A randomized, double-blind study of hydromorphone hydrochloride extended-release tablets versus oxycodone hydrochloride extended-release tablets for cancer pain: efficacy and safety in Japanese cancer patients (EXHEAL: a Phase III study of EXtended-releas

Abstract:

BACKGROUND:In Japan, there are limited options for switching opioid analgesics. Hydromorphone is an opioid analgesic that is routinely used instead of morphine for cancer pain; however, it is not yet available in Japan. The aim of this study was to assess the efficacy and safety of hydromorphone (DS-7113b) extended-release tablets in opioid-naïve patients with cancer pain not relieved by non-opioid analgesics. SUBJECTS AND METHODS:This was a multicenter, randomized, double-blind, parallel-group trial. A double-dummy method was used for blinding. Each randomized subject received either hydromorphone extended-release tablets plus placebo oxycodone hydrochloride extended-release tablets 4 mg/day (n=88) or placebo hydromorphone extended-release tablets plus oxycodone hydrochloride extended-release tablets 10 mg/day (n=93) orally for 7 days (once-daily dosing for hydromorphone and twice-daily dosing for oxycodone). The doses were adjusted as necessary. Efficacy was evaluated by change in visual analog scale (VAS) score from baseline to completion of treatment. RESULTS:The between-group difference in least squares mean changes in VAS score from baseline to completion or discontinuation of treatment was -0.4 mm (95% CI -5.9 to 5 mm) by analysis of covariance where the baseline VAS score was used as a covariate. The upper limit of the 95% CI was below 10 mm, which was predefined as the noninferiority limit. This verified the noninferiority of hydromorphone tablets relative to oxycodone tablets. The incidence of adverse events was 80.7% (71 of 88) in the hydromorphone group and 83.7% (77 of 93) in the oxycodone group. The most common adverse events were nausea, vomiting, somnolence, diarrhea, and constipation, most of which are commonly observed with opioid analgesics. CONCLUSION:The efficacy and safety of hydromorphone extended-release tablets were equivalent to those of the oxycodone extended-release formulation.

journal_name

J Pain Res

journal_title

Journal of pain research

authors

Inoue S,Saito Y,Tsuneto S,Aruga E,Ide A,Kakurai Y

doi

10.2147/JPR.S136937

subject

Has Abstract

pub_date

2017-08-18 00:00:00

pages

1953-1962

issn

1178-7090

pii

jpr-10-1953

journal_volume

10

pub_type

杂志文章
  • Analysis of the clinical effects of transforaminal endoscopic discectomy on lumbar disk herniation combined with common peroneal nerve paralysis: a 2-year follow-up retrospective study on 32 patients.

    abstract:BACKGROUND:Very few studies have discussed transforaminal endoscopic discectomy (TED) in the treatment of common peroneal nerve paralysis induced by lumbar disk herniation (LDH). This study aimed to evaluate the efficacy of TED in the treatment of LDH combined with common peroneal nerve paralysis. MATERIALS AND METHOD...

    journal_title:Journal of pain research

    pub_type: 杂志文章

    doi:10.2147/JPR.S120463

    authors: Wang YP,Zhang W,Zhang J,Sun YP,An JL,Ding WY

    更新日期:2017-01-05 00:00:00

  • New topical treatment of vulvodynia based on the pathogenetic role of cross talk between nociceptors, immunocompetent cells, and epithelial cells.

    abstract::Topical treatments of localized neuropathic pain syndromes in general are mostly neglected, mainly due to the fact that most pain physicians expect that a topical formulation needs to result in a transdermal delivery of the active compounds. On the basis of the practical experience, this study brings forth a new, some...

    journal_title:Journal of pain research

    pub_type: 杂志文章

    doi:10.2147/JPR.S115407

    authors: Keppel Hesselink JM,Kopsky DJ,Sajben N

    更新日期:2016-10-03 00:00:00

  • Opioids for chronic pain: a knowledge assessment of nonpain specialty providers.

    abstract:INTRODUCTION:Although the majority of opioids in the US are prescribed by nonpain specialists, these providers often report inadequate training in chronic pain management and opioid prescribing. The extent of health care providers' knowledge of opioid prescribing for chronic pain has not been well established. The purp...

    journal_title:Journal of pain research

    pub_type: 杂志文章

    doi:10.2147/JPR.S98273

    authors: Pearson AC,Eldrige JS,Moeschler SM,Hooten WM

    更新日期:2016-03-10 00:00:00

  • The impact of intravenous dexamethasone on the efficacy and duration of analgesia of paravertebral block in breast cancer surgery: a randomized controlled trial.

    abstract:Purpose:The study aimed at the evaluation of the impact of intravenous (IV) dexamethasone on efficacy and duration of analgesia of paravertebral block (PVB) in patients undergoing modified radical mastectomy (MRM). Patients and methods:This randomized, double-blind controlled trial included 50 patients with breast can...

    journal_title:Journal of pain research

    pub_type: 杂志文章

    doi:10.2147/JPR.S181788

    authors: Bakeer AH,Abdallah NM,Kamel MA,Abbas DN,Ragab AS

    更新日期:2018-12-19 00:00:00

  • Determination of Risk Factors for Pain After Transarterial Chemoembolization with Drug-Eluting Beads for Hepatocellular Carcinoma.

    abstract:Purpose:To identify risk factors for pain after transarterial chemoembolization with drug-eluting beads (DEB-TACE) for hepatocellular carcinoma (HCC). Patients and Methods:In this retrospective study, a total of 118 consecutive patients who underwent DEB-TACE between June 2016 and May 2019 with post-TACE pain were inc...

    journal_title:Journal of pain research

    pub_type: 杂志文章

    doi:10.2147/JPR.S246197

    authors: Wang TC,Zhang ZS,Xiao YD

    更新日期:2020-03-27 00:00:00

  • Is acupuncture an effective postherpetic neuralgia treatment? A systematic review and meta-analysis.

    abstract:Background:Postherpetic neuralgia (PHN) refers to pain which remains after the healing of rashes from herpes zoster. Previous literatures have shown that acupuncture has potential benefits for PHN, but evidence remains lacking. Thus, we have performed a systematic review and meta-analysis to identify the effectiveness ...

    journal_title:Journal of pain research

    pub_type: 杂志文章

    doi:10.2147/JPR.S199950

    authors: Pei W,Zeng J,Lu L,Lin G,Ruan J

    更新日期:2019-07-16 00:00:00

  • Peripheral and spinal TRPA1 channels contribute to formalin-induced long-lasting mechanical hypersensitivity.

    abstract:Background:Transient receptor potential ankyrin 1 (TRPA1) is a non-selective cation channel expressed by a subset of nociceptive neurons that acts as a multimodal receptor. Its activity contributes to modulate nociceptive transmission in acute inflammatory pain. However, the role of this channel in chronic pain has bee...

    journal_title:Journal of pain research

    pub_type: 杂志文章

    doi:10.2147/JPR.S153671

    authors: Martínez-Rojas VA,García G,Noriega-Navarro R,Guzmán-Priego CG,Torres-López JE,Granados-Soto V,Murbartián J

    更新日期:2017-12-27 00:00:00

  • A cross-sectional study of factors associated with the number of anatomical pain sites in an actual elderly general population: results from the PainS65+ cohort.

    abstract:BACKGROUND:Several studies have illustrated that multisite pain is more frequent than single pain site, and it is associated with an array of negative consequences. However, there is limited knowledge available about the potential factors associated with multisite pain in the elderly general population. OBJECTIVE:This...

    journal_title:Journal of pain research

    pub_type: 杂志文章

    doi:10.2147/JPR.S143060

    authors: Dragioti E,Larsson B,Bernfort L,Levin LÅ,Gerdle B

    更新日期:2017-08-23 00:00:00

  • Dietary methyl content regulates opioid responses in mice.

    abstract:BACKGROUND:Large interindividual differences in clinical responses to opioids and the variable susceptibility to abuse of this class of drugs make their use problematic. We lack a full understanding of the factors responsible for these differences. Dietary factors including methyl donor content have been noted to alter...

    journal_title:Journal of pain research

    pub_type: 杂志文章

    doi:10.2147/JPR.S42561

    authors: Liang DY,Sun Y,Clark JD

    更新日期:2013-01-01 00:00:00

  • Effects of vicarious pain on self-pain perception: investigating the role of awareness.

    abstract::The observation of pain in others may enhance or reduce self-pain, yet the boundary conditions and factors that determine the direction of such effects are poorly understood. The current study set out to show that visual stimulus awareness plays a crucial role in determining whether vicarious pain primarily activates ...

    journal_title:Journal of pain research

    pub_type: 杂志文章

    doi:10.2147/JPR.S132744

    authors: Terrighena EL,Lu G,Yuen WP,Lee TM,Keuper K

    更新日期:2017-07-31 00:00:00

  • The impact of anxiety and catastrophizing on interleukin-6 responses to acute painful stress.

    abstract:Objective:To examine the influence of anxiety and pain-related catastrophizing on the time course of acute interleukin-6 (IL-6) responses to standardized noxious stimulation among patients with chronic pain. Methods:Data were collected from 48 participants in the following demographically matched groups: patients with...

    journal_title:Journal of pain research

    pub_type: 杂志文章

    doi:10.2147/JPR.S147735

    authors: Lazaridou A,Martel MO,Cahalan CM,Cornelius MC,Franceschelli O,Campbell CM,Haythornthwaite JA,Smith M,Riley J,Edwards RR

    更新日期:2018-03-28 00:00:00

  • Intramuscular electrical stimulus potentiates motor cortex modulation effects on pain and descending inhibitory systems in knee osteoarthritis: a randomized, factorial, sham-controlled study.

    abstract:Background:Neuroplastic changes in nociceptive pathways contribute to severity of symptoms in knee osteoarthritis (KOA). A new look at neuroplastic changes management includes modulation of the primary motor cortex by transcranial direct current stimulation (tDCS). Objectives:We investigated whether tDCS combined with...

    journal_title:Journal of pain research

    pub_type: 杂志文章

    doi:10.2147/JPR.S181019

    authors: da Graca-Tarragó M,Lech M,Angoleri LDM,Santos DS,Deitos A,Brietzke AP,Torres IL,Fregni F,Caumo W

    更新日期:2019-01-03 00:00:00

  • Erratum: Effect of Ultrasound-Guided Peripheral Nerve Blocks of the Abdominal Wall on Pain Relief After Laparoscopic Cholecystectomy [Corrigendum].

    abstract::[This corrects the article DOI: 10.2147/JPR.S203721.]. ...

    journal_title:Journal of pain research

    pub_type: 已发布勘误

    doi:10.2147/JPR.S278204

    authors:

    更新日期:2020-08-26 00:00:00

  • A Review and Algorithm in the Diagnosis and Treatment of Sacroiliac Joint Pain.

    abstract:Introduction:The sacroiliac joint (SIJ) has been estimated to contribute to pain in as much as 38% of cases of lower back pain. There are no clear diagnostic or treatment pathways. This article seeks to establish a clearer pathway and algorithm for treating patients. Methods:The literature was reviewed in order to rev...

    journal_title:Journal of pain research

    pub_type: 杂志文章

    doi:10.2147/JPR.S279390

    authors: Falowski S,Sayed D,Pope J,Patterson D,Fishman M,Gupta M,Mehta P

    更新日期:2020-12-08 00:00:00

  • Celiac plexus block increases quality of life in patients with pancreatic cancer.

    abstract:Background:Pancreatic cancer is a malignant disease with a high mortality rate and severe pain that is challenging to manage. To reduce the excruciating abdominal pain, opioids and adjuvant agents are conventionally used. Objectives:PRNCPB is a treatment of neural therapy. The number of studies assessing the effect on...

    journal_title:Journal of pain research

    pub_type: 杂志文章

    doi:10.2147/JPR.S186659

    authors: Molnár I,Hegyi G,Zsom L,Saahs C,Vagedes J,Kapócs G,Kovács Z,Sterner MG,Szőke H

    更新日期:2019-01-14 00:00:00

  • A cross-cultural perspective of medical clowning: comparison of its effectiveness in reducing pain and anxiety among hospitalized Bedouin and Jewish Israeli children.

    abstract:PURPOSE:Medical clowning has proven effective for reducing pain, anxiety, and stress, however, its differential effects on children from different cultures have not yet been researched. This study evaluated the effects of medical-clowning intervention on anxiety and pain among Jewish and Bedouin children, and anxiety a...

    journal_title:Journal of pain research

    pub_type: 杂志文章

    doi:10.2147/JPR.S135678

    authors: Gilboa-Negari Z,Abu-Kaf S,Huss E,Hain G,Moser A

    更新日期:2017-07-05 00:00:00

  • Regional Differences in Opioid Prescribing in Germany - Results of an Analysis of Health Insurance Data of 57 Million Adult People.

    abstract:Background:Regional variations of opioid use have been reported from many countries. The objective of this study was to examine opioid prescribing patterns in Germany including low- and high-potency opioids (LPO and HPO) focusing on regional differences. Methods:Data source was the "Information system for health care ...

    journal_title:Journal of pain research

    pub_type: 杂志文章

    doi:10.2147/JPR.S259009

    authors: Jobski K,Dörks M,Bantel C,Hoffmann F

    更新日期:2020-10-07 00:00:00

  • Erector Spinae Plane Block for Lumbar Spinal Surgery: A Systematic Review.

    abstract:Background:Erector spinae plane block (ESPB) as a new trunk fascia block technique was proposed in 2016. ESPB has aroused the interest of many nerve block experts. However, there are few clinical studies on ESPB for lumbar surgery, and its effectiveness and safety are controversial. The goal of this review is to summar...

    journal_title:Journal of pain research

    pub_type: 杂志文章,评审

    doi:10.2147/JPR.S256205

    authors: Qiu Y,Zhang TJ,Hua Z

    更新日期:2020-07-01 00:00:00

  • Pain incidence, assessment, and management in Vietnam: a cross-sectional study of 12,136 respondents.

    abstract:Objective:To describe the rate and demographics of pain among Vietnamese people in 48 provinces and describe the impact of pain on individuals, levels of satisfaction with treatment results, and behavior of pain sufferers. Methods:The cross-sectional study was conducted in adults presenting to outpatient clinics throu...

    journal_title:Journal of pain research

    pub_type: 杂志文章

    doi:10.2147/JPR.S184713

    authors: Chuong NV,Pho DC,Thuy NTT,Nguyen DT,Luan NT,Minh LH,Khai LT,Linh NT,Kien NT

    更新日期:2019-02-25 00:00:00

  • A comparison between the administration of oral prolonged-release oxycodone-naloxone and transdermal fentanyl in patients with moderate-to-severe cancer pain: a propensity score analysis.

    abstract:BACKGROUND:Opioids are the most important pharmacological treatment for moderate-to-severe cancer pain, but side effects limit their use. Transdermal fentanyl (TDF) and oral prolonged-release oxycodone-naloxone (OXN-PR) are effective in controlling chronic pain, with less constipation compared to other opioids. However...

    journal_title:Journal of pain research

    pub_type: 杂志文章

    doi:10.2147/JPR.S141928

    authors: Roberto A,Greco MT,Legramandi L,Galli F,Galli M,Corli O

    更新日期:2017-09-04 00:00:00

  • Muscle injections with lidocaine improve resting fatigue and pain in patients with chronic fatigue syndrome.

    abstract:OBJECTIVE:Patients with chronic fatigue syndrome (CFS) complain of long-lasting fatigue and pain which are not relieved by rest and worsened by physical exertion. Previous research has implicated metaboreceptors of muscles to play an important role for chronic fatigue and pain. Therefore, we hypothesized that blocking ...

    journal_title:Journal of pain research

    pub_type: 杂志文章

    doi:10.2147/JPR.S139466

    authors: Staud R,Kizer T,Robinson ME

    更新日期:2017-06-26 00:00:00

  • Validation of the Swedish version of the Pain Catastrophizing Scale for Parents (PCS-P) for parents of children with cancer.

    abstract:Objectives:Pain is reported as one of the most common and burdensome symptoms for children with cancer. Pain catastrophizing is clearly related to pain intensity and disability. Catastrophizing in parents is associated with both child functioning and parent distress. The Pain Catastrophizing Scale for Parents (PCS-P) r...

    journal_title:Journal of pain research

    pub_type: 杂志文章

    doi:10.2147/JPR.S193164

    authors: Cederberg JT,Weineland S,Dahl J,Ljungman G

    更新日期:2019-03-18 00:00:00

  • Post-Cesarean Delivery Analgesic Outcomes in Patients Maintained on Methadone and Buprenorphine: A Retrospective Investigation.

    abstract:Background:Despite the increasing prevalence of opioid use disorder (OUD) in pregnant women, there are limited studies on their anesthesia care and analgesic outcomes after cesarean delivery (CD). Methods:Patients with OUD on either buprenorphine or methadone maintenance therapy who underwent CD at our institution fro...

    journal_title:Journal of pain research

    pub_type: 杂志文章

    doi:10.2147/JPR.S284874

    authors: Reno JL,Kushelev M,Coffman JH,Prasad MR,Meyer AM,Carpenter KM,Palettas MS,Coffman JC

    更新日期:2020-12-30 00:00:00

  • Current Perspectives on Spinal Cord Stimulation for the Treatment of Cancer Pain.

    abstract::Cancer and cancer treatment-related chronic pain affect a significant number of patients. The etiology of this pain is diverse and may include nociceptive and/or neuropathic characteristics. Treatment is often multifactorial and may require advanced interventional techniques, such as spinal cord stimulation (SCS). Thi...

    journal_title:Journal of pain research

    pub_type: 杂志文章,评审

    doi:10.2147/JPR.S263857

    authors: Hagedorn JM,Pittelkow TP,Hunt CL,D'Souza RS,Lamer TJ

    更新日期:2020-12-07 00:00:00

  • The prevalence of probable neuropathic pain in the US: results from a multimodal general-population health survey.

    abstract:Background:The prevalence of neuropathic pain (NeP) has been estimated within specific health conditions; however, there are no published data on its broad prevalence in the US. The current exploratory study addresses this gap using the validated PainDetect questionnaire as a screener for probable NeP in a general-popu...

    journal_title:Journal of pain research

    pub_type: 杂志文章

    doi:10.2147/JPR.S127014

    authors: DiBonaventura MD,Sadosky A,Concialdi K,Hopps M,Kudel I,Parsons B,Cappelleri JC,Hlavacek P,Alexander AH,Stacey BR,Markman JD,Farrar JT

    更新日期:2017-11-01 00:00:00

  • Prevalence of pain-related diagnoses in patients with dementia: a nationwide study.

    abstract:Purposes:To investigate the prevalence of pain-related diagnoses in patients with dementia and evaluate the association of pain-related diagnoses with demographic characteristics and dementia subtypes. Patients and methods:In this population-based retrospective cohort study, participants were recruited from a cohort o...

    journal_title:Journal of pain research

    pub_type: 杂志文章

    doi:10.2147/JPR.S172875

    authors: Lin PC,Li CH,Chou PL,Chen YM,Lin LC

    更新日期:2018-09-03 00:00:00

  • Does pain hypervigilance further impact the lack of habituation to pain in individuals with chronic pain? A cross-sectional pain ERP study.

    abstract:Aim:In chronic pain, habituation is believed to be impaired, and pain hypervigilance can enhance the pain experience. The goal of this study was to determine whether pain hypervigilance further worsens habituation of event-related potentials, measured in a pain-rating protocol of 25 painful somatosensory electrical sti...

    journal_title:Journal of pain research

    pub_type: 杂志文章

    doi:10.2147/JPR.S146916

    authors: Vossen CJ,Luijcks R,van Os J,Joosten EA,Lousberg R

    更新日期:2018-02-19 00:00:00

  • Comparison of the efficacy and safety of pregabalin for postherpetic neuralgia in Chinese and international patients.

    abstract:Purpose:Pregabalin is indicated for postherpetic neuralgia (PHN) in multiple countries, including China. This analysis compared pregabalin efficacy and safety in Chinese and international patients with PHN. Patients and methods:Data from Chinese and international randomized, double-blind, placebo-controlled trials wer...

    journal_title:Journal of pain research

    pub_type: 杂志文章

    doi:10.2147/JPR.S157856

    authors: Parsons B,Pan X,Xie L,Chen Y,Ortiz M,Whalen E

    更新日期:2018-09-03 00:00:00

  • Concurrent musculoskeletal and soft tissue pain in the upper extremity can affect the treatment and prognosis of carpal tunnel syndrome: redefining a common condition.

    abstract:Objective:To demonstrate the importance of recognizing and separating nonmedian nerve-related symptoms from those related to median nerve compression at the carpal tunnel. Methods:The records of 80 patients, aged 31-82 years (39 males and 41 females), who had undergone median nerve decompression using open and endosco...

    journal_title:Journal of pain research

    pub_type: 杂志文章

    doi:10.2147/JPR.S142153

    authors: Lazaro RP,Eagan TS

    更新日期:2017-10-24 00:00:00

  • Treatment of post-craniotomy acute severe supraorbital neuralgia using ultrasound-guided pulsed radiofrequency: a case report.

    abstract::Pulsed radiofrequency is an effective, safe, and nondestructive pain treatment technique that has been insufficiently reported in the treatment of supraorbital neuralgia. We report the successful use of pulsed radiofrequency to alleviate acute severe supraorbital neuralgia in a post-craniotomy patient. A 52-year-old f...

    journal_title:Journal of pain research

    pub_type:

    doi:10.2147/JPR.S166446

    authors: Xiao X,Ren H,Ji N,Luo F

    更新日期:2018-08-08 00:00:00