A 2-week, multicenter, randomized, double-blind, placebo-controlled, dose-ranging, phase III trial comparing the efficacy of oxymorphone extended release and placebo in adults with pain associated with osteoarthritis of the hip or knee.


BACKGROUND:Oxymorphone extended release (ER) is a tablet formulation of the mu-opioid agonist oxymorphone designed to achieve a low peak-to-trough fluctuation in plasma concentrations over a 12-hour dosing period. OBJECTIVE:This study compared the analgesic efficacy, dose response, and tolerability of 3 doses of oxymorphone ER given every 12 hours with those of placebo in patients with pain related to osteoarthritis (OA) of the hip or knee. METHODS:This was a 2-week, multicenter, randomized, double-blind, placebo-controlled, dose-ranging, Phase III trial. Patients with OA of the hip or knee who were receiving an opioid medication for chronic, moderate to severe pain or who were judged by the investigator to have received suboptimal analgesia with nonopioid analgesics entered a 2- to 7-day washout of analgesic medication. When pain in the index joint was >40 mm on a 100-mm visual analog scale (VAS), patients were randomized to receive 1 of 4 regimens: oxymorphone ER 10 mg q12h during weeks 1 and 2; oxymorphone ER 20 mg q12h in week 1 and 40 mg q12h in week 2; oxymorphone ER 20 mg q12h in week 1 and 50 mg q12h in week 2; or placebo q12h during weeks 1 and 2. The primary end point was the change in VAS score for arthritis pain intensity. Other assessments included the Western Ontario and McMaster Universities (WOMAC) OA Index subscales for pain, stiffness, and physical function and the composite index; the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) physical health component summary (PCS) score; the Chronic Pain Sleep Inventory (CPSI) score; vital signs; clinical laboratory parameters; and adverse events (AEs). AEs were recorded at each clinic visit. RESULTS:Three hundred seventy patients were randomized to treatment (95 oxymorphone ER 10 mg, 93 oxymorphone ER 40 mg, 91 oxymorphone ER 50 mg, and 91 placebo), and 198 completed the study. Least squares mean changes from baseline in the VAS arthritis pain intensity score were -21, -28, -29, and -17 mm in the oxymorphone ER 10, 40, and 50 mg and placebo groups, respectively (P = 0.002, modified Tukey linear trend test). Oxymorphone ER 40 and 50 mg produced significant improvements from baseline compared with placebo in the WOMAC subscale scores for pain (least squares mean change: -85.1, -108.0, and -42.5, respectively; P < or = 0.025 for 40 mg, P < or = 0.001 for 50 mg), stiffness (-40.5, -48.1, and -17.0; both, P < or = 0.001), and physical function (-256.8, -310.8, and -116.5; P < or = 0.01 and P < or = 0.001, respectively); the SF-36 PCS score (4.6, 3.6, and -0.1; P < 0.001); and the CPSI score (-21.2, -22.2, and -10.7; P < 0.05). The 10-mg dose also was associated with significant improvements compared with placebo in the WOMAC pain (-83.6; P < or = 0.025) and physical function subscales (-232.9; P < or = 0.025) and the SF-36 PCS score (3.9; P < 0.001). The most frequently reported AEs (> or =5% of patients) in the oxymorphone ER groups were nausea (39.4%), vomiting (23.7%), dizziness (22.6%), constipation (22.2%), somnolence (17.6%), pruritus (16.5%), and headache (15.0%). The majority of AEs with oxymorphone ER were mild or moderate in intensity. Three serious AEs (urinary retention, central nervous system depression, and pancreatitis) were considered possibly or probably related to study medication. CONCLUSION:In these patients with chronic, moderate to severe pain related to OA of the hip or knee, oxymorphone ER administered twice daily for 2 weeks produced dose-related reductions in arthritis pain intensity and improvements in physical function.


Clin Ther


Clinical therapeutics


Kivitz A,Ma C,Ahdieh H,Galer BS




Has Abstract


2006-03-01 00:00:00














  • Prevalence and correlates of potentially inappropriate prescribing among ambulatory older patients in the year 2001: comparison of three explicit criteria.

    abstract:OBJECTIVES:The aims of this study were to determine the prevalence of prescribing potentially inappropriate medications (PIMs) based on the 2002 Beers criteria among ambulatory patients aged > or =65 years, to compare PIM prevalence rates based on the 1997 Beers criteria and Zhan criteria with the rate obtained using t...

    journal_title:Clinical therapeutics

    pub_type: 杂志文章


    authors: Viswanathan H,Bharmal M,Thomas J 3rd

    更新日期:2005-01-01 00:00:00

  • Effects of LX4211, a dual sodium-dependent glucose cotransporters 1 and 2 inhibitor, on postprandial glucose, insulin, glucagon-like peptide 1, and peptide tyrosine tyrosine in a dose-timing study in healthy subjects.

    abstract:BACKGROUND:LX4211 is a first-in-class dual inhibitor of sodium-dependent glucose cotransporters 1 and 2 (SGLT1 and SGLT2). SGLT1 is the primary transporter for glucose absorption from the gastrointestinal tract, and SGLT2 is the primary transporter for glucose reabsorption in the kidney. SGLT1 inhibition reduces postpr...

    journal_title:Clinical therapeutics

    pub_type: 杂志文章,随机对照试验


    authors: Zambrowicz B,Ogbaa I,Frazier K,Banks P,Turnage A,Freiman J,Boehm KA,Ruff D,Powell D,Sands A

    更新日期:2013-08-01 00:00:00

  • Ease of use and acceptability of a new pen device for the administration of growth hormone therapy in pediatric patients: an open-label, uncontrolled usability test.

    abstract:BACKGROUND:Recombinant human growth hormone (GH) is used for the treatment of several conditions associated with growth retardation and metabolic dysfunction. These patients are typically diagnosed and treated from childhood, and treatment adherence in children might be problematic. To potentially improve treatment adh...

    journal_title:Clinical therapeutics

    pub_type: 杂志文章


    authors: Fuchs GS,Mikkelsen S,Knudsen TK,Kappelgaard AM

    更新日期:2009-12-01 00:00:00

  • Absorption and antiarrhythmic efficacy of sustained-release mexiletine.

    abstract::Absorption of the antiarrhythmic agent mexiletine from conventional capsules (200 mg) and two sustained-release formulations (360 and 432 mg) was studied in four healthy volunteer subjects, and use of the 360-mg preparation was studied in nine patients who had been using conventional capsules. In the four volunteers, ...

    journal_title:Clinical therapeutics

    pub_type: 杂志文章


    authors: Holt DW,Chadwick DE,Campbell RW

    更新日期:1983-01-01 00:00:00

  • Cost-effectiveness profiles with an expanding treatment population.

    abstract::In trying to identify the therapeutic impact of a drug, clinical trials eliminate potentially confounding factors such as comorbidities, poor compliance and treatment errors in diagnosis, dosing, and drug interactions. Elimination of these variables means that attempts to use clinical data as the basis for predicting ...

    journal_title:Clinical therapeutics

    pub_type: 杂志文章


    authors: Langley PC

    更新日期:1995-11-01 00:00:00

  • Efficacy and tolerability of besifloxacin ophthalmic suspension 0.6% administered twice daily for 3 days in the treatment of bacterial conjunctivitis: a multicenter, randomized, double-masked, vehicle-controlled, parallel-group study in adults and childre

    abstract:BACKGROUND:Besifloxacin is a topical fluoroquinolone with potent in vitro activity against a broad spectrum of ocular pathogens, including drug-resistant strains. Besifloxacin ophthalmic suspension 0.6% given 3 times daily for 5 days has been reported to be more effective than its vehicle in the treatment of bacterial ...

    journal_title:Clinical therapeutics

    pub_type: 杂志文章,多中心研究,随机对照试验


    authors: Silverstein BE,Allaire C,Bateman KM,Gearinger LS,Morris TW,Comstock TL

    更新日期:2011-01-01 00:00:00

  • Microvascular Dysfunction as Opposed to Conduit Artery Disease Explains Sex-specific Chest Pain in Emergency Department Patients With Low to Moderate Cardiac Risk.

    abstract:PURPOSE:Chest pain is a common emergency department (ED) presentation that is often unexplained. Recent evidence suggests that disease of the microvessels (arterioles) as opposed to the coronary artery (conduit artery) could explain one third of these cases, particularly in women. Brachial artery reactivity (BAR) is a ...

    journal_title:Clinical therapeutics

    pub_type: 杂志文章


    authors: Safdar B,Ali A,D'Onofrio G,Katz SD

    更新日期:2016-02-01 00:00:00

  • Nonadherence to oral linezolid after hospitalization: a retrospective claims analysis of the incidence and consequence of claim reversals.

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    journal_title:Clinical therapeutics

    pub_type: 杂志文章


    authors: Ball AT,Xu Y,Sanchez RJ,Shelbaya A,Deminski MC,Nau DP

    更新日期:2010-12-01 00:00:00

  • Evolution of self-care with over-the-counter medications.

    abstract::Self-care with over-the-counter (OTC) medicines has evolved from the "dark ages" of patent medicine manufacture and sale to a modern era of new drug development involving prescription-to-OTC switch. This evolution is largely due to the OTC Review, which placed science at the cornerstone of safety, effectiveness, and l...

    journal_title:Clinical therapeutics

    pub_type: 杂志文章,评审


    authors: Soller RW

    更新日期:1998-01-01 00:00:00

  • Allylestrenol: three years of experience with Gestanon in threatened abortion and premature labor.

    abstract::Allylestrenol was used to treat 375 women with threatened pregnancies. Results show that this drug is capable of maintaining pregnancy in a large series of ambulant patients and is safe for both mother and child. Allylestrenol does not maintain pregnancy if placental dysfunction is present, however. Newborns whose mot...

    journal_title:Clinical therapeutics

    pub_type: 杂志文章


    authors: Cortés-Prieto J,Bosch AO,Rocha JA

    更新日期:1980-01-01 00:00:00

  • Gangrenous and perforated appendicitis with peritonitis: treatment and bacteriology.

    abstract::A comparison of single-agent antimicrobial therapy in the treatment of patients with perforated or gangrenous appendicitis and peritonitis was performed in a double-blind, randomized, prospective trial. Pathologic documentation of advanced appendicitis and positive intraoperative specimen cultures were required for in...

    journal_title:Clinical therapeutics

    pub_type: 临床试验,杂志文章,随机对照试验


    authors: Bennion RS,Thompson JE,Baron EJ,Finegold SM

    更新日期:1990-01-01 00:00:00

  • Analysis of prescription pattern and guideline adherence in the management of asthma among medical institutions and physician specialties in Taiwan between 2000 and 2010.

    abstract:PURPOSE:The aim of this study was to evaluate prescription patterns of antiasthmatic medications in ambulatory care, guideline adherence by physician specialties and medical institutions, and the rate of hospitalization and emergency department visits due to asthma exacerbation. METHODS:The ambulatory visits between 2...

    journal_title:Clinical therapeutics

    pub_type: 杂志文章


    authors: Chou CL,Perng DW,Lin TL,Lin AM,Chen TJ,Wu MS,Chou YC

    更新日期:2015-10-01 00:00:00

  • Electrical Muscle Stimulation Induces an Increase of VEGFR2 on Circulating Hematopoietic Stem Cells in Patients With Diabetes.

    abstract:PURPOSE:External electric muscle stimulation (EMS) of the thigh muscles was found to reduce pain resulting from diabetic neuropathy (DN), a vascular complication of diabetes. This study investigated circulating hematopoietic stem cells (HSCs) after EMS treatment. Impaired function of HSCs and the subpopulation endothel...

    journal_title:Clinical therapeutics

    pub_type: 杂志文章


    authors: Hidmark A,Spanidis I,Fleming TH,Volk N,Eckstein V,Groener JB,Kopf S,Nawroth PP,Oikonomou D

    更新日期:2017-06-01 00:00:00

  • Pharmacokinetics and pharmacodynamics of aztreonam administered by continuous intravenous infusion.

    abstract::The pharmacodynamic parameter that appears to correlate best with a successful therapeutic outcome with beta-lactam antibiotics is the length of time the serum antibiotic concentration remains above the minimum inhibitory concentration (MIC) for the infecting pathogen. By maximizing this parameter, continuous administ...

    journal_title:Clinical therapeutics

    pub_type: 杂志文章


    authors: Burgess DS,Summers KK,Hardin TC

    更新日期:1999-11-01 00:00:00

  • Bioavailability of three rufinamide oral suspensions compared with the marketed 400-mg tablet formulation: results from a randomized-sequence, open-label, four-period, four-sequence crossover study in healthy subjects.

    abstract:BACKGROUND:Rufinamide is indicated for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome in patients aged ≥4 years. OBJECTIVES:The primary purpose of this study was to compare the relative bioavailability and other pharmacokinetics of rufinamide administered as a 400-mg tablet formulation (r...

    journal_title:Clinical therapeutics

    pub_type: 杂志文章,随机对照试验


    authors: Critchley DJ,Aluri J,Boyd P,Whayman M,Narurkar M,Delargy H,Bibbiani F

    更新日期:2011-01-01 00:00:00

  • Early experiences with the stable isotope method in children.

    abstract::A new technique to estimate water uptake by the gastrointestinal tract was tested in infants undergoing elective surgery. Patients were randomly allocated to receive either sterile water or a glucose-electrolyte solution labeled with the stable isotope H2O18. After absorption, the isotopic O18 comes to rapid equilibri...

    journal_title:Clinical therapeutics

    pub_type: 临床试验,杂志文章,随机对照试验


    authors: Mecrow I,Miller V,Preston T

    更新日期:1990-01-01 00:00:00

  • Comparative in vitro activity of Ro 09-1428, a novel cephalosporin with a catechol moiety.

    abstract::The in vitro activity of Ro 09-1428, a new parenteral cephalosporin, was compared with that of other beta-lactams and aminoglycosides in 1230 clinical isolates from 1028 consecutive patients. Using an agar dilution method, the drugs were tested against 625 isolates of Enterobacteriaceae, 68 Pseudomonas aeruginosa, 36 ...

    journal_title:Clinical therapeutics

    pub_type: 杂志文章


    authors: Qadri SM,Ayub A,Ueno Y,Saldin H

    更新日期:1992-07-01 00:00:00

  • Safety of bronchodilator therapy in pediatric asthma patients.

    abstract::This article reviews the drugs used in the treatment of childhood asthma (bronchodilators and anti-inflammatory agents) from the perspective of their safety and clinical tolerability. Adverse events observed in adults are likely to be seen to a greater degree in children and adolescents for many types of antiasthma dr...

    journal_title:Clinical therapeutics

    pub_type: 杂志文章,评审


    authors: Selcow JE

    更新日期:1994-07-01 00:00:00

  • Effects of cimetidine, ranitidine, and antacid on renal function.

    abstract::Serum creatinine and beta 2-microglobulin levels, endogenous creatinine clearance, the urinary beta 2-microglobulin excretion rate, and urinary protein levels were monitored serially in 29 patients with duodenal ulcers randomly allocated to receive eight weeks of treatment with cimetidine, ranitidine, or an antacid. A...

    journal_title:Clinical therapeutics

    pub_type: 杂志文章


    authors: Yeung CK,Wong KL,Ng MT,Lai CL

    更新日期:1984-01-01 00:00:00

  • New FDA-Approved Disease-Modifying Therapies for Multiple Sclerosis.

    abstract:PURPOSE:Interferon injectables and glatiramer acetate have served as the primary disease-modifying treatments for multiple sclerosis (MS) since their introduction in the 1990s and are first-line treatments for relapsing-remitting forms of MS (RRMS). Many new drug therapies were launched since early 2010, expanding the ...

    journal_title:Clinical therapeutics

    pub_type: 杂志文章,评审


    authors: English C,Aloi JJ

    更新日期:2015-04-01 00:00:00

  • Efficacy and tolerability of 0.5% timolol maleate ophthalmic gel-forming solution QD compared with 0.5% levobunolol hydrochloride BID in patients with open-angle glaucoma or ocular hypertension.

    abstract::We compared the efficacy of timolol maleate ophthalmic gel-forming solution 0.5% QD with that of levobunolol hydrochloride 0.5% BID, as measured by change in intraocular pressure (IOP), effect on heart rate, and ocular tolerability. The study had a positive-controlled, double-masked, randomized, multicenter, 12-week, ...

    journal_title:Clinical therapeutics

    pub_type: 临床试验,杂志文章,多中心研究,随机对照试验


    authors: Walters TR,Maloney S,Slater D,Liss C,Wilson H,Hartenbaum D

    更新日期:1998-11-01 00:00:00

  • A Study on the Application and Use of Artificial Intelligence to Support Drug Development.

    abstract:PURPOSE:The Tufts Center for the Study of Drug Development (CSDD) and the Drug Information Association (DIA) in collaboration with 8 pharmaceutical and biotechnology companies conducted a study examining the adoption and effect of artificial intelligence (AI), such as machine learning, on drug development. The study wa...

    journal_title:Clinical therapeutics

    pub_type: 杂志文章


    authors: Lamberti MJ,Wilkinson M,Donzanti BA,Wohlhieter GE,Parikh S,Wilkins RG,Getz K

    更新日期:2019-08-01 00:00:00

  • Weight-based heparin dosing: clinical response and resource utilization.

    abstract::The objective of this study was to assess a weight-based heparin (WBH) nomogram (80-U/kg bolus, 18-U/kg-per-hour initial infusion) and determine its clinical performance and impact on resource utilization. All patients treated with heparin for venous thromboembolism or unstable angina during a 15-week study period wer...

    journal_title:Clinical therapeutics

    pub_type: 临床试验,杂志文章


    authors: Lackie CL,Luzier AB,Donovan JA,Feras HI,Forrest A

    更新日期:1998-07-01 00:00:00

  • Limitations of the Current Standards of Care for Treating Gout and Crystal Deposition in the Primary Care Setting: A Review.

    abstract:PURPOSE:This article outlines several important issues regarding the management of patients with gout. The topics discussed include best practices for gout based on the most current guidelines, opportunities for improving gout management, and current and emerging therapies for gout. METHODS:[PubMed and Google Scholar ...

    journal_title:Clinical therapeutics

    pub_type: 杂志文章,评审


    authors: Keenan RT

    更新日期:2017-02-01 00:00:00

  • Pharmacokinetic, pharmacodynamic, efficacy, and safety data from two randomized, double-blind studies in patients with asthma and an in vitro study comparing two dry-powder inhalers delivering a combination of salmeterol 50 microg and fluticasone propiona

    abstract:BACKGROUND:The use of dry-powder inhalers (DPIs) to administer respiratory medicines is increasing, and new DPIs are likely to be developed because of expiring patents. However, there is considerable debate concerning the extent to which DPIs are interchangeable without altering disease control or the safety profile of...

    journal_title:Clinical therapeutics

    pub_type: 杂志文章


    authors: Daley-Yates PT,Parkins DA,Thomas MJ,Gillett B,House KW,Ortega HG

    更新日期:2009-02-01 00:00:00

  • Economic impact of introducing propentofylline for the treatment of dementia in Sweden.

    abstract::The purpose of this study was to estimate the impact of the introduction of propentofylline, a glial-cell modulator with neuroprotective properties, on the costs of dementia care in Sweden. To estimate the clinical effects of propentofylline treatment on dementia, we conducted a meta-analysis of four double-masked, pl...

    journal_title:Clinical therapeutics

    pub_type: 杂志文章,meta分析


    authors: Wimo A,Witthaus E,Rother M,Winblad B

    更新日期:1998-05-01 00:00:00

  • Efficacy and Safety of Fixed-dose Combination Therapy With Telmisartan and Rosuvastatin in Korean Patients With Hypertension and Dyslipidemia: TELSTA-YU (TELmisartan-rosuvaSTAtin from YUhan), a Multicenter, Randomized, 4-arm, Double-blind, Placebo-control

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    journal_title:Clinical therapeutics

    pub_type: 杂志文章,多中心研究,随机对照试验


    authors: Oh GC,Han JK,Han KH,Hyon MS,Doh JH,Kim MH,Jeong JO,Bae JH,Kim SH,Yoo BS,Baek SH,Rhee MY,Ihm SH,Sung JH,Choi YJ,Kim SJ,Hong KS,Lee BK,Cho J,Shin ES,Rhew JY,Kim H,Kim HS

    更新日期:2018-05-01 00:00:00

  • Effects of citicholine in subcortical dementia associated with Parkinson's disease assessed by quantified electroencephalography.

    abstract::Two groups of patients with idiopathic Parkinson's disease underwent quantified electroencephalography (EEGq) using fast Fourier transfer to assess the effects of treatment with citicholine. Evidence of cortical cognitive impairment was seen in one group but not in the other. Certain parameters were established which ...

    journal_title:Clinical therapeutics

    pub_type: 杂志文章


    authors: García-Mas A,Rossiñol A,Roca M,Lozano R,Rosselló J,Llinas J

    更新日期:1992-09-01 00:00:00

  • Utility of Therapeutic Drug Monitoring of Imatinib, Nilotinib, and Dasatinib in Chronic Myeloid Leukemia: A Systematic Review and Meta-analysis.

    abstract:PURPOSE:This study examined the utility of therapeutic drug monitoring (TDM) of imatinib, nilotinib, and dasatinib in adult patients with chronic-phase chronic myeloid leukemia (CML). TDM in CML entails the measurement of plasma tyrosine kinase inhibitor (TKI) concentration to predict efficacy and tolerability outcomes...

    journal_title:Clinical therapeutics

    pub_type: 杂志文章,meta分析


    authors: García-Ferrer M,Wojnicz A,Mejía G,Koller D,Zubiaur P,Abad-Santos F

    更新日期:2019-12-01 00:00:00

  • Assessment of the association between blood pressure control and health care resource use.

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    journal_title:Clinical therapeutics

    pub_type: 临床试验,杂志文章,多中心研究,随机对照试验


    authors: Lapuerta P,Simon T,Smitten A,Caro J,CHOICE Study Group. Caring for Hypertension on Initiation: Costs and Effectiveness.

    更新日期:2001-10-01 00:00:00