Evidence map›Paper›PMID 30288095›Full record

ArticleJournal of pain research2018

Analgesic efficacy, safety, and tolerability of a long-acting abuse-deterrent formulation of oxycodone for moderate-to-severe chronic low back pain in subjects successfully switched from immediate-release oxycodone.

John Markman, Diana S Meske, Ernest A Kopecky, Ben Vaughn, Melinda L O'Connor, Steven D Passik

Open access · goldAbstract read
In one paragraph

Article in Journal of pain research, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.8field-weighted citation impact, top 26% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 5 citations in OpenAlex.

  1. Interpol review of controlled substances 2016-2019.Forensic science international. Synergy · 2020
    Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors at 3 institutions in 1 country.

John MarkmanDepartment of Neurosurgery, Translational Pain Research Program, University of Rochester, Rochester, NY, USA.
Diana S MeskeCollegium Pharmaceutical Inc, Canton, MA, USA, dmeske@collegiumpharma.com.
Ernest A KopeckyCollegium Pharmaceutical Inc, Canton, MA, USA, dmeske@collegiumpharma.com.
Ben VaughnRho Inc., Chapel Hill, NC, USA.
Melinda L O'ConnorCollegium Pharmaceutical Inc, Canton, MA, USA, dmeske@collegiumpharma.com.
Steven D PassikCollegium Pharmaceutical Inc, Canton, MA, USA, dmeske@collegiumpharma.com.
Collegium Pharmaceutical (United States) · USRho (United States) · USUniversity of Rochester · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesThis post hoc analysis of data from a randomized, double-blind, placebo-controlled, enriched-enrollment randomized-withdrawal Phase III study evaluated the safety, tolerability, and analgesic efficacy of Oxycodone DETERx extended-release (ER), abuse-deterrent capsules (Xtampza

methodsContinuous outcomes were analyzed using a mixed-model repeated-measures approach; binomial outcomes were analyzed using chi-squared; and time-to-event outcomes using Kaplan-Meier analyses.

resultsA total of 110 subjects previously prescribed IR oxycodone entered the Open-label Titration Phase. Forty-four subjects were randomized to Oxycodone DETERx (n=22) or placebo (n=22) in the 12-week Double-blind Maintenance Phase. Efficacy results in this subgroup showed a statistically significant difference between Oxycodone DETERx and placebo in average pain intensity scores from Randomization Baseline to Week 12 (least squares mean [± standard error], -1.88 [0.70];

conclusionsOxycodone DETERx resulted in clinically meaningful and statistically significant efficacy in subjects with chronic low back pain who were previously prescribed IR oxycodone and were successfully switched to ER Oxycodone DETERx.

Indexed as

chronic low back painDETERxextended-releaseimmediate-releaseopioidoxycodoneXtampza ER

Identifiers

PMID30288095
PMCPMC6163025
OpenAlexW2892942776

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.