Single vs composite measures of pain intensity: relative sensitivity for detecting treatment effects.

Assay sensitivity remains a significant issue in pain clinical trials. One possible method for increasing assay sensitivity for detecting changes in pain intensity is to increase the reliability of pain intensity assessment by increasing the number of intensity ratings obtained, and combining these ratings into composite scores. The current study performed secondary analyses from a published clinical trial to test this possibility.

An open-label pharmacokinetic study of oxymorphone extended release in the presence of naltrexone in the older adult.

Objective: The aging population generally has greater need for analgesics and is best served by having as many good therapeutic options as possible. Geriatric analgesia requires special consideration of age-associated physiologic changes that can affect drug dosing. The study of extended-release (ER) oxymorphone in older (≥ 65 years of age) versus younger (18-40 years of age) male and female volunteers was described.

The meaning of global outcome measures in pain clinical trials: more than just change in pain intensity.

Objectives: To understand the factors that contribute to patient and physician global outcome ratings and the extent to which receiving different doses of opioids or placebo might influence the importance of these factors better.

Methods: A secondary analysis was performed using data from a prospective, multicenter, double-blind placebo-controlled, and active-controlled parallel group dose-ranging study comparing the efficacy of oxymorphone extended release (ER) 20 mg (ER20, N=121); oxymorphone ER 40 mg (ER40, N=121); oxycodone controlled release 20 mg (Oxy20, N=125); and placebo (N=124) in a sample of patients with osteoarthritis. We performed 2 regression analyses to identify the predictors of pretreatment to posttreatment improvement in patient and physician global ratings of arthritis status.

Reliability and validity of individual and composite recall pain measures in patients with cancer.

Objectives: To evaluate and compare the validity and reliability of individual and composite recall pain intensity measures.

Design: Secondary analyses using data from a published 14-day open-label crossover clinical trial comparing two active treatments.

Setting: Multiple settings.

Long-term tolerability and effectiveness of oxymorphone extended release in patients with cancer.

Objective: To evaluate the long-term safety, tolerability, and effectiveness of oxymorphone extended release (ER) in patients with cancer-related pain.

Design: Post hoc analysis of two-1-year open-label extension studies.

Setting: Multiple US cancer treatment facilities.

Negligible analgesic tolerance seen with extended release oxymorphone: a post hoc analysis of open-label longitudinal data.

Objective: To examine the development of analgesic tolerance in patients on oxymorphone extended-release (OxymER).

Design: Post hoc analysis of data from a previously conducted prospective 1 year multi-center open-label extension study in which patients were able to titrate as needed.

Patients: Sample of 153 hip and knee osteoarthritis (OA) subjects on OxymER.

Factors affecting acceptability of titrated oxymorphone extended release in chronic low back pain - an individual patient analysis.

Objective: To evaluate the influence of age, sex, and previous opioid experience on the likelihood of successfully titrating opioid-naive and experienced patients with chronic low back pain (CLBP) to an effective and well-tolerated dose of oxymorphone extended release (ER).

Methods: Post hoc analysis of open-label titration phases of two enriched-enrollment randomized-withdrawal phase III trials in 575 adults with moderate-to-severe CLBP. Opioid-naive patients (n = 325) initiated oxymorphone ER at 10 mg/day (5 mg q12 h).

The relationship of changes in pain quality to pain interference and sleep quality.

Unlabelled: Pain is a complex multidimensional experience that includes overall intensity/magnitude, unpleasantness/bothersomeness (affect), location, and quality. However, there is a paucity of research examining the importance of pain quality to patient functioning; most research focuses only on the intensity and affective components of pain. This study sought to address this gap by examining, in a sample of patients with carpal tunnel syndrome (CTS), the associations between pain quality and 2 domains of patient functioning: pain interference and sleep quality.

The assessment of pain quality: an item response theory analysis.

Unlabelled: Item Response Theory (IRT) is being increasingly used to develop and evaluate outcome measures. However, many pain measures, including those that assess pain quality, have yet to be evaluated from the IRT perspective. The current study evaluated the scales of a commonly used measure of pain quality (the Pain Quality Assessment Scale, or PQAS) using IRT analyses in 3 samples of patients with chronic pain.

The pain quality response profile of oxymorphone extended release in the treatment of low back pain.

Objective: In controlled trials of analgesics, the primary outcome variable is most often a measure of global pain intensity. However, because pain is associated with a variety of pain sensations, the effects of analgesic treatments on different sensations could go undetected if specific pain qualities are not assessed. This study sought to evaluate the utility of assessing the multiple components of non-neuropathic pain in an analgesic clinical trial.

Comparison of the effectiveness and tolerability of lidocaine patch 5% versus celecoxib for osteoarthritis-related knee pain: post hoc analysis of a 12 week, prospective, randomized, active-controlled, open-label, parallel-group trial in adults.

Background: Cyclooxygenase-2 (COX-2) selective inhibitors and nonselective NSAIDs are commonly used to treat osteoarthritis (OA) of the knee.

Objective: The aim of this study was to compare the effectiveness of the lidocaine patch 5% with that of celecoxib 200 mg/d in the treatment of OA-related knee pain; however, the study was terminated prematurely by the sponsor because of tolerability concerns regarding the class of COX-2 selective inhibitors. A post hoc analysis of the available data is presented here.

The dimensions of pain quality: factor analysis of the Pain Quality Assessment Scale.

Objective: To provide a better empirical understanding of the dimensionality of neuropathic and non-neuropathic pain quality.

Method: An exploratory factor analysis (FA) was performed with baseline pain quality data [assessed using the Pain Quality Assessment Scale (PQAS)] from patients with osteoarthritis of the knee (n=368) and low back pain (n=455) who had participated in a series of analgesic clinical trials. The results of the FA were then confirmed in a sample of patients with neuropathic pain secondary to carpal tunnel syndrome (n=138).

A comparison of the lidocaine patch 5% vs naproxen 500 mg twice daily for the relief of pain associated with carpal tunnel syndrome: a 6-week, randomized, parallel-group study.

Objectives: Carpal tunnel syndrome (CTS) is a common entrapment neuropathy caused by median nerve compression. This pilot clinical trial was designed to compare the safety and effectiveness of the lidocaine patch 5% to that of naproxen 500 mg twice daily for the treatment of neuropathic pain associated with CTS.

Methods: In this 6-week, randomized, parallel-group, open-label, multicenter study, participants from 2 practice sites, aged 18 to 75 years with clinical/electrodiagnostic evidence of CTS, were randomized to receive up to 3 lidocaine 5% patches every 24 hours or naproxen 500 mg twice daily for 6 weeks.

Efficacy and safety of rosiglitazone plus metformin in Mexicans with type 2 diabetes.

Background: Type 2 diabetes is a growing problem in Mexico. The present study was undertaken to evaluate the efficacy and safety of rosiglitazone 2 mg or 4 mg twice daily (bd) in combination with metformin 2.5 g/day in Mexican patients whose type 2 diabetes was inadequately controlled with metformin alone.