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OBJECTIVES: I. Study further the safety and efficacy of the alpha-receptor agonist midodrine in patients with neurogenic orthostatic hypotension.
II. Assess the quality of life in these patients with this treatment regimen.

开始日期2001-04-01

申办/合作机构

Roberts Pharmaceutical Corp.

ISRCTN10030693 / Completed临床3期

A Long-term clinical trial on the Efficacy and Safety profile of Doxofylline in Asthma: the LESDA study

开始日期1992-02-19

申办/合作机构

Roberts Pharmaceutical Corp.

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ISRCTN65297911 / Completed临床3期

A double-blind Phase III evaluation of doxofylline, theophylline, and placebo in patients with chronic reversible asthma

开始日期1991-08-13

申办/合作机构

Roberts Pharmaceutical Corp.

[+1]

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0 项与 Roberts Pharmaceutical Corp. 相关的专利（医药）

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项与 Roberts Pharmaceutical Corp. 相关的文献（医药）

1998-08-01·Journal of Liquid Chromatography & Related Technologies

A High Pressure Liquid Chromatography Assay Method for Analysis of Deslorelin and Benzyl Alcohol in Deslorelin Injection

作者: Iyer, Meera R ; Geller, Arthur M ; Sheth, Bhogi B ; Wood, George C ; Fleischner, Albert M

Deslorelin is a nonapeptide drug used for treatment precocious puberty in young women.A reversed-phase HPLC procedure was developed for the anal. of deslorelin and benzyl alc. in parenteral injection solution dosage forms.Both deslorelin and the preservative benzyl alc. were determined from a single sample injection.The separation and quantitation were achieved on a C₁₈ column at ambient temperature using a mobile phase of water/acetonitrile (70:30) containing sodium hexylsulfonate and triethylamine at pH 3.The wavelengths for the spectrophotometric detection were 275 nm for deslorelin and 254 nm for benzyl alc.The method showed linearity and good precision and accuracy at concentrations 2.93-550 mg deslorelin/mL 0.059-11 mL benzyl alc./mL which covered 0.6%-110% of the formulation label concentration range.The lower limits of quantitation for deslorelin and benzyl alc. were 2.93 μg/mL and 0.059 μL/mL, resp.

1998-07-01·Neurology1区 · 医学

A double-blind, dose-response study of midodrine in neurogenic orthostatic hypotension

1区 · 医学

Article

作者: Wright, R. A. ; Sheng, K. N. ; Perera, R. ; Low, P. A. ; Kaufmann, H. C. ; McElligott, M. A. ; Opfer-Gehrking, T. L.

OBJECTIVETo determine the best therapeutic strategy for the use of midodrine in patients with neurogenic orthostatic hypotension (NOH).BACKGROUNDMidodrine is a peripherally acting alpha-adrenergic agonist useful in the treatment of NOH. However, neither the most effective dosage of midodrine nor the required frequency of administration is established.DESIGN/METHODSMidodrine dose-blood pressure response, pharmacokinetics, and duration of action were examined in a double-blind, placebo-controlled, four-way crossover trial. Twenty-five patients with NOH were randomized to receive on successive days placebo or midodrine 2.5, 10, or 20 mg. Blood pressures of patients in the supine and standing positions were measured sequentially. A global assessment of the patient's overall symptom improvement after each leg of the study was performed. Blood levels of midodrine and its active metabolite, desglymidodrine, were assayed.RESULTSMidodrine significantly increased standing systolic blood pressure, with the increase peaking at 1 hour. There was a significant linear relation between midodrine dosage and mean systolic blood pressure. The mean score for global improvement of symptoms was significantly higher for midodrine (10 and 20 mg) compared with placebo. The half-life of desglymidodrine was approximately 4 hours.CONCLUSIONA 10-mg dose of midodrine prescribed two to three times daily is effective in increasing orthostatic blood pressure and ameliorating symptoms in patients with NOH.

1994-01-01·Journal of Biopharmaceutical Statistics4区 · 医学

Statistical evaluation of relationships between analgesic dose and ordered ratings of pain relief over an eight-hour period

4区 · 医学

Article

作者: Wilson, Jerome ; Gansky, Stuart A. ; Koch, Gary G.

Statistical considerations are discussed for the application of alternative methods to a clinical trial involving repeated ordinal ratings and multiple dosage levels of active drugs. Analyses included summary measures traditionally employed in studies of acute pain: sum of pain intensity differences from baseline, total pain relief, and total pain half gone. Estimators and confidence intervals of relative potency are developed for univariate and multivariate situations, using weighted least squares analysis with mean response and variances from Taylor series linearizations. The estimates from these methods are compared to those from traditional methods, such as ordinary least squares regression and Fieller's method for confidence intervals, as well as those from more recent developments, such as generalized estimating equations and sample survey data regression. A double-blind, two-center, randomized clinical trial of acute pain relief comparing placebo with two analgesics, each at two dosage levels, over an 8-hr period serves as an illustrative example for these techniques and comparisons.

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