Evidence map›Paper›PMID 21937568›Full record

Trial reportPalliative medicine2012

A randomized, double-blind, active-controlled, double-dummy, parallel-group study to determine the safety and efficacy of oxycodone/naloxone prolonged-release tablets in patients with moderate/severe, chronic cancer pain.

Sam H Ahmedzai, Friedemann Nauck, Gil Bar-Sela, Björn Bosse, Petra Leyendecker, Michael Hopp

Registry-linked trialAbstract readClinical Trial, Phase IIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Palliative medicine, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05216328 (OMAMA-study - Prevention of Opioid-induced Constipation in Patients With Advanced Cancer), which is not on this map. Cited by 63 papers, 12 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
63citing papers in PubMed, 12 pooled it
–field-weighted citation impact
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.

NCT05216328 phase4recruitingnot on this mapstarted 2022, after this paper: background citation

OMAMA-study - Prevention of Opioid-induced Constipation in Patients With Advanced Cancer

TypeinterventionalSponsorAmsterdam UMC, location VUmcRan2022 to 2025Enrolled330ConditionsConstipation, Opioid-InducedArmsMacrogol Only Product in Oral Dose Form, Magnesium hydroxide 724mg
3 · Its place in the literature

Who cites it

63 citing papers in PubMed, 12 syntheses or guidelines pooled it.

  1. Pooled it
  2. Oxycodone for cancer-related pain.The Cochrane database of systematic reviews · 2022
    Pooled it
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  7. Guideline
  8. Oxycodone for cancer-related pain.The Cochrane database of systematic reviews · 2017
    Pooled it
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  13. Trial
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  16. High dosage of a fixed combination oxycodone/naloxone prolonged release: efficacy and tolerability in patients with chronic cancer pain.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2017
    Trial
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  19. Long-term safety and efficacy of oxycodone/naloxone prolonged-release tablets in patients with moderate-to-severe chronic cancer pain.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2015
    Trial
  20. Management of breakthrough cancer pain in the emergency department.Clinical and experimental emergency medicine · 2026
    Article

3 more citing papers are in PubMed but not listed here.

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.

Sam H AhmedzaiSchool of Medicine and Biomedical Sciences, University of Sheffield, Sheffield, UK.
Friedemann Nauck
Gil Bar-Sela
Björn Bosse
Petra Leyendecker
Michael Hopp

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveAn examination of whether oxycodone/naloxone prolonged-release tablets (OXN PR) can improve constipation and maintain analgesia, compared with oxycodone prolonged-release tablets (OxyPR) in patients with moderate/severe cancer pain.

methodsRandomized, double-blind, active-controlled, double-dummy, parallel-group study in which 185 patients were randomized to receive up to 120 mg/day of OXN PR or OxyPR over 4 weeks. Efficacy assessments included Bowel Function Index (BFI), Brief Pain Inventory Short-Form (BPI-SF), laxative and rescue medication use. Quality of life (QoL) and safety assessments were conducted.

resultsAfter 4 weeks, mean BFI score was significantly lower with OXN PR; mean total laxative intake was 20% lower with OXN PR. Mean BPI-SF scores were similar for both treatments and the average rate of analgesic rescue medication use was low and comparable. QoL assessments were stable and comparable with greater improvements in constipation-specific QoL assessments with OXN PR. Overall, rates of adverse drug reactions were similar.

conclusionsOXN PR provides superior bowel function in cancer pain patients, compared with OxyPR, without compromising analgesic efficacy or safety. This study confirms that OXN PR is well tolerated and efficacious in cancer pain patients and results are in line with those seen in non-malignant pain patients.

Indexed as

AdultAgedAged, 80 and overAnalgesics, OpioidChronic PainConstipationDelayed-Action PreparationsDouble-Blind MethodDrug Therapy, CombinationFemaleHumansMaleMiddle AgedNaloxoneNeoplasmsOxycodoneAnalgesics, OpioidDelayed-Action PreparationsNaloxoneOxycodone

Identifiers

PMID21937568
PMCPMC3255516

What OpenQuestion holds

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LicenceCC BY
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Registered trials

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.