vol 26 (4) ◽  
pp. 283-289 ◽  
Author(s):  
James A. Koziol ◽  
Adriana Lucero ◽  
Jack C. Sipe ◽  
John S. Romine ◽  
Ernest Beutler
Keyword(s):  
Multiple Sclerosis ◽  
Clinical Trial ◽  
Rating Scale ◽  
Effect Sizes ◽  
Active Therapy ◽  
Double Blind ◽  
Treatment Groups ◽  
Negative Effect ◽  
The Individual ◽  
Positive Effect

Objective:The Scripps neurologic rating scale (SNRS) is a summary measure of individual components comprising a neurological examination, designed for use in multiple sclerosis (MS). Our objective is to evaluate the responsiveness of the SNRS, within the context of a 2-year, randomized, double-blind crossover study of the efficacy of cladribine for treatment of secondary progressive MS.Methods:Effect sizes were determined for the SNRS and its components, separately for each treatment group (initial placebo, and initial cladribine) over both years of the clinical trial, using a standard random effects model.Results:Individual components tended to show positive effect sizes (improvement) during periods of active therapy in both treatment groups, and negative effect sizes (deterioration) during periods of no active therapy. Summation indices derived from the individual components of the SNRS seemed somewhat more stable than the individual components. The two components mentation and mood, and bladder, bowel, or sexual dysfunction, were rather unresponsive in our clinical trial.Conclusion:Changes in the components of the SNRS over the course of our clinical trial were consistent between the two treatment groups. Most components were moderately responsive; and, the summary SNRS score appropriately summarized the moderate magnitudes of change evinced in the individual components.

Sign in / Sign up

Export Citation Format

Share Document