A Double-Blind Parallel Evaluation of the Efficacy and Safety of a Single Dose of Ketoprofen in Cancer Pain

1988 ◽  
Vol 28 ◽  
pp. S34-S39 ◽  
Author(s):  
John Stambaugh ◽  
Janet Drew
Keyword(s):  
Single Dose ◽  
Cancer Pain ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Parallel Evaluation

scholarly journals An Integrated Efficacy and Safety Analysis of Single-Dose Secnidazole 2 g in the Treatment of Bacterial Vaginosis

2020 ◽  
Vol 27 (2) ◽  
pp. 523-528
Author(s):  
Helen Pentikis ◽  
Nikki Adetoro ◽  
Diane Tipping ◽  
Sharon Levy
Keyword(s):  
Single Dose ◽  
Bacterial Vaginosis ◽  
Integrated Analysis ◽  
Adult Women ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Study Visit ◽  
Pivotal Study ◽  
The Us ◽  
Dose Oral

AbstractBacterial vaginosis (BV) is the most common gynecologic infection in women aged 14 to 49 years. Currently recommended treatments require extended dosing and are thus associated with poor adherence. A single-dose oral granule formulation of secnidazole 2 g (SOLOSEC™ [secnidazole], Symbiomix Therapeutics, a Lupin company, Baltimore, MD), a 5-nitroimidazole antibiotic with antimicrobial activity, has been approved by the US Food and Drug Administration for the treatment of BV in adult women. As part of the US registration package, two randomized, double-blind, placebo-controlled clinical studies were conducted to confirm the efficacy and safety of a novel single-dose oral formulation of secnidazole 2 g. This is an integrated analysis of efficacy and safety results from these studies, pivotal study 1 and pivotal study 2. By combining the results of the two studies, relevant information is presented especially when considering the effect of secnidazole on patients with recurrent episodes of BV and the difference in effect on patients of black race. Single-dose secnidazole 2 g was statistically superior to placebo on all primary and secondary efficacy outcomes in both trials, including clinical outcome responder rate (P < 0.001), achievement of Nugent scores in the normal range of 0 to 3 (P < 0.001), greater numbers of patients as therapeutic outcome responders at the test of cure/end of study visit on days 21–30 (P < 0.001), and fewer patients requiring additional treatment at the test of cure/end of study visit (P < 0.001), supporting the role for single oral dose secnidazole 2 g granules as treatment for women with BV.

Efficacy and Safety of a Novel, Single-dose Azithromycin Microsphere Formulation Versus 10 Days of Levofloxacin for the Treatment of Acute Bacterial Sinusitis in Adults

2005 ◽  
Vol 133 (2) ◽  
pp. 194-200 ◽  
Author(s):  
John J. Murray ◽  
Paz Emparanza ◽  
Eugenijus Lesinskas ◽  
Margaret Tawadrous ◽  
Jeanne D. Breen
Keyword(s):  
Single Dose ◽  
Clinical Success ◽  
Maxillary Sinusitis ◽  
Efficacy And Safety ◽  
Success Rates ◽  
Radiographic Evidence ◽  
Double Blind ◽  
Acute Bacterial Sinusitis ◽  
Cure Rates ◽  
International Multicenter

Objective To compare the efficacy and safety of a single 2.0-g dose of a novel azithromycin microsphere formulation with that of 10 days of levofloxacin, 500 mg/d, when used to treat adults with uncomplicated acute bacterial maxillary sinusitis (ABS). Study Design and Setting An international, multicenter, randomized, double-blind, double-dummy trial. Eligible outpatients ≥18 years of age with clinical and radiographic evidence of ABS underwent maxillary sinus aspiration before randomization. Primary endpoint was clinical efficacy at the test-of-cure visit (day 17-24). Results Clinical success rates were 94.5% (242/256) in azithromycin-microspheres-treated patients and 92.8% (233/251) in the levofloxacin group. In patients with documented Streptococcus pneumoniae, Haemophilus influenzae, or Moraxella catarrhalis, clinical cure rates were 97.3% (36/37), 96.3% (26/27), and 100% (8/8), respectively, for the azithromycin group and 92.3% (36/39), 100% (30/30), and 90.9% (10/11), respectively, for the levofloxacin group. Conclusions Single-dose azithromycin microspheres provided clinical and bacteriologic efficacy and safety comparable to 10 days of levofloxacin. Significance A novel microsphere formulation of azithromycin given as a single dose was safe and effective for the treatment of ABS.

Clinical efficacy and safety of a novel controlled-release morphine suppository and subcutaneous morphine in cancer pain: a randomized evaluation.

1995 ◽  
Vol 13 (6) ◽  
pp. 1520-1527 ◽  
Author(s):  
E Bruera ◽  
R Fainsinger ◽  
K Spachynski ◽  
N Babul ◽  
Z Harsanyi ◽  
...  
Keyword(s):  
Controlled Release ◽  
Cancer Pain ◽  
Pain Intensity ◽  
Clinical Efficacy ◽  
Oral Morphine ◽  
Mcgill Pain Questionnaire ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Patients With Cancer ◽  
Significant Difference

PURPOSE A significant number of cancer patients will require an alternate route of morphine administration at some point during their illness. This study compared the clinical efficacy and safety of a novel morphine sulfate controlled-release suppository (MS-CRS) and subcutaneous (SC) morphine in patients with cancer pain. METHODS Thirty patients with cancer pain were randomized in a double-blind crossover study to MS-CRS every 12 hours or SC morphine every 4 hours for 4 days each, using a 2.5:1 analgesic equivalence ratio. Pain intensity was assessed using a visual analog scale (VAS) and the Present Pain Intensity Index of the McGill Pain Questionnaire. Nausea and sedation were also assessed with a VAS. Evaluations were made by the patient at 8 AM, noon, 4 PM, and 8 PM and rescue morphine consumption recorded. RESULTS Twenty-three patients completed the study (13 men and 10 women; mean age, 64.0 +/- 2.0 years) and were treated with mean daily MS-CRS and SC morphine doses of 326 +/- 69 mg and 138 +/- 28 mg, respectively. There was a small but significant difference in overall ordinal pain-intensity scores in favor of MS-CRS (0.7 +/- 0.1 v 0.9 +/- 0.1, P = .0459). There were no significant differences between MS-CRS and SC morphine in overall VAS scores for pain intensity (13 +/- 3 v 13 +/- 3 mm), sedation (23 +/- 3 v 25 +/- 4 mm), and nausea (8 +/- 2 v 9 +/- 2 mm). The mean daily rescue analgesic consumption during MS-CRS and SC morphine did not differ significantly (1.2 +/- 0.4 v 1.2 +/- 0.4 doses/d). CONCLUSION MS-CRS, administered every 12 hours, provides analgesia comparable to SC morphine and represents a reliable, noninvasive alternative method of pain control for patients unable to take oral morphine.

Sign in / Sign up

Export Citation Format

Share Document